US-based polymer heart valves developer Foldax has unveiled promising one-year results for its TRIA Mitral Valve, which showed a positive safety profile and improved patient outcomes in the India Clinical Trial.
The multicentre clinical trial involved 67 patients aged 19 to 67 across eight sites in India, with an average age of 42.
It comprised 64% women in the participants, with nearly half of them being of childbearing age, and 73% had rheumatic heart disease.
The data, published in the Journal of the American College of Cardiology (JACC), indicate the world’s first one-year outcomes for a multicentre clinical study of a polymer heart valve.
Foldax CEO Ken Charhut said: “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.
Columbia University Heart Valve Center surgical director Isaac George said: “It is exciting to see the positive clinical outcomes associated with this novel polymer valve.
“This new type of valve sets out to reimagine how a device can address clinical needs that are underserved by current valve solutions.”
The key findings showed a considerable reduction of over 50% in mean gradient, from 9.7mmHg to 4.5mmHg, and a 90% increase in effective orifice area, from 0.9 cm² to 1.5 cm².
The study results, which include no valve-related mortality or reinterventions, are the highest reported in similar surgical mitral valve studies.
Patient quality of life saw significant improvements, with a 24-point increase in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score from 57.5 to 81.9.
In addition, the Six-Minute Walk Test distance improved by 65%, from 298.1m to 494.8m, underscoring enhanced physical capability.
Foldax designed its TRIA valves to be durable and potentially eliminate the need for lifelong anticoagulation, addressing the limitations of traditional tissue and mechanical heart valves.
The valves leverage LifePolymer, the company’s in-house polymer that is calcium-resistant, biostable, and biocompatible.
LifePolymer enables robotic production, enhancing manufacturing efficiency and quality.
TRIA Mitral Valve India Clinical Trial principal investigator Kaushal Pandey said: “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.”
Recently, Foldax secured the Indian Central Drugs Standard Control Organisation (CDSCO) approval for its TRIA Mitral Valve.
The company announced that the valve will be manufactured in India by Dolphin Life Science India, a generic pharmaceutical company based in Gujarat.
