Foldax Tria Mitral Valve Evaluated in Clinical Trial

June 27, 2025—Foldax Inc., a Utah-based developer of polymer heart valves, announced 1-year results from a clinical trial in India of the company’s Tria mitral valve. The Foldax Tria valves incorporate the company’s LifePolymer, which is formulated to be calcium-resistant, biostable, and biocompatible.

The results were presented at the New York Valves 2025 conference and concurrently published by Isaac George, MD, et al in Journal of the American College of Cardiology.

The company recently announced that the Tria device received regulatory approval in India. In the United States, the Tria mitral valve is for investigational use only and is not available for commercial sale.

According to the company, the prospective, multicenter trial enrolled 67 patients (ages, 19-67 years; average age, 42 years; women, 64%) at eight sites in India. Approximately half of the women in the trial were of childbearing age, and 73% of patients had rheumatic heart disease.

As outlined in the company’s press release, key 1-year results from the trial included the following:

• No valve-related mortality or reinterventions
• > 50% reduction in mean gradient (9.7 mm Hg to 4.5 mm Hg)
• > 90% increase in effective orifice area (0.9 cm² to 1.5 cm²)
• 24-point improvement in Kansas City Cardiomyopathy Questionnaire score, from 57.5 to 81.9
• 65% increase in 6-minute walk test distance (298.1 m to 494.8 m), indicating significant improvement in quality of life

“It is exciting to see the positive clinical outcomes associated with this novel polymer valve,” commented Dr. George in Foldax’s press release. “This new type of valve sets out to reimagine how a device can address clinical needs that are underserved by current valve solutions.” Dr. George is Surgical Director of the Heart Valve Center at Columbia University in New York, New York.

Kaushal Pandey, MD, Principal Investigator of the clinical trial and a cardiac surgeon at P.D. Hinduja Hospital in Mumbai, India, added, “I am proud to be the principal investigator in India for this groundbreaking trial and represent the highly esteemed clinical investigators who participated in the study. The Tria mitral valve provides hope for Indian patients—including younger patients and many women of childbearing age—for whom current valve options often fall short.”