Latest news with #TRIAMitralValveIndia
Business Wire
5 days ago
- Health
- Business Wire
Foldax Announces Positive One-Year Data on TRIA Mitral Valve
SALT LAKE CITY--(BUSINESS WIRE)--Foldax® Inc., a leader in the development of innovative polymer heart valves, today announced compelling one-year results from the India Clinical Trial of the TRIA™ Mitral Valve, showing a good safety profile, sustained hemodynamic performance, and statistically significant improvement in patient quality of life. These are the first one-year outcomes ever presented for a multicenter clinical study of a polymer heart valve worldwide. Results were presented today at New York Valves 2025, the annual conference organized by the Cardiovascular Research Foundation (CRF), and concurrently published in the Journal of the American College of Cardiology (JACC). 'It is exciting to see the positive clinical outcomes associated with this novel polymer valve.' Isaac George, M.D., Surgical Director of the Heart Valve Center at Columbia University. Share Key one-year results from the trial showed: No valve-related mortality or reinterventions >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), the highest reported in similar surgical mitral valve studies 24-point improvement in KCCQ score (57.5 to 81.9) and 65% increase in Six-Minute Walk Test distance (298.1 m to 494.8 m), indicating significant improvement in quality of life The prospective, multicenter trial enrolled 67 patients aged 19 to 67 across eight sites in India, with an average age of 42. 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, M.D., Surgical Director of the Heart Valve Center at Columbia University. '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, M.D., Principal Investigator of the TRIA Mitral Valve India Clinical Trial and Cardiac Surgeon at P.D. Hinduja Hospital in Mumbai. '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 maximize 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. The Journal of the American College of Cardiology (JACC) publication can be viewed at: *The TRIA Mitral Valve is approved for use in India by CDSCO. The TRIA Mitral Valve is for investigational use only and is not available for commercial sale in the U.S. Headquartered in Salt Lake City, Utah, Foldax is reinventing every aspect of the heart valve—from material to design to manufacturing—to develop surgical and transcatheter valves with the potential to last a lifetime, addressing limitations of tissue and mechanical valves. Foldax investors include Angel Physicians Fund, Biostar Capital, Caltech, Glenview Capital, Kairos Ventures, Memorial Care Innovation Fund and Sayan Bioventures. For more information on the TRIA Mitral Valve and Foldax's commitment to revolutionizing heart valve care, visit
Business Upturn
05-06-2025
- Health
- Business Upturn
Foldax Secures Approval for TRIA Mitral Heart Valve in India
SALT LAKE CITY, Utah, United States: Foldax® Inc., a leader in heart valve innovation, today announced that the Indian Central Drugs Standard Control Organization (CDSCO) approved its TRIA™ Mitral Valve. Dolphin Life Science India LLP will locally manufacture the TRIA Mitral Valve in India. This press release features multimedia. View the full release here: The TRIA Mitral Valve is made from proprietary LifePolymer material, developed specifically for heart valve use and engineered at a molecular level to be calcium-resistant, biostable and biocompatible. The valves are robotically manufactured for precision and consistency at scale. Traditional valves made from animal tissue are prone to calcification and degradation, limiting their durability and often leading to repeat surgeries, especially for younger patients. Mechanical valves, while durable, are prone to thrombosis and require lifelong anticoagulation therapy that can impact a patient's long-term quality of life. Foldax's vision for its novel polymer heart valves is to address the limitations of tissue and mechanical valves by making them durable, with the goal of avoiding the requirement for lifelong anticoagulation. The company's portfolio of valves in development (transcatheter and surgical), including robotic implantation capabilities, is based on its proprietary LifePolymer™, a polymer material developed specifically for heart valve use and engineered at a molecular level to be calcium-resistant, biostable, and biocompatible. All Foldax valves are robotically manufactured for precision and consistency at scale. Clinical research on the TRIA Mitral Valve demonstrates favorable safety, stable hemodynamics, and meaningful improvements in patient quality of life.1 'My experience with the TRIA Mitral Valve has shown me that there is now a compelling alternative for a diverse patient population, including those as young as 18 years old and women of childbearing age, many of whom suffer from mitral valve damage caused by rheumatic fever,' said Kaushal Pandey, MD, Principal Investigator of the TRIA Mitral Valve India clinical trial and Cardiac Surgeon at P.D. Hinduja Hospital in Mumbai. 'Gaining approval with our partner Dolphin Life Sciences for the world's first polymer heart valve marks a defining moment in the evolution of heart valve therapy and disrupts long-standing paradigms in the heart valve industry,' said Ken Charhut, Executive Chairman and CEO of Foldax. 'We intend to extend our unique platform utilizing LifePolymer material and proprietary robotic manufacturing into additional applications in transcatheter devices and other valve positions. We look forward to making a transformative impact in India and other geographies where we can fill critical unmet clinical needs.' *The TRIA Mitral Valve is for investigational use only and is not available for commercial sale in the U.S. About Foldax Headquartered in Salt Lake City, Utah, Foldax is reinventing every aspect of the heart valve – from material to design to manufacturing – to develop surgical and transcatheter valves with the potential to last a lifetime, addressing limitations of tissue and mechanical valves. Foldax investors include Angel Physicians Fund, Biostar Capital, Caltech, Glenview Capital, Kairos Ventures, Memorial Care Innovation Fund and Sayan Bioventures. For more information on the TRIA Mitral Valve and Foldax's commitment to revolutionizing heart valve care, visit . References: Isaac George, MD. Surgical Mitral Valve Replacement with a Novel Polymeric Valve: 30-Day Results from an Indian Clinical Study of the Foldax TRIA Valve. Presented at New York Valves: The Structural Summit, June 5-7, 2024, New York, New York. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same.
