Medical Device Network

Edwards Lifesciences buys mitral valve business Innovalve in $300m deal

The $300m deal with the Sheba Hospital spin-out means Edwards Lifesciences is expanding its heart its offerings in an $1.3bn market.

US-based medical device giant Edwards Lifesciences has announced that it is exercising its option to completely acquire Israeli company Innovalve Bio Medical to advance its early-stage transcatheter mitral valve replacement (TMVR) business for an estimated $300m.

The acquisition of the Israel-based Sheba Hospital spin-out comes following an initial investment in the firm, but now Edwards Life Sciences is seeking to acquire the whole company after its Innostay device saw clinical success and Food and Drug Administration (FDA) approval to commence limited clinical trials in the US, under the Investigational Device Exemption – Early Feasibility Study (IDE-EFS) pathway.

Innovalve says that its Innostay device is a minimally invasive, catheterisation-based TAVR device, intended for use in adult patients with symptomatic moderate-severe and severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement.

In an official filing with the US Securities and Exchange Commission (SEC), Edwards Lifesciences expects to pay approximately $300m in cash at the closing of the acquisition, which is expected to occur by the end of this year.

Following the 15 July announcement, Edwards Lifesciences stock saw a slight drop, dipping from a value of $91.50 per share, down to $89.51 at the time of writing. The same research found that in 2024 the overall market for TMVR devices sat at approximately $1.3bn, with that figure expected to climb to an estimated $3.2bn by the end of 2030.

Edward Lifesciences's corporate vice president Daveen Chopra said: “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’ SAPIEN M3 remains on track to become the first approved transfemoral TMVR system in Europe by the end of 2025. We believe the Innovalve technologies, paired with Edwards’ deep mitral expertise, will enable a TMVR platform that will expand the treatable population.”

GlobalData’s market model forecasts that more than 39,000 patients in the US will require mitral valve repairs in 2030, with the average price for these devices estimated to be $29,000 during that period. The acquisition news follows shortly after Edwards Lifesciences signed a deal with French medical technology company Affluent Medical to provide the company with its portfolio of mitral valve technologies for an upfront payment of €15m ($16.35m).

Elsewhere in the market of TMVR devices, US-based Pi-Cardia concluded patient enrolment for a pivotal study of its ShortCut device.