Pathologies - Affluent Medical

The lives of close to 600 million people worldwide are deeply affected by mitral insufficiency and urinary incontinence. Those with mitral insufficiency must undergo major surgery to avoid all cardiac problems, or even simply to survive. As for urinary incontinence, sufferers change their social life due to leaking, and have to make do with solutions that are difficult to implant and use. All expect easier solutions from modern medicine.

Which is what Affluent offers, with three leading-edge solutions: minimally invasive, adjustable and modelled on the human anatomy. Kalios™ and Epygon treat mitral insufficiency, and Artus treats urinary incontinence.
At the clinical phase today, each of these innovations will be available starting in 2027.

Solutions at the Clinical Phase of Study, and Soon Accessible for Everyone

Structural heart

Kalios™

Mitral valve repair

KaliosTM is the only mitral annuloplasty device that can be simply adjusted percutaneously by a cardiologist to treat both residual or recurrent mitral valve insufficiency, at any time after implantation, repeatedly and with a beating heart. Affluent Medical believes that KaliosTM would avoid further intervention for potentially 30% to 40% of patients over a five-year horizon.

Affluent Medical’s objective is to submit a De Novo application with current clinical data at the end of 2025 to be followed by commercial launch, subject to Edwards’ decisions, with whom Affluent Medical has signed several agreements related to its structural heart products and technologies.

Structural heart

Epygon

Mitral valve replacement

The only biomimetic mitral heart valve that mimics the anatomy of the native mitral valve. The transcatheter approach avoids an invasive open-heart procedure to treat mitral valve insufficiency.

In 2024, the company began a collaboration with Prof. Mohammad Sarraf, MD, interventional cardiologist at the Mayo Clinic in the US, to evaluate the benefits of the biomimetic design of the Epygon valve that aims to replicate the natural physiology of the native mitral valve to enable patients to recover good cardiac function more quickly.

Affluent Medical accelerated patient screening with the goal to implant up to ten patients to complete the pilot phase.

Urology

Artus

Urinary incontinence

Artus is the first artificial urinary sphincter that can be activated by the patient with a simple remote control for the treatment of moderate to severe urinary incontinence.

In January 2025, the Company announced the completion of the enrollment for the pilot phase of the European multicenter clinical study in humans with the successful 10th minimally invasive implantation in men.

To date, 100% of devices having been successfully activated and the safety profile remains positive. The pivotal phase, aiming to validate the device’s performance in reducing incontinence in several dozen patients, is scheduled to begin in Q2 2025.

With women representing about 80% of patients suffering from urinary incontinence, the Company will submit the dossier in order to begin a pilot study in women in the first half of 2025.