Foldax today announced one-year results from a clinical trial of its Tria polymer mitral heart valve offering.
In a trial based in India, the mitral valve demonstrated a good safety profile and sustained hemodynamic performance. Investigators reported a statistically significant improvement in patient quality of life.
“These results validate our strategy of taking heart valve therapy to a new level by bringing innovation to a platform of products that will help patients globally,” said Ken Charhut, CEO of Foldax.
Salt Lake City-based Foldax designed Tria to accommodate the anatomy and pressures of the mitral position. It combines the company’s proprietary LifePolymer with a valve design for resisting calcification. The company says its valve withstands stresses and strains without failure, restoring quality of life without lifelong anticoagulant use.
According to Foldax, currently available prosthetic valve options for treating mitral valve disease have limitations. Those include issues with durability for tissue valves made from porcine or pericardial tissue.
The novel polymer material — used in computer-designed leaflets — enables robotic production. That increases manufacturing efficiency and maximizes product quality and precision.
Foldax said this marks the first-ever presentation of one-year outcomes for a worldwide multicenter polymer heart valve clinical trial. Investigators presented their findings today at New York Valves 2025. They concurrently published results in the Journal of the American College of Cardiology (JACC).
More about the Foldax trial
The prospective, multicenter trial enrolled 67 patients between ages 19 and 67 across eight sites in India. Participants had an average age of 42 years old and, notably, 64% were women. Nearly three-quarters (73%) of patients had rheumatic heart disease.
Foldax reported 30-day results last year. The company secured regulatory approval in India for Tria earlier this month.
“I am proud to be the principal investigator in India for this groundbreaking trial and represent the highly esteemed clinical investigators who participated in the study,” said Dr. Kaushal Pandey, principal investigator of the TRIA mitral valve India clinical trial and cardiac surgeon at P.D. Hinduja Hospital in Mumbai. “The Tria mitral valve provides hope for Indian patients—including younger patients and many women of childbearing age—for whom current valve options often fall short.”
Key one-year results showed no valve-related mortality or reinterventions. Investigators saw a greater than 50% reduction in mean gradient (9.7 mmHg to 4.5 mmHg) and a greater than 90% increase in effective orifice area (0.9 cm² to 1.5 cm²). Patients recorded a 24-point improvement in the KCCQ score and a 65% increase in the six-minute walk test. These metrics represent significant improvements in quality of life.
“It is exciting to see the positive clinical outcomes associated with this novel polymer valve,” said Dr. Isaac George, surgical director of the Heart Valve Center at Columbia University. “This new type of valve sets out to reimagine how a device can address clinical needs that are underserved by current valve solutions.”
