Affluent Medical has received clearance from the external Data and Safety Monitoring Board (DSMB) to proceed to the pivotal phase of its clinical trial for Artus, the company's artificial urinary sphincter (AUS) designed to treat stress urinary incontinence (SUI). Early performance data revealed an impressive 87% average reduction in urinary leakage among patients in the pilot study.
The French clinical-stage medical technology company announced the milestone on May 15, 2025, following a review of positive safety data from the initial clinical phase. The multicenter European clinical study, named DRY, aims to validate that Artus can reduce urinary leakage by at least 50% in patients with moderate to severe SUI.
Promising Pilot Phase Results
During the pilot phase, 10 male patients between 67 and 79 years of age with BMIs ranging from 22.7 to 32.3 were successfully implanted with the Artus device. These patients exhibited highly severe stress incontinence at baseline, with urine leakage ranging from 207ml to 1992ml per day.
The surgical procedures had an average duration of approximately 40 minutes, and all devices (100%) were successfully activated six weeks after surgery. The efficacy data, measured by pad weight test three months after device activation, demonstrated the 87% average reduction in urinary leakage.
"The safety profile demonstrated in the pilot study is good, and the ease of use has been highlighted both for the surgical implantation and for patients with the use of the remote control," said Prof. Nicolas Barry Delongchamps, Professor of Urology at Cochin Hospital, Paris, and member of Affluent Medical's Scientific Board. "Preliminary results are promising and will be confirmed at a larger scale in the pivotal phase. Artus has the potential to significantly improve the quality of life for patients living with SUI."
Expanding Clinical Trial Footprint
The pivotal phase of the DRY trial will commence in the coming weeks, expanding to additional centers in Spain and Italy beyond the currently active sites. The study will enroll several dozen patients across leading urology centers in Italy, Spain, France, and Belgium.
Based on learnings from the pilot phase, Affluent Medical plans to reinforce training for surgeons and extend it to hospital staff and patients to support both the surgical procedure and the use of the device.
Addressing a Significant Unmet Need
Stress urinary incontinence affects more than 400 million individuals globally, representing a significant unmet medical need. The economic burden of incontinence is substantial, estimated at $7 billion annually in Europe and up to $66 billion in the United States.
Artus distinguishes itself as the first mechanic-electronic urinary sphincter of its kind. The fully implantable, adjustable device can be operated by patients via a remote control, offering a minimally invasive alternative to existing treatment options.
"For decades, patients living with SUI have faced limited innovation and inadequate solutions, leaving millions to cope with compromised quality of life and the emotional burden of the condition," said Sébastien Ladet, CEO of Affluent Medical. "With promising early results, DSMB clearance, and the pivotal phase now underway, we are one step closer to delivering a next-generation, less invasive alternative to existing systems – one that could significantly enhance continence, comfort, and day-to-day confidence for a large and underserved patient population, both for men and women."
Market Potential
The global market for urinary incontinence devices—including slings, neurostimulators, and artificial sphincters—is projected to reach $4.3 billion by 2027, growing at 11% annually according to Optima Insights. This represents a significant opportunity for innovative solutions like Artus.
About the Technology
Artus is designed to control the opening and closing of the urethra through a remote control that adapts to patients' daily activities. As part of Affluent Medical's portfolio of next-generation implants, the device aims to restore essential physiological functions through minimally invasive, innovative, adjustable, and biomimetic technology.
Founded by Truffle Capital, Affluent Medical is positioning itself to become a global leader in treating both structural heart diseases and urinary incontinence, the latter affecting one in four adults worldwide. The company focuses on developing implantable medical devices that are currently undergoing clinical studies in humans.
