Topical Antimicrobials Biocides could be useful but are toxic Poor quality of trials & small sample size SOS therapy?

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1 Super Oxidized Solutions (SOS) From the Basic Science to the Bedside Andrés A Gutiérrez MD PhD Oculus Innovative Sciences Petaluma, California

2 Use of Antimicrobials in Wound Care Oral-Parenteral Antibiotics First line therapy in wound infection / colonization Emergence of resistant bacteria Side effects and increased costs of treatment Topical Antimicrobials Biocides could be useful but are toxic Poor quality of trials & small sample size SOS therapy?

3 Early Super Oxidized Solutions Produced by the electrolysis of water and NaCl Acidic or alkaline ph High Chlorine content (> 500 ppm) Potent anti-infective agents w/ clinical uses Unstable - Shelf life of days or hours Irritation and sensitization Tanaka. JHI, 1996 Inoue, Artif Org, 1997

4 Challenge for Oculus Neutral ph Solution Low chlorine content Preserves biocidal activity Non irritation sensitization S T A B L E

5 ph neutral-super Oxidized Solutions Microcyn Technology Chemical Reactions O 2, O 3, and others Microcyn Technology utilizes a unique multi chamber electrolysis cell e - Anode H 2 O Cl 2 + H 2 O 2Cl - HOCl + HCl + NaOH Oxidized Water 99.9 % Reactive oxychlorine species 0.1 % FAC 80 ppm ph Stable for over 1 year NaOCl

6 Research & Development Phase 2 (1) Phase 3 (2) 2008 Pilot Studies US 3, EU 2, India Preclinical OUS Clinicals (21)

7 ph neutral-super Oxidized Solutions Microcyn Technology Core Technology Dermacyn TM Wound Care Medical (Oxum, Microcyn60) Device OIS-1080 Drug

8 ph Neutral Super Oxidized Solution Preclinical Background Biocide (planktonic bacteria & biofilms) Healing Safety Anti-Inflammatory Antihistamine Vasodilation

9 Preclinical Background Publications Yahagi N Artif Org 2000 Healing clean wounds Landa C J Hosp Infect 2005 Antimicrobial Various Wounds 2006 Overview Medina J Int Immun 2007 Anti-histamine,TNF block González D Int Wound J 2007 Fibroblast Le Duc Q Br J Dermatol 2007 Skin grafts & substitutes

10 Clinical Studies - Summary 21 physician clinical studies in US, Europe, India and Mexico > 700 patients on Microcyn TM No reported significant adverse events Significant in infection & bacterial count Other benefits in some clinical studies: healing time and hospital stay use of systemic antibiotics major amputations/re-interventions Significant cost savings

11 Reduced Healing Time Reduced healing time in patients with chronic wounds: Wound Type Control Patients Days to Healing % Reduction Diabetic Foot Saline Diabetic Foot Saline Diabetic Foot Betadine Diabetic Foot Betadine Leg Ulcers Other

12 Reduced Hospital Stay Reduced hospital stay: Indications Control Patients Hospital Days % Reduction Peritonitis Saline % * Burns Silver % * Diabetic foot Betadin %

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14 Severe DFI (UTC 2-3, B-D) Debridement ± Revascularization - Culture SOS Antibiotic OD Betadine Antibiotic OD Day > 3 FUA Surgical Closure Wound healing Dalla Paola, Wounds. 2006

15 Advanced Diabetic Foot Ulcers Dalla Paola, Wounds 2006 Post-surgical lesions UTC grades 2/3 SOS Betadine P Patients (n) Bacteria strains at beginning of study Strains after treatment Percentage eliminated Adverse effects / complications 14 94% % 18 < < Average wound healing time 43 days 55 days <0.001

16 Bacterial strains at study entry and during elective surgery (Day 3+) Staph MRSA Pseudo Strep GRAM - GRAM + Anaerobes D1 C Staph MRSA Pseudo Strep GRAM - GRAM + Anaerobes D2 C2

17 Summary of category of final surgery Dalla Paola conservative minor amp. major amp Dermacyn Controls

18 Clinical Evaluations Publications & Congresses Veverkova L. J Wound Healing 2005 Dalla Paola L. Wounds 2006 Bongiovanni C J Vasc Ultrasonography 2006 Zahumensky E Vnitr Lek 2006 Goretti C Int J Low Ext Wounds 2007 Ricci E EWMA 2007 Suri A SAWC 2007

19 Phase 2 Trial An Open Label, Three Arm, Pilot Study of the Safety and Efficacy of Topical nsos vs. Oral Levofloxacin vs. Combined Therapy for Non-Ischemic, Mildly Infected Diabetic Foot Ulcers clinicaltrials.gov

20 Phase 3 Trial A Randomized, Multi-Center, Double- Blind, Two-Arm, Placebo-Controlled, Safety and Efficacy Study of Topical OIS-1080, With and Without Systemic Antibiotics, in Mild Diabetic Foot

21 Anticipated Outcomes For mild infections, nsos is at least as effective as an oral antibiotic nsos is effective against MRSA? nsos has fewer adverse events than oral antibiotics nsos facilitates wound healing

22 Contact Information