Foldax Completes Enrollment in Tria LifePolymer Early Feasibility Study

Foldax has completed initial enrollment in its early feasibility study (EFS) for the Tria LifePolymer heart valve. Fifteen patients have been enrolled in four participating sites.
 
“The study is progressing well and we will be reporting on the early clinical experience later this year,” stated Amit Patel, M.D., MS, 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.
 
In January, the Christ Hospital Health Network became the third hospital in the world, and first in the Cincinnati region, to implant the next-generation Tria heart valve under a U.S. Food and Drug Administration Early Feasibility Study (EFS) for the treatment of aortic valve disease. Geoff Answini, M.D., medical director of the Cardiothoracic Surgery Program and J. Michael Smith, M.D., director of Cardiothoracic Surgical Research at the Lindner Research Center, implanted the flexible polymer heart valve, which has the potential to improve upon durability and thrombogenicity issues of currently available heart valves.

“We are excited to be one of the first in the country to offer this new technology, and further our commitment to advancing cardiovascular care on a national level while providing a unique resource to heart patients in our community,” said Dr. Answini. “The procedure was successfully performed on January 8 and the patient is doing very well and has been discharged.”

The first patient, Kenneth Abney, was happy to be a part of this trial if it meant helping others and providing more options to patients in the future. As a military physician assistant for 21 years, and 43 years of service, he not only understands the importance of research and advancing technology in the healthcare space, but even more, he has a commitment to sacrifice in order to help others, which he believes this new procedure will do. “I guess it’s the soldier in me,” he explained.

Tria heart valves combine LifePolymer, an advanced biopolymer material, and a patented design to create a valve with the potential for lowering the cost of medical care given the rising costs of using animal tissue valves and their associated durability and calcification concerns. 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.

“We are excited to be collaborating with Christ Hospital. The Aortic EFS combined with our progress toward mitral and transcatheter versions of the valves next year have the potential to revolutionize the heart valve industry. We are bringing 21st-century solutions to the worldwide problem of providing high quality products with an attractive value proposition,” stated Charhut.

Foldax’s Tria valves were developed by drawing on expertise from the Commonwealth Scientific and Industrial Research Organization (CSIRO), Caltech’s Division of Engineering and Applied Science and Chemistry Departments and leading clinicians. The company’s investors include Kairos Ventures and Biostar Capital.