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18.06.2024 17:45:42 - dpa-AFX: EQS-News: Affluent Medical achieves the clinical objective of the Dry pilot study in the first two patients with the Artus artificial urinary sphincter (english)
Affluent Medical achieves the clinical objective of the Dry pilot study in
the first two patients with the Artus artificial urinary sphincter
EQS-News: Affluent Medical SA / Key word(s): Miscellaneous
Affluent Medical achieves the clinical objective of the Dry pilot study in
the first two patients with the Artus artificial urinary sphincter
18.06.2024 / 17:45 CET/CEST
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
Affluent Medical achieves the clinical objective of the Dry pilot study in
the first two patients with the Artus artificial urinary sphincter
Aix-en-Provence, June 18, 2024 - 5:45 PM CEST - Affluent Medical (ISIN:
FR0013333077 - Ticker: AFME), a French clinical-phase MedTech company
specializing in the international development and industrialization of
innovative medical prostheses, is announcing the successful activation of
its Artus medical device for the treatment of urinary incontinence in the
first two patients as part of the European pilot study, "Dry".
After the successful implantation of the Artus device in an initial patient
in the Czech Republic, as reported last March, the device has been
successfully implanted in a 70-year-old man suffering from urinary
incontinence in Poland by the urologist Professor Piotr Chlosta, President
of the Department of Urology of the Faculty of Medicine of Jagiellonian
University in Krakow and Head of the Clinical Department of Urology and
Oncology at the University Hospital of Krakow.
This second minimally invasive procedure confirmed the ease with which the
Artus device can be prepared and implanted, with a surgery time of 45
minutes.
The two Artus devices were successfully activated six weeks after each
surgery. The safety criteria were met and both patients expressed no
discomfort using the device. A performance assessment will be carried out in
the pivotal phase, the aim being to reduce urinary leakage three months
after the activation of the device.
Sébastien Ladet, Affluent Medical CEO declares: "Achieving the objectives of
the pilot study on these first two patients is a very encouraging result. It
enables us to make further progress in demonstrating the safety of the
device, and to gather the first patient feedback. This step enables us to
move towards our goal of ten patients in the Dry pilot study by the end of
2024".
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 $4.3 billion by 2027, growing annually 11% between 2019 and 2027.
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:
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18.06.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS
News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The EQS Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com
---------------------------------------------------------------------------
End of News EQS News Service
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1927971 18.06.2024 CET/CEST
the first two patients with the Artus artificial urinary sphincter
EQS-News: Affluent Medical SA / Key word(s): Miscellaneous
Affluent Medical achieves the clinical objective of the Dry pilot study in
the first two patients with the Artus artificial urinary sphincter
18.06.2024 / 17:45 CET/CEST
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
PRESS RELEASE
Affluent Medical achieves the clinical objective of the Dry pilot study in
the first two patients with the Artus artificial urinary sphincter
* Second successful implantation of the innovative Artus medical device in
Krakow, Poland
* Successful activation of the Artus device in the first two patients six
weeks after surgery
* Artus, an artificial sphincter adapted to the treatment of incontinence
in both men and women, addresses a substantial medical need with 400
million patients affected worldwide
Aix-en-Provence, June 18, 2024 - 5:45 PM CEST - Affluent Medical (ISIN:
FR0013333077 - Ticker: AFME), a French clinical-phase MedTech company
specializing in the international development and industrialization of
innovative medical prostheses, is announcing the successful activation of
its Artus medical device for the treatment of urinary incontinence in the
first two patients as part of the European pilot study, "Dry".
After the successful implantation of the Artus device in an initial patient
in the Czech Republic, as reported last March, the device has been
successfully implanted in a 70-year-old man suffering from urinary
incontinence in Poland by the urologist Professor Piotr Chlosta, President
of the Department of Urology of the Faculty of Medicine of Jagiellonian
University in Krakow and Head of the Clinical Department of Urology and
Oncology at the University Hospital of Krakow.
This second minimally invasive procedure confirmed the ease with which the
Artus device can be prepared and implanted, with a surgery time of 45
minutes.
The two Artus devices were successfully activated six weeks after each
surgery. The safety criteria were met and both patients expressed no
discomfort using the device. A performance assessment will be carried out in
the pivotal phase, the aim being to reduce urinary leakage three months
after the activation of the device.
Sébastien Ladet, Affluent Medical CEO declares: "Achieving the objectives of
the pilot study on these first two patients is a very encouraging result. It
enables us to make further progress in demonstrating the safety of the
device, and to gather the first patient feedback. This step enables us to
move towards our goal of ten patients in the Dry pilot study by the end of
2024".
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 $4.3 billion by 2027, growing annually 11% between 2019 and 2027.
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 Sébastien LADET SEITOSEI ACTIFIN Financial
Chief Executive Officer communications / press relations
(1)investor@affluentmedical.com Ghislaine GASPARETTO / Jennifer
1. JULLIA +33 (0)6 21 10 49 24 / +33
mailto:investor@affluentmedical. (0)1 56 88 11 19
com (1)ghislaine.gasparetto@seitosei-ac
tifin.com /
(2)jennifer.jullia@seitosei-actifin
.com 1.
mailto:ghislaine.gasparetto@seitose
i-actifin.com 2.
mailto:jennifer.jullia@seitosei-act
ifin.com
PRIMATICE Media relations France MC SERVICES AG Media relations
Thomas ROBOREL de CLIMENS +33 Europe Caroline BERGMANN / Kirsten
(0)6 78 12 97 95 RÜHL +49 (0)211 529252 20 / +49
(1)thomasdeclimens@primatice.com (0)211 529252 16
1. (1)affluent@mc-services.eu 1.
mailto:thomasdeclimens@primatice mailto:affluent@mc-services.eu
.com
---------------------------------------------------------------------------
18.06.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS
News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The EQS Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com
---------------------------------------------------------------------------
Language: English
Company: Affluent Medical SA
320 avenue Archimède - Les pléiades III Batiment B
13100 Aix-en-Provence
France
E-mail: affluent@mc-services.eu
Internet: www.affluentmedical.com
ISIN: FR0013333077
EQS News ID: 1927971
End of News EQS News Service
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1927971 18.06.2024 CET/CEST
| Name | WKN | Börse | Kurs | Datum/Zeit | Diff. | Diff. % | Geld | Brief | Erster | Schluss | |
|---|---|---|---|---|---|---|---|---|---|---|---|
 |
AFFLUENT MEDICAL SAS EO 1 | A3CRZT | Frankfurt | 1,550 | 26.06.24 15:29:02 | -0,005 | -0,32% | 0,000 | 0,000 | 1,495 | 1,555 |
