Vascular Perfusion Solutions Receives Grant from Southwest-Midwest National Pediatric Device Innovation Consortium To Develop Portable Pediatric Heart Transplant Preservation Device

Pediatric Heart Transplant Patients Face Unique Challenges with Few Solutions; Grant Fosters Innovation Specifically Designed for Children

SAN ANTONIO, Texas--(BUSINESS WIRE)--Vascular Perfusion Solutions (VPS), Inc., is a San Antonio based medical device startup company focused on developing novel prolonged organ preservation technologies prior to transplantation, has received a $25,000 grant from the Southwest-Midwest National Pediatric Device Innovation Consortium (SWPDC).

VPS will use the grant to advance its current VP.S ENCORE® cardiac preservation technology into a portable pediatric device. Early activities supported by the grant include preclinical testing of pediatric hearts to adapt the VP.S ENCORE® PEDS™ (Pediatric Enhanced Delivery System) and developing anatomically appropriate modifications for the use of pediatric patients, especially 0-5 years of age.

Joseph Turek, MD, PhD, MBA, a pediatric heart surgeon with over 20 years’ experience who performed the world’s first partial heart transplant for a newborn, commented, “Development of a pediatric perfusion device is critical for expanding the donor pool and improving outcomes in pediatric cardiac transplantation. Unfortunately, children are an underserved population when it comes to innovation, adaptation of technology and clinical trials. It is our duty to advocate for them and to continue to advance the care in pediatric medicine.”

A great need currently exists for medical devices designed for children, influenced by economic, clinical, and regulatory challenges, as well as a lack of established mechanisms for industry partnerships. The purpose of the SWPDC prize is to foster the innovation of devices specifically designed for children.

Pediatric heart failure presents unique challenges compared to its adult counterpart, stemming from diverse causes such as congenital heart defects and cardiomyopathy. Despite different manifestations, heart transplantation remains the standard for end-stage heart failure in both adults and children.

In 2021, 1,146 pediatric heart transplant candidates awaited transplantation, with over 40 percent enduring waits of a year or more. Particularly concerning are outcomes for infants under 1 year old, with 23 percent succumbing to end-stage heart failure while on the waitlist.

Donor heart ischemic times, notably ≥4 hours, are associated with poorer 1-year post-transplant survival, posing greater risks to younger recipients. Despite this, over 40 percent of infant heart transplants exceed the 4-hour limit, influenced by factors such as the shortage of available donors and the need for complex reconstructive surgeries during transplantation.

“We are honored to be recognized by SWPDC for the potential to apply our technology to the pediatric patients,” said Dr. Kristina Andrijauskaite, Scientific Director at VPS. “We will expand our efforts to target additional funding in the coming months and look forward to developing a true solution for these children in need.”

Vascular Perfusion Solutions advocates for increasing heart transplant utilization rates in underserved populations by expanding geographic region, maintaining organ viability, and improving surgical outcomes in pediatric heart transplantation.

About VP.S ENCORE®

The VP.S ENCORE® cardiac preservation device, tested in more than 100 ovine, porcine, and human donor hearts not utilized for transplant, provides a simple, portable method for preserving and transporting hearts for transplantation and maintaining tissue viability longer than the current standard of care. The key is the perfusion of hypothermic, oxygenated, acellular (no blood) nutrient rich solution to the coronary arteries. The VP.S ENCORE® has been awarded Breakthrough Designation by the FDA and is currently undergoing preclinical testing for its first indication of use for standard criteria hearts in the U.S., Latin America, and Europe.

About Vascular Perfusion Solutions, Inc.

VPS believes that machine perfusion devices for preserving organs should be simple, portable, and accessible to all patients needing a lifesaving organ. Evidence-based science is the root of what VPS does by using science and engineering to come up with simple, elegant, and effective solutions to preserving the life of organs beyond the standard of care.

About SWPDC

SWPDC is a multi-institutional consortium that is supported by an FDA P50 grant, anchored by Texas Children’s Hospital (TCH) and Baylor College of Medicine (BCM), and is dedicated to improving children’s health by supporting pediatric device innovators.

Lisa Owens, LisaMMOwens@gmail.com, 210.601.6647