Affluent Medical signs deals with Edwards for structural heart products

Affluent will initially receive €5m for an exclusive option for Edwards to acquire Kephalios.

Archana Rani

French medical technology company Affluent Medical has signed agreements with Edwards Lifesciences for its mitral valve technologies, securing an upfront payment of €15m ($16.35m).

The agreements are structured around three key components. Firstly, Affluent will receive €5m for an exclusive option for Edwards to acquire Kephalios, Affluent’s subsidiary behind the adjustable mitral annulus Kalios, contingent on clinical outcomes.

During the option period, Affluent will retain exclusive management of Kalios development activities.

Secondly, Edwards will secure a global, non-exclusive licence to Affluent's intellectual property for a biomimetic cardiac mitral valve replacement technology, limited to open-heart surgery applications.

Affluent is set to receive future royalties on any commercialised products that utilise these patents.

The company maintains full patent rights for transcatheter valves, including the Epygon mitral valve currently undergoing clinical trials.

The third component involves an upfront payment of €5m from Edwards for an equity stake in Affluent.

This transaction will be executed through a capital increase, with Edwards gaining a 9.21% shareholding in Affluent.

In addition, FPCI Truffle Medeor and Ginko Invest will contribute to the capital increase by converting their shareholder loans into equity.

Affluent's flagship product Kalios is a mitral valve annuloplasty device. It is designed to allow percutaneous and minimally invasive adjustments by a cardiologist or surgeon post-implantation.

This device aims to treat mitral insufficiency without the need for additional open-heart surgeries.

Affluent Medical CEO Sébastien Ladet said: “Edwards’ strong global market presence and commercial infrastructure hold 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.”

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