18. Sep 2019
Biopolymers can help to save lives and improve the quality of life. The new Tria valve, developed by Foldax, Inc., has the potential to address durability and clotting issues associated with traditional artificial heart valves.
The Tria valve was implanted in a human patient at Beaumont Hospital in Michigan, USA. Dr. Marc Sakwa, Beaumont’s Chief of Cardiovascular Surgery, said, “The procedure was successfully performed on July 30th and the patient is doing well and has been discharged.”
Tria heart valves are made of LifePolymer, an advanced biopolymer material. They feature a patented design to create a valve with the potential for lowering the cost of medical care given the increasing costs of using animal tissue valves and their associated durability and calcification concerns. The valve is designed to reduce or eliminate the need for a lifetime of anticoagulant drugs, including their risks and side effects.
The proprietary biopolymer material and design of the Tria heart valves also allows for high volume manufacturing. The valves are robotically manufactured to provide the highest level of quality and precision and allow for future patient customization, while eliminating the variability of human production.
In February, Foldax, which is based in Salt Lake City, Utah, announced the U.S. Food and Drug Administration (FDA) had granted investigative device exemption (IDE) approval for an Early Feasibility Study of the Tria surgical aortic heart valve to treat aortic valve disease.
“The start of our EFS study in the US represents a major milestone for Foldax and heart valve patients worldwide since Tria valves represent true next generation technology. We are bringing 21st Century solutions to the worldwide problem of providing high quality products at an affordable price,” said Ken Charhut, Foldax executive chairman.
Foldax’s Tria valves were developed by drawing on expertise from the Commonwealth Scientific and Industrial Research Organization (CSIRO) for proprietary polymer development and Caltech’s Division of Engineering and Applied Science and Chemistry Department. The Company’s investors include Kairos Ventures and Biostar Capital.
The complete Tria heart valve platform will include valves developed for use in aortic and mitral valve disease with transcatheter and surgical applications. The company plans to complete enrolment in its Aortic EFS study at Beaumont Hospital and two additional sites this year.