A $2 million federal grant will enable Houston-based PolyVascular to launch human trials of what it hails as the first polymer-based heart valve for children.

In conjunction with the grant, Dr. Will Clifton has joined the medical device company as chief operating officer. He will oversee the grant as principal investigator, and will manage the company's operations and R&D. Clifton is president and co-founder of Houston-based Enventure, a medical innovation incubator and education hub. He previously was senior director of medical affairs at Houston-based Procyrion, a clinical-stage medical device company.

PolyVascular's Phase II grant came from the Small Business Innovation Research (SBIR) program, which promotes technological projects.

The PolyVascular heart valve will help treat congenital heart disease affecting more than 1 million around the world. PolyVascular plans to launch clinical trials of the valve in children 5 and over within two years.

"Congenital heart disease remains the most common category of birth defect and a leading cause of childhood death in the developed world," reads a March 30 news release from PolyVascular, founded in 2014.

PolyVascular says the valve can be implanted without surgery, and can avoid the use of valve replacements from humans or animals. Those valve replacements are difficult to find and often don't last too long, leading to frequent follow-up surgeries.

"Our aim at PolyVascular is to transform the care of children with congenital heart disease by developing an entirely new generation of valves made of medical-grade polymer devoid of any biological tissue," Dr. Henri Justino, chief medical officer at PolyVascular, says in a release. "The valves in use so far for children have been made of biological tissue. Unfortunately, our immune systems target and destroy this biological tissue, sometimes rapidly, rendering the valve ineffective."

The SBIR grant isn't the only win for PolyVascular in recent years.

In 2019, the startup came away with several honors in the 2019 Texas A&M New Ventures Competition. It won the pitch competition (complete with a $5,000 cash award), and received the Biotex Investment Prize, Amerra Visualization Services Prize, and GOOSE Society Investment Prize.

Also in 2019, PolyVascular, a member of TMCx's 2017 medical device cohort, won in the medical device and health disparities and equity categories at the fifth annual Impact Pediatric Health pitch competition. Additionally, the Southwest National Pediatric Device Consortium granted the company up to $25,000.

Last year, MedTech Innovator, a nonprofit accelerator in the medical technology sector, announced PolyVascular was one of 50 companies chosen to participate in the organization's flagship four-month accelerator program.

"During these uncertain and challenging times, the need for health innovations — specifically those that promise to deliver long-term value to the health care system and patients — is more critical than ever," said Paul Grand, CEO of MedTech Innovator.

Another Houston startup, Vivante Health, also was picked for the MedTech Innovator program. Vivante is a digital health company that helps people address digestive health and wellness.