Foldax and Dolphin Life Science India Sign Manufacturing Agreement

Foldax Inc. has announced a manufacturing agreement with Dolphin Life Science India for in-country manufacturing of the TRIA polymer mitral surgical heart valve. This will be the first time TRIA will be manufactured outside of the U.S.
 
TRIA mitral valve is designed to accommodate the pressure of the mitral position. Foldax’s LifePolymer is also used to resist calcification, withstand stresses without failure, and restore quality of life without using anticoagulants. 
 
“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 Managing Director of Dolphin Life Science India, Mukesh Chovatiya.
 
The LifePolymer material is computer-designed to help democratize the manufacturing process as well as enable manufacturing in any location. It has been designed to improve product variability, repeatability, precision, and quality. Processes are associated with animal-based tissue valve manufacturing. 
 
Dr. Kaushal Pandey recently investigated Foldax’s Indian clinical trial of the TRIA valve and 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.”
 
LifePolymer and TRIA heart valves are considered investigational and are not available for commercial sale in the US or any other region.