French clinical-stage medtech company Affluent Medical has signed several agreements with Edwards Lifesciences.

The deals cover Affluent’s Kalios adjustable mitral annulus as well as mitral valve technology. Affluent will receive a €15 million upfront payment in cash for the deal.

Kalios is touted as the only mitral valve annuloplasty device that can be percutaneously adjusted to treat residual and recurrent mitral insufficiency any time after implantation, repeatedly, and on a beating heart. This helps to avoid another open-heart surgery.

A €5 million payment covers Edwards’ exclusive option to acquire Kephalios, the wholly-owned Affluent subsidiary that supports Kalios, based on its study’s clinical outcomes. Operational activities for Kalios’ development will continue to be managed by Affluent.

Another €5 million payment relates to a global, non-exclusive license of Affluent’s intellectual property for the biomimetic cardiac mitral valve replacement technology, restricted to open-heart surgery. Affluent will receive future royalties on all potentially commercialized products using the licensed patents for their lifetime.

The final €5 million grants Edwards an equity stake in Affluent. The €1.38 subscription price per new share reflects a 15% discount to the volume-weighted average price of the company’s shares over the last 20 trading days preceding July 11, 2024. Once the transaction closes, Edwards will become a 9.21% shareholder in Affluent.

“We are proud to sign these agreements with the global leader in structural heart innovation. We look forward to welcoming Edwards as a shareholder in our company,” said Affluent CEO Sébastien Ladet. “Edwards’ strong global market presence and commercial infrastructure holds the potential for our product Kalios to help doctors and their patients worldwide, while creating a strong partnership for Kalios and surgical mitral valves using our technology. Affluent will continue to develop its transcatheter mitral valve Epygon and its urinary incontinence artificial sphincter Artus.”