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 […]
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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 […]
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 […]
Foldax touts FIH procedure for Tria polymer heart valve
Foldax today announced first-in-human use of its Tria heart valve in an FDA early feasibility study for the treatment of aortic valve disease. The procedure was performed July 30 at Beaumont Hospital in Royal Oak, Mich. The patient is “doing well and has been discharged,” Beaumont chief of cardiovascular surgery Dr. Marc Sakwa said in […]
FDA green-lights early feasibility trial for Foldax’s Tria biopolymer heart valve
Early stage cardiovascular device company Foldax said today it won FDA investigational device exemption approval to launch an early feasibility study of its Tria surgical aortic heart valve. The valve uses a proprietary biopolymer material, dubbed LifePolymer, as well as a proprietary design, the Salt Lake City-based company said. Foldax touted that the Tria heart […]