Affluent Medical Announces Positive Early Clinical Data for Artus, the First Electro-Mechanical Artificial Urinary Sphincter, Showing 87% Reduction in Urinary Leakage

Affluent MedicalPublication of a Study on Artificial Urinary SphincterArtusClinical data from early research (DRY）, the study showsActively study the effects and gain approval to conduct pivotal clinical trials.

• The average operation time was about 40 minutes, and all devices (100%) were successfully activated six weeks after the operation.
  

• Average urine leakage reduction of 87%(Evaluated by the pad weighing test three months after device activation, far exceeding expectations). The key phase will be launched in the coming weeks, with new research centers in Spain and Italy, and continued expansion beyond the existing centers.

PI Evaluation

"The pilot study demonstrated good safety, with the convenience of surgical implantation and patients' ease of using remote control being particularly prominent. The preliminary results are encouraging, and the key phase will further validate its potential for large-scale application. Artus is expected to significantly improve the quality of life for SUI patients."

---Nicolas Barry Delongchamps  Cochin Hospital

Executive Evaluation

"For decades, SUI patients have faced a lack of innovation and insufficient efficacy. Artus aims to break this deadlock. With early positive data, DSMB approval, and advancement into the pivotal stage, we are one step closer to providing a new generation of minimally invasive solutions for millions of underserved patients worldwide — a solution that will significantly enhance patients' urinary control, comfort, and confidence in life, benefiting both men and women."

---Sébastien Ladet  CEO of Affluent Medical

Stress Urinary Incontinence (SUI) is a condition with a vast patient population (over 400 million patients globally), yet existing solutions fall far short of meeting the demand.ArtusAs the world's first electromechanical artificial urinary sphincter, it provides a minimally invasive treatment option for moderate to severe SUI through a fully implantable and adjustable design. Patients can autonomously control the opening and closing of the urethra via a remote control, achieving personalized management.

ArtusIs the first solution for both male and female stress urinary incontinence, implanted through minimally invasive surgery, with the entire procedure taking only 30 minutes.

ArtusImplantable Unit (Driver), Single Adjustable Cuff, and Remote ControlThree DepartmentsParts composition.

Once the patient adapts to the cuffAfter，CuffCan be connected with the driverConnection。DriverThrough electromechanical motion controlCuffTightening or relaxing.

The remote control is an external controller that can drive the device through remote wireless control., thereby controlling the cuffTighten or relax.

• Can be personalized and adjusted according to the severity of incontinence for each woman.
• Easy to operate, just press the main button on the remote control to achieve urination.

• Simulating the physiological structure of the human body, Artus is designed to permanently adapt to the patient's lifestyle.

• At each patient follow-up, the cuff closure can be adjusted based on the potential progression of the condition and the patient's lifestyle.