BIOFEST INVEST APPLICANT
Vascular Perfusion Solutions, Inc.
Legal Entity Type: C-Corp
Company Type: Medical Device
Company Stage: Development
No. of Employees: 10
Desired Financial Amount: $5M Series A / Total Amount for commercialization $24M
Vascular Perfusion Solutions, Inc. (VPS) was established in 2016 by licensing a vascular perfusion system to preserve limbs, invented by Professor Leonid Bunegin from the University of Texas System. VPS in collaboration with the 59th Medical Wing and UT Health received a $1M DOD grant to study the long-term preservation of porcine limbs using the technology invented by professor Bunegin. VPS started raising funds to continue to develop the technology and develop new intellectual property moving beyond limbs and expanding into organ preservation. VPS has now 7 patents on its own to preserve organs and is currently working on commercializing its first product for prolonged cardiac preservation. The VP.S ENCORE® Cardiac Preservation device is currently under preclinical testing and once it receives FDA approval, it will be the only device on the market for prolonged heart preservation for heart transplantation.
Rafael J Veraza- CEO & President: Scientist and entrepreneur with over 15 years of experience, focused on the commercialization of biotechnology, innovative medical devices, and healthcare innovation. Dr. Veraza’s scientific team led the company to receive FDA Breakthrough Device Designation for their cardiac transport device and are currently undergoing pre-clinical animal testing in preparation for Clinical Trials in the US. Under Dr. Veraza’s leadership, the company has received funding from DARPA in collaboration with the Wyss Institute at Harvard to test the use of novel compounds in inducing hibernation-like states for prolonged organ preservation. Dr. Veraza has a bachelor’s degree in biology from the Honors College at UTSA, a Master’s in Public Health from Emory University and a PhD in Translational Science from the joint PhD program between UT Health San Antonio, UT Austin, and UTSA. Israel Jessop, MS- Director of Engineering: 23 years of experience in medical device design and development. A former engineer at J&J, LifeCell (Abbvie), 19 issued patents with additional patent applications still pending. Kristina Andrijauskaite, PhD, MS, MEd- Scientific Director: Over 15 years of multidisciplinary research experience including organ preservation, cancer, and space exploration. She has made significant contributions toward translating in-vitro and in-vivo findings into clinical trials. Michelle D. Watt, RN- Clinical Director: Her responsibilities include oversight of all clinical operations, as well as managing human resources and accounts payable. She has over ten years of experience in Nursing and Nursing management within a large metropolitan hospital system including both bedside and operational management experience. She has served on multiple committees in both corporate and hospital settings. Kurt Dasse, PhD- Clinical and Regulatory Consultant – Over 30 years developing and commercializing medical devices in the cardiovascular space including the first implantable left ventricular assist device (HeartMate 1000 IP) for end-stage heart-failure patients.
Board of directors
Tom DeBrooke- Chairman of the Board/Co-Founder of VPS – Harvard MBA, Serial Entrepreneur Leonid Bunegin- Co-Founder of VPS, Retired professor of Anesthesiology from UT Health San Antonio, over 40 years of experience in research and development of medical devices. Mark Muller- Retired Patent Attorney Schwegaman, Lundberg and Woessner, Electrical Engineer at Southwest Research Institute Celia Jairala- Member of the board and director at TXMCD Corporation Klaus Weiswurm- Founder of Innovation Technology Machinery Rafael J Veraza, PhD, MPH- CEO & President at VPS. Over 15 years of experience in biotechnology research and medical device commercialization.
Product / Service
disease area / application
Heart Transplants, Regenerative Medicine, Organ Transplant
product / Service
VPS vision: Preserving organs on-demand to solve the global organ shortage, currently preserved with ice-filled coolers and complex expensive technology. Goal: Become the standard of care for preserving organs, starting with heart transplants. Problem: In the United States, more than 100,000 patients are on the organ transplant waiting list. The standard of care is an ice-filled cooler, which limits transport time to only 4 hours for a heart. Given the limited time, around 17 heart failure patients die every day in the U.S. waiting for a life-saving transplant. Solution: Extend Viability and Limit Ischemic Injury Time & superior preservation are essential for reducing global organ shortage. The VP.S ENCORE™ hypothermic oxygenated machine perfusion device can preserve cardiac tissue for up to 24 hours and beyond based on preclinical testing. Our technology goes beyond medical devices, we have also demonstrated the use of our technology to test drugs for pharma and biotech as a service to generate revenue. We have two business pillars: 1) Medical Device Platform Technology- Start with the heart and then target the kidney, liver, and lungs. 2) Contract Research Service using our proprietary perfusion technology to preserve organs outside of the body and test drugs to derisk the drug development process for biotech and pharma.
technology / ip
We have 7 filled patents protecting our technology around organ preservation. VP.S ENCORE® is Unparalleled in Three Significant Ways: Portability | While most machine perfusion devices in the market are large and complex, the VP.S ENCORE® is truly portable. Ease of Use | No need for blood, blood products or complex perfusate solutions. Accessibility | The competition’s device costs $250K with a replacement cartridge priced at more than $65K. In contrast, VP.S ENCORE® will sell at a fraction of the cost of other devices.
We intend to license our technology or get acquired by one of the large organ preservation companies currently in the market. Contract Preclinical Research: Working with sales reps and through our network of collaborators.
Organ Preservation Market: $1.3B (USA) growth at 5% CAGR Contract Preclinical Research Market: $2B (USA) 10% CAGR Total Market: $3.3B (Combining both business pillars)
Paragonix Sherpa Pak- Static Cold Storage- FDA-approved for heart preservation for up to 4 hours. Not active perfusion, it’s a styrofoam cooler with thermal control. Price $15K Transmedics Organ Care System- Normothermic Preservation of the heart. FDA-approved for only extended criteria hearts and DCD hearts. Clinical Trial results demonstrated lower survival of patients using the OCS compared to the standard of care (hearts preserved in the ice cooler) for standard criteria hearts. Cost: $200k per machine plus $85K per single-use cartridge, requires up to 5 people to operate. Publicly traded TMDX Market Cap: $2B XVIVO Perfusion- Hypothermic oxygenated perfusion – In development, the machine uses active cooling, heavy, complex perfusate solution using cocaine. High regulatory burden. Lung device costs $200K. Not approved by the FDA.
Desired financial amount
$5M Series A / Total Amount for commercialization $24M
Pre-Seed/Seed: $6.6M Series A- $1M/5M Grants: $1.5M
Burn Rate: $180k/month Available Cash: $1.5M
$5M Series A is to complete the engineering development of the VP.S ENCORE® device for the GLP Animal transplant study. Complete and submit data to the FDA on the GLP Animal Transplant Study at Texas Heart Institute and begin the clinical trial design for the early feasibility clinical trial.
The VP.S ENCORE® device will be sold as part of the organ acquisition cost to the Organ Procurement Organization (57) and/or Transplant Center (35 centers). The organ acquisition cost passes down to the patient either through CMS or private insurance and then it gets reimbursed to our company. We are already generating revenue from our Contract Research Arm through small biotech and pharma contracts plus grants. Total generated in the last 12 months: $530K
We intend to license the VP.S ENCORE® Cardiac Device to one of the big players in the market. We plan on using liquidity events to continue funding the company and developing next-generation organ preservation devices for kidneys, liver, and lungs. As well as growing our CRO business arm until we can get acquired by a large organization.