Foldax 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).
