CARMAT Presented Its Progress on the EFICAS Clinical Study at the 36th Journées de La Pitié in Paris
23 Octobre 2023 - 7:00AM
Business Wire
- 7 Aeson® implants have been performed as part of the study,
including 4 over the last 4 weeks
- The pace of implants allows the Company to anticipate the
completion of the study in 2025, in line with its objective
Regulatory News:
CARMAT (FR0010907956, ALCAR), designer and developer of the
world's most advanced total artificial heart, aimed at providing a
therapeutic alternative for patients suffering from advanced
biventricular heart failure (the "Company" or
"CARMAT"), announces that it has presented its progress on
the EFICAS clinical trial at the 36th “Journées de La Pitié”
national conference on heart and lung transplantation and
circulatory assistance, organized by the cardiology institute of
the Pitié Salpêtrière hospital from October 18 to 20, 2023 in
Paris.
Prof. Christian Latrémouille, Director of Surgical Affairs at
CARMAT, provided an update on the latest progress of this
large-scale study at a session dedicated to innovations: "Seven
Aeson® implants have been performed as part of the study since its
initiation in several of the French centers involved. The pace of
study enrollment is accelerating, with 4 implants performed over
the last 4 weeks. This ramp-up is the result of growing experience
in patient selection and attest to the steep learning curve of the
surgical procedure. Post-operative patient recovery is increasingly
satisfactory, which gives us great confidence in Aeson®’s
performance and the success of the study, anticipated to be
completed in 2025. I would like to thank all the participating
teams for their commitment and look forward to seeing additional
centers join us in our efforts to offer as many patients as
possible an effective alternative to heart transplant."
EFICAS is a prospective study designed to include 52 patients
eligible for transplants, currently enrolled by a network of 6
French cardiology centers. It will enable CARMAT to gather
additional data on the efficacy and safety of its artificial heart,
as well as medico-economic data to support the value proposition of
the prosthesis, and in particular the reimbursement of the device
in France. The primary objective of the study is 180-day
post-implantation survival without disabling stroke, or successful
heart transplant within 180 days of implantation.
Pr. Lebreton of Pitié Salpêtrière Hospital (AP-HP),
Paris, says: "We are delighted to have implanted a first
patient with the Aeson® total artificial heart as part of the
EFICAS clinical study. The patient is recovering very quickly, and
most of his symptoms of advanced heart failure have already
disappeared."
Pr. Obadia of Hôpital Louis Pradel (Hospices Civils de Lyon),
principal investigator of the EFICAS study, comments: "With our
second Aeson® implant within a month, our learning curve is rapid,
and we remain impressed with the device's performance. The CARMAT
team provides excellent support to the hospital teams, before,
during and after each implant."
Pr. Vincentelli, from the Lille Regional University Hospital
(CHRU), says: "The Aeson® heart is an absolute necessity in the
therapeutic arsenal against end-stage heart failure. This total
artificial heart has enabled us to safely prepare and wait for
heart transplants in young patients who have no longer responded to
conventional treatment."
CARMAT teams also attended the 7th “Journée” VAD Meeting,
organized by the French-speaking coordination for the development
of cardiac assistance (COFDAC), on October 19, 2023. This was an
opportunity to demonstrate the Aeson® device to VAD coordinators in
France, who play a key role in the management of patients on
circulatory assistance.
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 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. 23-0323. 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).
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version on businesswire.com: https://www.businesswire.com/news/home/20231022692746/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 Quentin Massé
Tel.: +33 1 44 71 94 92 carmat@newcap.eu
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