Foldax Touts Positive One-Year Data on TRIA Mitral Valve

Foldax Inc. is sharing compelling one-year results from India’s clinical trial of the TRIA Mitral Valve, showing a good safety profile, sustained hemodynamic performance, and statistically significant improvement in patient quality of life.

The results are the first one-year outcomes ever presented for a multicenter clinical study of a polymer heart valve. The data was concurrently published in the Journal of the American College of Cardiology (JACC).

Key one-year results from the trial showed:

• No valve-related mortality or reinterventions
• >50% reduction in mean gradient (9.7 mmHg to 4.5 mmHg) and >90% increase in effective orifice area (0.9 cm² to 1.5 cm²), the highest reported in similar surgical mitral valve studies
• A 24-point improvement in KCCQ score (57.5 to 81.9) and 65% increase in Six-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,” said Isaac George, M.D., surgical director of the Heart Valve Center at Columbia University. “This new type of valve sets out to reimagine how a device can address clinical needs that are underserved by current valve solutions.”

The prospective, multicenter trial enrolled 67 patients aged 19 to 67 across eight sites in India, with an average age of 42. Notably, 64% were women, and of these, nearly half were of childbearing age, a significantly larger percentage than typically seen in clinical studies. Seventy-three percent of patients had rheumatic heart disease.

“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,” said Kaushal Pandey, M.D., principal investigator of the TRIA Mitral Valve India Clinical Trial and cardiac surgeon at P.D. Hinduja Hospital in Mumbai. “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.”

Foldax’s vision for its polymer heart valves is to address the limitations of tissue and mechanical options by making its valves durable, with the future goal of avoiding a requirement for lifelong anticoagulation. TRIA valves incorporate a proprietary polymer—LifePolymer —formulated to be calcium-resistant, biostable and biocompatible. The novel polymer material enables TRIA valves to be robotically produced, which is designed to increase manufacturing efficiency and maximize product quality and precision.

“These results validate our strategy of taking heart valve therapy to a new level by bringing innovation to a platform of products that will help patients globally,” Foldax CEO Ken Charhut commented.

*The TRIA Mitral Valve is approved for use in India by CDSCO. The TRIA Mitral Valve is for investigational use only and is not available for U.S. commercial sale.

Headquartered in Salt Lake City, Utah, Foldax is reinventing every aspect of the heart valve—from material to design to manufacturing—to develop surgical and transcatheter valves with the potential to last a lifetime. Its investors include Angel Physicians Fund, Biostar Capital, Caltech, Glenview Capital, Kairos Ventures, Memorial Care Innovation Fund, and Sayan Bioventures.