BIOFEST INVEST APPLICANT

Vascular Perfusion Solutions, Inc.

Company Contact:

Legal Entity Type: C-Corp

Company Type: Medical Device

Company Stage: Development

No. of Employees: 12

Desired Financial Amount: Series A- $12M

Background

Company Background

VPS co-founder Leonid Bunegin had the vision of saving lives with simple and cost-effective medical technology. Bunegin invented the Sherpa static (non-perfusion) cardiac transport device. VPS chairman of the board Tom DeBrooke founded Paragonix, and with Bunegin, obtained the first FDA clearance for a cardiac transport device. DeBrooke and Bunegin joined together to form VPS, to provide hypothermic, oxygenated perfusion for organ preservation, leaping well beyond the original Sherpa capability. CEO Mark Muller is an engineer and intellectual property attorney with over 35 years of experience in technology transfer. Our technical team consists of highly skilled STEM underrepresented minorities, including women and BIPOC. Original IP license came out of UT Health San Antonio invented by our CTO/CSO Leonid Bunegin. The VP.S ENCORE™ now has added 6 new patents submitted for review under VPS.

Management

CEO Tom DeBrooke is a long-term business deal maker and turnaround specialist. CTO Leonid Bunegin has spent decades researching oxygenated perfusion, preservation, and resuscitation to enhance limb and vascular system viability in the closely related fields of organ transplantation and limb/appendage replantation. Bunegin and Translational Science Director Rafael Veraza have published peer-reviewed articles on organ preservation and collaborated with the DOD, Harvard Wyss Institute and DARPA. Engineering Director Israel Jessop has extensive experience in medical device development from companies like J&J and Allergan. Our top-tier professionals in translational medicine and engineering are bringing ENCORE to market.

Board of directors

Donald E. Ingber, MD, PhD Founding Director, Wyss Institute for Biologically Inspired Engineering at Harvard University Judah Folkman Professor of Vascular Biology, Harvard Medical School & Vascular Biology Program, Boston Children’s Hospital Professor of Bioengineering, Harvard John A. Paulson School of Engineering and Applied Sciences Ingber has authored more than 500 publications and 165 patents, founded 5 companies, and has presented 550 plenary presentations and invited lectures world- wide. He is a member of the National Academy of Engineering, National Academy of Medicine, National Academy of Inventors, American Institute for Medical and Biological Engineering, and the American Academy of Arts and Sciences. He was named one of the Top 20 Translational Researchers world-wide in 2012 and 2020 (Nature Biotechnology) Francisco G. Cigarroa, MD Pediatric Transplant surgeon at UT Health San Antonio First Hispanic to be named Chancellor of The University of Texas System He received his bachelor’s degree in biology from Yale University and his medical degree from The University of Texas Southwestern Medical Center at Dallas. He completed fellowships in pediatric surgery and transplant surgery at Johns Hopkins Hospital. William Bauta, PhD Senior Vice President of Research and Development, Therapeutics bioAffinity Technologies. Dr. Bauta is a medicinal chemist with more than 25 years of experience in discovery, development and commercialization of pharmaceuticals to treat oncology, virology, neuroscience, immunology and metabolic diseases. Dr. Bauta was Associate Director of Science at Genzyme Corporation and held a similar position at Ilex Products, Inc., where he was responsible for the discovery, development and FDA approval of multiple therapeutics. He holds several patents and has published in the journal Science and more than a dozen other scientific journals and conference proceedings. Dr. Bauta received his Ph.D. from the University of Chicago. Major General Byron Hepburn, MD Associate Vice-president and the Inaugural Director of the Military Health Institute at UT Health San Antonio Dr. Hepburn has had a distinguished military career spanning 38 years. He served as the inaugural Director of the San Antonio Military Health System (SAMHS). In addition, he was Commander of the 59th Medical Wing and Wilford Hall Ambulatory Surgical Center, Joint Base San Antonio-Lackland. Previously, he served as Deputy Surgeon General of the Air Force, where he directed all operations of the Air Force Medical Service. Dr. Hepburn is a distinguished graduate of the U.S Air Force Academy and the Uniformed Services University of Health Sciences School of Medicine, David Sachs, MD Physician Investigator at Center for Transplantation Sciences, Mass General Research Institute Paul S. Russell/Warner Lambert Professor of Surgery, Emeritus- Harvard Medical School Research Staff, Surgery Massachusetts General Hospital Professor of Surgical Sciences (in Surgery) and Professor of Medical Sciences (in Medicine) Columbia Vagelos College of Physicians and Surgeons Dr. Sachs has published over 700 articles in scientific journals. His research achievements include: 1) discovery of Ia (Class II) antigens in 1973; 2) development of monoclonal anti-bodies to MHC antigens; 3) development of a unique large animal model for transplantation using miniature swine; 4) use of mixed marrow reconstitution as a means of inducing specific transplantation tolerance; and 5) studies of specific transplantation tolerance to allografts and xenografts in murine, swine and primate models.

Product / Service

disease area / application

Organ Transplantation

product / Service

The VP.S ENCORE™ cardiac preservation device provides a simple, portable, acellular method for preserving and transporting hearts for transplantation and maintaining tissue viability and function longer than the current standard of care- the ice cooler. VP.S ENCORE™ uses hypothermic oxygenated perfusion, enclosed in a thermal compact portable case to transport hearts from an organ donor to a recipient. We believe the device has the potential to solve a universally accepted patient healthcare need: increasing the number of organs available for transplant by extending the time an organ can remain viable outside the body – from roughly four hours (in the case of a heart) to 8 and up to 24 hours. Preliminary data preserving porcine hearts in our device, demonstrates that after 8 and 24 hours of preservation, cardiac function and viability are significantly higher than porcine hearts preserved in the standard of care for 4 hours. FDA has granted Breakthrough Device Designation and we are currently working on preclinical transplant studies. In addition, our company is developing technologies to limit organ reperfusion injury, and in collaboration with DARPA, the Wyss Institute at Harvard and DOD we are working on technology to achieve organ banking.

technology / ip

The VP.S ENCORE™ device benefits patients awaiting a life-saving organ by increasing the time that a heart can be preserved beyond the 4 hours in the standard of care, which currently limits the availability of hearts for patients. It also increases the quality of the organ by providing oxygenated perfusion to keep the organ viable during preservation. For the providers and the healthcare system, it provides an efficient and cost-effective solution to improve patient outcomes. Further by loosening the time constraints, transplant centers and providers can consider additional cost-saving options to a process that is already highly cost-constrained. Our IP is indeed unique and has been verified in a preliminary fashion with an international search by a European patent examiner on our first patent filing, dealing with one of the fundamental operational principles of VPS device. We have at least five follow-up filings that deal with other aspects of the invention, some fundamental and some peripheral (but offering significant convenience to operators).

distribution channels

Sold directly to Organ Procurement Organizations (57 in the U.S.)., and Incorporated into the Transplant Center organ procurement cost. The organ procurement cost passes down to the recipient through CMS or private insurance then reimbursed to VPS. The primary market is U.S., with a launch Q1 2024 after PMA, followed by Europe and Australia Q4-2024, followed by Latin America, and India Q1 2025

market size

VPS plans to capture 20% of the heart transplant procedure market currently being serviced which corresponds to 3597 annual heart transplants conducted in the United State. Addressable market is projected to be $125,895,000 ($35,000/unit X annual procedures). In addition, the VPS Serviceable Market Impact (20%) leads to $25,179,000. In subsequent years we project to double the market share and expand to other organs. The TAM for organs worldwide is $12.3 B and is expected to increase to $62.5B.

competition

Transmedics OCS, XVIVO Perfusion and Paragonix SherpaPak. OCS Heart is a normothermic cost-prohibited device that has PMA for extended criteria hearts only, their clinical trials failed to demonstrate efficacy and safety with standard criteria hearts. We will be competing against Transmedics by capturing the indication of use for all standard criteria and extended criteria hearts. XVIVO perfusion is our closest competitor with a hypothermic oxygenated perfusion device, however, their device requires blood products and a complex perfusate solution including cocaine. SherpaPak uses static cold preservation with no perfusion. Our device is cost-effective, simpler and does not require blood products.

Financials

Desired financial amount

Series A- $12M

previous funding

Friends and Family/ Family Offices Pre-Seed Raised: $2M Seed Raised: $4.6M Total Raised: $6.6M Non dilutive funding from grants: DOD: $1M DARPA: $300K Total: $1.3M

current financials

Burn rate: $250k / month Remaining operating runway: 4 months Available cash: $1.4M

financial use

Series A: $12M Operating Expensed and the following milestones: 1. Presubmission with FDA for approval of GLP animal transplant study at Texas Heart Institute [Q2-2022] 2. Complete GLP transplant study at Texas Heart Institute [Q3-2022] 3. Design Freeze [Q4-2022] 4. Early Feasibility Clinical Study FDA Pre-Sub Meeting [Q4-2022]

revenue

Device will be sold at $35,000 per disposable device plus services( $10-$15k) Sold directly to Organ Procurement Organizations (57 in the U.S.)., and Incorporated into the Transplant Center organ acquisition cost via a negotiated contract with each entity. The organ acquisition cost passes down to the recipient through CMS or private insurance then reimbursed to VPS.

exit strategy

We intend to commercialize our VP.S ENCORE™ device, go through an IPO or get acquired.

Pitch Video

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