Edwards Lifesciences acquires Innovalve for US$300M

USA—US-based medical device giant Edwards Lifesciences has announced its decision to fully acquire Israeli company Innovalve Bio Medical for an estimated US$300 million, with the acquisition expected to close by the end of 2024.

The acquisition news follows shortly after Edwards Lifesciences signed a deal with Affluent Medical to provide its portfolio of mitral valve technologies for an upfront payment of €15m ($16.35m)

With this acquisition of the Israel-based Sheba Hospital spin-out, in which Edwards made an initial investment in 2017, the company hopes to grow its early-stage transcatheter mitral valve replacement (TMVR) business.

 Since the initial investment, Innovalve has demonstrated significant progress in its program, with its Innostay device achieving clinical success and receiving Food and Drug Administration (FDA) approval.

Innovalve, a spin-out from Israel-based Sheba Hospital, has made significant progress in its program, with its Innostay device achieving clinical success and receiving Food and Drug Administration (FDA) approval.

This approval has allowed the commencement of limited clinical trials in the US under the Investigational Device Exemption – Early Feasibility Study (IDE-EFS) pathway.

Combined with Edwards’ existing mitral innovations, the acquisition enhances the company’s TMVR technologies to address large unmet structural heart patient needs and support sustainable long-term growth.

 Innovalve will join the transcatheter mitral and tricuspid therapies (TMTT) product group, led by corporate vice president Daveen Chopra.

In an official filing with the US Securities and Exchange Commission (SEC), Edwards Lifesciences revealed plans to pay approximately US$300 million 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 US$91.50 per share to US$89.51 at the time of writing.

 The same research found that in 2024, the overall market for TMVR devices was valued at approximately US$1.3 billion, with projections estimating it will climb to US$3.2 billion by the end of 2030.

In his address, Daveen Chopra noted that the acquisition builds on their understanding of the complexity of mitral disease and the need for a differentiated range of therapies for these patients.

He also stated that Edwards’ SAPIEN M3 is on target to become the first certified transfemoral TMVR system in Europe by the end of 2025, and that the Innovalve technologies, along with Edwards’ deep mitral expertise, will enable a TMVR platform that will increase the treatable population.

Additionally, 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 US$29,000 during that period.

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