In the trial, patients experienced a 24-point improvement in their Kansas City Cardiomyopathy Questionnaire score. Credit: Jo Panuwat D / Shutterstock.

Foldax has revealed one-year outcomes from the India Clinical Trial of the TRIA mitral valve.

Presented at the Cardiovascular Research Foundation (CRF)-organised annual conference, New York Valves 2025, the results indicate a good safety profile and statistically significant patient quality-of-life improvements.

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The key findings from the trial include no deaths or reinterventions related to the valve, more than 50% decrease in mean gradient, and an increase of over 90% in effective orifice area.

Additionally, patients experienced a 24-point improvement in their Kansas City Cardiomyopathy Questionnaire (KCCQ) score and a 65% increase in Six-Minute Walk Test distance, underscoring the valve’s potential to enhance quality of life.

The multi-centre, prospective trial enrolled 67 subjects between the ages of 19 and 67 across eight Indian sites.

The company noted that 64% of the subjects were women and around half were of childbearing age. 73% of the subjects had rheumatic heart disease.

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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.”

Foldax aims to overcome the limitations of tissue and mechanical heart valves with its polymer heart valves, which are designed to be durable and potentially eliminate the need for lifelong anticoagulation.

The LifePolymer used in TRIA valves is said to resist calcification, ensuring biostability and biocompatibility, preventing the requirement for animal-based components.

The TRIA Mitral Valve is currently not available for commercial sale in the US as it is still under investigation.

Earlier this month, the company secured approval from the Indian Central Drugs Standard Control Organization (CDSCO) for the valve, which will be locally manufactured by Dolphin Life Science.

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