HighLife Medical

HighLife Medical is a private structural heart medtech company developing and now beginning to commercialize a transcatheter mitral valve replacement system for patients with symptomatic moderate-severe or severe mitral regurgitation who are not good candidates for surgery or edge-to-edge repair. Founded in 2010 in Paris, the company built a dual-component valve-in-ring TMVR technology designed for transfemoral, beating-heart implantation with broad annular size coverage. HighLife received U.S. FDA IDE approval in June 2024 to start a U.S. pivotal study, FDA Breakthrough Device designation in April 2025, and CE Mark approval in January 2026, enabling an initial European rollout. The company operates from Paris with a U.S. site in Irvine, California, where valves are manufactured. HighLife also reports a license agreement with Peijia Medical in China and clinical activity across Europe, the U.S., Asia-Pacific, and Australia.