Published: Dec 14, 2020
SALT LAKE CITY--(BUSINESS WIRE)-- Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval for the company to initiate a U.S. clinical study of its Tria™ biopolymer mitral surgical heart valve. The company anticipates the first use of its mitral valve in a human will take place in the coming weeks.
The mitral valve is the second of three Tria biopolymer heart valve products in the Foldax portfolio, and addresses a large unmet clinical need based on the prevalence of rheumatic fever worldwide.
The first of the company’s products – an aortic surgical heart valve – is currently enrolling a U.S. clinical study as a result of FDA approval of an expanded study last October. The third valve product is a transcatheter aortic valve replacement (TAVR), which is in the pre-clinical testing phase.