Foldax Completes Enrollment in India Clinical Trial Evaluating TRIA™ Polymer Surgical Mitral Heart Valve

By November 27, 2023 December 16th, 2023 News

Foldax®, Inc., a leader in the development of innovative, polymer heart valves, today announced completion of enrollment in the Indian clinical trial of the TRIA™ polymer surgical mitral heart valve. Positive 30-day data for the first 35 patients in the study was presented at the recent Transcatheter Cardiovascular Therapeutics (TCT) conference by Isaac George, M.D., Surgical Director of the Heart Valve Center at Columbia University. The data showed that TRIA valve implantation resulted in 0% reoperation, 0% blood clotting and 0% bleeding events.

The TRIA mitral valve is designed specifically for the anatomy and pressures of the mitral position. It combines the company’s proprietary polymer – LifePolymer™ – with an innovative valve design intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants.

“We are excited to see early promising results from the TRIA polymer mitral valve,” said Kaushal Pandey, MD, with P.D. Hinduja Hospital in Mumbai, India. “The blood flow dynamics are excellent, and the polymer material properties are formulated to resist calcification, one of the main causes of tissue valve failure.”

The Indian TRIA surgical mitral valve study is a prospective multicenter clinical trial. Since commencing in March 2023, the trial has enrolled its target of 66 patients across eight sites in India, making it one of the fastest-enrolling studies of any heart valve and reinforcing the need for a durable mitral valve replacement option. Patients will be assessed at six months and one year for safety, hemodynamic performance, and durability. Additionally, a registry tracking these patients for five years will be implemented.

India was selected for the clinical trial because approximately two to three million people in the country have rheumatic heart valve disease caused by rheumatic fever, which attacks the mitral valve, and causes it to close improperly and leak. Patients often contract rheumatic disease early in life and their valves begin failing when they are still young.

In the Indian TRIA mitral valve trial, the patient age ranges from 19 to 68 years old, with an average age of 39, much younger than the nearly 60-year-old average age for tissue valve replacement in other mitral studies. Sixty-two percent of patients are female, and 60 percent of female patients are less than 40 years old, significantly larger percentages than typically seen in clinical studies.

“It is especially rewarding to offer the TRIA polymer heart valve to women of child-bearing age,” said Dasari Prasada Rao, M.D., Chief Cardiac Surgeon at Apollo Spectra Hospital in Ameerpret, Hyderabad. “The TRIA polymer valve is designed to last a patient’s lifetime, without the requirement of taking blood thinners indefinitely. With the TRIA valve, women can hold onto the hope of having children without facing repeat surgeries.”

The lower average age and high percentage of child-bearing females suggests that both physicians and patients believe the TRIA valve with LifePolymer will not have the limited durability or quality-of-life tradeoffs seen with currently available heart valves.

“Prior to TRIA, patients had to choose between tissue valves made from porcine or pericardial tissue that have limited durability and are not culturally acceptable in India, and mechanical valves that click audibly when opening and closing and require lifelong blood thinning medication,” said Anil Jain, M.D. with Epic Hospital in Gujarat. “With growing positive clinical experience, the TRIA valve has the potential to become the valve of choice for patients of all ages with mitral valve regurgitation.”

“Treating the final patient in this rapidly enrolled Indian TRIA mitral surgical valve clinical study builds on the exciting phase of innovation and growth at Foldax over the past year,” said Gregory D. Casciaro, CEO of Foldax. “We now have patents in India covering both our LifePolymer material and our valve design, further acknowledging and protecting our innovative polymer and valves.”

“Thanks to the expertise and support of our physician partners in both India and the United States, we can continue to clinically implant our ‘designed for mitral’ TRIA valves made with LifePolymer. Across our total clinical experience, over 150 valves have been implanted, making TRIA the most widely studied polymer valve in humans,” Casciaro continued. “We look forward to continuing to follow these patients and validating the robust nature of the TRIA valve.”

The TRIA heart valve is for investigational use only and is not available for commercial sale.