BTIG analysts say that Edwards expects to pay $300 million in cash at closing.
Irvine, California–based Edwards made its initial investment in Innovalve in 2017. It says the company has since demonstrated progress with promising early clinical evidence for its transcatheter mitral valve replacement (TMVR) technology.
Innovalve developed its valve with a unique approach based on specially designed arms. This allows for the development of multiple innovative procedures for valve replacement and repair therapies. The company has its first TMVR system, Innostay, in clinical trials.
The Innostay valve utilizes a unique rotational maneuver of those arms, leading the native mitral valve tissue to wrap around the prosthesis. This provides firm anchoring and sealing, leading to improvements in post-procedural symptoms of mitral regurgitation (MR).
Edwards said in a news release that it plans for Innovalve to join its transcatheter mitral and tricuspid therapies (TMTT) product group. Corporate VP Daveen Chopra leads that group, which develops the Sapien M3 TMVR system already.
The company expects the deal to close by the end of 2024. It marks the second big mitral valve play made by Edwards in the space of just a few days. The company last week entered into a series of deals with Affluent Medical, agreeing to pay $16.3 million for licensing and development efforts involving Affluent’s Kalios adjustable mitral annulus and mitral valve technology.
“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,” said Chopra. “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.”
The analysts’ view on Edwards’ TMVR play
BTIG analysts Marie Thibault and Sam Eiber reiterated their “Neutral” rating for Edwards in the aftermath of this announcement.
They also labeled Edwards’ reiteration of its expectations for Sapien M3 approval in Europe by the end of 2025 as important. The analysts suggest that Innovalve can help to develop a differentiated range of therapies to expand the treatable population.
“The deal doesn’t come as a complete surprise, as we know EW is narrowing its focus on structural heart disease following the planned sale of the Critical Care business.”
BD announced last month that it plans to buy Edwards’ Critical Care unit in a $4.2 billion deal.
