The U.S. FDA has granted IDE approval to the cardiac device startup Foldax Inc., to initiate clinical testing of its Tria mitral surgical heart valve. Patient enrollment is expected to begin in early 2021.
Startup Foldax Inc. has raised a $20 million series D round to back its development of biopolymer-based surgical and minimally invasive heart valves. Heart valves typically are either based on porcine or bovine tissues or are mechanical.