Foldax Tria Mitral Valve Launched in India

September 5, 2025—Foldax Inc., in conjunction with its local India-based manufacturing partner Dolphin Life Science LLP, announced the launch of the Tria polymer mitral valve in India. In June 2025, the company announced that the Tria mitral valve received regulatory approval by CDSCO, India’s Central Drugs Standard Control Organization.

The company, which is based in Utah, advised that as part of the launch, it has initiated the Evolve Training & Certification Program to ensure high-quality outcomes and surgeon preparedness. Physicians who complete training will be certified to implant the valve at participating hospitals.

On June 27, Foldax announced 1-year results from the Indian clinical trial of the Tria mitral valve. The results were presented at the New York Valves 2025 conference and concurrently published by Isaac George, MD, et al in Journal of the American College of Cardiology.

Foldax stated that the device, which incorporates the company’s LifePolymer, is formulated to be calcium-resistant, biostable, and biocompatible.

The Tria mitral valve is limited to investigational use only in the United States, advised the company.