Medizone International — Shareholder Meeting (August 2009)
42 slides from Medizone International's shareholder meeting presentation, Aug 31, 2009
Slide 1: Research and Development Update
AsepticSure™ Research and Development Update Medizone International Annual General Meeting August 26", 2009
Slide 2: Introduction
AsepticSure™ Introduction * Today in America a person dies.every:5 minutes from largely preventable hospital acquired infections (HAIs). This silent epidemic kills an estimated 100,000 Americans every year.(CDC)
Slide 3: Research & Development Update Table of Contents
AsepticSure™ Research & Development Update Table of Contents 1. Problem Definition = Human Suffering = Financial Burden New Legislation Remedial Actions A Role for Ozone The Science Behind AsepticSure™ Engineering Specifications Developmental Milestones Business Case Emerging Applications eo On oar
Slide 4: Problem Definition
AsepticSure™ Research and Development Update Problem Definiti
Slide 5: The Silent Epidemic
The Silent Epidemic MRSA — Scanning EM * MRSA is only one of-five highly lethal bacteria which is ubiquitous within healthcare.and associated facilities worldwide. Such infections are of growing concern to the public and healthcare workers alike * “Deadly infections (such as these) are on the rise,
Slide 6: Problem Definition
AsepticSure™ Problem Definition * According to the CDC, approximately 99,000 Americans develop invasive MRSA infections every year;.and about 19,000 of them die...the death rate is approximately 20% * Amore virulent strain of community-acquired MRSA appears to have a 50% mortality rate, but is not c
Slide 7: Problem Definition
AsepticSure™ Problem Definition HAls can have devastating consequences... ® Elsevier 2004. Infectious Diseases 2c - www.idreference.com MRSA — Stemal Wound Infection MRSA - Brain Abscess
Slide 8: Magnitude of Human Suffering
AsepticSure™ Problem Definition Magnitude of Human Suffering * The American Academy of Orthopaedic Surgeons identifies MRSA as the single biggest concern for surgical procedures and suggests that it is a silent epidemic (2007) * The major causative agents (bacteria) for hospital-based infections are
Slide 9: Magnitude of Human Suffering
ticSu re™ Problem Definition Magnitude of Human Suffering 400,000 350,000 300,000 Be Ht o + 7 1993 1995 1997 1999 2001 2003 2005 - CDC (2007) The number of annual hospital admissions with MRSA infections has been growing rapidly since the early 90’s
Slide 10: Magnitude of Human Suffering
Magnitude of Human Suffering Estimated number of Hospital Acquired Infections by site of infection: Major Site of Infection Estimated Number of Infections Surgical Site Infection (SSI) 290,485 Central Line Associated Bloodstream Infections 92,014 (CLABSI) Z Ventilator Associated Pneumonia (VAP) 52,5
Slide 11: Magnitude of Human Suffering
AsepticSure™ Problem Definition Magnitude of Human Suffering ¢ Estimated number of deaths is approximately 99,000 annually in the US. (CDC 2007) ¢ Number of deaths worldwide is not known, but estimated-to be 2-3 orders of magnitude higher. ¢ Estimated deaths in Canada from HAIs is 12,000 annually, (
Slide 12: Financial Burden
Problem Def Financial Burden * CDC (2009) estimates the financial burden of hospital acquired infections (HAIs) to be from $28.4 Billion (low) to $45.0 Billion (high) per year. * The average attributable patient cost is $25,072 (in 2005 dollars) ° Range of estimated direct medical costs: Range of Es
Slide 13: Shifting Financial Burden
AsepticSure™ Problem Definition Shifting Financial Burden vvvwvVvVv Vv As of Oct. 1, 2009, Medicare has stopped paying hospitals for treatment of the following conditions if they are not present on admission: Catheter-associated urinary tract infections Pressure ulcers (decubitus ulcers) Vascular ca
Slide 14: New Legislation
AsepticSure™ Problem Definition New Legislation Congressional Legislation (111) Concerning HAls H.R. 3104 Bill Status: Introduced 6/26/09; referred to House Energy and Commerce Committee Purpose: Requires public reporting of health care-associated infections data by hospitals and ambulatory surgical
Slide 15: The Affects of New Legislation
AsepticSure™ Problem Definition The Affects of New Legislation ¢ These infections are now reportable in 18 of the US states, and will soon be reportable on a mandatory basis across the US; in all likelihood, incidence statistics will increase dramatically as hospitals are obliged to report their adm
Slide 16: A Clinical and Public Health Imperative
AsepticSure™ Problem Definition A Clinical and Public Health Imperative ¢ Hospitals, long-term care facilities and home care providers must invest in new resources to prevent infections in the patients they serve. ¢ Infection control strategies have been developed, but with varying degrees of succes
Slide 17: Remedial Actions
AsepticSure™ Research and Development Update Remedial Actions
Slide 18: Current Cleaning Procedures are Not Working
AsepticSure™ Remedial Actions Current Cleaning Procedures are Not Working CDC (2007) reported that major public health initiatives to control these infections have had only marginal success Chlorinated solutions with or without amrmmonia have demonstrated limited success, and cannot be used on elect
Slide 19: Infection Control Strategies
AsepticSure™ Remedial Actions Infection Control Strategies (con’t) The overall impact of infection contr | ; / he Ea strategies on HAIs has.been minimal to date, yet the answer still lies in prevention.
Slide 20: A Role for Ozone
AsepticSure™ Research and Development Update A Role for
Slide 21: A Role for Ozone
AsepticSure™ A Role for Ozone * Ozone has a long, successful history of use as a potent anti-bacterial, anti-fungal and anti-viral agent * Ozone was first used as a disinfectant in 1881 by Dr. Kellog * In 1893 Ozone was used.in the Netherlands for water purification ¢ Presently, in excess of 3,000 m
Slide 22: A Role for Ozone
AsepticSure™ A Role for Ozone * Research conducted in New York City has also demonstrated that Ozone is effective against-Legionella Bacteria, as well as pseudomonas populations in those water purification plants * Ohio State University (2001) demonstrated a 4 log difference in sporicidal action of
Slide 23: The Science Behind AsepticSure
AsepticSure™ Research and Development Update The Science Behind AsepticS: S fe/
Slide 24: Development Team
AsepticSure™ The Science Behind AsepticSure Development Team Dr. Michael Shannon, Director, Medical Affairs, Medizone International MD, MA, MSc President and Chair, Canadian Foundation for Global Health Dr. Dick Zoutman, Medical Microbiologist and Infectious Disease Specialist and Senior Scientific
Slide 25: Recent Findings
AsepticSure™ The Science Behind AsepticSure Recent Findings Control O3 Treatment Now you see them.... Now you dort...
Slide 26: Recent Findings
The eorence Behind AsepticSure™ Recent Findings Pathogen Bacterial Reduction E coli 5 log reduction 99.999% MRSA 4.88 log reduction 99.998% VRE 4.5 log reduction 99.995% C difficile 4 log reduction 99.99% Pseudomonas 4.2 log reduction 99.992% O03 Concentration an Time Confidential
Slide 27: Ozone Decontamination Test Facility
Slide 28: Engineering Specifications
AsepticSure™ Research and Development Update
Slide 29: System Specifications
AsepticSure™ System Specifications Engineering Specifications for the Commercial System *Room size: 2500 cubic feet *Charging time: 15 minutes *Maximum Treatment Time: 90 minutes Ozone Destruct Time: 20 minutes Weight: Transportable *Quality Assurance: Field hardened with built-in monitoring & diagn
Slide 30: Regulation and Licensing
AsepticSure™ Research and Development Update Regulation | Licensing
Slide 31: Assessment of critical or rate limiting regulatory issues
Assessment of critical or rate limiting regulatory issues REPS and ree *Opinion. 1: 3 It may be considered? a pesticide teed for decontamination (as would be the case in anti-terrorism applications). Submission of safety and effectiveness data may be required. The precedent technology is vaporized h
Slide 32: Assessment of critical or rate limiting regulatory issues (EPA and FDA)
Assessment of critical or rate limiting regulatory issues (EPA and FDA) (con’t) Opinion 2: M is the lowest and safest medical device class. According to FDA 21 CFR Parts 862-892 the technology is exempted from pre-market authorisation, so FDA approval need only be sought when the technology is matur
Slide 33: Developmental Milestones
AsepticSure™ Research and Development Update
Slide 34: Developmental Milestones
Developmental Milestones Developmental Lifecycle Activity Equipment Laboratory | See slide Validate/Develop treatment 2009-10 Queens Testing protocols University Room Upscale of Validate basic protocols to 4 | Q4 2009 Queens Scale laboratory logs bacterial kill University / Testing equipment to Hosp
Slide 35: Business Case
AsepticSure™ Research and Development Update Business
Slide 36: Business Case
AsepticSure™ Business Case A business case for Medizone to pursue the development of an ozone-based technology for hospital sterilization... ¢ Acompelling argument; a public health imperative.
Slide 37: Value Proposition
AsepticSure™ Business Case Value Proposition Assumptions: All US hospitals have similair capabilities (surgery, ICU, ER) For these purposes all US hospitals will be considered similar in size For these purposes, the business model assumed equipment sales and training rather than a service delivery m
Slide 38: Value Proposition
AsepticSure™ Business Case Value Proposition The number of registered hospitals in the US is 5,756 (2006) Assuming 3 AsepticSure units per hospital at a notional cost of $150,000 + $20,000 for related training, the cost for full US coverage would be approximately $978.5 million Current research resu
Slide 39: Value Proposition
AsepticSure™ Business Case Value Proposition ¢ Ifa hospital is properly decontaminated the reduction in infection rates is expected to be significant (20-30% is a modest estimate, but will be validated) * CDC estimates a $6.8 Billion savings to the US system with a 20% reduction in infections ¢ Ther
Slide 40: Emerging Applications
AsepticSure™ Research and Development Update Emerging Applications
Slide 41: Emerging Applications - Global
AsepticSure™ Emerging Applications - Global * Expand beyond immediate hospital applications to include: « Mobile hospital facilities « Chronic Care Facilities « Essential Public Infrastructure (Educational, transport, communications facilities etc.) » Public Arenas * Bioterrorism Countermeasures * I
Slide 42: Conclusion
AsepticSure™ Conclusion Hospital Acquired Infections The magnitude of the problem is immense. The solution clearly lies in prevention. AsepticSure™ will play a key role.
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