wavepulse™ sterilization bacterial spores bacillus atrophaeus prions creutzfeldt-jakob disease...
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ONEighty C Technologies
ONEighty C Technologies Corporation believes that this presentation contains forward-looking statements. Such forward-looking statements are based on
management’s current expectations and are subject to risks and uncertainties that could cause results to differ materially from the forward-looking statements. The
Company assumes no obligation to update any forward-looking statements as a result of new information or future events or developments, except as required by law.
Problem: Sterilizing Medical Devices
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CRE-infected endoscope tips led to deaths at UCLA Medical
Center
Blood, bone, flesh and rust inside instruments
More than 1.6 million endoscopy procedures annually
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Deadly bacteria on medical scopes trigger
infections
Deadly superbug-related scopes sold without FDA approval?
FDA Issues Warning on Medical Device After Superbug Outbreak
Agency Says Type of Endoscope Is Hard
to Clean, Allowing Deadly Bacteria to Be
Transmitted
Deadly Superbug CRE Linked To 2 Deaths
In Los Angeles
Increasing Complexity of Surgical Equipment
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Traditional Surgical Devices
Simple tools Temperature tolerant Metal Smooth surfaces Come apart easily for cleaning
Complex, minimally invasive devices Temperature sensitive Rubber, plastic, metals, adhesives Articulating parts Long lumens
Advanced Surgical Devices
Current Technology Does Not Sterilize All Infectious Organisms
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Susceptible
Infectious Organism Example Current Technology
Lipid or medium-sized viruses HIV, Herpes, Hepatitis B
Disinfection - Low Vegetative bacteria S. aureus, P. aeruginosa
Fungi Aspergillus, Candida Disinfection - Intermediate Nonlipid or small viruses Polio, Coxsackie
Mycobacteria M. tuberculosis Disinfection - High
Coccidia Cryptoporidum Sterilization
Bacterial spores Bacillus atrophaeus
Prions Creutzfeldt-Jakob Disease Sterilization without prion destruction
Resistant
Guideline for Disinfection and Sterilization in Healthcare Facilities, CDC 2008
Ste
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Emerging Infectious Risks
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Emerging Risks Impact
CRE Carbapenem-resistant Enterobacteriaceae
May contribute to death in 50% of infected patients (CDC)
C. diff Clostridium difficile
Est. 29,000 deaths in USA
MRSA Methicillin-resistant Staphylococcus aureus
MRSA-related hospitalization >11 / 100,000 patients
Prions Not destroyed by existing sterilization processes
Greatest risk in brain, spinal and eye surgeries >100,000 /year
Prions: Emerging Infectious Risk
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Medtronic Devices May Have Exposed Patients to Creutzfeldt-
Jakob Disease
N.H. patients possibly
exposed to fatal brain disease
30K in U.K. Could Carry
Human Form of Mad Cow
Disease
• Not destroyed by any existing sterilization methods
Severe Patient Infection and Death Risks
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Unmet Needs • Non-sterility of reprocessed
medical devices due to residual pathogens, bodily fluids or tissues
• Limited efficacy of current low-temperature sterilization processes
• Inability to destroy extremely stable proteins (e.g. prions)
High Risk and Fatal Consequences
• Recent deaths from CRE or
C.diff - infected endoscopes
• Severe infection or death from MRSA and other bio-pathogens
• Death from incurable Creutzfeldt-Jakob Disease (Mad Cow)
WAVEPulse™ Sterilization Process
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• New technology • Combines microwave, heat
and water • Fragments DNA/RNA and
proteins • Raises standards to
Sterilization
WAVEPulse™ High Performance Sterilization
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High temperature SAL 10-4 to 10-6
Existing processes
On-
site
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Proprietary Processes, Safe, Effective
WAVEPulse™ Heat-sensitive or
heat-tolerant devices
WAVEPulse™ Differentiation Characteristics
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• Faster, cheaper, smarter • Improves patient safety • Non-toxic process • Sterilizes, de-immunizes, de-toxifies • Low-temperature sterilization • Unequalled 10-10 SAL • Compliant data tracking
WAVEPulse™: New Standard Of Sterilization
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Sterility Assurance Level System Pathogen
Sample Surviving
Pathogens
10-4 Autoclave 1 billion 100,000
10-10 WAVEPulse™ 1 billion 0.1
Highly-disinfected
Sterilization: Autoclave 10-4
10-10
WAVEPulse™ Disinfected
Standard Continuum
$1.7B Addressable Market Opportunity For
Heat-Sensitive Device Sterilization In US Alone
• 11% CAGR for heat-sensitive sterilization equipment market
• 20-25% of medical instruments require low temperature sterilization, up from 10-15% 10 years ago
• Growth drivers include reprocessing of devices or instruments that are indicated and labeled for multi-use
• WAVEPulse™ platform aligns with increasing cost reduction pressure
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WAVEPulse™ Milestones
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Achieved: • 10-10 SAL • Anthrax Sterilization (spore of greatest resistance) • 80oC sterilization • Prion destruction
Near-Term Goals: • Next generation prototype • 60oC sterilization • Optimized microwave function • Combined sterilization, de-immunization, detoxification • Biofilm penetration
Collaboration Goals: • Develop improved end-user experience • Beta-testing
Leadership Team
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Eric Walters, CEO and Co-Founder EVP/CFO of PolyMedica [NASDAQ:PLMD]. Grew medical device revenue
from $1M to $350M. Company was later acquired for $1.5B cash. Raised >$100M capital.
Michael Fritz, BOD Member Founder, Plexius Consulting Principal, IBM Global Services and AT Kearney Consulting
Advisory Expertise Microbiology, physics, market research, independent laboratory validation,
production design, CAD/CAM and specialty manufacturing, FDA regulatory, IP
Corporate Partners Product Resources Toxikon Corporation
Unmatched Performance Characteristics = Value
Proposition
Entry of novel, non-toxic process into healthcare market
Sterilization of reprocessed medical devices due to residual pathogens, bodily fluids or tissues
Prion destruction
Higher standard for low-temperature sterilization
WAVEPulse ™ fragments DNA and destroys pathogens
Unequalled10-10 Sterility Assurance Level exceeds existing processes
Fully-owned patents
ONEighty C Technologies
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WAVEPulse™ Sterilization
Contact information
Eric G. Walters
CEO and Co-Founder
(978) 505-7339
www.oneightyc.com
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ONEighty C Technologies
WAVEPulse™ Sterilization