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Salt Lake City, February 27, 2024–(BUSINESS WIRE)–Foldax® Inc., a pioneer in the development of innovative polymer heart valves, today announced a manufacturing agreement with Dolphin Life Science India LLP that will enable domestic manufacturing of the TRIA™ polymer mitral valve surgical heart. The contract was announced. This is the first time we have introduced valves outside of the United States.
The TRIA mitral valve is specifically designed to accommodate the anatomy and pressure of the mitral valve location. The company’s proprietary polymer, LifePolymer™, and innovations aimed at resisting calcification, withstanding stress and strain without failure, and restoring patients’ quality of life without the need for lifelong anticoagulants. Combines standard valve design.
The new LifePolymer material and computer-designed valves help democratize the manufacturing process, minimizing the people and processes associated with animal-based bioprosthetic valve manufacturing, allowing manufacturing anywhere, reducing product variability and accuracy. , improve reproducibility, and quality.
“Our partnership with Dolphin Life Science India LLP represents a pivotal move to expedite the commercial release of the TRIA valve in our initial target commercial region of India,” said Foldax, Inc. said Ryan Stanfield, vice president of engineering and operations.
“We are proud to collaborate with Foldax to bring TRIA valve manufacturing capabilities to India. Millions of rheumatic heart disease (RHD) patients will benefit from this new polymer valve in their lives. We aim to bring about positive change,” he said. Dolphin Life His Science India Managing Director Mukesh Chobatiya said:
Dr. Kaushal Pandey, an investigator on the company’s recent TRIA valve clinical trial in India, which he believes is the fastest enrolling clinical trial of any surgical mitral valve, said: I commented. “Mechanical valves are also needed as products currently on the market often lack durability and patient acceptance. I’m encouraged by the progress the company is making.”
The TRIA heart valve and LifePolymer technology are considered research and will not be commercially available in the United States or elsewhere.
Dolphin Life Science India LLP is an expert in medical device manufacturing. The company is registered with India’s regulatory bodies Drugs Controller General of India (DCGI) and Central Drugs Standards Control Organization (CDSCO).
About Foldax
Foldax Inc. reinvents every aspect of heart valves, from materials to design and manufacturing, addressing historical tradeoffs to develop surgical and transcatheter valves designed to last a lifetime. We are a medical device company that is working on
For more information about Foldax, please visit www.foldax.com.
Foldax’s investors include Angel Physicians Fund, Biostar Capital, Caltech, Glenview Capital, Kairos Ventures, Memorial Care Innovation Fund, and Sayan Bioventures.
View source version on businesswire.com. https://www.businesswire.com/news/home/20240227774410/ja/
contact address
Media contact:
Michelle McAdam, Chronic Communications, Inc.
michelle@chronic-comm.com
(310) 902-1274
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