DJ Affluent Medical: Excellent valve performance at 1 year follow up and rising recognition of Epygon biomimetic mitral valve.
Affluent Medical
Affluent Medical: Excellent valve performance at 1 year follow up and rising recognition of Epygon biomimetic mitral
valve.
29-Feb-2024 / 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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PRESS RELEASE
Excellent valve performance at 1 year follow up and rising recognition of Epygon biomimetic mitral valve
-- Case study of the first successful human implantation published in an American peer-reviewed journal
-- One-year follow up transesophageal echocardiography examination confirms excellent prosthetic performance
-- Interventional cardiologist community increasingly recognizes hemodynamic value proposition of Epygon
Aix-en-Provence, 29 February 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 reported supportive findings on the clinical value of Epygon, its cutting-edge device being developed to replace
mitral valves in patients suffering from mitral insufficiency.
An article on the successful first human implantation of its transcatheter mitral valve, Epygon, entitled, "A
Mono-Leaflet, Low-Profile Transcatheter Mitral Prosthesis - First-in-Human Implantation", was published in the highly
respected, peer-reviewed Journal of the American College of Cardiology: Cardiovascular Interventions. The first
implantation of Epygon was conducted in February 2023 via a minimally invasive transcatheter procedure by Prof. Stefano
Salizzoni, MD, PhD, cardiac surgeon and co-investigator of the Minerva pilot clinical study, and his team, at the
Molinette Hospital of Health and Science in Torino, Italy. The article summarizes the procedure and the follow up at 6
months, which showed continued good prosthetic performance.
Recently, the patient reached the 1-year follow up. Examination through a transesophageal echocardiogram revealed
excellent valve performance, with neither mitral regurgitation nor paravalvular leak.
These promising results are in line with a survey conducted with up to 60 interventional cardiologists and cardiac
surgeons. 70% of the interventional cardiologists surveyed stated they would refer patients to cardiac surgeons if the
Epygon valve was available and based on the potential value of excellent hemodynamic properties.
Mohammad Sarraf, MD, Interventional Cardiologist at the Mayo Clinic, top ranked hospital in the US, stated: "The Epygon
valve's unique design, focusing on replicating the natural anatomy and physiology of the native mitral valve, sets it
apart from other mitral valve designs. Its asymmetrical profile and large mono leaflet aim to mimic the natural vortex
of bloodstream flow. This design innovation holds promise for improving left ventricle function, particularly in frail
patients. By closely emulating the natural structure and flow dynamics of the mitral valve, the Epygon device may
enhance overall cardiac performance and contribute to better patient outcomes."
Epygon is the first biomimetic transcatheter mitral valve to mimic the native mitral valve and restore the natural
vortex of blood flow in the left ventricle. Its transcatheter implantation makes it a fast and minimally invasive
procedure, avoiding open heart surgery.
Mitral valve regurgitation is a serious and potentially fatal disease affecting 2% of the world's population, or
approximately 160 million people. However, fewer than 4% of patients with a severe form can receive open heart surgery,
which poses a high risk of death and hospitalization. The market for mitral valve repair surgery is estimated to be
worth USD1.5 billion in the U.S.-Europe region in 2023, growing at 3.5% per year.
The publication, entitled "A Mono-Leaflet, Low-Profile Transcatheter Mitral Prosthesis - First-in-Human Implantation",
can be accessed online here: https://www.jacc.org/doi/abs/10.1016/j.jcin.2023.09.033.
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 in preclinical and
clinical studies.
Kalios, the first mitral adjustable annuloplasty ring, should be the first Affluent Medical device to be marketed.
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 Caroline Bergmann / Kirsten RÜHL
Thomas Roborel de Climens
+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: 20240229_Affluent Medical_Epygon_final
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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: 1848861
End of Announcement EQS News Service
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1848861 29-Feb-2024 CET/CEST
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(END) Dow Jones Newswires
February 29, 2024 11:45 ET (16:45 GMT)
