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Business Venture Proposal
www.avicure.com
2701 Baglyos Circle, Suite B
Bethlehem, PA 18020
TEL: 610-317-3460
Contact: Mr. Frank Bonanni, President
inquiries@avicure.com
2
About AVIcure
AVIcure Bioscience, L.L.C. is a limited liability company organized under the laws of the State
of New Jersey. We are a medical device company focused on the design, development and
commercialization of products to alleviate symptoms of autoimmune and infectious
diseases.
AVIcure's medical devices incorporate leading-edge clinical research and proprietary
ultraviolet blood irradiation (UVBI) technology. Our flagship product—the
ImmunoModulator™ has been shown to diminish symptoms and potentially result in
profound remission for victims of certain disorders traditionally considered autoimmune
(and thus “incurable” to date) and diseases with bacterial or viral origins.
This patented technology has demonstrated substantial and promising therapeutic
potential to successfully treat a large and growing patient population in the United States
and beyond, and merits further FDA clinical testing. We seek $20 million (USD) to fund two
clinical studies focusing on Crohn’s Disease (CD) in exchange for a twenty-percent share of
AVIcure. Investment and expense projections may be reviewed in the attached “Proceeds
Use Document”.
This Business Venture Proposal offers a basic overview for interested investors.
Superior Quartz Products, Inc (SQP-Bethlehem, PA) serves as AVIcure’s product
development, testing, prototype manufacturing and administrative facility. SQP is also the
inventor and manufacturer of the highly advanced proprietary ultraviolet bulbs used in
AVIcure products.
Our mission is to design and deliver cost-effective, minimally invasive medical devices
designed to alleviate symptoms of autoimmune and infectious diseases, and ensure the
quality and reliability of human blood supplies worldwide.
Research Studies Completed to Date for AVIcure’s ImmunoModulator™
AVIcure is seeking investment funding to conduct clinical trials of the ImmunoModulator™. These studies will test the
effectiveness of the device on CD (and secondarily on other disorders including Complex Regional Pain Syndrome
(CRPS), Influenza A, Hepatitis B, Hepatitis C and other diseases with similar bacterial or viral origins).
Please note: some prior clinical trials of the ImmunoModulator™ were conducted with successful results by Energex,
the company whose assets were purchased entirely by AVIcure. (See details elsewhere in this Proposal). These trials
will be used in part as a basis for AVIcure to continue human trials for both bacterial and viral indications.
The trials that AVIcure plans to conduct are addressed in the Operations Section of our Detailed Proposal, and are
available upon a qualified request.
After successfully passing US FDA Phase 1 and Phase 2 clinical trials, the ImmunoModulator™ may represent
significant potential for the relief of and/or profound remission of the symptoms of CD, CRPS, Hepatitis C and
diseases traditionally considered autoimmune, offering a minimally invasive, non-biologic therapy that’s effective,
cost-efficient and convenient.
Our machines have the
potential to create a
profound remission — if
not cure outright —
several diseases
traditionally considered
autoimmune that were
once thought to be
‘incurable.’
Other therapeutic
approaches merely seek
to manage and
mitigate the
debilitating and costly
symptoms of disorders
like Crohn’s Disease.
That’s simply not good
enough anymore. Even
the most modern
biologics and
pharmaceuticals, used
in isolation of UVBI, are
still far too expensive
and years away from
widespread accessibility
to patients suffering
worldwide.
We can do better. And
we will.
--J. Todd Kuenstner,
3
AVIcure’s Breakthrough Medical Device Technology
Chairman, Chief Medical Officer, and co-founder of AVIcure Bioscience, Dr. J. Todd Kuenstner had a very personal
stake in the search for, if not a cure, what he refers to as a “profound remission” in CD: Two young members of his
own family suffered from its symptoms. A pathologist and researcher at a university teaching hospital, Dr. Kuenstner
put his passion for solving the CD puzzle and his physician’s background to work. His unique background and goal of
developing a better, long-term answer for CD ultimately led him to the same technology proven by Dr. Emmett Knott,
long before the dawn of antibiotics: Ultraviolet Blood Irradiation (UVBI).
“Phototherapy” or “Photobiolumination,” as it was called in the early 20th Century, was successfully used to treat
Lupus Vulgaris or tuberculosis of the skin by Dr. Niels Finsen, who won the Nobel Prize for Physiology and Medicine
in 1903. Nine hundred patients were treated by Dr. Finsen with remarkable results. Then in 1928, Dr. Emmett Knott’s
U.S.-patented “Means for Treating Blood-Stream Infection” resulted in his “Knott Hemo-Irradiator” that incorporated
a rudimentary ultraviolet bulb, vacuum extraction system and a cuvette. The device was used from the 1930s through
the 1950s on thousands of patients with various infectious diseases, with multiple reports in accredited U.S. medical
literature of positive patient outcomes.
This proven UVBI application is core to AVIcure’s medical devices—while featuring far more sophisticated and
effective engineering and manufacturing technology. AVIcure’s ImmunoModulator™ is also designed to capitalize on
promising current medical research implicating the gut bacterium Mycobacteriuim avium subspecies
paratuberculosis (MAP) as the cause of CD and possibly other debilitating autoimmune (AI) disorders. Although a
variety of antibiotics with antimycobacterial properties are having a more positive effect on CD symptoms than at
any time in history, antibiotic regimens alone are thus far proving inadequate.
AVIcure sought to most effectively meld the most promising anti-MAP pharmaceuticals with UVBI to combat CD and
other AI disorders. Doing so requires a medical device that would pass muster under the US Food and Drug
Administration’s (FDA) stringent medical device regulations—regulations that didn’t exist during the mid-twentieth
century success of the rudimentary “Knott Hemo-Irradiator.” Co-Founder and AVIcure V.P. of Engineering Thomas
Petrie provided the answer. Incorporating modern materials and engineering practices, along with proprietary
ultraviolet bulb technology from Superior Quartz Products, Petrie designed the ImmunoModulator™.
AVIcure ImmunoModulator™: Our Flagship Product
Developed over five years and incorporating six significant proprietary, patented design and
engineering features, the ImmunoModulator™ is our flagship medical device. It is not just
first in its class, but unequivocally best in its class in the field of UVBI devices designed to treat
whole blood with ultraviolet photopheresis. Early-stage studies demonstrate that the
ImmunoModulator™ mitigates symptoms of bacterial and viral infectious diseases and
autoimmune diseases, including Complex Regional Pain Syndrome (CRPS).
The device integrates substantial proprietary AVIcure technology. More than two years were devoted just to the
design and testing of the ImmunoModulator™’s unique ultraviolet lamp. This lamp, developed and patented by our
manufacturing partner, Superior Quartz Products, is the core technology of the device, designed to generate what
are considered to be optimal germicidal wavelengths between 200 nanometers (nm) and 400 nm.
In addition, cofounder Thomas Petrie also devoted hundreds of hours of research and testing to create a unique
diffusion chamber to maximize the exposure of the patient’s blood to the UV germicidal lamp. That diffusion
chamber, in combination with an integrated peristaltic pump that regulates blood flow through the device,
guarantees rapid treatment and minimal patient inconvenience. A disposable closed circuit IV kit ensures safe blood
drawing and reinfusion to the patient. The entire device has been engineered to perform with less than 0.07% red
4
cell hemolysis during the entire brief treatment— less than the body’s natural hemolysis rate. Treatment protocols
range from one treatment per week to biweekly treatments over three to four months depending upon the
monitored results.
The ImmunoModulator™ utilizes a safe and simple procedure that is minimally inconvenient to the patient, which
also means the treatments can be highly affordable. Each treatment is a 20-minute procedure intended to be
administered on an outpatient basis. Treatments are autologous (using the subject’s own blood) and require a blood
withdrawal of 1.5 ml per pound to a maximum of 250 ml— roughly half the amount of blood drawn during a typical
1 pint blood donation. The drawn blood is processed through the ImmunoModulator™, where it is exposed to a
precise amount of UV light. During the process, pathogens are inactivated. The treated blood is then reinfused into
the patient.
This device demonstrates a favorable safety and efficacy profile with no adverse effects and is far less expensive than
current conventional pharmaceutical-based therapies. Multiple published reports indicate efficacy of the
ImmunoModulator™ against a wide range of pathogens.
The science and studies behind AVIcure’s ImmunoModulator™ UVBI technology can offer a meaningful alternative
to antibiotic therapy for patients suffering from bacterial, viral and autoimmune disease symptoms.
Decades of laboratory research and clinical studies support and explain its efficacy against bacterial and viral
infections. When irradiated by UV light, bacterial or viral DNA forms “thymine dimers,” molecular lesions that prevent
further replication of those targeted microbes. When applied to ribonucleic acid (RNA)-based viruses, UV light induces
the formation of molecular lesions known as “uracil dimers” which also prevent further viral replication. Normal
lymphocytes and, it is presumed, other blood cells can repair that damage.
Since the dawn of antibiotics, as the history of modern medical history reflects, pharmaceuticals have ruled the
infectious disease—and more recently, the autoimmune disorders-- therapies market while device-based treatments
have faded rapidly in popularity. Even proven, cost-effective technologies like UVBI were largely forgotten in favor of
pills, syrups and injections. AVIcure’s ImmunoModulator™ could offer a significantly more effective, cost-efficient
alternative to that current “default” medical response protocol for bacterial, viral and
autoimmune diseases.
Virtually every patient diagnosed with CRPS, CD, Rheumatoid Arthritis, Multiple Sclerosis,
Psoriasis, Ulcerative Colitis, type 1 diabetes mellitus, Systemic Lupus Erythematosus, or other
debilitating disorder has heard the term autoimmune disease used to describe their illness.
Medically speaking, the term autoimmune (AI) disease is a categorical, rather than a specific
clinical description for roughly 80 different disorders that affect about 50 million Americans
and tens of millions more worldwide. AI disorders develop when the body’s immune system
attacks healthy body cells. The resulting symptoms can range from relatively modest (for
example, mild psoriasis) to crippling pain—as in many patients who suffer from CRPS, CD,
Rheumatoid Arthritis and other chronic illnesses.
Unfortunately, this categorical description of so many different disorders with so many
diverse and debilitating symptoms masks a simple medical fact: We don’t know with
certainty what actually causes AI disorders. Thus, AI disease has become a catch-all term, used to classify a
dismayingly wide range of disorders with an equally discouragingly large number and variety of symptoms.
According to the Crohn’s and Colitis Foundation of America, the estimated direct cost for all patients with
inflammatory bowel diseases (IBD) alone in the US is $1.84 billion. In the United States, 1.4 million suffer with the
We believe that the
ImmunoModulator™
in combination with
the right anti-MAP
antibiotics can
actually create what is
in effect a
“personalized vaccine”
from a small amount
of the infected Crohn’s
Disease patient’s
blood.
--Dr. J. Todd Kuenstner
5
most common CD symptoms, including abdominal pain, persistent diarrhea, rectal bleeding, fever and weight loss.
Many patients require numerous hospitalizations and surgery.
AI diseases are considered incurable. The most fortunate patients — those who can afford the escalating costs of
health insurance and conventional pharmaceutical therapy — can only look forward to the better management and
mitigation of the painful symptoms and the unpredictable nature of CRPS, CD and other disorders. The less fortunate,
lacking either the financial resources or the geographic proximity to best-in-class medical care, will likely continue to
tolerate pain, discomfort, embarrassment and psychological and mental drain that invariably result from AI
symptoms.
US Clinical Study using the ImmunoModulator™
Hepatitis C clinical trials in two human studies with over 200 human treatments were completed using the
ImmunoModulator™. The trials were established to prove the safety and efficacy of the ImmunoModulator™ on a
standalone basis. The summary of observations reflected improvement in viral load, improvement in liver enzymes
and a reduction in liver inflammation. UVBI was determined to be safe and had a beneficial effect in the treatment
of HCV. In addition, it was determined that this device potentially should be studied for use in psoriasis and with
infectious diseases that have few treatment options. As a result of these tests, the FDA approved the
ImmunoModulator™ for the next level of human testing.
US Animal Studies using the ImmunoModulator™
H1N1 Influenza research conducted at the request of the FDA in a mouse model significantly diminished morbidity
and mortality in ImmunoModulator™- treated mice. The infected mice showed little or no injury after treating them
with blood processed by the ImmunoModulator™
Simian Immunodeficiency virus (SIV) monkeys infected with SIV (similar to HIV) demonstrated significant viral load
reduction after ImmunoModulator™ treatments.
Other AVIcure Products: The HemaSterilizer™ System and the PRFD™ (Pulsed Radio Frequency Device)
AVIcure anticipates marketing the HemaSterilizer™ worldwide as the first chemical-free blood sterilization UVBI
device with a 99.99% success rate in the inactivation of pathogens and one that can help prevent the spread of
viruses—including Ebola, West Nile, and human herpes virus and several small DNA virus strains (TTV-SEN-V).
Existing systems used to minimize blood pathogens are often complicated to use and sometimes utilize potentially
toxic chemicals such as dimethylmethylene blue, psoralen, S-303 and others. And some medical devices currently in
use lack efficacy when used to inactivate PEN110, TTV and SEN-V, dangerous pathogens. AVIcure’s benchtop device
is simple to operate and maintain, and in keeping with our commitment to UVBI devices that are innovative, effective
and affordable, will be marketed at a price accessible to blood banks and drawing centers worldwide. It irradiates
blood in the C band to inactivate viral and bacterial organisms that might be present in donated blood. A disposable
kit exposes donated blood from donor bags through the HemaSterilizer™ and back into a new donor bag.
AVIcure PRFD™ (Pulsed Radio Frequency Device) is a patented, FDA-approved device proven to be safe and effective
in the relief of chronic temporomandibular joint (TMJ) dysfunction and chronic anterior knee pain. This device utilizes
unique pulsed radio frequency energy waves to create low-level electronic stimulation in tissue. Results of two
randomized, double-blind placebo controlled studies conducted at Tufts University demonstrated that subjects
treated with the AVIcure PRFD had significant improvement in pain and range-of-motion when compared to subjects
that received a placebo treatment. AVIcure plans to license and/or sell the rights to manufacture and distribute this
unique FDA-approved device in domestic and international markets.
6
Trademarks & Patents
Energex Systems, Inc., ImmunoModulator™ and HemaSterilizer™, PRFD™ are trademarks owned by AVIcure
Bioscience, LLC.
AVIcure Leadership Team
Dr. Todd Kuenstner, M.D., Chairman and Chief Medical Officer (Founder) Dr. Kuenstner is a pathologist and the
Director of Clinical Laboratories at Charleston Area Medical Center in Charleston, West Virginia. He holds several
patents in the area of noninvasive hemoglobin monitoring, noninvasive carbon monoxide monitoring, and two
pending patents for the use of UVBI to induce profound remission/possible cure in MAP infections.
Frank Bonanni, President (Founder) A specialist in healthcare product development and startups, Mr. Bonanni has
held executive positions at C.R. Bard Medical Corporation, Murray Hill, NJ and North American Sterilization and
Packaging Co.
Thomas Petrie, Vice President, Engineering (Founder) Mr. Petrie designed and holds the patents for AVIcure’s
ImmunoModulator™, and pending patents for the HemaSterilizer™. Mr. Petrie’s responsibilities include product
development, project management, research and development and overseeing AVIcure’s contract engineering and
manufacturing operations.
Dennis Losco, Treasurer (Founder) Mr. Losco has been the President and CEO of Superior Quartz Products since 1995.
A mechanical engineer, he has designed over 10,000 medium pressure mercury and metal halide ultraviolet lamps
over the last 46 years.
Kenneth R. Cohen, General Counsel (Founder) Mr. Cohen is a member of the law firm of Davidson, Sochor, Ragsdale
& Cohen, LLC in Elmwood Park, New Jersey.
Roger Marvinney, Vice President, Marketing (Founder)
Mr. Marvinney is currently employed with North American Sterilization and Packaging Company (NASP) as VP Sales
and Marketing and is responsible for business development, customer service, production planning, procurement,
and marketing for medical device manufacturing.
Legal Counsel Davidson, Sochor, Ragsdale & Cohen, LLC, Elmwood Park, N.J.
Patent attorneys: Lerner, David, Littenberg, Krumholz & Mentlik, LLP, Westfield, N.J.
DISCLAIMER: The AVIcure ImmunoModulator™, HemaSterilizer™ and Pulsed Radio Frequency Device™ are
investigational devices and have not been approved by the FDA for commercial distribution in the United States.
Proceeds Use Document
2016 2017 2018 3 Year totals
Revenue
Stock Sale 20,000,000.00$ 20,000,000.00$
Total Revenue 20,000,000.00$ 20,000,000.00$
Expenses
Phase 1 - Infrastructure Development
FDA Requirements 75,000.00$ 175,000.00$ 175,000.00$ 425,000.00$
Quality Program 100,000.00$ 175,000.00$ 175,000.00$ 450,000.00$
Legal/Attorney/Patent 350,000.00$ 100,000.00$ 100,000.00$ 550,000.00$
Phase 2 - Medical studies
Crohn's/MAP 1,200,000.00$ 975,000.00$ 750,000.00$ 2,925,000.00$
Psoriasis 750,000.00$ 750,000.00$ 500,000.00$ 2,000,000.00$
Complex Regional Pain -syndrome (Orphan Disease) 1,000,000.00$ 750,000.00$ 500,000.00$ 2,250,000.00$
Salaries 750,000.00$ 850,000.00$ 1,000,000.00$ 2,600,000.00$
Operational Expenses 150,000.00$ 200,000.00$ 300,000.00$ 650,000.00$
R&D Development
2nd Generation ImmunoModulator 250,000.00$ 500,000.00$ 1,500,000.00$ 2,250,000.00$
HemaSterilizer 500,000.00$ 1,500,000.00$ 3,000,000.00$ 5,000,000.00$
Consultants/Stipends 200,000.00$ 200,000.00$ 300,000.00$ 700,000.00$
Other Expenses 100,000.00$ 50,000.00$ 50,000.00$ 200,000.00$
Total Expenses 5,425,000.00$ 6,225,000.00$ 8,350,000.00$ 20,000,000.00$

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AVIcure Short Proposal

  • 1. Business Venture Proposal www.avicure.com 2701 Baglyos Circle, Suite B Bethlehem, PA 18020 TEL: 610-317-3460 Contact: Mr. Frank Bonanni, President inquiries@avicure.com
  • 2. 2 About AVIcure AVIcure Bioscience, L.L.C. is a limited liability company organized under the laws of the State of New Jersey. We are a medical device company focused on the design, development and commercialization of products to alleviate symptoms of autoimmune and infectious diseases. AVIcure's medical devices incorporate leading-edge clinical research and proprietary ultraviolet blood irradiation (UVBI) technology. Our flagship product—the ImmunoModulator™ has been shown to diminish symptoms and potentially result in profound remission for victims of certain disorders traditionally considered autoimmune (and thus “incurable” to date) and diseases with bacterial or viral origins. This patented technology has demonstrated substantial and promising therapeutic potential to successfully treat a large and growing patient population in the United States and beyond, and merits further FDA clinical testing. We seek $20 million (USD) to fund two clinical studies focusing on Crohn’s Disease (CD) in exchange for a twenty-percent share of AVIcure. Investment and expense projections may be reviewed in the attached “Proceeds Use Document”. This Business Venture Proposal offers a basic overview for interested investors. Superior Quartz Products, Inc (SQP-Bethlehem, PA) serves as AVIcure’s product development, testing, prototype manufacturing and administrative facility. SQP is also the inventor and manufacturer of the highly advanced proprietary ultraviolet bulbs used in AVIcure products. Our mission is to design and deliver cost-effective, minimally invasive medical devices designed to alleviate symptoms of autoimmune and infectious diseases, and ensure the quality and reliability of human blood supplies worldwide. Research Studies Completed to Date for AVIcure’s ImmunoModulator™ AVIcure is seeking investment funding to conduct clinical trials of the ImmunoModulator™. These studies will test the effectiveness of the device on CD (and secondarily on other disorders including Complex Regional Pain Syndrome (CRPS), Influenza A, Hepatitis B, Hepatitis C and other diseases with similar bacterial or viral origins). Please note: some prior clinical trials of the ImmunoModulator™ were conducted with successful results by Energex, the company whose assets were purchased entirely by AVIcure. (See details elsewhere in this Proposal). These trials will be used in part as a basis for AVIcure to continue human trials for both bacterial and viral indications. The trials that AVIcure plans to conduct are addressed in the Operations Section of our Detailed Proposal, and are available upon a qualified request. After successfully passing US FDA Phase 1 and Phase 2 clinical trials, the ImmunoModulator™ may represent significant potential for the relief of and/or profound remission of the symptoms of CD, CRPS, Hepatitis C and diseases traditionally considered autoimmune, offering a minimally invasive, non-biologic therapy that’s effective, cost-efficient and convenient. Our machines have the potential to create a profound remission — if not cure outright — several diseases traditionally considered autoimmune that were once thought to be ‘incurable.’ Other therapeutic approaches merely seek to manage and mitigate the debilitating and costly symptoms of disorders like Crohn’s Disease. That’s simply not good enough anymore. Even the most modern biologics and pharmaceuticals, used in isolation of UVBI, are still far too expensive and years away from widespread accessibility to patients suffering worldwide. We can do better. And we will. --J. Todd Kuenstner,
  • 3. 3 AVIcure’s Breakthrough Medical Device Technology Chairman, Chief Medical Officer, and co-founder of AVIcure Bioscience, Dr. J. Todd Kuenstner had a very personal stake in the search for, if not a cure, what he refers to as a “profound remission” in CD: Two young members of his own family suffered from its symptoms. A pathologist and researcher at a university teaching hospital, Dr. Kuenstner put his passion for solving the CD puzzle and his physician’s background to work. His unique background and goal of developing a better, long-term answer for CD ultimately led him to the same technology proven by Dr. Emmett Knott, long before the dawn of antibiotics: Ultraviolet Blood Irradiation (UVBI). “Phototherapy” or “Photobiolumination,” as it was called in the early 20th Century, was successfully used to treat Lupus Vulgaris or tuberculosis of the skin by Dr. Niels Finsen, who won the Nobel Prize for Physiology and Medicine in 1903. Nine hundred patients were treated by Dr. Finsen with remarkable results. Then in 1928, Dr. Emmett Knott’s U.S.-patented “Means for Treating Blood-Stream Infection” resulted in his “Knott Hemo-Irradiator” that incorporated a rudimentary ultraviolet bulb, vacuum extraction system and a cuvette. The device was used from the 1930s through the 1950s on thousands of patients with various infectious diseases, with multiple reports in accredited U.S. medical literature of positive patient outcomes. This proven UVBI application is core to AVIcure’s medical devices—while featuring far more sophisticated and effective engineering and manufacturing technology. AVIcure’s ImmunoModulator™ is also designed to capitalize on promising current medical research implicating the gut bacterium Mycobacteriuim avium subspecies paratuberculosis (MAP) as the cause of CD and possibly other debilitating autoimmune (AI) disorders. Although a variety of antibiotics with antimycobacterial properties are having a more positive effect on CD symptoms than at any time in history, antibiotic regimens alone are thus far proving inadequate. AVIcure sought to most effectively meld the most promising anti-MAP pharmaceuticals with UVBI to combat CD and other AI disorders. Doing so requires a medical device that would pass muster under the US Food and Drug Administration’s (FDA) stringent medical device regulations—regulations that didn’t exist during the mid-twentieth century success of the rudimentary “Knott Hemo-Irradiator.” Co-Founder and AVIcure V.P. of Engineering Thomas Petrie provided the answer. Incorporating modern materials and engineering practices, along with proprietary ultraviolet bulb technology from Superior Quartz Products, Petrie designed the ImmunoModulator™. AVIcure ImmunoModulator™: Our Flagship Product Developed over five years and incorporating six significant proprietary, patented design and engineering features, the ImmunoModulator™ is our flagship medical device. It is not just first in its class, but unequivocally best in its class in the field of UVBI devices designed to treat whole blood with ultraviolet photopheresis. Early-stage studies demonstrate that the ImmunoModulator™ mitigates symptoms of bacterial and viral infectious diseases and autoimmune diseases, including Complex Regional Pain Syndrome (CRPS). The device integrates substantial proprietary AVIcure technology. More than two years were devoted just to the design and testing of the ImmunoModulator™’s unique ultraviolet lamp. This lamp, developed and patented by our manufacturing partner, Superior Quartz Products, is the core technology of the device, designed to generate what are considered to be optimal germicidal wavelengths between 200 nanometers (nm) and 400 nm. In addition, cofounder Thomas Petrie also devoted hundreds of hours of research and testing to create a unique diffusion chamber to maximize the exposure of the patient’s blood to the UV germicidal lamp. That diffusion chamber, in combination with an integrated peristaltic pump that regulates blood flow through the device, guarantees rapid treatment and minimal patient inconvenience. A disposable closed circuit IV kit ensures safe blood drawing and reinfusion to the patient. The entire device has been engineered to perform with less than 0.07% red
  • 4. 4 cell hemolysis during the entire brief treatment— less than the body’s natural hemolysis rate. Treatment protocols range from one treatment per week to biweekly treatments over three to four months depending upon the monitored results. The ImmunoModulator™ utilizes a safe and simple procedure that is minimally inconvenient to the patient, which also means the treatments can be highly affordable. Each treatment is a 20-minute procedure intended to be administered on an outpatient basis. Treatments are autologous (using the subject’s own blood) and require a blood withdrawal of 1.5 ml per pound to a maximum of 250 ml— roughly half the amount of blood drawn during a typical 1 pint blood donation. The drawn blood is processed through the ImmunoModulator™, where it is exposed to a precise amount of UV light. During the process, pathogens are inactivated. The treated blood is then reinfused into the patient. This device demonstrates a favorable safety and efficacy profile with no adverse effects and is far less expensive than current conventional pharmaceutical-based therapies. Multiple published reports indicate efficacy of the ImmunoModulator™ against a wide range of pathogens. The science and studies behind AVIcure’s ImmunoModulator™ UVBI technology can offer a meaningful alternative to antibiotic therapy for patients suffering from bacterial, viral and autoimmune disease symptoms. Decades of laboratory research and clinical studies support and explain its efficacy against bacterial and viral infections. When irradiated by UV light, bacterial or viral DNA forms “thymine dimers,” molecular lesions that prevent further replication of those targeted microbes. When applied to ribonucleic acid (RNA)-based viruses, UV light induces the formation of molecular lesions known as “uracil dimers” which also prevent further viral replication. Normal lymphocytes and, it is presumed, other blood cells can repair that damage. Since the dawn of antibiotics, as the history of modern medical history reflects, pharmaceuticals have ruled the infectious disease—and more recently, the autoimmune disorders-- therapies market while device-based treatments have faded rapidly in popularity. Even proven, cost-effective technologies like UVBI were largely forgotten in favor of pills, syrups and injections. AVIcure’s ImmunoModulator™ could offer a significantly more effective, cost-efficient alternative to that current “default” medical response protocol for bacterial, viral and autoimmune diseases. Virtually every patient diagnosed with CRPS, CD, Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis, Ulcerative Colitis, type 1 diabetes mellitus, Systemic Lupus Erythematosus, or other debilitating disorder has heard the term autoimmune disease used to describe their illness. Medically speaking, the term autoimmune (AI) disease is a categorical, rather than a specific clinical description for roughly 80 different disorders that affect about 50 million Americans and tens of millions more worldwide. AI disorders develop when the body’s immune system attacks healthy body cells. The resulting symptoms can range from relatively modest (for example, mild psoriasis) to crippling pain—as in many patients who suffer from CRPS, CD, Rheumatoid Arthritis and other chronic illnesses. Unfortunately, this categorical description of so many different disorders with so many diverse and debilitating symptoms masks a simple medical fact: We don’t know with certainty what actually causes AI disorders. Thus, AI disease has become a catch-all term, used to classify a dismayingly wide range of disorders with an equally discouragingly large number and variety of symptoms. According to the Crohn’s and Colitis Foundation of America, the estimated direct cost for all patients with inflammatory bowel diseases (IBD) alone in the US is $1.84 billion. In the United States, 1.4 million suffer with the We believe that the ImmunoModulator™ in combination with the right anti-MAP antibiotics can actually create what is in effect a “personalized vaccine” from a small amount of the infected Crohn’s Disease patient’s blood. --Dr. J. Todd Kuenstner
  • 5. 5 most common CD symptoms, including abdominal pain, persistent diarrhea, rectal bleeding, fever and weight loss. Many patients require numerous hospitalizations and surgery. AI diseases are considered incurable. The most fortunate patients — those who can afford the escalating costs of health insurance and conventional pharmaceutical therapy — can only look forward to the better management and mitigation of the painful symptoms and the unpredictable nature of CRPS, CD and other disorders. The less fortunate, lacking either the financial resources or the geographic proximity to best-in-class medical care, will likely continue to tolerate pain, discomfort, embarrassment and psychological and mental drain that invariably result from AI symptoms. US Clinical Study using the ImmunoModulator™ Hepatitis C clinical trials in two human studies with over 200 human treatments were completed using the ImmunoModulator™. The trials were established to prove the safety and efficacy of the ImmunoModulator™ on a standalone basis. The summary of observations reflected improvement in viral load, improvement in liver enzymes and a reduction in liver inflammation. UVBI was determined to be safe and had a beneficial effect in the treatment of HCV. In addition, it was determined that this device potentially should be studied for use in psoriasis and with infectious diseases that have few treatment options. As a result of these tests, the FDA approved the ImmunoModulator™ for the next level of human testing. US Animal Studies using the ImmunoModulator™ H1N1 Influenza research conducted at the request of the FDA in a mouse model significantly diminished morbidity and mortality in ImmunoModulator™- treated mice. The infected mice showed little or no injury after treating them with blood processed by the ImmunoModulator™ Simian Immunodeficiency virus (SIV) monkeys infected with SIV (similar to HIV) demonstrated significant viral load reduction after ImmunoModulator™ treatments. Other AVIcure Products: The HemaSterilizer™ System and the PRFD™ (Pulsed Radio Frequency Device) AVIcure anticipates marketing the HemaSterilizer™ worldwide as the first chemical-free blood sterilization UVBI device with a 99.99% success rate in the inactivation of pathogens and one that can help prevent the spread of viruses—including Ebola, West Nile, and human herpes virus and several small DNA virus strains (TTV-SEN-V). Existing systems used to minimize blood pathogens are often complicated to use and sometimes utilize potentially toxic chemicals such as dimethylmethylene blue, psoralen, S-303 and others. And some medical devices currently in use lack efficacy when used to inactivate PEN110, TTV and SEN-V, dangerous pathogens. AVIcure’s benchtop device is simple to operate and maintain, and in keeping with our commitment to UVBI devices that are innovative, effective and affordable, will be marketed at a price accessible to blood banks and drawing centers worldwide. It irradiates blood in the C band to inactivate viral and bacterial organisms that might be present in donated blood. A disposable kit exposes donated blood from donor bags through the HemaSterilizer™ and back into a new donor bag. AVIcure PRFD™ (Pulsed Radio Frequency Device) is a patented, FDA-approved device proven to be safe and effective in the relief of chronic temporomandibular joint (TMJ) dysfunction and chronic anterior knee pain. This device utilizes unique pulsed radio frequency energy waves to create low-level electronic stimulation in tissue. Results of two randomized, double-blind placebo controlled studies conducted at Tufts University demonstrated that subjects treated with the AVIcure PRFD had significant improvement in pain and range-of-motion when compared to subjects that received a placebo treatment. AVIcure plans to license and/or sell the rights to manufacture and distribute this unique FDA-approved device in domestic and international markets.
  • 6. 6 Trademarks & Patents Energex Systems, Inc., ImmunoModulator™ and HemaSterilizer™, PRFD™ are trademarks owned by AVIcure Bioscience, LLC. AVIcure Leadership Team Dr. Todd Kuenstner, M.D., Chairman and Chief Medical Officer (Founder) Dr. Kuenstner is a pathologist and the Director of Clinical Laboratories at Charleston Area Medical Center in Charleston, West Virginia. He holds several patents in the area of noninvasive hemoglobin monitoring, noninvasive carbon monoxide monitoring, and two pending patents for the use of UVBI to induce profound remission/possible cure in MAP infections. Frank Bonanni, President (Founder) A specialist in healthcare product development and startups, Mr. Bonanni has held executive positions at C.R. Bard Medical Corporation, Murray Hill, NJ and North American Sterilization and Packaging Co. Thomas Petrie, Vice President, Engineering (Founder) Mr. Petrie designed and holds the patents for AVIcure’s ImmunoModulator™, and pending patents for the HemaSterilizer™. Mr. Petrie’s responsibilities include product development, project management, research and development and overseeing AVIcure’s contract engineering and manufacturing operations. Dennis Losco, Treasurer (Founder) Mr. Losco has been the President and CEO of Superior Quartz Products since 1995. A mechanical engineer, he has designed over 10,000 medium pressure mercury and metal halide ultraviolet lamps over the last 46 years. Kenneth R. Cohen, General Counsel (Founder) Mr. Cohen is a member of the law firm of Davidson, Sochor, Ragsdale & Cohen, LLC in Elmwood Park, New Jersey. Roger Marvinney, Vice President, Marketing (Founder) Mr. Marvinney is currently employed with North American Sterilization and Packaging Company (NASP) as VP Sales and Marketing and is responsible for business development, customer service, production planning, procurement, and marketing for medical device manufacturing. Legal Counsel Davidson, Sochor, Ragsdale & Cohen, LLC, Elmwood Park, N.J. Patent attorneys: Lerner, David, Littenberg, Krumholz & Mentlik, LLP, Westfield, N.J. DISCLAIMER: The AVIcure ImmunoModulator™, HemaSterilizer™ and Pulsed Radio Frequency Device™ are investigational devices and have not been approved by the FDA for commercial distribution in the United States.
  • 7. Proceeds Use Document 2016 2017 2018 3 Year totals Revenue Stock Sale 20,000,000.00$ 20,000,000.00$ Total Revenue 20,000,000.00$ 20,000,000.00$ Expenses Phase 1 - Infrastructure Development FDA Requirements 75,000.00$ 175,000.00$ 175,000.00$ 425,000.00$ Quality Program 100,000.00$ 175,000.00$ 175,000.00$ 450,000.00$ Legal/Attorney/Patent 350,000.00$ 100,000.00$ 100,000.00$ 550,000.00$ Phase 2 - Medical studies Crohn's/MAP 1,200,000.00$ 975,000.00$ 750,000.00$ 2,925,000.00$ Psoriasis 750,000.00$ 750,000.00$ 500,000.00$ 2,000,000.00$ Complex Regional Pain -syndrome (Orphan Disease) 1,000,000.00$ 750,000.00$ 500,000.00$ 2,250,000.00$ Salaries 750,000.00$ 850,000.00$ 1,000,000.00$ 2,600,000.00$ Operational Expenses 150,000.00$ 200,000.00$ 300,000.00$ 650,000.00$ R&D Development 2nd Generation ImmunoModulator 250,000.00$ 500,000.00$ 1,500,000.00$ 2,250,000.00$ HemaSterilizer 500,000.00$ 1,500,000.00$ 3,000,000.00$ 5,000,000.00$ Consultants/Stipends 200,000.00$ 200,000.00$ 300,000.00$ 700,000.00$ Other Expenses 100,000.00$ 50,000.00$ 50,000.00$ 200,000.00$ Total Expenses 5,425,000.00$ 6,225,000.00$ 8,350,000.00$ 20,000,000.00$