Foldax Granted IDE for Mitral Valve Clinical Study

By December 21, 2020 February 3rd, 2021 News

Foldax had some significant developments with its mitral valve program recently. The Salt Lake City, UT-based company was granted IDE approval to begin a clinical study of the Tria Biopolymer mitral Surgical Heart valve.

The mitral valve study IDE comes shortly after Foldax won a nod from FDA to expand a clinical study of the device in the aortic valve. Foldax is also working on a transcatheter aortic valve replacement device, which is in the pre-clinical testing phase.

Enrollment for the 15-patient mitral valve trial will begin in January and could end by the beginning of 2Q21. The study will undoubtedly be powered by the $20 million series D round Foldax secured in June.

Ken Charhut, chairman of Foldax said the company’s mission was to “reinvent” the heart valve. In an interview with MD+DI, Charhut spoke about the device’s progress and the challenge of the mitral valve.

“Unlike the aortic position, the mitral side is a tougher hemodynamic environment,” Charhut told MD+DI. “And by that, I mean the pressures that a mitral valve sees are more extreme than what you may see on the aortic side. The structure of the mitral valve in the heart is different, so how you anchor it into the heart is different than the aortic. It’s been a more difficult valve historically to try to come out with one that meets the needs of the patients.”

He added, “This one is truly where you have a trade-off today. There’s a trade-off being a mechanical valve that should last your lifetime and require you to take anticoagulation drugs for the rest of your life, or a tissue valve that doesn’t last as long as they do in the aortic position so you’re likely to need repeat surgeries. There’s no good valve today for this position. And our promise – reinventing the valve is to come out with a valve that balances both of those needs.”

Foldax stands out from other companies in the space because its valves are robotically manufactured. The company said this reduces variability, enables high precision, repeatability, and quality, while substantially improving the economics of heart valve manufacturing.

“Robots don’t get COVID-19,” Charhut said. “They continue to work every day. We are much less affected by COVID-19 today or whatever comes next because we’re just relying on the machines to do work. You can get much greater accuracy out of the [robot]. They can be more dexterous than the human hand. You get consistency.”

Loud Noise in Mitral Valve Market

In 2020 most noise made in the mitral valve space was drowned out by the pandemic. However, there were some developments.

As the pandemic was setting in Mardil Medical was able to have success with its VenTouch, a minimally invasive option and combination therapy that simultaneously treats the distorted valve, the dilated ventricle, and the displaced papillary muscles in patients suffering from Type IIIb Functional Mitral Valve Regurgitation (FMR).

The Minneapolis, MN-based company was able to treat its third patient in its FMR trial.

CardioMech turned up the volume in late August by raising $18.5 million in a series A round. The proceeds would support an in-human feasibility trial for a transcatheter system that it hopes could be used as an alternative to open-heart cardiac surgery to reduce or eliminate mitral regurgitation.

LivaNova’s mitral valve developments began late last year and carried over into 2020. The London-based company announced its exodus of the mitral valve space in November of 2019. LivaNova scrapped its Caisson transcatheter mitral valve replacement program because of consistent yearly declines it had seen in its heart valve business.

LivaNova made plans to get out of the valve business altogether when it announced it would sell the unit to Gyrus Capital investment for $73 million. The measure came after activist investor PrimeStone Capital urged LivaNova to restructure and focus on its neuromodulation and cardiovascular businesses.