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Foldax, Inc. Enters Manufacturing Agreement with Dolphin Life Science India LLP to Hasten Future Commercial Launch

Tuesday, February 27, 2024

Foldax has recently forged a strategic partnership with Dolphin Life Science India LLP to establish local manufacturing facilities for the TRIA™ polymer mitral surgical heart valve in India. This collaboration marks a significant milestone as it represents the first time the TRIA valve will be produced outside the United States.

The TRIA mitral valve is uniquely designed to accommodate the specific anatomy and pressures of the mitral position. It integrates Foldax's proprietary LifePolymer™ with an innovative valve design aimed at resisting calcification, enduring stresses and strains without failure, and enhancing patient quality of life without the need for lifelong anticoagulants.

The utilization of the LifePolymer material and advanced computer-designed valve technology aims to streamline the manufacturing process, reduce dependence on animal-based tissue valves, facilitate production in diverse locations, and enhance product consistency, precision, and quality.

Foldax's initiative to bring TRIA valve manufacturing capabilities to India holds promise for millions of rheumatic heart disease (RHD) patients who could benefit from this novel polymer valve. It's important to note that the TRIA heart valve and LifePolymer technology are currently in the investigational stage and are not available for commercial sale in the U.S. or any other region.

Dolphin Life Science India LLP, known for its expertise in medical device manufacturing, is fully compliant with India's regulatory bodies, including the Drugs Controller General of India (DCGI) and the Central Drugs Standard Control Organization (CDSCO).

Source: businesswire.com

 

 

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