Affluent Medical announces 10th successful human implantation of its Artus urinary sphincter, marking completion of the pilot phase.

DJ Affluent Medical announces 10th successful human implantation of its Artus urinary sphincter, marking completion of the pilot phase.

Affluent Medical 
Affluent Medical announces 10th successful human implantation of its Artus urinary sphincter, marking completion of the 
pilot phase. 
30-Jan-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 10th successful human implantation of its Artus urinary sphincter, marking completion of the 
pilot phase 
 
 
   -- Completion of the pilot phase of the European multicenter clinical study in humans with the successful 10 
  th minimally invasive implantation of the Artus urinary sphincter. 
   -- 100% successful activation of implanted devices to date. 
   -- Good clinical safety profile observed during pilot phase. 
   -- Promising preliminary performance results collected on the first patients. 
 
Aix-en-Provence, January 30, 2025 - 5:45 p.m. CET - Affluent Medical (ISIN: FR0013333077 - Ticker: AFME - "Affluent"), 
a French clinical-stage medical technology company specializing in the international development and industrialization 
of innovative implantable medical devices, today announced the successful completion of the pilot phase of the clinical 
study of the Artus system, an artificial urinary sphincter (AUS) for the treatment of stress urinary incontinence in 
men. 
 
The pilot study cohort consists of ten men, with the primary objectives being device activation at six weeks after 
surgery and safety profile assessment at eight weeks. 
The tenth implantation of the Artus artificial urinary sphincter was successfully performed in the second week of 
January 2025 in Poland, marking the end of patient enrollment for the pilot phase. The first patient was implanted in 
Q2 2024 at Thomayer University Hospital in Prague, Czech Republic, by Dr. Zachoval. 
The device was implanted in 10 patients, with each procedure lasting approximately 40 minutes due to the innovative 
design of the Artus sphincter. To date, 100% of devices have been successfully activated and the safety profile remains 
positive. 
"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", emphasizes 
Prof. Nicolas Barry Delongchamps, Prof. of Urology, Cochin Hospital, Paris, and member of the Scientific Board of 
Affluent Medical. 
The results from this initial clinical phase will guide the execution of the pivotal phase, scheduled to begin in Q2 
2025. This phase aims to validate the device's performance in reducing incontinence in several dozen patients. 
"The completion of the pilot study for our Artus device marks an important milestone for Affluent Medical and patients 
suffering from urinary incontinence. The initial performance results are promising, enabling us to proceed to the 
pivotal phase to demonstrate these findings on a larger scale. As the safety profile is good, it is also an opportunity 
to start the clinical evaluation of the device in women, who represent about 80% of patients suffering from urinary 
incontinence", comments Sébastien Ladet, CEO of Affluent Medical. 
Submission of the clinical study file for women 
Urinary incontinence significantly impacts the quality of life of patients, particularly women, who often experience 
psychological and isolation disorders, as demonstrated by a meta-analysis by Pizzol et al, with a study carried out on 
25,000 women. 
With one in three women and one in six men[1] suffering from urinary incontinence in their lifetime, Affluent Medical 
has developed an implantable device for both men and women. 
The prevalence of urinary incontinence (UI) in women ranges from 16% to 62% varying with age, with stress urinary 
incontinence (SUI) being the most common subtype. 
The Company will submit the dossier in order to begin a pilot study in women in the first half of 2025, aiming to 
extend indications for its Artus urinary sphincter. 
Artus is an implantable artificial urinary sphincter designed to treat moderate to severe urinary incontinence in men 
and women. Controlling the opening and closing of the urethra, it is activated by a remote control and adapts to the 
patient's lifestyle. 
Affluent Medical emphasizes that urinary incontinence, affecting more than 400 million people worldwide, is a major 
public health problem. Few innovations have been introduced in this market for 40 years, leaving a population of 
patients suffering from reduced quality of life and psychological distress associated with this condition. 
According to Optima Insights, the global market for medical devices to treat urinary incontinence (including slings, 
neurostimulators and artificial sphincters) could reach USD4.3 billion by 2027, with an annual growth rate of 11% between 
2019 and 2027. The economic cost of this disease to healthcare systems is estimated at USD7 billion per year in European 
countries and up to USD66 billion in the United States[2]. 
 
 
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 humans. 
Subject to raising the funds necessary to finance its strategy and the positive results of ongoing clinical studies, 
the Company aims to gradually market its products from 2026, directly or indirectly. 
 
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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[1] Source: State of the art Artus - Thomas Jefferson university hosp. Dr. Shenot - 2023

[2] Source: State of the art Artus

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Regulatory filing PDF file File: 20250130_PR_Affluent_Medical_Patient 10_Artus - EN final

=------------------------------------------------------------------ 
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:   2078341 
 
End of Announcement EQS News Service 
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2078341 30-Jan-2025 CET/CEST

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January 30, 2025 11:45 ET (16:45 GMT)