Private and Confidential · 2009. 9. 5. · The Oculus Microcyn technology stabilizes the ions and keeps the solution's pH level neutral, making it harmless to healthy tissues and

American Board of Healthcare Law and Medicine

Private and Confidential

Microcyn Technologies: New Disruptive Biotechnological Anti-Infectives

Which Prevents Mutation

Prepared

by

Thomas A. Gionis, MD JD MPH MBA MHA LLM FCLM FICS Chairman

American Board of Healthcare Law and Medicine President, Aristotle University

Dean and Professor of Public Health, Aristotle University School of Public Health United States Fulbright Scholar in Law

United States Fulbright PEER Review Committee – Global / Public Health UCLA Visiting Scholar in Public Health, UCLA School of Public Health

Department of Health Services, Division of Healthcare Management and Policy Fellow, International College of Surgeons

May 7, 2009

Copyright 2009 by Thomas A. Gionis, MD JD MPH MBA MHA LLM FCLM. All rights are Reserved. No part of this document may be reproduced in any form, stored in a retrieval system, or transmitted, in any form, or by an means, inclusive of, but not limited to the following: electronic, mechanical, photocopying, recording, digitizing, or otherwise, without the express written acknowledgment, consent and permission of the author, Thomas A. Gionis, MD JD MPH MBA MHA LLM FCLM, Aristotle University, 6185 Paseo del Norte, Carlsbad, California 92011.


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Microcyn Technologies: New Disruptive Biotechnological Anti-Infective Which Precludes Mutation

Introduction The evidence is clear throughout the globe – Infectious diseases account for millions of deaths every year and infectious diseases are emerging and re-emerging at unprecedented exceptional rates. In fact, in the last five years alone, the World Health Organization (WHO) has documented more than 1,100 epidemics. Emerging and re-emerging infectious diseases are the most vivid evidence that all infectious diseases are constantly evolving in the interplay between pathogens, their hosts and other environmental factors influencing both – their pathogenicity and virulence are related to their ability to adapt and mutate. More than 36 newly emerging infectious diseases were identified (by the United Stated Institute of Medicine and the WHO between 1973 and 2003) - and new emerging infectious diseases continue to be identified. It is important to note that according to the United States Centers of Disease Control (CDC) nearly 70 percent of emerging infectious disease episodes during the past 10 years have been zoonotic diseases, which are diseases transmitted from animals to humans. Common vectors include mosquitoes, birds, beef from infected cattle, etc. To combat the spread of infections and infectious diseases – either coming from humans or from animals – the best remedies must include: (1) disinfecting hard surfaces where pathogens may reside; (2) frequent hand washing; (3) treating infectious germs with agents which DO NOT permit mutation to occur. Oculus Innovative Sciences is a biopharmaceutical company that develops, manufactures and markets a wide spectrum of products based upon the shelf-stable Microcyn® Technology platform, which is intended to help eradicate surface pathogens on hard surfaces and from medical equipment, and intended to prevent and treat infections in wounds, burns and diseases. Microcyn has demonstrated the ability to safely treat a wide range of pathogens, including antibiotic-resistant strains of bacteria such as MRSA, viruses, fungi and spores. In fact, the effectiveness of Microcyn is best summarized by a simple listing of what Microcyn kills on contact: Avian influenza A H5N1 virus (“Bird flu virus”), HIV virus, West Nile Virus, Hepatitis A & B virus, Poliovirus, Herpes Simplex Virus, Influenza A H1 virus, RSV virus, Tuberculosis (Tb), MRSA, VRE, Pseudomonas, and Salmonella typhi – just to name a few. Microcyn technologies address the important features of combating infections and infectious disease epidemics in ways unparalleled by other disinfectants and even antibiotics – that is because the use of the Microcyn PRECLUDES mutation through its disruptive biotechnology. In that way, micro-organisms such as viruses, bacteria and fungi are killed before they can adapt to Microcyn and NO mutation is permitted – this is not possible with other solutions, disinfectants or even antibiotics.


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What follows below is a description of the uses of the various Microcyn technologies through its product lines: Microcyn (Cidalcyn; disinfectant of hard surfaces and medical equipment), Dermacyn (human wound care; trauma and burns); and Vetericyn (animal and bird diseases). About Microcyn The Microcyn technologies are a group of products manufactured by a United States F.D.A. regulated company known as Oculus Innovative Sciences, Inc. Oculus employs disruptive technologies to manufacture its products known as Microcyn (Cidalcyn), Dermacyn, and Vetericyn. The basic underling Oculus “Microcyn technology” is the common foundation for these Oculus products. The entire Microcyn product line (Microcyn, Dermacyn, and Vetericyn) have existing global governmental approvals including multiple United States F.D.A. approvals, multiple European Union C.E. Mark approvals, and multiple United States E.P.A. approvals, in addition to the noted approvals by the Governments of Canada and Mexico. It is the safe, effective and non-toxic features of Microcyn, coupled with its world-wide effectiveness in the medical and commercial use as a Disinfectant Cleaner, Sanitizer, Germicidal, Bacteriocidal, Tuberculocidal, and Virucidal, which has provided for its global recognition. Microcyn is a United States EPA approved Bactericidal, Tuberculocidal, and Virucidal Hospital grade disinfectant. It has been recognized as formulated for effective disinfection in households, effective disinfection in hospitals, and effective disinfection in industrial areas. It is currently used globally as a Hospital Disinfectant Cleaner, Household Disinfectant Cleaner, Laboratory Disinfectant Cleaner, Commercial Facility Disinfectant Cleaner, Institutional Disinfectant Cleaner, Medical Disinfectant Cleaner, Surface Disinfectant Cleaner, Laboratory Disinfectant Cleaner, Disinfectant Cleaner, Dental Disinfectant Cleaner, Veterinary Disinfectant Cleaner, as well as being formulated for Effective Food Contact Sanitization and as a Food Contact Sanitizer. It is especially important to recognize that Microcyn is a widely-used hospital-grade multipurpose disinfectant cleaner and food contact sanitizer for use on hard non-porous inanimate surfaces. It is manufactured in the United States and Europe by a US Department of Health and Human Services, Food and Drug Administration (F.D.A.) registered and regulated company manufacturer. This manufacturer has obtained certification for compliance with ISO 13485:2003. Additionally, Microcyn has TNO Certification BV, which is an independent institute recognised by the Dutch Council for Accreditation. Mechanism of Action The fundamental basic technology used to manufacture Microcyn is based on the chemistry of oxidation. When electric current is passed through purified water, the hydrogen and


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oxygen atoms in a water molecule are split into positively charged hydrogen ion and negatively charged hydroxide ion. Since the ions are no more stable, they look out for electrons that can stabilize them. The Microcyn product line is manufactured using a sophisticated, multi-chamber electrolysis process in which ionic species are selectively produced and isolated. This process allows for the production of a pH-neutral solution while minimizing the level of chlorine in the final product. The resulting solution– highly oxidized water - is a potent killer for single-celled organisms like bacteria, viruses and other micro-organisms otherwise lethal for humans and their environs. When Microcyn comes in contact with microorganisms, its highly concentrated ions want to rush inside the bacterial cell wall where the ion concentration is less (via osmosis), thereby rupturing (disrupting) the bacterial (or viral) cell membrane and killing the organism. The diagram on the right shows how when a single-celled organism is surrounded by the water, in which the oxygen atoms, each short of an ion, act as ion thieves to rebalance themselves. This fractures the cell’s membrane integrity, like a weak spot in a dyke. The action is quick – depending on the microbe up to 30 times faster than alcohol, which doesn’t kill spores. Because it’s not bleach-based, high levels of chlorine are not required to increase the kill rate – thus making it safe for humans. The diagram below graphically shows how the highly concentrated ions in a Microcyn solution is outside a bacterial, viral or other microbe cell want, they want to rush inside the cell where there is a lower concentration. The ions try to rebalance themselves in this way. When the bacteria or virus cell membrane is damaged, the ions rush inside the microbe and causes the microbe to “disrupt” – this kills the microbe. Because the organism has essentially “exploded” there is no chance it can cause a mutation and develop even more resistant bacteria or viruses.


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The Oculus Microcyn technology stabilizes the ions and keeps the solution's pH level neutral, making it harmless to healthy tissues and stable with a shelf life of about one (1) year. Product Features - - Safe & Non-Toxic Microcyn has very important features which makes its use advantageous and also makes it safe for use on the public. In addition to being Non-toxic and patient safe, they include:

(1). Non-Toxic (2). Fast-Acting (3). Broad-Spectrum Disinfection (4). Broad-Spectrum Sanitizer (5). Non-Corrosive (6). Non-flammable (7). Multi-functional (8). No Special handling (9). No Special disposal requirements (10). Durable; one (2) year shelf life (11). Ready-to-use (12). No Dilution required (13). No Mixing required (14). Kills viruses and bacteria on hard non-porous

inanimate surfaces and food contact areas (15). Eliminates odor causing bacteri

Summary of United States FDA Approvals The following is a summary of the multiple United States FDA approvals and general uses which apply to the various Microcyn product lines:

United States FDA Approval #(1) 2005 FDA Approval: Dermacyn Wound Dressing intended for use in moistening & lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions and minor burns.

United States FDA Approval #(2) 2005 FDA Approval: Dermacyn Wound Cleanser is intended for use in moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritation of the skin.

United States FDA Approval #(3) 2005 FDA Approval: Dermacyn Wound Care – OTC is intended for general - purpose use, including moistening of absorbent wound dressing & cleaning minor superficial skin abrasions.

United States FDA Approval #(4) 2005 FDA Compliant For moistening and lubricating: For use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions and burns. For irrigating and debriding: A super oxidized, non-toxic, non-irritating, no rinse dermal wound irritant that facilitates removal of wound debris as it cleanses and debrides.


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Summary of United States EPA Approvals The following is a summary of the multiple United States FDA approvals and general uses which apply to the various Microcyn product lines: United States E.P.A. #(1) 2006 Oculus Microcyn Disinfectant (OMD)

Bactericidal / Tuberculocidal / Virucidal / Sanitizer Disinfectant / Disinfectant Cleaner (Hospital –Grade / Households / Industrial Areas)

United States E.P.A. #(2) 2007 Oculus Microcyn Sanitizer OMS) Food Contact Sanitizer

European Union CE Mark 2004 Debriding, irrigating and moistening acute and chronic wounds in comprehensive wound treatment by reducing microbial load and creating moist environment

Mexico Product Registration 2003 Antiseptic disinfection solution for high level disinfection of medical instruments, and/or equipment and clean-rooms, areas of medical instruments, equipment and clean rooms.

Mexico Product Registration 2004 Antiseptic treatment of wounds and infected areas. Canada Class II Medical Device 2004 Moistening, irrigating, cleansing and debriding acute and

chronic dermal lesions, diabetic ulcers and post-surgical wounds.

Summary of Microcyn Product Line & Uses The following is a summary of the general uses of the Product line of Microcyn Technologies:

“Dermacyn”

A human wound care product. Promotion of Human wound healing, Human wound lubricating, Human wound disinfecting, Human wound debriding

“Microcyn”

Disinfectant Cleaner, Sanitizer and Germicidal. Commercial Grade and Home-use Disinfectant; Food Sterilizer

“Vetericyn”

A veterinary wound care product. Promotion of veterinary wound healing and trauma Eliminates wound odors Safely cleans, rinses wounds.


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Microcyn Anti-Viral and Anti-Microbiocidal Activity Microcyn has a recognized broad spectrum microbiocidal activity and kills the following bacteria, viruses, and spores:

Acinetobacter* Aspergillus niger Bacteroides fragilis* Clostridium difficile Escherichia coli* Enterococcus hirae* Enterobacter aerogenes * Enterococcus faecalis *

Haemophilus influenzae, * Klebsiella pneumoniae* Listeria Monocytogenes Proteus mirabilis, * Pseudomonas aeruginosa* Salmonella enteritiditis Salmonella cholerasesuis Serratia marcescens, *

Staphylococcus aureus* Staphylococcus epidermidis * Staphylococcus haemolyticus* Staphylococcus pyogene, * Methiciline resistant Staphylococcus aureus (MRSA) Vancomycin resistant Enterococcus faecalis (VRE) *

Bacteriocidal

*After exposure for 30 seconds, there was a reduction of the bacterial load >5 log10 Tuberculocidal Mycobacterium tuberculosis (Tb)

Mycobacterium bovis Mycobacterium avis

Sanitizer Salmonella typhi Virucidal Human Immunodeficiency Virus (HIV Virus)

Avian influenza A H5N1 virus (“Bird flu virus”) West Nile Virus Hepatitis A & B Virus Influenza A H1 Virus Polio Virus Herpes Simplex Virus RSV Virus Adenovirus group Rhinovirus Type 37 Human Coronavirus Canine Parvovirus

Sporicidal Bacillus atrophaeus Fungicidal Candida albicans *

Trichophyton mentagrophytes (Athlete’s Foot Fungus)


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Microcyn Patient Safety Microcyn is well recognized as “patient-safe” – this is shown through the following Biocompatibility Studies:

BIOCOMPATIBILITY STUDIES

Category Sub-category Standard / method Result Genotoxicity ISO 10993-3:2003 Pass

Cytotoxicity ISO 10993-5:1999 Pass

Acute oral toxicity ISO 10993-11:1996 Pass

Acute dermal toxicity ISO 10993-11:1996 Pass

Toxicity

Acute inhalation toxicity

ISO 10993-11:1996 Pass

Sensitization Dermal sensitization ISO 10993-10:2002 Pass

Skin irritation ISO 10993-10:2002 Pass Irritation

Ocular irritation ISO 10993-10:2002 Pass


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Microcyn Disinfectant – Sanitizer Approved US EPA Uses The following are approved uses of the Microcyn Disinfectant-Sanitizer:

Educational Homes Governmental Day Care Centers Home Kitches Police Stations

Playgrounds Bathrooms Fire Stations Pre-Schools Laundry Rooms Governmental Offices

Elementary Schools Bedrooms Governmental Buildings Grade Schools Family Room Government Waiting Rooms High Schools Patios-Garages Jails – Prisons - Correctional

Colleges Appliances Airports Universities Cribs Hospitals Cafeterias Bassinettes Emergency Rooms

Accommodations Sanitization of Hard Surfaces Commercial

Hotels Glass Baby Bottles Office Buildings Motels Kitchen Utensils Restaurants

Mobile Homes Food Containers Stores Condos Beverage Containers Shopping Centers

Bed & Breakfast Inns Storage Containers Malls Commercial Kitchens Feed Containers Movie Theatres

Day Care Centers Food Contact Surfaces Food Processing Plants Drinking Fountains Microwave Exteriors Food Storage Areas

Sinks Refrigerator Exteriors Institutional Kitchens Handrails Playgrounds Recreational Facilities Highchairs Clinics / Medical Centers Laboratories / Manufacturing

Computers / Desks Medical Equipment Hair & Nail Salons / Barber Shops Workstations Cars / Boats Factories

Tables Taxis Athletic Exercise Facilities Airplanes Restrooms

Conclusion The product line of Microcyn, Dermacyn, and Vetericyn is a remarkable breakthrough of new anti-infectives – they kill viruses, bacteria and fungi by disruptive biotechnology. In that way, micro-organisms are killed and not permitted to adapt and mutate. Because this product line is safe and non-toxic, it is ideally suited to protect communities and preserve the public’s health through the elimination of infections, contaminations, and infectious diseases.

Thomas A. Gionis, MD JD LLM MPH MBA MHA FCLM FICS Chairman, American Board of Healthcare Law and Medicine President, Aristotle University Dean and Professor of Public Health, Aristotle University School of Public Health United States Fulbright Scholar in Law United States Fulbright PEER Review Committee – Global / Public Health UCLA Visiting Scholar in Public Health, UCLA School of Public Health

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Private and Confidential · 2009. 9. 5. · The Oculus Microcyn technology stabilizes the ions and keeps the solution's pH level neutral, making it harmless to healthy tissues and