(News Bulletin 247) – The medtech company, specializing in innovative minimally invasive implants designed to restore physiological functions, announced the success of the first implantation in humans of its Artus artificial sphincter for the treatment of urinary incontinence of effort.

Affluent Medical announces an important milestone for its artificial sphincter dedicated to the treatment of urinary incontinence. The French company was delighted this Tuesday morning by the “success” of the first implantation in humans of Artus, its minimally invasive medical device for the treatment of urinary incontinence.

Artus is an implantable artificial urinary sphincter developed for the treatment of moderate to severe urinary incontinence in men and women. The device that controls the opening and closing of the patient’s urethra is activated by the patient via a remote control and has been designed to allow adaptation to the patient’s lifestyle.

This operation was performed on a 68-year-old Czech man suffering from severe urinary incontinence, as part of the European “Dry” pilot study. The procedure lasted approximately 80 minutes and “went as planned,” says Affluent Medical. “The patient is doing well and was discharged five days after the operation without complications,” adds the medtech, which specifies that the Artus device will be activated “six weeks after implantation as soon as the healing of the wound after surgery is complete.” .

10 men by the end of the year

“This first implementation of Artus constitutes an important step for Affluent Medical. With approximately 400 million people suffering from urinary incontinence, there is hope for a better quality of life thanks to our innovative solution,” rejoices Sébastien Ladet, Chairman and CEO of Affluent Medical.

On the Paris Stock Exchange, the announcement was welcomed since Affluent Medical shares jumped 14.3% to 1.38 euros, around 2:15 p.m.

The medtech intends to capitalize on this success to continue its Dry pilot study. Affluent Medical explains that it intends to treat ten men as part of this study by the second half of 2024. The company plans to “launch a pivotal study in 2025 with a total of 70 patients and initiate trials in the woman”, specifies Invest Securities for its part. “New centers, particularly in Poland, should soon be opened to accelerate recruitment,” continues the research office.

“Nevertheless, the group is behind schedule on its commercial schedule which provided for submission of CE marking in 2024 with potential marketing in 2025,” adds Invest Securities.

A major public health problem

From a clinical point of view, “this announcement is positive”, welcomes the financial intermediary while its system meets a high medical need with 400 million patients affected worldwide, Affluent Medical would like to point out.

Urinary incontinence, “qualified as a major public health problem” by medtech, is characterized by an involuntary, uncontrollable flow of urine, explains health insurance. This pathology is generally more common in women than in men, particularly in younger patients (aged 25 and over) with disorders resulting from multiple births or in older patients (40 and over) following treatments for prostate cancer or of the bladder.

“Urinary incontinence has a major impact on the social life and mental health of patients, many of whom develop anxiety and depressive disorders, because the pathology remains taboo for the vast majority of patients,” Affluent Medical also recalls.

This pathology is “on the verge of becoming a major health problem in Europe, exacerbated by the aging of the population and causing a total economic burden of 320 billion euros in 2030,” adds the medtech.

The market addressed by Affluent Medical is therefore colossal. According to figures from the OptimaInsights institute cited by medtech, the global market for medical devices for the treatment of urinary incontinence (including strips, neurostimulators and artificial sphincters) is expected to reach $4.3 billion by 2027, representing annual growth of 11% between 2019 and 2027.

In addition to urinary incontinence, the company has developed other minimally invasive implants designed to restore essential physiological functions for the treatment of structural heart disease, which is the leading cause of death worldwide.