Foldax Signs Indian Manufacturer to Help Expedite Mitral Valve Commercialization in the Country

Novel Tria aortic heart valve

Heart Valve Pioneer Foldax® Inc., will see its innovative TRIA™ polymer mitral surgical heart valves being manufactured in India. A newly announced agreement with Dolphin Life Science will enable in-country manufacturing of the product outside of the U.S. for the first time.

The Tria™ Mitral Valve

The TRIA™ mitral valve is designed specifically to accommodate the anatomy and pressures of the mitral position. It combines the company’s proprietary polymer – LifePolymer™ – with an innovative valve design. The result is intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants. 

The novel LifePolymer material and computer-designed valve help to democratize the manufacturing process, says Fold’s press release. It effectively minimizes the people and processes associated with animal-based tissue valve manufacturing. This in turn enables manufacturing in any location, and improves product variability, precision, repeatability, and quality. 

Company comments

“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,” said Ryan Stanfield, Vice President of Engineering and Operations with Foldax, Inc. 

“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 (RHD) patients who can benefit from this novel polymer valve,” said Mukesh Chovatiya, Managing Director of Dolphin Life Science India.

Clinician comments

Dr. Kaushal Pandey, an investigator in the Company’s recent India clinical trial of the TRIA valve, who believes it to be the fastest-enrolling clinical trial for any surgical mitral valve, commented, “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.”

The TRIA heart valve and LifePolymer technology are considered investigational and are not available for commercial sale in the U.S. or any other region.

Find our coverage of the Foldax Tria aortic valve trial in India, here.

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