From graduating Hart High School to becoming CEO of a company that’s seen recent breakthroughs in heart surgery technology, Santa Clarita native Doug Bernstein said how his life has panned out is due to following, well, his heart.
His company, PECA Labs, successfully implanted its MASA Valve in a pediatric patient, a 21-month-old child, in Philadelphia — marking a significant milestone in the company’s, and the industry’s, efforts to bring the first polymer pulmonary valve to market.
The breakthrough is considered important for a number of reasons. There are a few materials used for pulmonary valve (one of the heart’s four valves) reconstruction, but they’re usually made of metal, ceramic or an organic material.
Organic material is preferred for young children or infants, because the valve needs to remain malleable as the person, and the person’s heart, grows. But, the body can sometimes reject an organic material or it can be subjected to calcification — which means the patient will have to undergo another open heart surgery, or multiple, to ensure their ticker keeps beating smoothly.
However, the hope is that a polymer, or plastic, pulmonary valve is the closest replica of an organic material that doesn’t come with its downsides. While Bernstein said his company cannot definitively claim this means only one initial surgery would be all that is needed, it is the hope of the product — as is saving families thousands of dollars in medical costs.
The plastic valve has been in the research and development phase for a decade and seeing it finally make a real impact on the lives of real patients is something Bernstein said he’s looked forward to for a long time.
“It can be hard doing something every day for 10 years to step outside of it and look into the biggest steps that we’ve taken,” said Bernstein. “It’s great to see it come to fruition … we’ve been able to hear that the parents are happy that their child is mobile and starting to play and that’s just infinitely meaningful.”
Bernstein himself was born with a congenital defect — a diaphragmatic hernia, which is basically a hole in his diaphragm that allowed internal organs to move where they weren’t supposed to. He owes his life to an emergency surgery at birth.
“It’s actually sort of a crazy story,” said Bernstein.
Back in the 1990s, when Bernstein was born, there weren’t pediatric heart surgeons on every corner. The practice was not as developed as it is today and it required a specialized surgeon to perform it. Luckily for Bernstein, there was one in town who had been flown in for another patient the day earlier. The story that’s been told to him was that this surgeon was at the airport, ready to board a flight home, when he got the call.
“It was just sort of luck that he hadn’t gotten there and made his flight yet,” said Bernstein.
His condition spurred a nearly lifelong fascination with science, genetics and eventually a formal education in biomedical engineering at Carnegie-Mellon University — where his company is based.
His company’s recent medical breakthrough, which he’s proud of, did come with a dose of humility as well. Bernstein said that it was just another step in a larger goal of advancing medical technology to save more lives.
The valve has received Humanitarian Use Device (HUD) and Investigational Device Exemption (IDE) approvals from the U.S. Food and Drug Administration. The company has initiated enrollment for its MASA Valve Early Feasibility Clinical Study at four clinical sites in the United States.