It doesn’t take long for the implant to “look like what you were born with” and patients essentially have a healed heart, Engels says.

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Healing Heart Valves

A Gainesville biotech firm is pioneering regenerative products to repair damaged or diseased cardiac tissue.

BACKED VENTURE: CORVIVO CARDIOVASCULAR
FOF INVESTMENT: $1 MILLION

More than 1.5 million Americans suffer moderate to severe tricuspid regurgitation due to damaged or defective heart valves. For decades, thousands of those patients have received synthetic valve replacements that often wear down and need replacement. There’s a reluctance to use them at all for infants with congenital birth anomalies since the replacement valve can’t grow with the child’s heart.

Gainesville-based Corvivo Cardiovascular may be about to change that. Working with University of Florida medical researchers, it takes material from a pig’s small intestinal submucosa (the intestinal wall) to build extracellular matrices. Those matrices support cells and blood supply to help regenerate damaged or diseased tissue.

The pig tissue is processed to remove proteins that might cause the body to reject the transplanted material.

It’s a structure already used to heal burn victims and broken bones and stimulate nerve repair, says Corvivo co-founder and CEO John Engels. Corvivo is finishing tests that should lead to FDA approval for its regenerative heart valve.

Existing valves “have saved a lot of people’s lives so in no way do I want to say that these haven’t been remarkable products. They have,” Engels says. “But it’s time to update them and that’s our mission. We want to disrupt those technologies from the ’70s and update them.”

It doesn’t take long for the implant to “look like what you were born with” and patients essentially have a healed heart, he says.

Engels, who earned his MBA from the Wharton School of Business, previously helped found and build Axogen, a Gainesville nerve repair startup that today has more than $200 million in revenue and employs more than 450 people. The area’s ecosystem for startups has improved dramatically in the past 20 years, he says, thanks to better support from groups like UF Innovate, which helps take ideas from the lab to the marketplace. Capital from the Florida Opportunity Fund also makes a big difference.

“There’s lab space here, there’s a labor force here,” Engels says. “The competition isn’t as high for all those folks. Eventually that will change and that’ll be for the good. That means there will be more and more companies here fighting for the best employees and for the investment.”

He has 10 employees and consultants today and plans to add a commercial team as the company looks to the next funding round.

The fund invested in Corvivo last December after federal regulators greenlit the final study needed for approval. “Their investment was absolutely key for us because it helped us catalyze other investors to fulfill this round. The commitments that came in because they came into the round were very, very helpful. That’s what makes a company like us successful — getting early backers to take the earlier stage risk, which can turn into a really great return for investors.”

A great return is important, but Engels says helping people through medical device innovation “is part of my mission in life. … It’s really fun to do this kind of work because you can have this really great goal — let’s heal the heart by disrupting the space that needs new innovation. I think that’s at the heart of what the Florida (Opportunity) Fund is all about, supporting those types of entrepreneurs or inventors here in Florida. That’s what will build future jobs.”