AsepticSure

Report
AsepticSure – Semper Paratus
February 9, 2012
DEVELOPMENT TEAM
Name
Role
Dr. Michael Shannon,
President and Director of Medical Affairs, Medizone International
President and Chair, Canadian Foundation for Global Health
Commodore Rtd. (Rear Admiral equivalent) Canadian Naval Forces
MD, MA, MSc
Dr. Dick Zoutman,
MD, FRCPC
Mr. Bernard Lim,
C.Eng
Dr. David Barnes,
Medical Microbiologist and Infectious Disease Specialist and Senior Scientific
Consultant, Medizone International
President, JTL Global Ventures
Senior Product Development Advisor
MD
CEO of Biotheragene Clinical Research Consultants
Regulatory Advisor, Medizone International
Mr. Gordon Wehner
MBA
President QualMed
Regulatory Affairs, Senior Advisor
Mr. Robert Hirons,
President Cottspat Corporation
Intellectual Property Law and International Patent Agent
Mr. Brad Goble,
MBA
President and CEO, TDV Global
February
9,2012
Senior Advisor,
Business Development & International Affairs
2
PROBLEM DEFINITION
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)
The problem is not new. It has been developing
for two decades, but has now reached pandemic
proportions and is the 4th leading cause of death
in the US.
February 9,2012
3
PROBLEM DEFINITION
"Every year, more than ninety thousand
Americans die from similar infections
that have become resistant to
antibiotics. That stunning figure is higher
than the death toll from AIDS, car
accidents and prostate cancer
combined."
Dan Rather Reports, The Huffington Post, Jan. 12, 2011.
February 9,2012
4
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%
• A more virulent strain of community-acquired MRSA
appears to have a 50% mortality rate. Schools,
playgrounds, gyms and other public facilities are
now at risk.
• With bacteria becoming increasingly resistant to
antibiotics, treatment is no longer an effective option.
February 9,2012
5
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:
 Clostridium difficile (C difficile);
 Escherichia coli (E coli);
 Pseudomonas aeruginousa;
 Methicillin-resistant Staphylococcus aureus (MRSA); and,
 Vancomycin-resistant Enterococcus (VRE).
February 9,2012
6
PROBLEM DEFINITION
Magnitude of Human Suffering
• Estimated number of Hospital Acquired Infections
(HAIs) by site of infection:
Major Site of Infection
All Hospital Acquired Infections (HAIs)
Estimated Number of Infections
1,737,125
Surgical Site Infection (SSI)
290,485
Central Line Associated Bloodstream Infections
(CLABSI)
92,011
Ventilator Associated Pneumonia (VAP)
52,543
Catheter Associated Urinary Tract Infection
449,334
Clostridium difficile-associated disease
178,000
February 9,2012
- CDC (2009)
7
PROBLEM DEFINITION
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
Estimates
(billions)
20% of
infections
preventable
(billions)
50% of
infections
preventable
(billions)
70% of
infections
preventable
(billions)
2007 CPI-U
$28.4 – $33.8
$5.7 - $6.8
$14.2 - $16.9
$19.9 - $23.7
2007 CPI Hospital
Inpatient Services
$35.7 - $45.0
$7.1 - $9.0
$17.9 - $22.5
$25.0 – $31.5
February 9,2012
8
- CDC (2009)
PROBLEM DEFINITION
Emerging Threats.......
“Our nation must have the nimble, flexible
capacity to produce MCMs rapidly in the face
of any attack or threat, known or unknown,
including a novel , previously unrecognized,
naturally occurring emerging infectious disease.”
– The Public Health Emergency Medical Countermeasures Review, HHS,
August 2010
To achieve this goal, the approach must be
highly efficacious (>6 logs), rapidly deployable,
inexpensive and environmentally friendly.
February 9,2012
9
EXISTING APPROACHES
Infection Control Strategies for Habitable Hospital Spaces
Pathogen
Bacterial Reduction
with AsepticSure
(90 min total time)
Other Ozone Based
Systems
Other Peroxide Based
Systems
(high H2O2 conc.)
E coli
6.5 log reduction
99.99995%
2.5 – 4 log reduction
99.5 – 99.99%
4 log reduction
99.99%
MRSA
7 log reduction
99.99999%
2.5 – 4 log reduction
99.5 – 99.99%
4 log reduction
99.99%
VRE
6 log reduction
99.99995%
2.5 – 4 log reduction
99.5 – 99.99%
4 log reduction
99.99%
6.5 log reduction
99.99995%
2.5 – 4 log reduction
99.5 – 99.99%
4 log reduction
99.99%
7 log reduction
99.99999%
2.5 – 4 log reduction
99.5 – 99.99%
4 log reduction
99.99%
C difficile
Pseudomonas
February 9,2012
10
PRODUCT OVERVIEW
The AsepticSure Advantage
• Combination of anti-oxidant gases (O3 and H202)
•
•
produces very unique free radicals known as
Trioxidanes, with higher anti-oxidant potential than
Ozone or Peroxide alone.
By definition, hospital spaces and other public
facilities can effectively and reliably be sterilized,
(greater than a 6 log reduction) with a turn around
time of 90 minutes
The reduced concentration of gases used renders
AsepticSure harmless to the environment, electronic
equipment, paint and treatment surfaces
February 9,2012
11
PRODUCT OVERVIEW
The AsepticSure Advantage
• AsepticSure technology is effective (6+ logs) at 80PPM O3, 1%
H202, 80% RH, 20-24 degrees C, for 30 minute exposure
against: all bacteria contaminating hospitals, all bacteria
contaminating sports equipment, all viruses (enveloped, and
non-enveloped), all fungi and fungal spores.
• AsepticSure is also 100% effective against all insects, eggs
and larvae including Cimex lectularius (bed bugs).
• AsepticSure is ideal for Bioterrorism countermeasures.
February 9,2012
12
Implications for Bioterrorism Countermeasures
Evidence to date indicates that the efficacy of
AsepticSure as a decontamination process is
not limited by unique characteristics of
pathogens (Aerobic vs. Anaerobic, Spore
former vs. Non-Spore formers), nor is it limited by
the nature of the contaminated surface or the
presence of a biofilm. The data for Bacillus
subtilus and Bacillus atrophaeus is compelling.
Indications are that this technology will prove
equally effective against all “A” List pathogens.
February 9,2012
13
Organism
Ozone
(PPM)
RH %
Exp.
(min)
Log
Reduction
H202 %
MRSA
80
1
80
30
6.36
VRE
80
1
80
30
5.96
Pseudo
80
1
80
30
5.01
E.coli
80
1
80
30
6.02
Salmonella
80
1
80
30
6.97
Listeria
80
1
80
30
6.21
C.Diff
80
1
80
30
6.97
Bacillus subtilis
80
1
80
90
6.93
Bacillus atropheus
80
1
80
90
6+
February 9,2012
14
AsepticSure™ Model – Profile View
February 9,2012
15
COMMERCIAL DEVELOPMENT
Potential Applications
Medical Facilities
& Equipment
Hospital
Sterilization
• Long-term and
Intermediate Care
Facilities
• Chronic Care Facilities
• Routine Medical
Monitoring Equipment
Public Health &
Public infrastructure
•
•
•
•
•
•
•
Food Preparation Facilities
Agriculture & Kennel Facilities
Sports Facilities
Sports Equipment & Uniforms
Hotel/Motel Units
Mobile & Field
Hospitals/Response Units
Contaminated Areas & Public
Infrastructure (Building
Remediation)
Medical
Countermeasures
February 9,2012
16
The Growing Threat of Bioterrorism
“Biological weapons and their use or proliferation by
states or non-state actors presents a significant
challenge to our national security...it is quite possible
that we would not obtain specific warning of an
imminent threat or impending attack in time to stop it.”
- National Strategy for Countering Biological Threats, November 2009
“Exposure to anthrax spores can be deadly......AL
Qaida is known to have experimented with toxic
chemicals in the past and the US has made protecting
against bioterrorism a priority”
“Pakistan Says Anthrax sent to Premier’s Office” Associated Press Feb 1/12
February 9,2012
17
In the last two decades bioterrorism has emerged as
a serious threat with serious deficiencies in response
capacity and capability now being recognized.
The implications to National security are indeed
significant.
As a cornerstone to its countermeasures strategy a
rapidly deployable system with proven
effectiveness against a broad range of pathogens
across a broad range of environmental conditions is
desperately needed to fill this recognized gap.
February 9,2012
18
The Growing Threat of Bioterrorism
If lives are to be saved and the
population protected, the impact of an
attack must be quickly contained, public
infrastructure maintained and immediate
response personnel protected.
Any reduction in health care infrastructure
threatens what little surge capacity may be
available.
February 9,2012
19
The Growing Threat of Bioterrorism
• Limiting the spread of an agent reduces the
risk of exposure which reduces the number of
casualties and therefore, saves lives.
• Rapid effective remediation of infrastructure
maintains surge capacity which saves lives.
• Rapid decontamination of vehicles,
emergency shelters, diagnostics,
communication equipment, medical supplies,
food, and water saves lives.
February 9,2012
20
The ASEPTICSURE mobile
decontamination system offers
an effective, inexpensive solution
that fills critical gaps in MCMs for
biological threats in a way not
previously possible.
February 9,2012
21

similar documents