Foldax Marks TRIA Surgical Valve Milestone

Foldax Inc.’s TRIA valves have surpassed 200 patient life years in human recipients. Patient life years represent the cumulative time the valve has been implanted in patients, offering insight into the duration of its use and its impact on cardiac function over time.
 
TRIA valves aim to improve heart valve disease management during a patient’slifetime. They incorporate a proprietary polymer—LifePolymer—that has been shown to resist calcification. The novel polymer material allows TRIA valves to be robotically produced, minimizing manpower and process, and maximizing product quality and precision, according to the company. TRIA valves have demonstrated excellent and stable hemodynamics clinically and have restored patient quality of life without requiring long-term use of anticoagulants.
 
“The LifePolymer material exhibits ideal biomaterial properties for flexible leaflets in a totally synthetic heart valve replacement, and it is encouraging to see the continued durability and performance in patients,” said David Grainger, Ph.D., Department Chair of Biomedical Engineering at the University of Utah and chairman of Foldax’s Scientific Advisory Board. “Synthetic polymer leaflets in prosthetic cardiac valves hold the potential to reduce calcification and blood clotting while improving blood flow and durability.”
 
TRIA valves have been studied in U.S. Food and Drug Administration- and the Drugs Controller General of India-approved clinical trials in the United States and India.
 
“There are 120 active TRIA patients we continue to follow in our clinical studies, encompassing over 200 patient life years,” Foldax CEO/Board Executive Chairman Ken Charhut stated. “Among them are early TRIA valve patients with almost five years of experience and many more who have had the valve for over four years. These positive, durable results give us confidence to expand our clinical study to transcatheter aortic valves (TAVR). We are excited to continue gaining clinical knowledge and make our TRIA valves available to more patients soon.”
 
TRIA heart valves are for investigational use only and is not available for commercial sale in the United States or any other region.
 
Headquartered in Salt Lake City, Foldax is developing surgical and transcatheter valves designed to last a lifetime. Its investors include Angel Physicians Fund, Biostar Capital, Caltech, Glenview Capital, Kairos Ventures, Memorial Care Innovation Fund, and Sayan Bioventures.