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Katie Hobbins | Aug 29, 2023

PolyVascular, a medtech company developing a non-surgical heart valve for children with congenital heart disease, has obtained $2 million in funding from non-profit pediatric initiative, CobiCure Medical Technologies, along with strategic support and resources. Previously, the company secured $3.5 million in grants from sources including the National Institutes of Health (NIH) Small Business Innovation Research Phase I and Phase II, as well as $750,000 in private funding.

Nearly 40,000 children are born with congenital heart defects every year, according to the Centers for Disease Control and Prevention, and require open-heart surgery within the first few months of life. As children outgrow valves with age, additional open-heart surgery is often needed.

Current treatments for congenital heart disease include an allograft donor pulmonary valve or animal sourced pulmonary valve. Allograft donor pulmonary valves require open heart surgery with a high risk of complications and can cause immune system sensitization. Animal sourced pulmonary valves, which are only available for teenagers and adults, are suitable for open heart surgery and minimally invasive procedures, however, are expensive and difficult to manufacture. Additionally, the risk of endocarditis, stent fractures, and valve degeneration are heightened.

PolyVascular’s transcatheter pulmonary valve, which the company states is the only of its kind that can be used for children as young as 2-years-old, is made of patented biocompatible polymer tri-leaflet within a polymer-covered durable metal stent. The valve is placed by a minimally invasive, small incision, non-surgical procedure and is designed to eliminate endocarditis complications caused by animal tissue valves.

“The PolyVascular valve will be the first transcatheter pulmonary valve designed for young children,” Will Clifton, MD, PolyVascular COO, told MD+DI. “Currently approved non-surgical options are only sized for teens and adults, which means young children must undergo surgery to have a pulmonary valve replacement. Our solution will eliminate surgeries in young children by providing a catheter-based valve replacement solution.”

Additionally, pediatric patients won’t experience complications from outgrowing the valve.

“Our valve can be over-expanded to accommodate an adult size valve,” Clifton said. “As the child outgrows the PolyVascular valve, an adult sized transcatheter valve may be placed inside of ours. No surgery is required once the child outgrows our valve.”

The CobiCure grant, according to PolyVascular, will help advance development of the valve and move it closer towards becoming the “first of its kind to demonstrate human clinical readiness,” according to a press release. “This strategic collaboration aims to accelerate this life-saving technology for children born with congenital heart defects…”

“The partnership with CobiCure provides critical funding to help advance our pediatric technology towards clinical readiness,” Clifton told MD+DI. “The strategic partnership will also leverage CobiCure's medical device expertise to supplement our team's experience.”

CobiCure, which is part of the Advancium Health Network, focuses on providing pediatric medtech innovators with an expedited pathway to sustainable commercialization through strategic support, resources, and funding, according to the company. Often, such support is out of reach for pediatric innovators, CobiCure highlighted, because of a lack of investment in pediatric medical devices, which can deepen gaps in care, and leave patients with limited options.

"This investment from CobiCure MedTech is a testament to the progress our team has made and acknowledges the need for better solutions for children with congenital heart disease," said Henri Justino, MD, PolyVascular CMO, and interventional cardiologist, in the release. "We're grateful for the trust placed in our team by CobiCure. With their support, we are one step closer to reaching this vulnerable population to improve their quality of life and offer parents greater peace of mind."

PolyVascular’s heart valve is currently in the verification and validation product phase, according to Clifton, who added, “We anticipate enrolling first patients in Q1 2025.”

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