At a Glance

• The company hopes for its first regulatory approval in India later this year.

• The Tria mitral surgical heart valve showed promising 30-day results in a multicenter study.

• Foldax plans to leverage positive study outcomes from India to support FDA approval for its polymer heart valve.

Foldax is targeting India for the first approval of its polymer mitral surgical heart valve. The Salt Lake City, UT-based company spoke with MD+DI regarding its regulatory plans after reporting positive 30-day results from a prospective, multicenter, single-arm, clinical study of the Tria mitral surgical heart valve with LifePolymer conducted in India at the New York Valves: The Structural Heart Summit 2024.

“Our first regulatory approval will be in India,” Ken Charhut, Foldax CEO told MD+DI. “We expect that to happen later this year. One of the reasons we picked India is because it has a very high incidence of rheumatic heart disease. Rheumatic heart disease patients tend to be younger. You get it as a child and if it is untreated… some years later your mitral valve begins to kind of disintegrate. Most importantly this can happen with young women of child-bearing age. If they get a mechanical valve it necessitates the need for long-term blood thinners, which negates their opportunity to start a family.”

The Tria mitral surgical valve study enrolled 67 patients ranging from 19 to 67 years of age at eight sites across India. The device stands out because of the LifePolymer component.

“The LifePolymer material is uniquely formulated for heart valves and has been shown in animal studies to resist calcification, which can lead to stiffening leaflets that restrict blood flow through the valve,” said Isaac George, MD, Surgical Director of the Heart Valve Center at Columbia University in a press release. “Now, in the India study, imaging of the Tria mitral surgical valve in humans at 30 days shows no sign of calcifying or deteriorating leaflets. A durable non-animal tissue heart valve that may not require long-term anti-blood clotting medication could be transformative in providing new options for patients suffering from mitral valve disease,” he said.

Charhut said the study is significant because there haven’t been a great deal of studies published on surgical mitral valves lately.

“On the surgical mitral side, there hasn’t been a published study for almost 20 years until recently… when Edwards Lifesciences published the COMMENCE Trial data for their Mitrus product. So, while not exactly matching patients [COMMENCE] is a comparator for us to look at the performance of our device. We are meeting or exceeding what [Edwards] was reporting with their Mitrus Mechanical Valve at the same time point.”

The company said it will focus on obtaining approval in the US, too.

“What we’ve presented with these 30-day data is a trial that was presented under the same rigors of the same type of trial we would do in the US for approval,” Charhut said. “We’ve been partnering with FDA to bring this polymer valve to the U.S. for many years. They have been very encouraging, and we have been very open with what we’re doing. So, we’re working this year to get the final data to begin a U.S. pivotal trial of the mitral valve. We hope to begin that trial next year.”