Foldax has announced the presentation of one-year results from the India clinical trial of the Tria mitral valve, showing a good safety profile, sustained haemodynamic performance, and statistically significant improvement in patient quality of life.
These are the first one-year outcomes ever presented for a multicentre clinical study of a polymer heart valve worldwide, the company says in a press release. The results were presented New York Valves 2025 (25–27 June, New York, USA) and 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, a >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), and a 24-point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) score (57.5 to 81.9) and 65% increase in six-minute walk test distance (298.1m to 494.8m), indicating significant improvement in quality of life.
The prospective, multicentre trial enrolled 67 patients aged 19 to 67 across eight sites in India, with an average age of 42 years. 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.
“It is exciting to see the positive clinical outcomes associated with this novel polymer valve,” said Isaac George (Columbia University, New York, USA). “This new type of valve sets out to reimagine how a device can address clinical needs that are underserved by current valve solutions.”
“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 (Hinduja Hospital, Mumbai, India), principal investigator of the TRIA mitral valve India clinical trial. “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 novel 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 maximise 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,” said Ken Charhut, CEO of Foldax.
