Foldax treats first patients outside U.S. with polymer mitral heart valve

An animation of the Tria surgical mitral valve. [Image from Foldax]Foldax announced today that the first 30 patients have been treated outside the U.S. with its Tria polymer surgical mitral heart valve.

The procedures took place as part of the commencement of a clinical trial in India. Tria remains investigational and not available for commercial sale.

Salt Lake City-based Foldax designed Tria to accommodate the anatomy and pressures of the mitral position. It combines the company’s proprietary LifePolymer with a valve design for resisting calcification. The company says its valve withstands stresses and strains without failure, restoring quality of life without lifelong anticoagulant use.

According to Foldax, currently available prosthetic valve options for treating mitral valve disease have limitations. Those include issues with durability for tissue valves made from porcine or pericardial tissue. Additionally, some countri…

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Foldax gets greenlight in India for biopolymer surgical aortic heart valve clinical trial

Foldax this week announced that India’s medical device regulatory body approved initiation of a clinical trial to study its Tria biopolymer surgical aortic heart valve.

Salt Lake City-based Foldax designed the Tria heart valve to resist calcification, withstand stresses and strains without failure and restore patient quality of life without the lifelong use of anticoagulants.

Get the full story on our sister site, Medical Tubing + Extrusion.

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Foldax closes $20m Series D

Heart valve designer and manufacturer Foldax announced today that it closed a Series D funding round with proceeds of $20 million.

MemorialCare Innovation Fund led the round, which also included new investors Angel Physicians Fund and Sayah Bioventures. All existing investors, including BioStar Capital, Kairos Ventures and Caltech, participated as well.

Salt Lake City-based Foldax said in a news release that the funds will be used to add patients to its recently completed early feasibility study for its Tria surgical aortic biopolymer heart valve. Other uses include initiating and enrolling patients into a clinical trial for its surgical mitral valve and development of a transcatheter aortic valve replacement (TAVR) device for a first-in-human clinical study.

The Tria heart valve is constructed with LifePolymer, a biopolymer material, and robotically manufactured. The replacement valve is designed to address the durability and thrombogenicity issues of c…

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