Foldax has announced a manufacturing agreement with Dolphin Life Science India to enable in-country manufacturing of the Tria polymer mitral surgical heart valve outside of the USA for the first time.
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 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 democratise the manufacturing process, minimising the people and processes associated with animal-based tissue valve manufacturing, enabling manufacturing in any location, and improving product variability, precision, repeatability, and quality.
“Our collaboration with Dolphin Life Science India 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.
“We are honoured 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.
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 USA or any other region.
Dolphin Life Science India is an expert in manufacturing medical devices. The company is registered with India’s regulatory bodies, the Drugs Controller General of India (DCGI), and the Central Drugs Standard Control Organization (CDSCO).
