CARMAT Announces First Implant of Its Total Artificial Heart in a Female Recipient
21 September 2021 - 7:00AM
Business Wire
The procedure was performed at UofL Health -
Jewish Hospital by University of Louisville physicians in the first
cohort of the U.S. Early Feasibility Study
Regulatory News:
CARMAT (FR0010907956, ALCAR), the designer and developer of the
world’s most advanced total artificial heart, aiming to fulfill an
unmet medical need by providing a therapeutic alternative to people
suffering from end-stage biventricular heart failure, announces the
first implant of its bioprosthetic artificial heart, Aeson®, in a
female recipient.
The implant procedure was performed by a team led by Dr. Mark S.
Slaughter, Professor and Chair of the Department of Cardiovascular
and Thoracic Surgery at the University of Louisville and UofL
Physician at Jewish Hospital, Louisville, Kentucky, within the
framework of the first cohort of 3 patients of the U.S. Early
Feasibility Study (EFS). The recipient is a 57-year-old woman who
was suffering from severe biventricular heart failure and had
undergone cardiac surgery several years before.
Mark S. Slaughter, MD, heart surgeon at UofL Health - Jewish
Hospital and University of Louisville, and principal investigator
of the study, stated: “The Aeson® artificial heart is compact
enough to fit inside smaller chest cavities, more frequently found
in women, which gives hope to a wider variety of men and women
waiting for a heart transplant and increases the chances for
success. With our second Aeson® implant within one month, we are
quickly gaining experience, including patients who underwent
previous cardiac surgery, and continue to be impressed by the
performance of the device.”
Stéphane Piat, Chief Executive Officer of CARMAT,
concluded: “This 3rd implant in the US was a landmark event not
only because it allowed us to finalize the enrollment of the first
cohort of patients of the EFS, but very importantly because it is
the first time ever that our device has helped a woman suffering
from heart failure. This achievement confirms that the size
limitations for adults are minimal, which makes us very confident
in Aeson®’s potential to become a therapy of choice for a broad
patient population.”
●●●
About CARMAT
CARMAT is a French MedTech that designs, manufactures and
markets the Aeson® artificial heart. The Company’s ambition is to
make Aeson® the first alternative to a heart transplant, and thus
provide a therapeutic solution to people suffering from end-stage
biventricular heart failure, who are facing a well-known shortfall
in available human grafts. The world’s first physiological
artificial heart that is highly hemocompatible, pulsatile and
self-regulated, Aeson® could save, every year, the lives of
thousands of patients waiting for a heart transplant. The device
offers patients quality of life and mobility thanks to its
ergonomic and portable external power supply system that is
continuously connected to the implanted prosthesis. Aeson® is
commercially available as a bridge to transplant in the European
Union and other countries that recognize CE marking. Aeson® is also
currently being assessed within the framework of an Early
Feasibility Study (EFS) in the United States. Founded in 2008,
CARMAT is based in the Paris region, with its head offices located
in Vélizy-Villacoublay and its production site in Bois-d’Arcy. The
Company can rely on the talent and expertise of a multidisciplinary
team of more than 200 highly specialized people. CARMAT is listed
on the Euronext Growth market in Paris (Ticker: ALCAR / ISIN code:
FR0010907956).
For more information, please go to www.carmatsa.com and follow
us on LinkedIn.
●●●
Name: CARMAT ISIN code:
FR0010907956 Ticker: ALCAR
●●●
Disclaimer
This press release and the information contained herein do not
constitute an offer to sell or subscribe to, or a solicitation of
an offer to buy or subscribe to, shares in CARMAT (the “Company”)
in any country. This press release may contain forward‐looking
statements that relate to the Company’s objectives and prospects.
Such forward‐looking statements are based solely on the current
expectations and assumptions of the Company’s management and
involve risk and uncertainties including, without limitation, the
Company’s ability to successfully implement its strategy, the rate
of development of CARMAT’s production and sales, the pace and
results of ongoing and future clinical trials, new products or
technological developments introduced by competitors, changes in
regulations and risks associated with growth management. The
Company’s objectives as mentioned in this press release may not be
achieved for any of these reasons or due to other risks and
uncertainties.
The significant and specific risks pertaining to the Company are
those described in the Universal Registration Document (“Document
d’Enregistrement Universel”) filed with the Autorité des Marchés
Financiers (AMF, the French stock market authorities) under number
D.21-0076. Readers and investors’ attention is, however, drawn to
the fact that other risks, unknown or not deemed to be significant
or specific, may or could exist.
Aeson® is an active implantable medical device commercially
available in the European Union and other countries that recognize
CE marking. The Aeson® total artificial heart is intended to
replace the ventricles of the native heart and is indicated as a
bridge to transplant in patients suffering from end-stage
biventricular heart failure (INTERMACS classes 1-4) who are not
amenable to maximal medical therapy or a left ventricular assist
device (LVAD) and are likely to undergo a heart transplant within
180 days of the device being implanted. The decision to implant and
the surgical procedure must be carried out by healthcare
professionals trained by the manufacturer. The documentation
(clinician manual, patient manual and alarm booklet) should be read
carefully to understand the characteristics of Aeson® and
information necessary for patient selection and the proper use of
Aeson® (contraindications, precautions, side effects). In the
United States, Aeson® is currently exclusively available within the
framework of an Early Feasibility Study authorized by the Food
& Drug Administration (FDA).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210920005854/en/
CARMAT Stéphane Piat Chief Executive Officer
Pascale d’Arbonneau Chief Financial Officer Tel.: +33 1
39 45 64 50 contact@carmatsas.com
Alize RP Press Relations
Caroline Carmagnol Tel.: +33 1 44 54 36 66
carmat@alizerp.com
NewCap Financial Communication & Investor
Relations
Dusan Oresansky Quentin Massé Tel.: +33 1 44 71 94
92 carmat@newcap.eu
Carmat (EU:ALCAR)
Historical Stock Chart
Von Mär 2024 bis Apr 2024
Carmat (EU:ALCAR)
Historical Stock Chart
Von Apr 2023 bis Apr 2024