DJ Affluent Medical announces successful first-in-human implantation of its artificial sphincter Artus for the treatment of stress urinary incontinence.
Affluent Medical
Affluent Medical announces successful first-in-human implantation of its artificial sphincter Artus for the treatment
of stress urinary incontinence.
12-March-2024 / 06:30 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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PRESS RELEASE
Affluent Medical announces successful first-in-human implantation of its artificial sphincter Artus for the treatment
of stress urinary incontinence
-- Minimally invasive implantation of innovative medical device Artus in Prague, Czech Republic
-- Procedure represents important milestone: first male patient treated in Affluent's European pilot study
'Dry'
-- Artificial sphincter adapted for the treatment of incontinence in both women and men meets high medical
need: 400 million patients affected worldwide
Aix-en-Provence, 12 March 2024 - Affluent Medical (ISIN: FR0013333077 - Ticker: AFME), a French clinical-phase MedTech
company specializing in the international development and industrialization of innovative medical prostheses, today
announced the successful first-in-human implantation of the minimally invasive medical device Artus for the treatment
of urinary incontinence as part of the European pilot study 'Dry'.
This first implantation of the artificial urinary sphincter Artus was successfully performed by Prof. Roman Zachoval,
MD, PhD, head of the Department of Urology at Thomayer University Hospital in Prague, Czech Republic, on a 68-year-old
male with severe urinary incontinence. Also present was Prof. Nicolas Barry Delongchamps, Urology Professor at Cochin
University Hospital in Paris, France, as surgical advisor of the clinical study.
"Artus is easy to prepare and implant due to its innovative design compared to the previous generation of urinary
sphincters. With the positioning of the cuff around the urethra and the implantation of the control unit, the different
steps of the implantation were straightforward", said Prof. Roman Zachoval. "We performed successful communication
tests between the control unit and the remote control at the end of the surgery. The patient is doing well and was
discharged five days after the surgery with no complications."
The procedure lasted about 80 minutes and went according to plan. Activation of the device is scheduled for six weeks
post-implantation, pending full recovery and wound healing.
"This first-in-human implantation of Artus is an important milestone for Affluent Medical. For the estimated 400
million individuals battling urinary incontinence, our innovative solution offers hope for improved quality of life. We
intend to treat ten men as part of our pilot study 'Dry' and expect completion in H2 2024. In a next step, we will
transition to the pivotal study to support market approval and start a trial to treat female patients", explained
Sébastien Ladet, CEO of Affluent Medical.
Artus is an implantable artificial urinary sphincter developed for the treatment of moderate to severe urinary
incontinence in both men and women. The device that controls the opening and closing of the patient's urethra is
activated by the patient via a remote control and has been designed to allow adaptation to the patient's lifestyle.
Follow this link for an animation about how the investigational device is implanted and working: https://
www.youtube.com/watch?v=2A9uvvuxJFE
"Artus is different from current devices in three essential ways. It is easy to implant. It is potentially safer for
patients thanks to the ability to adjust the level of constraint, and therefore decrease the potential urethra's
erosion," explained Prof. Nicolas Barry Delongchamps. "Additionally, the use of Artus can be personalized: The patient
can choose among several modes according to his or her activity, and the doctor can adjust the degree of tightening
according to each patient's need and the progression of the pathology. Finally, the device is so much easier to use for
patients, thanks to the remote control."
Urinary incontinence is a major public health problem worldwide. The pathology affects men and women alike at different
stages of their lives. It is generally more prevalent among women than men, notably among younger patients (aged 25 and
over) with disorders resulting from multiple child births or in older patients (40 and over) from prostate or bladder
cancer treatments. Urinary incontinence has a major impact on social life and mental health. Many patients develop
anxiety and depression disorders, as the pathology remains vastly taboo.
According to Optima Insights, the global market for medical devices for the treatment of urinary incontinence
(including slings, neurostimulators and artificial sphincters) is expected to reach USD4.3 billion by 2027, growing
annually 11% between 2019 and 2027.
An international study by the leading European Association of Urology (EAU) demonstrates the economic and environmental
burden of urinary incontinence in the 27 countries of the European Union, in addition to the deteriorated quality of
the life of millions of patients waiting for a new innovative treatments. The costs calculated by the EAU in connection
with urinary incontinence come to a total of EUR69 billion for 2023. These include the impact of incontinence on patient
health, the costs of medical consultations and products such as adult diapers, incontinence-related absenteeism from
work, admissions to nursing homes and the environmental impact of care related to this condition. If no measures are
taken, incontinence is poised to become a major health problem in Europe, exacerbated by an ageing population and
resulting in a total economic burden of EUR320 billion in 2030.
About Affluent Medical
Affluent Medical is a French MedTech company, founded by Truffle Capital, with the ambition to become a global leader
in the treatment of structural heart diseases, which are the world's leading cause of mortality, and urinary
incontinence, which currently affects one in four adults.
Affluent Medical develops next-generation, mini-invasive, innovative, adjustable, and biomimetic implants to restore
critical physiological functions. The product candidates developed by the Company are currently all in clinical
studies.
Subject to raising the necessary funds to finance its strategy and to positive results from ongoing clinical studies,
the Company's ambition is to gradually commercialize its products early 2026.
For more information, visit www.affluentmedical.com
Contacts:
AFFLUENT MEDICAL SEITOSEI.ACTIFIN
Financial communications / press relations
Sébastien Ladet Ghislaine GASPARETTO / Jennifer JULLIA
Chief Executive Officer +33 (0)6 21 10 49 24 / +33 (0)1 56 88 11 19
investor@affluentmedical.com ghislaine.gasparetto@seitosei-actifin.com / jennifer.jullia@seitosei-actifin.com
MC SERVICES AG
PRIMATICE
Media relations Europe
Media relations France
Thomas Roborel de Climens Caroline Bergmann / Kirsten RÜHL
+33 (0)6 78 12 97 95
+49 (0)211 529252 20 / +49 (0)211 529252 16
thomasdeclimens@primatice.com
affluent@mc-services.eu
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Regulatory filing PDF file File: 20240312_Affluent Medical_PR_Artus_1st_in_human
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Language: English
Company: Affluent Medical
320 avenue Archimède, Les pléiades III Bâtiment B
13100 Aix en Provence France
France
Phone: +33 4 42 95 12 20
E-mail: jerome.geoffroy@affluentmedical.com
Internet: https://www.affluentmedical.com/
ISIN: FR0013333077
Euronext Ticker: AFME
AMF Category: Inside information / Other releases
EQS News ID: 1856021
End of Announcement EQS News Service
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1856021 12-March-2024 CET/CEST
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(END) Dow Jones Newswires
March 12, 2024 01:30 ET (05:30 GMT)
