Affluent Medical has announced significant progress in its clinical development program for the Artus artificial urinary sphincter, with plans to expand trials to female patients suffering from stress urinary incontinence (SUI). The SPHINX pilot study, scheduled to launch in the second half of 2025, will evaluate the device's safety and performance in women at leading medical centers across France, Spain, and Belgium.
This advancement follows the successful completion of preparatory evaluations that confirmed the feasibility of minimally invasive implantation in women. Professor Véronique Phé, a leading European urologist from Tenon Hospital in Paris who will serve as the principal investigator for the SPHINX study, successfully performed the first implantation of the Artus device in a female anatomy model using the Da Vinci robotic-assisted laparoscopy system.
"The SPHINX study represents a major step forward in the treatment of female SUI," said Professor Phé. "Our preparatory evaluations confirm that the Artus device offers the same ease of minimally invasive implantation in women as observed in men. Coupled with a good clinical safety profile and promising preliminary performance results, we are confident in the potential of this innovative therapy to improve the lives of more patients in need."
Successful Completion of Male Patient Pilot Study
The expansion to female patients builds upon Affluent Medical's recent success with the DRY pilot study in male patients. In January 2025, the company announced the successful completion of this initial clinical phase, which involved ten men receiving the Artus implant. The primary objectives of the pilot study were to evaluate device activation at six weeks post-surgery and assess the safety profile at eight weeks.
All ten implantation procedures were completed successfully, with each operation lasting approximately 40 minutes due to the innovative design of the Artus sphincter. Notably, 100% of the devices have been successfully activated to date, and the safety profile remains positive.
Professor Nicolas Barry Delongchamps, Professor of Urology at Cochin Hospital in Paris and a member of Affluent Medical's Scientific Board, emphasized, "This first phase of the clinical study demonstrates the safety of the Artus device and the ease of use for minimally invasive procedure in men. All conditions are in line to continue the next phase of the clinical study."
Addressing a Significant Unmet Need
Urinary incontinence represents a major public health challenge, affecting more than 400 million people worldwide. Women account for approximately 80% of those affected by this condition, which significantly impacts quality of life and often leads to psychological distress and social isolation.
The prevalence of urinary incontinence in women ranges from 16% to 62%, varying with age, with stress urinary incontinence being the most common subtype. Despite the widespread nature of this condition, few innovations have been introduced in this market for the past 40 years.
Sébastien Ladet, CEO of Affluent Medical, commented on the significance of these developments: "Our progress toward the SPHINX study underlines our commitment to addressing unmet needs in female urology. We are working closely with leading European clinical centers and experts to bring this novel, patient-friendly solution to those living with stress urinary incontinence."
Innovative Technology and Market Potential
The Artus device is designed to treat moderate to severe stress urinary incontinence through a fully implantable, adjustable mechanism that patients can easily operate via remote control. The technology offers a minimally invasive alternative to existing treatment options, controlling the opening and closing of the urethra and adapting to the patient's lifestyle.
According to Optima Insights, the global market for medical devices to treat urinary incontinence—including slings, neurostimulators, and artificial sphincters—could reach $4.3 billion by 2027, with an annual growth rate of 11% between 2019 and 2027. The economic burden of this condition on healthcare systems is substantial, estimated at $7 billion per year in European countries and up to $66 billion in the United States.
Next Steps in Clinical Development
Following the successful completion of the male patient pilot study, Affluent Medical plans to begin the pivotal phase of the clinical study in Q2 2025. This phase aims to validate the device's performance in reducing incontinence in several dozen patients.
Simultaneously, the company will submit the necessary documentation to initiate the SPHINX pilot study for women in the first half of 2025. This strategic expansion of indications for the Artus urinary sphincter represents a significant opportunity to address the needs of the larger female patient population affected by stress urinary incontinence.
Affluent Medical, a French clinical-stage medical technology company founded by Truffle Capital, specializes in the development and industrialization of innovative implantable medical devices. Subject to securing the necessary funding and positive clinical study results, the company aims to gradually market its products from 2026, either directly or indirectly.
