Startup Foldax Inc. has raised a $20 million series D round to back its development of biopolymer-based surgical and minimally invasive heart valves. Heart valves typically are either based on porcine or bovine tissues or are mechanical.

Salt Lake City-based Foldax will use the financing to back clinical trials for its surgical aortic heart valve, which is known as Tria, and its surgical mitral valve as well as to advance its transcatheter aortic valve replacement (TAVR) device ahead of a planned first-in-man study.

Cracking calcification

“Tissue valves continue to still have one issue: calcification, which makes them fail and need to be replaced. While they are a great improvement, they are still not a total solution because most people's valves are replaced because of calcium deposits,” Foldax co-founder and executive chairman Ken Charhut explained to BioWorld. “So, you've replaced a failure point with another product, which will have the same failure point at some point. Tissue valves, while they greatly improve the clinical arena, and what's available for patients, they still suffer from the same failure as the native heart, which is calcification.”

Charhut worked with Baxter in the mid-90s, where he experienced the market transition from mechanical valves to tissue valves. The former requires life-long use of anticoagulants, while the latter does not. But tissue valves require replacement usually after about 15 years, often due to calcification problems.

The biopolymer, dubbed Lifepolymer, was used to design valves that eliminate calcification and can endure the stresses and strains of nonstop use in the heart. It also would not require lifelong anticoagulant use.

In addition, tissue-based heart valves are quite expensive and labor intensive to produce. That has kept their use largely limited to the wealthiest countries. With its biopolymer, Foldax can produce its own valve from end-to-end using robotic manufacturing that could significantly cut the costs of heart valve production – thereby making them less expensive and with the potential to be more widely used.

“When you look at how they're made, it’s still labor-intensive,” said Charhut. “They're one of the last medical products around that really is not highly automated. So, the opportunity to take a polymer that could be well characterized with the design – and be able to do it robotically – is very attractive. We can deliver to the community a product that could last longer and offer a higher quality life.”

Foldax expects it could meet U.S. demand with about 2,000 square feet of manufacturing space and five employees, while a comparable operation using standard tissue valve techniques would require more on the order of 300,000 square feet and 3,000 employees.

Pipeline plans

The company has completed a feasibility study for a surgical aortic heart valve, but has continued enrolling due to demand from investigators. But it aims to first pursue an FDA approval for a surgical mitral valve, which is more in demand. Use of surgical aortic valves has declined with the rise of transcatheter aortic valve replacement (TAVR); still Foldax is pursuing a clinical trial for a surgical aortic heart valve that would support an FDA approval.

Foldax is also creating a TAVR implant that is ready to be tested in animals. This financing round is slated to support a first-in-human clinical trial of the biopolymer-based TAVR.

“This financing should get us to a first-in-man study with the TAVR product,” said Charhut and allow for continued work on the surgical valves. “We probably will start a project outside of the U.S. for commercialization in one of the large, second-tier markets. And we really want to start the pivotal trials and have a clear path to market in the developed countries.

Memorialcare Innovation Fund (MCIF) led the financing, with Angel Physicians Fund (APF) and Sayan Bioventures joining as new investors. All of the existing investors participated in the round including Biostar Capital, Kairos Ventures and Caltech. MCIF Managing Director Brant Heise joined the board in conjunction with the investment.

Heise said Foldax technology has the potential to positively impact health care systems by both improving clinical outcomes and quality of life for patients. “The creativity demonstrated by the company in overcoming traditional obstacles has been striking,” he added. Another investor, Manish Bhandari, Managing Partner at APF and Sayan Bioventures, called Foldax technology “truly revolutionary.”

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