Affluent Medical's Artus Robotic Urinary Sphincter Shows 87% Improvement in Pilot Trial Results
Key Insights
Affluent Medical (search)'s Artus robotic urinary sphincter demonstrated an average 87% improvement in reducing urinary leakage during its completed pilot phase clinical trial.
The first-of-its-kind fully implantable device showed strong safety profile and ease of use for both surgeons and patients in the European multicenter study.
The company has received approval to advance into pivotal phase trials, with the DRY study targeting at least 50% reduction in urinary leakage across multiple European centers.
Affluent Medical (search)'s innovative Artus robotic urinary sphincter has demonstrated promising clinical results in its pilot phase trial, showing an average 87% improvement in reducing urinary leakage among implant patients. The French medical technology company presented these findings at two major international conferences, attracting significant attention from the global medical community.
The pilot phase of the European multicenter clinical trial was completed in May 2025, with results presented at the 22nd Urological Association of Asia (UAA) Congress in Taiwan and the International Continence Society (ICS) annual meeting in Abu Dhabi, UAE. Professor Véronique Phe of Tenon Hospital (search), a member of Affluent Medical (search)'s Scientific Advisory Board, delivered the presentation to US and Asian healthcare professionals at the UAA Congress.
Clinical Trial Results and Safety Profile
The trial demonstrated several key advantages of the Artus device, including its safety profile, ease of surgical implantation, and patient-friendly operation through remote control functionality. The device represents the first robotic urinary sphincter of its kind, designed as a fully implantable solution for treating moderate to severe stress urinary incontinence (SUI).
Professor Roman Zachoval, Head of the Department of Urology at Thomayer University Hospital (search) in Prague and one of the trial investigators, also presented the results at the ICS meeting. Zachoval notably performed the first implantation of the artificial urinary sphincter in the Czech Republic in March 2024.
"Discussions with the medical community attending the UAA Congress revealed a keen interest in the Artus next-generation urinary sphincter," said Professor Phe. "With no real innovation over the past several decades to address a medical need that has become a real public health issue, Artus has the potential to provide a very promising therapeutic solution for all male and female patients suffering from moderate to severe urinary incontinence."
Advancing to Pivotal Phase
Following the successful pilot results, Affluent Medical (search) received approval from the Data Safety Monitoring Boards (DSMB) in May to proceed to the pivotal phase. The upcoming European multicenter clinical trial, called DRY, aims to validate the efficacy of Artus in reducing urinary leakage by at least 50%.
The company is currently recruiting several dozen patients across leading urology centers, with plans to expand investigation sites to Italy, Spain, and France by the end of 2025, in addition to countries already approved for the pilot study. Two new investigation centers have opened in France, with the company targeting implantation of both male and female patients in France potentially by the end of 2025.
Addressing a Global Health Challenge
The Artus device addresses a significant unmet medical need, as urinary incontinence affects over 400 million people worldwide and represents a major public health problem. According to Affluent Medical (search), there has been no breakthrough in treating this condition over the past 40 years, leaving patients with reduced quality of life and associated psychological disorders.
The device's adjustable design allows customization according to each patient's specific needs, distinguishing it from existing treatment options. Affluent Medical (search) plans to present these clinical results at additional international urology conferences to increase visibility and awareness of the Artus device within the medical community.
Affluent Medical (search), founded by Truffle Capital (search), specializes in developing next-generation implants that are minimally invasive, innovative, adjustable, and biomimetic, designed to restore essential physiological functions. The company aims to become a global leader in treating structural heart diseases and urinary incontinence, with all candidate products currently undergoing clinical studies in humans.