Affluent Medical Announces Progress Toward European Clinical Study of Artificial Sphincter Artus for the Treatment of Urinary Stress Incontinence in Women.

DJ Affluent Medical Announces Progress Toward European Clinical Study of Artificial Sphincter Artus for the Treatment of Urinary Stress Incontinence in Women.

Affluent Medical 
Affluent Medical Announces Progress Toward European Clinical Study of Artificial Sphincter Artus for the Treatment of 
Urinary Stress Incontinence in Women. 
15-Apr-2025 / 17:45 CET/CEST 
Dissemination of a French Regulatory News, transmitted by EQS Group. 
The issuer is solely responsible for the content of this announcement. 
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Affluent Medical Announces Progress Toward European Clinical Study of Artificial Sphincter Artus for the Treatment of 
Urinary Stress Incontinence in Women 
 
 
   -- SPHINX pilot study in women is set to launch across Europe in H2 2025 
   -- Preparatory evaluations using robotic-assisted implantation confirm that the minimally invasive procedure 
  in women is feasible. 
 
Aix-en-Provence, April 15, 2025 - 5:45 pm. CET - Affluent Medical (ISIN: FR0013333077 - Ticker: AFME - "Affluent"), a 
French clinical-stage medical technology company specializing in the development and industrialization of innovative 
implantable medical devices, today announced progress toward its upcoming SPHINX clinical study. The study, which is 
set to launch across Europe, in the second half of 2025, will assess the safety and performance of the Artus artificial 
urinary sphincter in female patients at leading medical centers in France, Spain and Belgium. This marks a significant 
step in expanding treatment options for women suffering from stress urinary incontinence (SUI). 
In preparation for the launch of the SPHINX study, Affluent Medical successfully completed the first implantation of 
its Artus device in a female anatomy model. The procedure was led by Professor Véronique Phé, a leading European 
urologist from Tenon Hospital in Paris, and evaluated the surgical approach in women. Utilizing the Da Vinci 
robotic-assisted laparoscopy system, it was confirmed that the device can be implanted with precision and ease, 
demonstrating its suitability for minimally invasive surgery. 
Professor Véronique Phé, who will serve as principal investigator for the SPHINX study, commented: "The SPHINX study 
represents a major step forward in the treatment of female SUI. 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." 
Sébastien Ladet, CEO of Affluent Medical, added: "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." 
Severe Urinary incontinence is a widespread condition that significantly affects quality of life, with women accounting 
for approximately 80% of the more than 400 million individuals affected globally. Artus is designed to treat moderate 
to severe SUI through a fully implantable, adjustable device that patients can easily operate via remote control. The 
technology offers a minimally invasive and effective alternative to existing treatment options and has demonstrated 
promising results in male patients from the recently completed DRY pilot study. 
 
 
About Affluent Medical 
Affluent Medical is a French medical technologies company, founded by Truffle Capital, that aims to become a global 
leader in the treatment of structural heart diseases, one of the world's leading causes of mortality, and urinary 
incontinence, which currently affects one in four adults. 
Affluent Medical develops next-generation implants that are minimally invasive, innovative, adjustable and biomimetic, 
designed to restore essential physiological functions. The candidate products developed by the Company are all 
undergoing clinical studies in human. 
For more information, please visit www.affluentmedical.com 
 
 
Contacts: 
AFFLUENT MEDICAL       SEITOSEI.ACTIFIN 
               Financial communications / Press relations 
Sébastien Ladet        Ghislaine Gasparetto / Jennifer Jullia 
Chief Executive Officer    [phone] / [phone] 
[e-mail] [e-mail] / [e-mail] 
               MC SERVICES AG 
PRIMATICE 
               Media relations Europe 
Public Relations France 
Thomas Roborel de Climens   Maximilian SCHUR / Julia BITTNER 
[phone] 
               [phone] / [phone] 
[e-mail] 
               [e-mail] 

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Regulatory filing PDF file File: 20250415_PR_Affluent_Medical_Artus

=------------------------------------------------------------------ 
Language:    English 
Company:     Affluent Medical 
         320 avenue Archimède, Les pléiades III Bâtiment B 
         13100 Aix en Provence France 
         France 
Phone:      [phone] 
E-mail:     [e-mail] 
Internet:    https://www.affluentmedical.com/ 
ISIN:      FR0013333077 
Euronext Ticker: AFME 
AMF Category:  Inside information / Other releases 
EQS News ID:   2118560 
 
End of Announcement EQS News Service 
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2118560 15-Apr-2025 CET/CEST

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April 15, 2025 11:46 ET (15:46 GMT)