Foldax Signs Agreement With Dolphin Life Science India for Manufacturing of Tria Mitral Valve

February 27, 2024—Foldax Inc., a developer of polymer heart valves, announced a manufacturing agreement with Dolphin Life Science India LLP to enable in-country manufacturing of the Tria polymer mitral surgical heart valve outside of the United States for the first time.

According to the company, the Tria mitral valve is designed to accommodate the anatomy and pressures of the mitral position. It combines the company’s polymer—LifePolymer—with a valve design intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants.

Foldax further stated that the LifePolymer material and computer-designed valve help to “democratize” the manufacturing process, minimizing the people and processes associated with animal-based tissue valve manufacturing, enabling manufacturing in any location, and improving product variability, precision, repeatability, and quality.

The Tria heart valve and LifePolymer technology are considered investigational and are not available for commercial sale in the United States or any other region, noted Foldax.

Kaushal Pandey, MD, who is an investigator in the company’s recent India clinical trial of the Tria valve, commented in the press release, “We have a pressing need in India for alternatives to tissue and mechanical valves, as current commercial offerings often fall short in durability and patient acceptance. I am encouraged to see the company’s progress in getting one step closer to making this exciting heart valve available to Indian patients who critically need it.”

Ryan Stanfield, Vice President of Engineering and Operations with Foldax, stated, “Our collaboration with Dolphin Life Science India LLP represents a pivotal move toward expediting the commercial release of the Tria valve in our first targeted commercial region of India.”

Mukesh Chovatiya, Managing Director of Dolphin Life Science India, added, “We are honored to collaborate with Foldax to bring the Tria valve manufacturing capability to India, with the intent of making a positive difference in the lives of millions of rheumatic heart disease patients who can benefit from this novel polymer valve.”