Foldax, Inc. Gains Approval to Begin US Clinical Trials of the First and Only Biopolymer Heart Valve Platform
February 14, 2019
SALT LAKE CITY–(BUSINESS WIRE)–Foldax, Inc. today announced that the U.S. Food and Drug Administration
(FDA) has granted IDE approval to begin an Early Feasibility Study of
the Tria surgical aortic heart valve for the treatment of aortic valve
disease.
Using breakthrough LifePolymer™ – a proprietary advanced biopolymer
material – and a proprietary valve design, the Tria heart valve is
designed to be a lifetime valve with hemodynamic performance and quality
of life similar to natural human valves but without using animal tissue
or the side effects of long-term anticoagulants. Intended for use in
transcatheter or surgical heart valve applications, the Tria heart
valves are robotically manufactured to provide the highest level of
quality and precision.
“We look forward to introducing the Tria heart valve to patients in the
United States”, says Amit Patel, MD of the University of Utah, who will
be serving as primary investigator in upcoming clinical trials. “With
the Tria heart valve we have the opportunity to overcome the challenges
with today’s heart valves. The Tria valve is truly a revolutionary
option for the more than one million Americans who have moderate or
severe heart diseases.”1
The complete Tria heart valve platform will include valves developed for
use in aortic, mitral, and tricuspid valve disease. The company plans to
continue its development efforts and clinical trials, in pursuit of OUS
and US regulatory approvals.
“The FDA IDE approval to proceed with clinical investigation of the Tria
heart valve represents a significant milestone for the Company.” said
Ken Charhut, Executive Chairman of Foldax, Inc. “It is the first step in
bringing a 21st Century solution to patients with valve
disease. Our goal is to transform the way heart valves have been made
for the last 40 years by bringing high quality, value and patient
specific options to clinic.”
ABOUT FOLDAX, INC.
Headquartered in Salt Lake City, Utah, Foldax, Inc. develops
long-lasting replacement heart valves with the goal of improving
hemodynamic performance and providing a quality of life similar to
natural human valves. The company’s Tria heart valves are
revolutionizing the industry as the first and only biopolymer heart
valve platform, utilizing LifePolymer™ material. These long-lasting
transcatheter and surgical heart valves are designed to provide
sustainable quality-of-life improvement for people with aortic, mitral,
or tricuspid valve disease.
References:
1. Heart Valve Society of America (2018, April 11). About the Heart
Valve Society of America. Retrieved from http://www.heartvalvesocietyofamerica.org/more.html.
Contacts
Amber Chao
+1 949-271-1180
amberc@devicepharm.com