- Enrolment expected to be completed in the first half of
2025
- Publication of study results on 52 patients anticipated at the
end 2025
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”), today
announces that it has reached half of the enrolments targeted in
the EFICAS study.
Continued momentum in the EFICAS study implants
The 26th Aeson® implant recently carried out as part of the
EFICAS study has enabled CARMAT to reach the half-way mark in the
52 recruitments targeted as part of this study carried out
exclusively in France.
The continuing good momentum in implants testifies to the very
encouraging spread of the therapy in France, and to its increasing
adoption by the medical community. Of the 10 hospitals taking part
in the study, 9 have already carried out at least one implant, and
8 at least two.
EFICAS is the largest study ever initiated by CARMAT. It is a
key study both for obtaining reimbursement for Aeson® in France,
and for obtaining the “PMA” (marketing authorization for Aeson® in
the United States), which the Company anticipates for 2027 (subject
in particular to the successful completion of the EFS study in the
United States, the second cohort of which is anticipated to start
in Q1 2025).
Significant scientific publications expected in 2025
The momentum in the EFICAS study allows the Company to
anticipate the completion of the enrolment (52 patients) in the
first half of 2025, and the publication of the study results1 at
the end of 2025.
In addition, the Company anticipates in the first half of 2025,
the publication in a scientific journal of the clinical results of
Aeson® in a cohort of 10 patients who have been on ECMO2 support
prior to being implanted with Aeson®. This publication aims to
demonstrate the efficacy and safety of Aeson® in high-risk
patients.
CARMAT believes that these scientific publications will enable
Aeson®'s clinical results to be widely disseminated within the
medical community and will be a key factor for wider adoption of
its therapy and for the Company's growth.
Stéphane Piat, Chief Executive Officer of CARMAT,
comments: “EFICAS is an essential study for scientifically
objectifying the clinical results of Aeson® on a large sample of
patients, and thus facilitating their dissemination within the
medical community. If the final results of the study confirm their
interim results, their publication at the end of 2025 should
contribute to a significant acceleration in the adoption of Aeson®
by European physicians.
We also anticipate another major scientific publication in the
first half of 2025, focusing on the clinical results of Aeson® in
high-risk patients.
These publications should be a key catalyst for our growth in
Europe, from next year onwards. They will also be decisive for our
medium-term objectives, namely the access to the U.S. market, on
the one hand, and ultimately, the approval of Aeson® as a
destination therapy, on the other.”
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 and available on CARMAT's
website, as updated in the Company's 2024 half-year financial
report published today.
Readers' attention is particularly drawn to the fact that the
Company's current financing horizon is limited to the end of
September 2024 and that, given its financing requirements and
outstanding dilutive instruments, 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,
changes in technology and 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 due to these or
other unknown risk factors and uncertainties, or factors which the
Company does not currently consider material and specific.
Aeson® is an active implantable medical device commercially
available in the European Union and other CE-marked countries. The
Aeson® total artificial heart is intended to replace the ventricles
of the native heart and is indicated as a bridge to transplantation
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 heart transplantation within 180 days of implantation.
The implant decision and 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 available
exclusively as part of a feasibility clinical trial approved by the
Food & Drug Administration (FDA).
________________________________________ 1 Results on 52
patients. The primary endpoint of the study is a support with
Aeson® at 6 months without disabling stroke or a heart transplant
within 6 months. 2 ECMO = Extra-corporeal membrane oxygenation.
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version on businesswire.com: https://www.businesswire.com/news/home/20240911315128/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)
過去 株価チャート
から 10 2024 まで 11 2024
Carmat (EU:ALCAR)
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から 11 2023 まで 11 2024
