Foldax is a medical device company reinventing heart valve technology by developing surgical and transcatheter valves designed to overcome the limitations of existing tissue and mechanical valves. The company's innovative TRIA heart valve combines a proprietary biopolymer called LifePolymer with an advanced valve design intended to resist calcification, withstand stresses without failure, and restore patient quality of life without requiring lifelong anticoagulant medication.
The LifePolymer material, specifically engineered for heart valve leaflets, exhibits superior biocompatibility, durability, and resistance to calcification compared to traditional tissue or mechanical valves. This novel polymer enables Foldax to robotically manufacture TRIA valves, ensuring consistent quality, precision, and cost-effectiveness.
In June 2024, Foldax reported positive 30-day results from a clinical study of the TRIA mitral surgical heart valve. The valve demonstrated favorable safety and hemodynamics, aligning with established standards. As of April 2024, the TRIA valves surpassed 200 patient life years in human recipients, showcasing their durability and performance over time.
In May 2023, Foldax secured full ownership rights to the proprietary LifePolymer patent portfolio, previously licensed from Australia's CSIRO. This strategic move enables Foldax to explore LifePolymer's potential applications beyond heart valves, including drug delivery, orthopedics, and other medical devices.
Additionally, Foldax announced a manufacturing agreement with Dolphin Life Science India LLP in February 2024, facilitating in-country production of the TRIA mitral valve outside the US.
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