After previously backing the startup, Edwards Lifesciences is exercising its option to acquire Innovalve and its mitral valve replacement implant.
In an SEC filing, Edwards said it plans to pay about $300 million in cash upfront, with the deal slated to close before the end of this year.
According to Innovalve, the company has received an FDA green light to conduct human feasibility trials in the U.S. using its Innostay system. The transcatheter implant is designed to form a tight seal within the mitral valve regardless of its natural shape, by twisting together and holding shut the valve’s tendon-like cords before deploying the prosthetic implant—a device that literally tugs at the heartstrings.
“Building on our learnings of the complexity of mitral disease, we know there is a need for a differentiated range of therapies for these patients,” Edwards’ transcatheter mitral and tricuspid therapy group leader, Daveen Chopra, said in a statement.
“Edwards’ SAPIEN M3 remains on track to become the first approved transfemoral TMVR system in Europe by the end of 2025,” Chopra added. “We believe the Innovalve technologies, paired with Edwards’ deep mitral expertise, will enable a TMVR platform that will expand the treatable population.”
Edwards first invested in Innovalve Bio Medical in 2017, as it was being spun out of Sheba Medical Center in Tel Aviv, Israel. Since then, Edwards said the company has shown “promising early clinical experience.”
The heart valve maker last week also invested in (PDF) the France-based mitral valve designer Affluent Medical, including 15 million euros to obtain options for its adjustable mitral ring and open-surgery valve implant, as well as an equity stake in the company.