Dive Brief:
- Edwards Lifesciences said Monday it exercised an option to buy Innovalve Bio Medical, an Israel-based startup that is developing transcatheter mitral valve replacement technologies.
- Edwards expects to pay about $300 million in cash at the closing of the acquisition, which is forecasted for the end of 2024, according to a Monday Securities and Exchange Commission filing.
- In a separate deal announced Friday, Edwards agreed to pay 15 million euros (about $16.3 million) for a stake in France’s Affluent Medical and access to its technologies. The agreements include an exclusive option to buy its mitral ring subsidiary and a global license for biomimetic mitral valve replacement technology. Of the total payment to Affluent, 5 million euros will give Edwards a 9.21% equity position in the company, Affluent said.
Dive Insight:
While transcatheter aortic valve replacement (TAVR) remains Edwards’ largest business, the company is increasingly focused on driving adoption of treatments for mitral and tricuspid disease. Sales of transcatheter mitral and tricuspid therapies (TMTT) climbed year over year by 72% in the first quarter to $73 million.
Earlier this year, Edwards’ Evoque device became the first transcatheter procedure to receive Food and Drug Administration approval to treat patients with tricuspid regurgitation, avoiding the need for open-heart surgery.
The cardiac valve specialist, which is selling its critical care group for $4.2 billion to BD, is now looking to broaden its portfolio of mitral valve repair and replacement devices with the addition of several new technologies.
In its statement on the Innovalve acquisition, Edwards said its Sapien M3 device remains on track to become the first transfemoral transcatheter mitral valve replacement system in Europe by the end of 2025.
“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,” Daveen Chopra, leader of Edwards’ TMTT group, said in the statement. “We believe the Innovalve technologies, paired with Edwards’ deep mitral expertise, will enable a TMVR platform that will expand the treatable population.”
Innovalve’s mitral valve replacement program has shown progress in early clinical work since Edwards’ initial investment in 2017 in the early-stage company, Edwards said.
In the Affluent deal, Edwards will spend 5 million euros for the exclusive option to buy the company’s Kephalios subsidiary, which is developing an adjustable cardiac mitral ring called Kalios. Affluent, which was founded by Truffle Capital, will continue to manage development of Kalios during the life of the option.
The remaining 5 million euros will pay for a nonexclusive license covering intellectual property for Affluent’s biomimetic mitral valve replacement in open-heart surgery. Affluent may receive additional royalties on future products using the licensed patents and will retain full patent rights for transcatheter valves, including its Epygon mitral valve in clinical development.