Foldax Inc. has announced encouraging one-year outcomes from clinical trials of its TRIA™ mitral heart valve, a new generation polymer-based device intended to offer a durable alternative to traditional heart valve replacements. The results were unveiled at the New York Valves 2025 conference and published in the Journal of the American College of Cardiology, highlighting significant advances for patients with mitral valve disease.

The prospective, multicenter trial enrolled two separate patient cohorts: one across eight sites in the United States and a second, larger group at eight centers in India. In the U.S. trial, subjects ranged between 20 and 73 years of age, with 64% identified as women; around half of the female participants were of childbearing age, and 24% of all subjects had rheumatic heart disease. In the India trial, 67 patients aged 19 to 67 were enrolled, with a mean age of 42, a 64% female composition, and a notably higher prevalence of rheumatic heart disease at 73%.

According to Foldax, key clinical findings included a robust safety profile over one year, with no valve-related mortality, no serious valve-related adverse events, and no requirement for reintervention. Patients demonstrated substantial functional and quality-of-life benefits, notably:

• A mean reduction in pressure gradient from 9.7 mmHg to 4.5 mmHg, which represents an improvement of over 50% (India trial).
• Increase in effective orifice area from 0.9 cm² to 1.5 cm², a gain exceeding 90% (India trial). In the U.S. trial, the rise exceeded 70%.
• A 24-point enhancement in Kansas City Cardiomyopathy Questionnaire (KCCQ) score, from 57.5 to 81.9, indicating better patient-reported health outcomes (India trial).
• A 65% increase in distance covered during the Six-Minute Walk Test, from 298.1 meters to 494.8 meters (India trial), and a 50% increase reported in the U.S. cohort.
• Improvement in New York Heart Association (NYHA) functional class scores, reflecting gains in heart failure symptoms.

The TRIA mitral valve is constructed using Foldax's proprietary LifePolymer™, which is billed as calcium-resistant, biostable, and biocompatible. The valve is manufactured via robotic processes to enhance precision and consistency, and is designed to overcome some of the historical limitations of both biological and mechanical valves—namely limited durability, propensity for calcification, and the need for lifelong anticoagulation therapy.

The latest regulatory milestone was achieved in June 2025, when India's Central Drugs Standard Control Organization (CDSCO) approved the TRIA mitral valve, marking the world's first commercial authorization for a polymer heart valve. Manufacturing will be carried out locally by Dolphin Life Science India LLP.

Currently, the TRIA mitral valve has not been approved for commercial sale in the United States, as ongoing studies continue to assess its long-term safety and efficacy.

Experts suggest that these clinical results highlight the TRIA valve’s promise, especially for younger patients and women of childbearing age—populations that are often underserved by current heart valve technologies. The device is also considered well suited for patients with rheumatic heart disease, reflecting global health needs.

Additional information on the study and device can be found via the original article on Yahoo Finance and other trade sources such as Biospace and PCROnline.

Editor’s note: This report is based on information released by Foldax Inc. and third-party sources, and is provided for general informational purposes. It should not replace medical consultation or advice. Always consult a healthcare professional for guidance specific to your medical condition.