- More than 100 healthcare professionals from 41 hospitals and
10 countries rallied to share their experiences of the Aeson®
artificial heart
- All hospitals taking part in the event confirmed their
intent to introduce or expand the use of Aeson® in their clinical
practice
Regulatory News:
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20241125445962/en/
(Photo: Business Wire)
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”), announces the success of its first "Aeson®
European User Meeting", held on 21 and 22 November 2024 in
Chantilly, near Paris.
Strong and promising interest in Aeson® from the French and
international medical community
The forum brought together more than 100 European leaders in
cardiology (cardiologists, surgeons, anaesthetists, intensivists,
nurses, specialized distributors, etc.), representing 41 hospitals
and 10 countries (France, Germany, Italy, Spain, Poland, the
Netherlands, Serbia, Slovenia, Macedonia and Israel), demonstrating
an extremely strong interest from the medical community in the
Aeson® artificial heart.
Thorough and constructive exchanges among peers, based on
growing experience of using Aeson®
Following a summary of the clinical experience and results of
Aeson® by Dr Piet Jansen, Medical Director of CARMAT, the different
thematic sessions were led by a number of European physicians who
have already used Aeson®, enabling them to share their experience
with their peers (including those who have not yet implanted
Aeson®).
Discussions focused in particular on:
- Patient selection and case studies: numerous real-life
cases of Aeson® implants were presented, demonstrating the device's
ability to meet the needs of a wide range of patient profiles,
including those who had been placed under ECMO1 prior to the
implantation.
- Anatomical fit and post-operation recovery: discussions
confirmed the high degree of anatomical fit of the device, as well
as the rapid recovery of a majority of patients, enabling them to
get discharged from hospital, on average 56 days after the
implantation, and then to proceed with a heart transplant in
optimal conditions.
- Surgical techniques: detailed feedback on the key steps
of the implantation and explantation procedures enabled
participants to better anticipate the management of the
specificities of such surgeries.
- Patient management: several sessions were also devoted
to sharing in-depth experience on patients’ management, from a
psychological, physical and medication standpoints, before, during
and after implant.
Strong intent to use Aeson® among participants
Out of the 41 hospitals represented, around half of them had
already performed at least one Aeson® implant, which provided a
wealth of information to the twenty or so centers trained and
present at the conference, which had not yet done so.
In this context, drawing on his experience of 7 Aeson® implants
at the Lille University Hospital (France), Professor Vincentelli
and Dr Moussa shared their approach and advice for a successful
initiation and development of an Aeson® programme in a hospital,
stressing in particular the need for close collaboration between
all key stakeholders (hospital administration, cardiologists,
surgeons, anaesthetists, nurses, etc).
When asked about their intent to carry-on or start implanting
Aeson®, all the hospitals taking part in the meeting, confirmed
that they were planning to implant the device in 2025, which paves
the way for a strong growth in sales over the coming months.
Ultimate goal: Secure “destination therapy” status
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 on Aeson® support without
subsequent heart transplant. Destination therapy was mentioned
several times by participants in the forum, as a natural and
anticipated therapeutic development for Aeson®.
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 for transplant.
Approval in “DT” would be a decisive step in meeting the
critical challenge of graft shortage, given that only 5% of
patients in need of a transplant can actually benefit from it. As
such, the DT indication represents the largest addressable market
opportunity in cardiology. CARMAT anticipates that securing this
indication could take a few years.
Stéphane Piat, Chief Executive Officer of CARMAT,
comments : “I'm delighted with the success of this first User
Meeting organized by CARMAT. Over and above the high number of
participants, which in itself, is exceptional, it is really the
quality of the discussions and the enthusiasm and commitment of the
healthcare professionals behind our Aeson® heart that make me very
optimistic about the deployment of our artificial heart.
The experience shared by the physicians during the meeting
confirms a real need for our therapy, a very wide range of patients
who could benefit from Aeson®, and our high-quality clinical
results. All this feedback leads me to believe that the number of
implants is going to grow in centers already using Aeson®, and that
many of the 30 or so trained hospitals, that have not yet carried
out their first implant, will take the plunge in the near
future.
Combined, our clinical results, state-of-the-art production
facilities and strong support of the medical community, position us
well to become the leader in the fast-growing advanced heart
failure market.
I would like to thank all the participants in this conference,
especially the physicians who have led the various workshops, and
the CARMAT teams who have organized this event. More than ever, I
believe that together, we can make Aeson® the reference treatment
for advanced 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 ECMO = Extracorporeal membrane oxygenation
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241125445962/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)
Historical Stock Chart
From Oct 2024 to Nov 2024
Carmat (EU:ALCAR)
Historical Stock Chart
From Nov 2023 to Nov 2024
