Edwards Lifesciences recently announced that it would acquire Innovalve Bio Medical, an early-stage transcatheter mitral valve replacement (“TMVR”) company.  Edwards had the option to acquire Innovalve following an initial investment in 2017.  The acquisition is expected to close by the end of the year.

Regarding the acquisition, Daveen Chopra, head of Edwards’ transcatheter mitral and tricuspid therapies product group, stated:

We believe the Innovalve technologies, paired with Edwards’ deep mitral expertise, will enable a TMVR platform that will expand the treatable population….  Edwards’ SAPIEN M3 remains on track to become the first approved transfemoral TMVR system in Europe by the end of 2025.

Innovalve, founded in 2017 at the Sheba Medical Center in Israel, currently makes the Innostay TMVR system.  According to Innovalve, the Innostay “utilizes a unique rotational maneuver of specially designed arms which lead to the native Mitral Valve tissue to wrap around the Valve prosthesis, providing firm anchoring and sealing, leading to significant improvement in post-procedural symptoms of mitral regurgitation.”  Innovalve is conducting an early feasibility study to evaluate the safety and performance of the Innostay in treating mitral valve regurgitation.  That study is expected to be completed in September 2028.