Avenova presentation Nov 2015

60
AVENOVA (formerly i - Lid Cleanser) A NEW DIMENSION IN LID AND LASH HYGIENE NovaBay Pharmaceuticals, Inc. (New York Stock Exchange: NBY) For more information contact: Ron Najafi, Ph.D. CEO & Founder And consult: www.Avenova.com

Transcript of Avenova presentation Nov 2015

Page 1: Avenova presentation Nov 2015

AVENOVA(formerly i-Lidtrade Cleanser)

A NEW DIMENSION IN LID AND LASH HYGIENE

NovaBay Pharmaceuticals Inc(New York Stock Exchange NBY)

For more information contact

Ron Najafi PhD

CEO amp Founder

And consult wwwAvenovacom

The San Francisco Bay Area

Home to NovaBay Pharmaceuticals(A view from our facilities)

NovaBay PharmaceuticalsEmployees 28 founded in 2000 by Ron Najafi PhD (chemist)

NovaBay Dedicated Sales Force 37 all across the US

Location Emeryville CA

Capital Structure Public Company listed on NYSE NBY

Focus Non-Antibiotic Antimicrobials

Marketed products (Neutrox platform)

ndash AVENOVA (formerly i-Lidtrade Cleanser ) Lid amp Lash Hygiene Blepharitis

MGD and Dry Eye

ndash NeutroPhase Diabetic Ulcer Venous and Pressure Ulcers including NF

ndash CelleRx Burn associated with Post Laser Resurfacing

Pre-Market Products (Aganocide platform)

ndash Bladder Irrigation Solution for patients with Spinal Cord Injury and recurrent

blockage and encrustation

ndash Skin Infection (Impetigo and Acne)

Global Partnerships PBE (in the US) IHT (USA) Galderma (France) Virbac

(France) Pioneer Pharma (China and Southeast Asia) Shin Poong (Korea) Biopharm

(North African and Middle East) Alpha Pharma (Ukraine) and Sarmedic (Israel)

ldquoThe Most Under-

recognized

The Most

Underappreciated

The Most Undertreated

disease

in Ophthalmic Carerdquo

Anatomy of Eye Eye Lid amp Meibomian Gland

Meibomian Gland

Blepharitis Causes

Meibomian Gland Dysfunction (MGD)

Gland Oil Keep

the water from

evaporating amp

preventing Dry

Eye

Expressing the Meibomian Gland

Shows Dysfunction present

Tooth Paste

like

consistency is

bad

Doctor is

pressing

against lower

eye lid

Blepharitis Infection and

Inflammation of EyeLid

Blepharitis Meibomian Gland Dysfunction

Associated Dry Eye Pre-Operative Lid

Hygiene

Chronic lid amp lash hygiene

- 24 million blepharitis patients

- 65 million MGD dry eye patients

- 3 million cataract patients

- 15 million refractive surgery patients

Total Potential Market $700 million

Antibiotics (topical or systemic)

Steroid (topical or systemic)

Warm Eye Compress to help with

Meibomian Glands

Gland Expression

Food supplements such as Omega 3 fatty

Acid

No FDA approved Therapy

Standard of Care includes

Traditional Therapies for

Blepharitis MDG amp Associated

Dry Eye

Traditional Warm Compress + Gland

Expression

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 2: Avenova presentation Nov 2015

The San Francisco Bay Area

Home to NovaBay Pharmaceuticals(A view from our facilities)

NovaBay PharmaceuticalsEmployees 28 founded in 2000 by Ron Najafi PhD (chemist)

NovaBay Dedicated Sales Force 37 all across the US

Location Emeryville CA

Capital Structure Public Company listed on NYSE NBY

Focus Non-Antibiotic Antimicrobials

Marketed products (Neutrox platform)

ndash AVENOVA (formerly i-Lidtrade Cleanser ) Lid amp Lash Hygiene Blepharitis

MGD and Dry Eye

ndash NeutroPhase Diabetic Ulcer Venous and Pressure Ulcers including NF

ndash CelleRx Burn associated with Post Laser Resurfacing

Pre-Market Products (Aganocide platform)

ndash Bladder Irrigation Solution for patients with Spinal Cord Injury and recurrent

blockage and encrustation

ndash Skin Infection (Impetigo and Acne)

Global Partnerships PBE (in the US) IHT (USA) Galderma (France) Virbac

(France) Pioneer Pharma (China and Southeast Asia) Shin Poong (Korea) Biopharm

(North African and Middle East) Alpha Pharma (Ukraine) and Sarmedic (Israel)

ldquoThe Most Under-

recognized

The Most

Underappreciated

The Most Undertreated

disease

in Ophthalmic Carerdquo

Anatomy of Eye Eye Lid amp Meibomian Gland

Meibomian Gland

Blepharitis Causes

Meibomian Gland Dysfunction (MGD)

Gland Oil Keep

the water from

evaporating amp

preventing Dry

Eye

Expressing the Meibomian Gland

Shows Dysfunction present

Tooth Paste

like

consistency is

bad

Doctor is

pressing

against lower

eye lid

Blepharitis Infection and

Inflammation of EyeLid

Blepharitis Meibomian Gland Dysfunction

Associated Dry Eye Pre-Operative Lid

Hygiene

Chronic lid amp lash hygiene

- 24 million blepharitis patients

- 65 million MGD dry eye patients

- 3 million cataract patients

- 15 million refractive surgery patients

Total Potential Market $700 million

Antibiotics (topical or systemic)

Steroid (topical or systemic)

Warm Eye Compress to help with

Meibomian Glands

Gland Expression

Food supplements such as Omega 3 fatty

Acid

No FDA approved Therapy

Standard of Care includes

Traditional Therapies for

Blepharitis MDG amp Associated

Dry Eye

Traditional Warm Compress + Gland

Expression

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 3: Avenova presentation Nov 2015

NovaBay PharmaceuticalsEmployees 28 founded in 2000 by Ron Najafi PhD (chemist)

NovaBay Dedicated Sales Force 37 all across the US

Location Emeryville CA

Capital Structure Public Company listed on NYSE NBY

Focus Non-Antibiotic Antimicrobials

Marketed products (Neutrox platform)

ndash AVENOVA (formerly i-Lidtrade Cleanser ) Lid amp Lash Hygiene Blepharitis

MGD and Dry Eye

ndash NeutroPhase Diabetic Ulcer Venous and Pressure Ulcers including NF

ndash CelleRx Burn associated with Post Laser Resurfacing

Pre-Market Products (Aganocide platform)

ndash Bladder Irrigation Solution for patients with Spinal Cord Injury and recurrent

blockage and encrustation

ndash Skin Infection (Impetigo and Acne)

Global Partnerships PBE (in the US) IHT (USA) Galderma (France) Virbac

(France) Pioneer Pharma (China and Southeast Asia) Shin Poong (Korea) Biopharm

(North African and Middle East) Alpha Pharma (Ukraine) and Sarmedic (Israel)

ldquoThe Most Under-

recognized

The Most

Underappreciated

The Most Undertreated

disease

in Ophthalmic Carerdquo

Anatomy of Eye Eye Lid amp Meibomian Gland

Meibomian Gland

Blepharitis Causes

Meibomian Gland Dysfunction (MGD)

Gland Oil Keep

the water from

evaporating amp

preventing Dry

Eye

Expressing the Meibomian Gland

Shows Dysfunction present

Tooth Paste

like

consistency is

bad

Doctor is

pressing

against lower

eye lid

Blepharitis Infection and

Inflammation of EyeLid

Blepharitis Meibomian Gland Dysfunction

Associated Dry Eye Pre-Operative Lid

Hygiene

Chronic lid amp lash hygiene

- 24 million blepharitis patients

- 65 million MGD dry eye patients

- 3 million cataract patients

- 15 million refractive surgery patients

Total Potential Market $700 million

Antibiotics (topical or systemic)

Steroid (topical or systemic)

Warm Eye Compress to help with

Meibomian Glands

Gland Expression

Food supplements such as Omega 3 fatty

Acid

No FDA approved Therapy

Standard of Care includes

Traditional Therapies for

Blepharitis MDG amp Associated

Dry Eye

Traditional Warm Compress + Gland

Expression

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 4: Avenova presentation Nov 2015

ldquoThe Most Under-

recognized

The Most

Underappreciated

The Most Undertreated

disease

in Ophthalmic Carerdquo

Anatomy of Eye Eye Lid amp Meibomian Gland

Meibomian Gland

Blepharitis Causes

Meibomian Gland Dysfunction (MGD)

Gland Oil Keep

the water from

evaporating amp

preventing Dry

Eye

Expressing the Meibomian Gland

Shows Dysfunction present

Tooth Paste

like

consistency is

bad

Doctor is

pressing

against lower

eye lid

Blepharitis Infection and

Inflammation of EyeLid

Blepharitis Meibomian Gland Dysfunction

Associated Dry Eye Pre-Operative Lid

Hygiene

Chronic lid amp lash hygiene

- 24 million blepharitis patients

- 65 million MGD dry eye patients

- 3 million cataract patients

- 15 million refractive surgery patients

Total Potential Market $700 million

Antibiotics (topical or systemic)

Steroid (topical or systemic)

Warm Eye Compress to help with

Meibomian Glands

Gland Expression

Food supplements such as Omega 3 fatty

Acid

No FDA approved Therapy

Standard of Care includes

Traditional Therapies for

Blepharitis MDG amp Associated

Dry Eye

Traditional Warm Compress + Gland

Expression

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 5: Avenova presentation Nov 2015

Anatomy of Eye Eye Lid amp Meibomian Gland

Meibomian Gland

Blepharitis Causes

Meibomian Gland Dysfunction (MGD)

Gland Oil Keep

the water from

evaporating amp

preventing Dry

Eye

Expressing the Meibomian Gland

Shows Dysfunction present

Tooth Paste

like

consistency is

bad

Doctor is

pressing

against lower

eye lid

Blepharitis Infection and

Inflammation of EyeLid

Blepharitis Meibomian Gland Dysfunction

Associated Dry Eye Pre-Operative Lid

Hygiene

Chronic lid amp lash hygiene

- 24 million blepharitis patients

- 65 million MGD dry eye patients

- 3 million cataract patients

- 15 million refractive surgery patients

Total Potential Market $700 million

Antibiotics (topical or systemic)

Steroid (topical or systemic)

Warm Eye Compress to help with

Meibomian Glands

Gland Expression

Food supplements such as Omega 3 fatty

Acid

No FDA approved Therapy

Standard of Care includes

Traditional Therapies for

Blepharitis MDG amp Associated

Dry Eye

Traditional Warm Compress + Gland

Expression

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 6: Avenova presentation Nov 2015

Meibomian Gland

Blepharitis Causes

Meibomian Gland Dysfunction (MGD)

Gland Oil Keep

the water from

evaporating amp

preventing Dry

Eye

Expressing the Meibomian Gland

Shows Dysfunction present

Tooth Paste

like

consistency is

bad

Doctor is

pressing

against lower

eye lid

Blepharitis Infection and

Inflammation of EyeLid

Blepharitis Meibomian Gland Dysfunction

Associated Dry Eye Pre-Operative Lid

Hygiene

Chronic lid amp lash hygiene

- 24 million blepharitis patients

- 65 million MGD dry eye patients

- 3 million cataract patients

- 15 million refractive surgery patients

Total Potential Market $700 million

Antibiotics (topical or systemic)

Steroid (topical or systemic)

Warm Eye Compress to help with

Meibomian Glands

Gland Expression

Food supplements such as Omega 3 fatty

Acid

No FDA approved Therapy

Standard of Care includes

Traditional Therapies for

Blepharitis MDG amp Associated

Dry Eye

Traditional Warm Compress + Gland

Expression

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 7: Avenova presentation Nov 2015

Blepharitis Causes

Meibomian Gland Dysfunction (MGD)

Gland Oil Keep

the water from

evaporating amp

preventing Dry

Eye

Expressing the Meibomian Gland

Shows Dysfunction present

Tooth Paste

like

consistency is

bad

Doctor is

pressing

against lower

eye lid

Blepharitis Infection and

Inflammation of EyeLid

Blepharitis Meibomian Gland Dysfunction

Associated Dry Eye Pre-Operative Lid

Hygiene

Chronic lid amp lash hygiene

- 24 million blepharitis patients

- 65 million MGD dry eye patients

- 3 million cataract patients

- 15 million refractive surgery patients

Total Potential Market $700 million

Antibiotics (topical or systemic)

Steroid (topical or systemic)

Warm Eye Compress to help with

Meibomian Glands

Gland Expression

Food supplements such as Omega 3 fatty

Acid

No FDA approved Therapy

Standard of Care includes

Traditional Therapies for

Blepharitis MDG amp Associated

Dry Eye

Traditional Warm Compress + Gland

Expression

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 8: Avenova presentation Nov 2015

Expressing the Meibomian Gland

Shows Dysfunction present

Tooth Paste

like

consistency is

bad

Doctor is

pressing

against lower

eye lid

Blepharitis Infection and

Inflammation of EyeLid

Blepharitis Meibomian Gland Dysfunction

Associated Dry Eye Pre-Operative Lid

Hygiene

Chronic lid amp lash hygiene

- 24 million blepharitis patients

- 65 million MGD dry eye patients

- 3 million cataract patients

- 15 million refractive surgery patients

Total Potential Market $700 million

Antibiotics (topical or systemic)

Steroid (topical or systemic)

Warm Eye Compress to help with

Meibomian Glands

Gland Expression

Food supplements such as Omega 3 fatty

Acid

No FDA approved Therapy

Standard of Care includes

Traditional Therapies for

Blepharitis MDG amp Associated

Dry Eye

Traditional Warm Compress + Gland

Expression

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 9: Avenova presentation Nov 2015

Blepharitis Infection and

Inflammation of EyeLid

Blepharitis Meibomian Gland Dysfunction

Associated Dry Eye Pre-Operative Lid

Hygiene

Chronic lid amp lash hygiene

- 24 million blepharitis patients

- 65 million MGD dry eye patients

- 3 million cataract patients

- 15 million refractive surgery patients

Total Potential Market $700 million

Antibiotics (topical or systemic)

Steroid (topical or systemic)

Warm Eye Compress to help with

Meibomian Glands

Gland Expression

Food supplements such as Omega 3 fatty

Acid

No FDA approved Therapy

Standard of Care includes

Traditional Therapies for

Blepharitis MDG amp Associated

Dry Eye

Traditional Warm Compress + Gland

Expression

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 10: Avenova presentation Nov 2015

Blepharitis Meibomian Gland Dysfunction

Associated Dry Eye Pre-Operative Lid

Hygiene

Chronic lid amp lash hygiene

- 24 million blepharitis patients

- 65 million MGD dry eye patients

- 3 million cataract patients

- 15 million refractive surgery patients

Total Potential Market $700 million

Antibiotics (topical or systemic)

Steroid (topical or systemic)

Warm Eye Compress to help with

Meibomian Glands

Gland Expression

Food supplements such as Omega 3 fatty

Acid

No FDA approved Therapy

Standard of Care includes

Traditional Therapies for

Blepharitis MDG amp Associated

Dry Eye

Traditional Warm Compress + Gland

Expression

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 11: Avenova presentation Nov 2015

Antibiotics (topical or systemic)

Steroid (topical or systemic)

Warm Eye Compress to help with

Meibomian Glands

Gland Expression

Food supplements such as Omega 3 fatty

Acid

No FDA approved Therapy

Standard of Care includes

Traditional Therapies for

Blepharitis MDG amp Associated

Dry Eye

Traditional Warm Compress + Gland

Expression

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 12: Avenova presentation Nov 2015

Traditional Therapies for

Blepharitis MDG amp Associated

Dry Eye

Traditional Warm Compress + Gland

Expression

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 13: Avenova presentation Nov 2015

Traditional Warm Compress + Gland

Expression

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 14: Avenova presentation Nov 2015

Omega 3

Fatty Acid

Omega 3 Fatty Acid

Rich in EPA amp DHA

Eicosapentaenoic Acid (EPA) 20 carbons and 5 double bonds

Docosahexaenoic Acid (DHA) 22 carbons and 6 double bonds

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 15: Avenova presentation Nov 2015

PHARMA Blepharitis MGD managementndash Meibomian Gland Dysfunction (MGD) with secondary staph

overpopulation Demodex Blepharitis

PRE-OP Manage Blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

CONTACT LENS Contact Lens intolerancendash Reducing microbial load and improving tear film while

dealing with removal of inflammatory modulators are

supportive of reducing contact lens intolerance

Application of Avenova

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 16: Avenova presentation Nov 2015

Why Control of Lid Flora Matters

Blepharitis

MGD with secondary staph

overpopulation

Pre-op application to manage blepharitis

ndash Refractive

ndash Cataract

ndash Retinal

Contact lens wearer

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 17: Avenova presentation Nov 2015

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Blepharitis

MGD

Multifactorial

Chronic

Disease

Affects

Quality of life

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 18: Avenova presentation Nov 2015

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 19: Avenova presentation Nov 2015

Avenova (formerly i-Lidtrade Cleanser)for Conditions of the Lids and Lashes

Proprietary Technology

ndash Neutrox NovaBay Proprietary (gt99 Pure) 001 Pure (99)

hypochlorous solution in saline is by prescription only

ndash No hypochlorite impurity which is often present in OTC

solutions

ndash No resistance is expected based on novel mechanism of

action

Significant Market Poorly Served

ndash Eyelid hygiene therapy part of the treatment for blepharitis

ndash Currently marketed products have little to no benefit

ndash 4 of 18 ndash 22 year olds

ndash 71 of 65+ year olds

ndash US Market Estimate of $500+ mil

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 20: Avenova presentation Nov 2015

Why Neutroxtrade

PURE Hypochlorous Acid [ HOCl ]

Cl

O

H

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 21: Avenova presentation Nov 2015

Neutroxtrade(NovaBayrsquos Proprietary Pure Hypochlorous Acid)

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 22: Avenova presentation Nov 2015

Organism (ATCC number) Time to Kill Reduction

Aspergilus brasiliensis 16404 60 seconds gt9999

Bacteroides fragilis 25285 60 seconds gt99999

Candida albicans 10231 60 seconds gt9999

Clostridium perfingens 13124 60 seconds gt9999

Enterobacter aerogenes 51697 60 seconds gt99999

Enterococcus faecium (VRE) 51559 60 seconds gt9999

Haemophilus influenzae 49144 60 seconds gt99999

Klebsiella pneumoniae 10031 60 seconds gt99999

Proteus mirabilis 14153 60 seconds gt99999

Pseudomonas aeruginosa 27853 60 seconds gt999999

Serratia marcescens 14756 60 seconds gt99999

Corynebacterium amycolatum 49368 60 seconds gt9999

Staphylococcus aureus (MRSA) 33591 60 seconds gt99999

Staphylococcus aureus 29213 60 seconds gt99999

Staphylococcus epidermidis 12228 60 seconds gt99999

Staphylococcus haemolyticus 29970 60 seconds gt9999

Staphylococcus hominis 27844 60 seconds gt9999

Staphylococcus saprophyticus 35552 60 seconds gt9999

Streptococcus pyogenes 49399 60 seconds gt9999

Propionibacterium acnes 29399 60 seconds gt99999

Vibrio vulnificus 27562 60 seconds gt99999

Neutroxreg

NovaBayrsquos Proprietary Pure (gt99) 001 hypochlorous Acid in saline

Skin pathogens are highlighted The CLSI guideline for evaluating the bactericidal activity of an antimicrobial agent was adapted for this study A 500 ul aliquot of each test organism was

added to separate tubes containing 5 mL AVENOVA (final inoculum 107 CFUmL) After 1 min a 30 ul aliquot was removed from each tube and diluted 110 in DeyEngley (DE) neutralizing

broth followed by three additional ten-fold dilutions in DE This procedure was repeated at 4 minutes and 10 minutes post-inoculation Each dilution was plated onto the appropriate agar

media in duplicate for quantitation Plates were then incubated under the appropriate conditions for each organism and CFU were counted Details of the procedures can be found in Report

FD-1403R00

Excellent in-

solution

activity

against a

broad range

of pathogens

Fast acting

onset of

activity

Effective

against

pathogens

commonly

found on the

lids amp lashes

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 23: Avenova presentation Nov 2015

27

Avenovatrade demonstrated excellent activity in solution

compared with the market leading lid and lash cleanser

Organism S aureus MRSA S epidermidis S haemolyticus P acnes

NovaBay

Avenovareg

lt 1 minute lt 1 minute lt 1 minute lt 1 minute lt 1 minute

OcuSoftreg Lid

Scrub Foam

gt 30 minute gt 30 minute gt 30 minute gt 30 minute gt 30 minute

NovaBayrsquos in-house methodology for determining therapeutic index was utilized

fibroblast cells were used to assess safety Each agent was serially diluted to arrive at a ldquocell saferdquo concentration At that concentration

antimicrobial time kill was measured vs various microorganism (shown above) More on this methodology at

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 24: Avenova presentation Nov 2015

Avenova has higher Therapeutic

Index than Betadine

bull Fast acting onset of microbial activity

bull Extremely low toxicity levels

bull 1000 times less toxicity than Betadinereg

28

Tested AVENOVAreg Betadinereg Surgical

Scrub (Povidone-

iodine 75)

Nontoxic

Dilution

110 110000

Time to 4 log10

kill

lt1 minute gt24 hours

Tested Against S aureus ATCC 33591

Antimicrobial Activity Comparison of Pure Hypo-chlorous Acid (001) with other Wound and Skin Cleansers at Non-Toxic Concentrations

Russell Hoon Suriani Abdul Rani Ramin Najafi Lu Wang Dmitri Debabov SAWC Spring 2013 and WHD 2013

The In Vitro Antimicrobial Activity of Wound and Skin Cleansers at Nontoxic Concentrations

Suriani Abdul Rani MS Russell Hoon Ramin (Ron) Najafi PhD Behzad Khosrovi PhD Lu Wang PhD and Dmitri Debabov PhD

ADVANCES IN SKIN amp WOUND CARE FEBRUARY 2014 VOL 27 NO 2 page 66-69

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 25: Avenova presentation Nov 2015

Bacteria Biofilm Complicates Blepharitis

29

bull Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing

(Mertz ndash Wounds ndash May 2003)

A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 26: Avenova presentation Nov 2015

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 27: Avenova presentation Nov 2015

31

NovaBay Avenovareg has Potent Anti-biofilm

Activity Compared to Saline

bull In vitro Biofilm of P fluorescens breaks up upon

introduction of Avenovareg

SALINE (control) NovaBay AVENOVAreg

For literature references pointing to anti-biofilm activity of Avenova

Click here

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 28: Avenova presentation Nov 2015

Hypochlorous Acid

Hypochlorous acid (HOCL) released from neutrophil cells

Part of bodyrsquos immune response

Kills microorganisms

Neutralizes toxins released from pathogens and inflammatory mediatorsndash helps suppress the bodyrsquos

inflammatory response

32

neutrophil

cell

HOCL

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 29: Avenova presentation Nov 2015

Representation of bacteria-produced toxins

which attack human cells

34

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 30: Avenova presentation Nov 2015

Representation of human cell response to

bacteria-produced toxins

35

Biological reactivity of hypochlorous acid Implications for microbicidal mechanisms of leukocyte myeloperoxidase

J MICHAEL ALBRICH CAROL A MCCARTHY AND JAMES K HURST

Proc National Acad Sci Vol 78 No 1 pp 210-214 January 1981

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 31: Avenova presentation Nov 2015

Representation of the Mechanism of Action of

Hypochlorous 01 in In-Vitro Models

Kills

bacteria

Blocks

bacteria

produced

toxins

Blocks

human

cell

produced

pro-

inflammat

ory

mediators

Different effects of hypochlorous acid on human neutrophil metalloproteinases activation of collagenase and inactivation of collagenase and

gelatinase Michaelis J1 Vissers MC Winterbourn CC Arthritis Rheum 1994 Mar37(3)424-7

Inhibition of collagenase activity by N-chlorotaurine a product of activated neutrophils Davies JM1 Horwitz DA Davies KJ Department of Medicine

Albany Medical College New York 12208

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 32: Avenova presentation Nov 2015

Dx of DES and Blepharitisco irritation pain used Maxitrol drops and

ointment for 2 wks + warm compress and eye scrub with Baby Shampoo Was

shown how to clean his lids and lashes in the office with Saline

Still returned 2 wks later with similar symptoms Maxitrol was dcrsquod and

Avenova given After 2 wks RTC with improved symptoms and improved

clinically on Exam

After Use of Baby Shampoo After use of Avenova

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 33: Avenova presentation Nov 2015

Typical Blepharitis Case

Vision

ndash OD 2030

ndash OS 2020-

TAP OD 21 OS 23

Exam

ndash Blepharitis

ndash Debris on lashes

ndash Conjunctival

hyperemia

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 34: Avenova presentation Nov 2015

bull From end of 2008 until end of 2012

bull Patient was seen 25 times

bull Between visits he would call and get Rx for Ab

bull Received courses of

bull Bacitracin neomycin polymyxin tobradex

maxitrol zylet oral doxy used Ocusoft

bull Patient developed skin ulcer from Ocusoft use

bull 10 of patients who use these over the counter

eye lid scrubs will develop contact dermatitis

bull Eczema type reaction due to their detergent

based components

Patient Case History Chronic Blepharitis

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 35: Avenova presentation Nov 2015

40

Avenovatrade

(formerly i-Lid Cleanser)

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 36: Avenova presentation Nov 2015

41

with

Neutrox

as preservative

Avenovatrade

(formerly i-Lid Cleanser)

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 37: Avenova presentation Nov 2015

Severe Ocular Surface Disease

with Demodex

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 38: Avenova presentation Nov 2015

Overpopulation of Demodexmay be the cause for Blepharitis

Regular Microscope

Electron Microscope

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 39: Avenova presentation Nov 2015

Patient with Demodex

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 40: Avenova presentation Nov 2015

After 3 wks of use of Avenovatradefewer Demodex amp better looking Lids and Lashes

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 41: Avenova presentation Nov 2015

Patients with acute or early stage meibomian gland

disease have a frothy tear film or bubbles which is

evident of soapy like substance here at the lid margin

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 42: Avenova presentation Nov 2015

Avenova has potent in-vitro

anti-toxin and anti-lipase activity

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 43: Avenova presentation Nov 2015

Staph aureus is a consistent Lipase producer

Breaking down natural lipids (triglycerides)

produced by Meibomian Glands

Bacteria Lipase activity is responsible for the

breakdown of lipid to fatty acids ndash [Invest Ophthalmol Vis SciApril 1986 vol 27 no 4 486-491]

Assuming Lipase causes saponification of lipid

and conversion to fatty acid and soap Can

Avenova breakdown Lipase and prevent

saponification (soap making)

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 44: Avenova presentation Nov 2015

In Laboratory Testing Avenovatrade(formerly i-Lid

Cleanser) inactivates Rapidly Bacterial Lipase

Comparison of Bacterial Lipase Activity in the Presence of Eye Lid Cleansers

A Epstein L Pang K Najafi-Tagol R Najafi D W Stroman D Debabov

Accepted for presentation at ARVO 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 45: Avenova presentation Nov 2015

bull Serial dilutions of AVENOVAtrade were incubated for

1 h with S aureus alpha-hemolysin toxin (1

ugmL) and S pyogenes streptokinase (175 umL)

bull 01 ugmL AVENOVAtrade (1000 dilution)

completely inactivated S aureus alpha-hemolysin

toxin

bull 0001 ugmL AVENOVAtrade (100000 dilution)

completely inactivated S pyogenes streptokinase

Activity of AVENOVAtrade against

Bacterial Toxins

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 46: Avenova presentation Nov 2015

Mechanism of Action

for Anti-Toxin and anti-Lipase Activity

SS

RRrsquo + HOCl

SS

R

Rrsquo

O O

O O

SS

RRrsquo

Cl

Cl

H2O

HOCl

Cl

Very Fast

Reaction

Kinetics of the reactions of hypochlorous acid and amino acid chloramines with thiols methionine and ascorbate Free Radic Biol Med

200130(5)572-9

Herbert Spiegel Advances in Clinical Chemistry Vol 35 2001 Academic Press

Oxidized

And unfolded Protein

Highly water soluble and

non-immunogenic

Waldemar Gottardi Dmitri Debabov and Markus Nagl N-Chloramines a Promising Class of Well-Tolerated Topical Anti-Infectives Antimicrob

Agents Chemother 2013 57(3)1107

Staphylococcus aureus alpha toxin

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 47: Avenova presentation Nov 2015

Chronic use of antibiotic will

result in antibiotic resistant

strainshellip we must be vigilant

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 48: Avenova presentation Nov 2015

Product Comparison (Ingredients)

59

OCuSoft SteriLid Oasis

Lid

and

Lash

LIDCLE

NZ

VisiClean

se

Eye

Scrub

Ingredient 001 pure

(gt99)

Hypochlorous

acid saline

Water PEG-

80 Sorbitan

Laurate

Sodium

Tricedeth

Sulfate

PEG-150

Distearate

Disodium

Lauroamphod

iacetate

Cocamidopro

pyl

Hydroxysultai

ne Sodium

Laureth-13

Carboxylate

Sodium

Chloride

Quaternium-

15

Water PEG 80

Sorbitan

Laurate

Sodium

Trideceth

Sulfate

Cocamidopropyl

Betaine

Sodium

Lauroamphoace

tate PEG 150

Distearate

Sodium Laureth

13 Carboxylate

Linalool Oil

Hepes Acetate

Sodium

Perborate

Monohydrate

Panthenol

Allantoin

(Comfrey Root)

Sodium

Chloride Tea

Tree (Melaleuca

Alternifolia) Oil

Tris EDTA

Water

Poloxamer

Polyethylen

eGlycolBo

rateHyalur

onanMethy

lparaben

Carbopol

940

non-foaming

pH balanced

formulation of

non-ionic

surfactant in

purified water

Water

Cocamidopropyl

Betaine PEG-

80 Sorbitan

Laurate

Sodium

Trideceth

Sulfate PEG-

150 Distearate

Aloe

Barbadensis

Leaf Extract

Chamomilla

Recutita

(Matricaria)

Flower Extract

Cucumis

Sativus

(Cucumber)

Fruit Extract

Althaea

Officinalis Root

Extract Avena

Sativa (Oat)

Kernel Extract

Tetrasodium

EDTA Citric

Water USP

(Purified)

PEG 200

Hydrogenated

Glyceryl

Palmate

Disodium

Laureth

Sulfosuccinat

e

Cocoamidopr

opylamine

Oxide PEG

80 Glyceryl

Cocoate

Benzyl

Alcohol

Edetate

Disodium

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 49: Avenova presentation Nov 2015

Does not generate

Resistance

Mechanical Debridement

Anti-ToxinAnti-biofilm

Activity

Bacterial Removal

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 50: Avenova presentation Nov 2015

To Open an account contact

NovaBay by calling

1-800-890-0329

Retail to patients $30-40

If used according to instructions

1st bottle will last 2 weeks

(2X per day application)

2nd bottle will last 1 month

(1X per day application)

Thank you

Page 51: Avenova presentation Nov 2015

Thank you