- Milestone of 30 heart transplants post Aeson® support,
passed
- Strong interest in Aeson® from the medical community: more
than 100 European experts will share their experience at the first
‘Aeson® European User Meeting’ at the end of November
Regulatory News:
CARMAT (FR0010907956, ALCAR), designer and developer of the
world’s most advanced total artificial heart, aiming to provide a
therapeutic alternative for people suffering from advanced
biventricular heart failure (the “Company” or
“CARMAT”), provides an update on Aeson® artificial heart’s
uptake as a bridge to transplant in Europe.
Growing adoption of Aeson® as a bridge-to-transplant solution
in Europe
By the end of October 2024, 30 patients had successfully
undergone heart transplant after being supported by the Aeson®
artificial heart, confirming the ability of the device to provide
physiological support tailored to each patient, enabling them to
approach heart transplant in optimal physical condition when a
human graft becomes available.
Out of these 30 transplants carried out in 7 different
countries1 (including 16 in France and 5 in Germany), 16 have been
performed since the beginning of 2024, demonstrating a clear
acceleration in the adoption of Aeson® as a bridge-to-transplant
solution in Europe.
These 30 patients benefited from Aeson® support for an average
of 156 days before transplant (the maximum duration recorded being
308 days).
As a reminder, the Aeson® artificial heart is CE marked for the
“bridge to transplant” indication. It can therefore be marketed in
Europe (and in other countries recognizing the CE marking) for this
indication, and more specifically in patients suffering from
end-stage biventricular heart failure (Intermacs classes 1-4) who
cannot benefit from maximal medical therapy or a left ventricular
assist device (LVAD), and who are likely to receive a heart
transplant within 180 days of implantation.
Strong interest in Aeson® from the medical community
At the end of November 2024, CARMAT organizes the first ‘Aeson®
European User Meeting’. This event will enable more than 100
European leaders in the field of cardiology to share their
experience with the Aeson® artificial heart. The event will focus
on case studies and feedback from the various stakeholders managing
patients (cardiologists, surgeons, anaesthetists, intensive care
specialists, etc.), with a view to better identifying patients who
could benefit from Aeson®, and enhancing the level of expertise of
the centres. It will thus mark an important step towards wider
adoption of the device, and better management of patients suffering
from advanced biventricular heart failure.
This event is part of the intensification, over the course of
2024, of the information and training effort around Aeson®,
including in particular CARMAT’s participation in about ten key
conferences attended by several hundred participants. This
testifies to the growing interest shown by healthcare professionals
in this innovative device, and to the critical need for effective
solutions to treat patients who frequently find themselves at a
therapeutic standstill.
Ultimate goal: Get the ‘destination therapy’
indication
Building on its growing and extremely encouraging experience in
the bridge-to-transplant indication, CARMAT continues to ultimately
aim for the ‘destination therapy’ (‘DT’) indication, which would
enable patients to live sustainably under Aeson® support without
subsequent heart transplant.
To this end, CARMAT confirms that it plans to resume its PIVOTAL
study in Europe in the second half of 2025, on a cohort of patients
not eligible to transplant.
Approval in ‘DT’ would be decisive in meeting the critical
challenge of the graft shortage, given that only 5% of patients in
need of a transplant can currently benefit from it. As such, the DT
indication represents the largest addressable market opportunity in
cardiology. CARMAT estimates that obtaining this indication could
take a few years.
Stéphane Piat, Chief Executive Officer of CARMAT,
comments: “The growing success of our Aeson® artificial heart as a
bridge to transplant solution demonstrates the impact of this
innovation on the lives of patients suffering from advanced heart
failure. With 30 patients successfully bridged to transplant thanks
to Aeson®, including 16 since the beginning of the year, our device
continues to prove that it has the potential to become a first-line
solution to save patients at the ultimate stage of the disease. As
we look ahead to the first Aeson® user meeting, which will bring
together over 100 European experts, we are proud to see the medical
community becoming increasingly committed to the adoption of our
technology. Together, we can make Aeson® a new benchmark in the
treatment of advanced biventricular heart failure.”
●●●
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 circa 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 it contains do not
constitute an offer to sell or subscribe, or the solicitation of an
order to buy or subscribe, CARMAT shares in any country.
This press release may contain forward-looking statements about
the Company's objectives and prospects. These forward-looking
statements are based on the current estimates and expectations of
the Company's management and are subject to risk factors and
uncertainties, including those described in its universal
registration document filed with the Autorité des Marchés
Financiers (AMF) under number D.24-0374, as updated by an amendment
to the 2023 universal registration document filed with the AMF on
17 September 2024 under number D. 24-0374-A01 (together the ‘2023
Universal Registration Document’), and available on CARMAT's
website.
Readers' attention is particularly drawn to the fact that the
Company's current financing horizon is limited to the beginning of
2025 and that, given its financing requirements and the dilutive
instruments in circulation, the Company's shareholders are likely
to experience significant dilution of their stake in the Company in
the short term. The Company is also subject to other risks and
uncertainties, such as the Company's ability to implement its
strategy, the pace of development of CARMAT's production and sales,
the pace and results of ongoing or planned clinical trials,
technological developments, changes in the competitive environment,
regulatory developments, industrial risks and all risks associated
with managing the Company's growth. The forward-looking statements
contained in this press release may not be achieved as a result of
these factors or other unknown risks and uncertainties or factors
that the Company does not currently consider material and
specific.
Aeson® is an active implantable medical device commercially
available in the European Union and other countries recognising the
CE mark. 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 with end-stage biventricular heart failure
(Intermacs classes 1-4) who cannot benefit from maximal medical
therapy or a left ventricular assist device (LVAD) and who are
likely to benefit from a heart transplant within 180 days of
implantation. The decision to implant and the surgical procedure
must be carried out by healthcare professionals trained by the
manufacturer. The documentation (clinician's manual, patient's
manual and alarm booklet) must be read carefully to learn about the
characteristics of Aeson® and the information required for patient
selection and proper use (contraindications, precautions, side
effects) of Aeson®. In the United States, Aeson® is currently only
available as part of a feasibility clinical trial approved by the
Food & Drug Administration (FDA).
1 France, Germany, Italy, Poland, Czech Republic, USA and
Kazakhstan
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241112076354/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 6 64 18 99 59
carmat@alizerp.com
NewCap Financial Communication & Investor
Relations
Dusan Oresansky Jérémy Digel Tel.: +33 1 44 71 94
92 carmat@newcap.eu
Carmat (EU:ALCAR)
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