Foldax Gains Approval to Conduct Aortic Heart Valve Trial in India

Foldax Inc. has been granted permission by Indian regulators to conduct a clinical trial of its TRIA biopolymer surgical aortic valve.

The trial will examine TRIA’s ability to surgically treat patients with aortic valve disease.

“After promising outcomes from our U.S. early feasibility study, we are excited to expand our clinical study of the TRIA biopolymer valve globally, beginning in India. This study is the first step to commercializing our device outside of the U.S.,” said Frank Maguire, CEO of Foldax. “Our platform technology is well suited to one of the largest heart valve replacement markets in the world that has relied on mechanical heart valves to treat both aortic and mitral disease. The TRIA valves are designed to be uniquely durable while sparing patients from the negative consequences of blood thinning medication. Additionally, our robotic manufacturing process allows us to consider in-country manufacturing with the same precision and quality as our U.S.-based manufacturing.”

The TRIA valve reimagines the heart valve by combining the company’s proprietary biopolymer (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 executives claim TRIA is the first and only heart valve to be robotically produced, thanks to its polymer leaflets that can be consistently manufactured with precise thicknesses and are designed to achieve a valve with predictable lifetime performance. 

Seventy percent of aortic valve replacements currently being performed in India implant mechanical valves. Mechanical valves are durable but require life-long anticoagulant use to minimize blood clotting. Anticoagulant therapy creates an ongoing bleeding risk that can limit a patient’s lifestyle, diminish their quality of life, and potentially lead to hemorrhage and death.
  
The TRIA heart valve is for investigational use only and is not available for commercial sale. 
 
Headquartered in Salt Lake City, Utah, Foldax develops surgical and transcatheter valves designed to last a lifetime addressing historical tradeoffs.