Foldax® Completes Enrollment in Tria LifePolymer™ Early Feasibility Study

Company demonstrates excellent progress in its surgical aortic heart valve study

SALT LAKE CITY–(BUSINESS WIRE)–Foldax® announced today that it has completed initial enrollment in its early feasibility study (EFS) for the Tria LifePolymer™ heart valve. Fifteen patients have been enrolled in 4 participating sites.

“The study is progressing well and we will be reporting on the early clinical experience later this year,” stated Amit Patel, MD, MS, the principal investigator of the study.

The aortic EFS is the first in a series of clinical studies Foldax will be conducting on its Tria LifePolymer heart valve line. LifePolymer is a patented polymer formulated specifically for heart valve application with the goal of enhancing durability, hemodynamic performance and providing exceptional value over current heart valves. The next studies will focus on surgical mitral valve and transcatheter aortic valve applications.

“This accomplishment would not be possible without the significant contributions of our clinical investigators and their teams at Ohio Health in Columbus, The Christ Hospital in Cincinnati, St. Vincent’s in Indianapolis and Beaumont Hospital in Detroit. We are looking forward to initiating our surgical mitral and TAVR clinical studies to continue our goal of transforming heart valve therapy,” stated Ken Charhut, Foldax Executive Chairman.

About FOLDAX®

Headquartered in Salt Lake City, Utah, Foldax is developing replacement heart valves with the goal of improving hemodynamic performance, durability, and providing a quality of life similar to natural human valves. Tria heart valves are revolutionizing the industry as the first and only biopolymer heart valve platform, utilizing LifePolymer™ material eliminating the use of animal tissue. These transcatheter and surgical heart valves are designed to be long-lasting and provide sustainable quality-of-life improvement for people with aortic or mitral valve disease. For additional information, visit www.foldax.com.

Contacts

Mike Numamoto | Vice President, Marketing

Mike.numamoto@foldax.com

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