June 27, 2025 — Foldax announced promising one-year clinical trial results for its Tria polymer mitral heart valve, demonstrating safety, sustained hemodynamic performance, and significant quality-of-life improvements.
The prospective, multicenter trial in India enrolled 67 patients (average age 42, 64% women, 73% with rheumatic heart disease). Key findings included no valve-related mortality or reinterventions, a >50% reduction in mean gradient (9.7 to 4.5 mmHg), and a >90% increase in effective orifice area (0.9 to 1.5 cm²). Patients also showed a 24-point increase in KCCQ scores and a 65% improvement in six-minute walk tests.
Foldax’s proprietary LifePolymer material resists calcification and is produced robotically for precision and durability, aiming to overcome limitations of traditional tissue valves. The company recently secured regulatory approval for Tria in India.
“This novel valve provides hope, especially for younger and female patients,” said Dr. Kaushal Pandey, principal investigator of the trial.
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