The Latest Cardiac and Vascular News
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the Drugs Controller General of India (DCGI), India’s regulatory body for medical devices, has approved initiation of a clinical trial of the TRIA™ biopolymer surgical aortic heart valve. The TRIA valve reimagines […]
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced completion of enrollment in the U.S. early feasibility study of the TRIA™ surgical aortic heart valve. The TRIA valve reimagines the heart valve by combining the company’s proprietary biopolymer – LifePolymer™ – with […]
Second Product from Tria Biopolymer Valve Portfolio to Move into Human Study SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced the successful first-in-human use of its biopolymer Tria™ heart valve in surgically replacing a diseased mitral valve. The first case was […]
Company’s LifePolymer Material Used in First Polymer Heart Valves Ever Approved by FDA for Use in Clinical Trials SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced publication of a research paper in Advanced NanoBiomed Research that concluded that its LifePolymer™ biopolymer “exhibits ideal […]
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 […]
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval to expand the U.S. clinical study of the Tria™ surgical aortic heart valve. This next stage of enrollment is expected to begin […]
SALT LAKE CITY–(BUSINESS WIRE)–Foldax® announced today that it has been selected as Company of the Year among 10 cardiovascular device company finalists by MedTech Outlook Magazine. Foldax was honored for its innovative Tria™ heart valve, the first biopolymer heart valve to receive FDA […]
Tria Heart Valve Made with Proprietary LifePolymer Reimagines Material, Design and Manufacturing to Solve Long-Standing Heart Valve Issues SALT LAKE CITY–(BUSINESS WIRE)–Foldax® announced today that it has been selected as a finalist in the Fierce Innovation Awards – Life Sciences Edition 2020, […]
SALT LAKE CITY–(BUSINESS WIRE)–Heart valve innovator Foldax®, a company reinventing every aspect of the heart valve, from material to design to manufacturing, today announced the closing of a $20 million Series D round of funding. MemorialCare Innovation Fund (MCIF) led the […]
Annual Awards Program Recognizes Outstanding Health & Medical Technology Products and Companies SALT LAKE CITY–(BUSINESS WIRE)–Foldax® announced today that MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global health and medical […]
