2. Overview: AVIcure BioScience, LLC.
• AVIcure develops, manufactures and markets patented medical devices for:
– Blood component pathogen reduction ( 10-6
sterilization )
– Immune System Stimulation
– Pulse Radio Frequency (Pain Relief)
• Founded in 2013
• Located in Bethlehem, PA
• Total employees: 8
• Capitalization:
– Funding from initial investors
– Private Placement
– Sale of Assets
– Corporate Sponsorship
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3. Company Strengths
• Deep pipeline addresses high need market segments:
– Blood pathogen reduction
– Immune system stimulation
• Strong IP position
• A strong management team and advisers with scientific and business expertise to
execute company business plan
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3 Private and Confidential
4. 4
The Blood Management Company
Confidential
AVIcure Focus
AVIcure designs, develops and
manufactures medical devices using
advanced ultraviolet light technology.
The devices, though different in
application, use ultraviolet light to
stimulate the immune system and
reduce blood borne pathogens providing
for both therapeutic and preventative
applications.
5. AVIcure Portfolio – focus on blood purification
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5 Private and Confidential
Product Indication Research Preclinical Clinical Trials Marketed
Market
Opportunity
HemaSterilizer™
Blood Pathogen
Inactivation
$2.5 Billion (US)
and $7.5 Billion
(Global)
ImmunoModulator Chronic viral infections
$12.3 Billion (US;
for Hepatitis C and
influenza)
AVIcure™ Device
Chronic
temporomandibular joint
(TMJ) pain and anterior
knee pain
$300 Million
(Global)
6. 6
The HemaSterilizer™
HemaSterilizer (HS) technology provides a medical device
platform designed to inactivate pathogens in Red Blood
Cell (CRBC) concentrates intended for transfusion using UV
light technology.
Confidential
Pipeline Products - HemaSterilizer™
7. Market Need: Blood Safety
Viral disease transmission
• Improved but still present
– <than 1:1M transfusions for HIV, 1:250,000 for hepatitis C,
and 1:500Kfor hepatitis B
• Emerging viruses
– Ebola virus, West Nile virus, human herpes virus 8, and
several small DNA viruses (TTV, SEN-V)
• Microbial contamination
• Approved inactivation protocols lacking
– No completely reliable method for pathogen inactivation in
donated blood components and whole blood in US
• Potential safety and blood component recovery issues
– Immune reactions, reduced RBC recovery and survival
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LACK OF ACCESS TO SAFE BLOOD WORLDWIDE
No completely reliable pathogen inactivation system available
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8. The HemaSterilizer™ Concept
• Device exposes concentrated red blood
cells (CRBC) to an Ultraviolet C (UVC) light
source
• Designed for use in a blood bank
• Uses proprietary design to minimize
handling and achieve sterilization
acceptance
• Initial Phase 1 bench testing
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10. Why the HemaSterilizer™ System Will Perform
• UVC was shown to reduce the levels of
purposely contaminated red cells with no
adverse effect.
• Initial inactivation goal is 5 Log with <1%
hemolysis.
• AVIcure’s Bench laboratory test results:
– RBC Concentration inactivation test
achieved 6 Log reduction with some
induced hemolysis.
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11. Comparison: HemaSterilizer vs.
Other RBC Sterilization Methods
• Uses known principles to
achieve inactivation without
drugs/chemicals
• Inactivates all known
viruses
• Excellent recovery and
survival of RBCs
• Relative ease of use
• Require potentially toxic
chemicals (PEN110,
Dimethylmethylene blue,
Riboflavin, Psoralen, S-303,
others)
• Immunogenicity (S-303)
• Lack of efficacy against
some pathogens (PEN110
against TTV and SEAN-V)
• Reduced RBC recovery and
survival
• Complicated use
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HemaSterilizer “Other” Systems
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12. Status & Next Steps
• Phase 1 prototype model available for testing
• Preclinical Studies
– Demonstrate inactivation of pathogenic (model) viruses >5 logs with
<1% hemolysis
– RBC recovery and survival after 42 days storage
– <1% hemolysis after 42 day standard storage
– Assess immunogenicity
• Clinical Studies with Sponsorship
– Phase I, II and III human clinical studies designed to demonstrate
safety
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13. 13
The ImmunoModulator™
First-in-class patented ImmunoModulator (IM) technology
designed to address life threatening RNA viruses,
“autoimmune” diseases (e.g. Psoriasis) and potentially
other illnesses by treating whole blood with ultraviolet
(UV) photopheresis
Confidential
Pipeline Products - ImmunoModulator™
14. Market Need: Hard-to-Treat Diseases
• Hepatitis C
– 3.2 million patients in U.S.
– 170 million patients worldwide
• Human HIV
– 1.1 million patients in U.S.
– 33.4 million patients worldwide
• H1N1/Influenza
– < 200,000 hospitalized in U.S. annually
– 3-5 million severe cases reported worldwide
• Psoriasis
– 4.5-7 million patients in U.S.
– 125 million patients worldwide
• MAP (Mycobacterium Avium Paratuberculosis)
– Role in Crohn disease (CD), Type 1 diabetes mellitus (T1DM) and Multiple Sclerosis
(MS)- first case of MAP eradication with cure of CD used UVBI
– Role in complex Regional Pain Syndrome (CRPS)
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TARGETS BLOOD-BORNE DISEASES SUCH AS HEPATITIS C, HIV/AIDS, H1N1
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15. The ImmunoModulator™ Concept
• IM device exposes the patient’s whole blood to an
Ultraviolet (UV) light source
– Treatment process involves removing a small amount
of blood (3-4%) from the patient, then exposing the
blood to a precise amount of UV energy for a precise
amount of time
– During treatment, UV exposed cells activate the
immune system resulting in immune modulation.
– After exposure, the blood is returned to the patient
through the same portal it was drawn from
– The treated blood stimulates immune system cells.
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16. The ImmunoModulator™ System
• ImmunoModulator (IM) technology developed to utilize broad band ultraviolet light
(200nm-400nm).
• Unlike conventional drug therapies that appear to be limited by a patient's ethnicity
and viral genotype, the IM is uniquely safe and highly effective for all ethnic groups
and viral genotypes
• Demonstrates favorable safety and efficacy profile of standard HCV and HIV
treatments
• No recorded severe adverse event (300 Procedures)
• Potentially viable alternative or adjunctive treatment for a wide range of pathogens,
“autoimmune” diseases and certain cancers
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FIRST-IN-CLASS DEVICE
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18. Clinical Studies/Data
Data to date:
• Hepatitis C
– Granted two IDE approvals by FDA for human non-responder trials
– Safety and efficacy data from first trial sufficient to initiate second
• Human HIV
– Early results suggest reduction in viral load and stable CD4 counts
• H1N1/Influenza A
– Pre-clinical research conducted at the request of the U.S. Food and
Drug Administration
– Initial results suggests device inhibited viruses and reduced
inflammation in the lungs
• Psoriasis
– Two HCV study patients had prior histories of moderate and severe
psoriasis. Both patients experienced long term reduced symptoms.
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STUDIES PREVIOUSLY CONDUCTED IN MULTIPLE INDICATIONS
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19. Future
• Influenza Study
• Mycobacterium Avian Complex (MAC) Study
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Mechanism of Action
• Viral Diseases
• Bacterial Diseases
• Immune Deficiencies such as Crohn's Disease and Psoriasis
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• Todd Kuenstner, CEO and Chief Medical Officer. Dr Kuenstner is a pathologist who is currently the
Medical Director or Clinical Laboratories at the Charleston Area Medical Center in Charleston, West
Virginia. Previously, he was the Director of Clinical Chemistry for Aurora Health Care in southeastern
Wisconsin. He received his pathology training at the Walter Reed Army Medical Center in Washington,
D.C.. In addition to being a practicing physician Dr. Kuenstner is an inventor and holds several patents
pertaining to non-invasive hemoglobin and carboxy-hemoglobin testing.
• Frank R. Bonanni, President. BS Chemistry from Fairleigh Dickinson University. Experience includes
Corporate Vice President International Development at CRBard, Inc., Vice President Business
Development and CEO at North American Sterilization and Packaging.
• Kenneth R. Cohen, Esq. General Counsel. Graduated from Rutgers University and New York University
School of Law. Kenneth R. Cohen is a member of the law firm of Davidson, Sochor, Ragsdale & Cohen,
LLC. His practice includes business law, estate planning, and administration, asset protection and elder
law with special emphasis in taxation.
• Dennis A. Losco, Vice President of Operations. Graduated from Fairleigh Dickinson with a BS degree in
Mechanical Engineering in 1967. Joining Superior Quartz Products in 1969 as head of their engineering
department, he has been designing medium pressure lamps for forty five years. Inventor of a platform
based multiple foil high current seal for medium pressure lamps. He has served as President of Superior
Quartz Products since 1995.
Confidential
Officers
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• Dennis J. Losco, Controller. Graduated from Farleigh Dickinson in 1991 with a degree in Business Management.
Joined Superior Quartz Products, Inc in 1991 and has held several positions of increasing responsibility, including
Director of Sales and Corporate Treasurer. Assumed responsibility of controller at AVIcure in 2013.
• Jeffry W. Losco, Vice President of Mechanical Engineering. Lafayette College - 1993 - BS Mechanical Engineering.
Superior Quartz Products - 1988-Present - VP and Director of Engineering. Co-Inventor of Patent for Cup Seal
Design for Foil-less high current medium pressure lamp. Co-Inventor of Patent for Discharge Lamp with Self
Supporting Electrode Structures. Avicure Bioscience - 2013-Present - Vice President of Mechanical Engineering
and Chairman of Science Committee.
• Joseph W Losco, Vice President of Electrical Engineering. Graduated from Bucknell University, Cum Laude, with a
degree in Electrical Engineering in 2004. After graduation began working at Superior Quartz Products, Inc. as the
Director of Electrical Engineering. In 2013, he joined AVIcure as Vice President of Electrical Engineering.
• Roger R. Marvinney Sr., Vice President of Marketing. Over 20 years of building sales and marketing organizations
in Silicon Valley high technology companies with an initial background in corporate finance at a global NY
financial institution. Mr. Marvinney has established a very successful record in venture funded start-ups and is
responsible for developing North American Sterilization and Packaging's core business as well as building the new
medical device technology incubator business for North American Sterilization and Packaging.
• Thomas Petrie, Vice President of Technology. The inventor of the ImmunoModulator and HemaSterilizer
technologies. He has spent his entire career in the medical device industry where he has held senior management
positions at Becton Dickenson, Data Scope, and Personal Diagnostics. His involvement with UVBI technologies
exceeds 20 years.
Confidential
Officers
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• Preston A. Marx, PhD. He is a Professor of Tropical Medicine at the Tulane School of Public
Health and Tropical Medicine, the Tulane National Primate Research Center, and a member of the
AIDS Research Advisory Committee, National Health Institute.
• Dr. Konstantin “Gus” Kousoulas, PhD. He is the Director of Biotechnology and Molecular
Medicine (BIOMMED) at Louisiana State University, School of Veterinary Medicine and the LSU-
Tulane NIH COBRE Center for Experimental Infectious Disease Research.
• Noshir Mehta Professor and Chair. Asst Dean at Tufts Dental School; Assoc. Dean International
Relations; Chair. General Dentistry and Director Craniofacial Pain center at Tufts University School
of Dental Medicine
• Stuart Weg, MD. Stuart Weg, MD has 30 years' experience in anesthesiology and pain
management. His practice evolved from mainstream pain management to use alternative
therapies to treat many chronic diseases and other types of imbalances that have been difficult to
treat effectively with conventional medicine. Dr. Weg received his medical doctorate from the
University of Monterrey in Mexico and completed an internship at Memorial Sloan Kettering
Cancer Center as well as an anesthesia residency at Beth Israel Hospital Medical Center with the
New York Mount Sinai Medical School. He also completed a preceptorship in Invasive Pain
Management under the Chair of Anesthesiology at Texas Tech University.
Confidential
Advisers
