- This world first for Aeson® was achieved by teams at the
Marie-Lannelongue Hospital in France as part of the EFICAS®
study
- The Marie-Lannelongue Hospital is one of the 8 French centers
approved to carry out implants as part of this study
- Enrolment of the first 10-patient cohort of the study has been
completed
Regulatory News:
CARMAT (FR0010907956, ALCAR) (Paris: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"), today announced the first implantation of the
Aeson® heart in a patient suffering from a cardiac tumor.
The patient implanted was suffering from a tumor invading the
heart mass, responsible for rhythmic and restrictive cardiopathy,
which eluded standard medical treatment. Only complete surgical
removal of the heart could be considered as a hope of treatment. It
is in this context that the Aeson® total artificial heart was
implanted for the first time in the world in this type of
indication.
The implant was carried out at the Marie-Lannelongue Hospital in
Plessis-Robinson (in the western suburbs of Paris) by the teams of
Professor Julien Guihaire, cardiac surgeon, and Professor Elie
Fadel, thoracic surgeon.
Prof. Julien Guihaire and Prof. Elie Fadel said: "We are
delighted to have been able to provide a solution to this patient
in a very difficult situation, for whom there was no other
alternative than a total heart replacement with Aeson®. This
first-in-man implant performed in our hospital is a continuation of
the commitment to the CARMAT project by our teams since the
beginning of 2010, including in particular the performance of
numerous implant simulations in the Marie-Lannelongue Hospital
research laboratory. Aeson® offers real hope for patients with
invasive cardiac tumors whose treatment options and survival are
currently extremely limited.”
The implant was performed as part of the CARMAT's EFICAS study,
which aims to gather additional data on the efficacy and safety of
its Aeson® 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.
Eight French cardiology centers1 are now involved in the EFICAS
study, which will include a total of 52 patients. To date,
enrolment of the first cohort of 10 patients has been finalized,
and the study is on track for completion in 2025.
Stéphane Piat, Chief Executive Officer of CARMAT,
concludes: "I would like to thank the teams at the
Marie-Lannelongue Hospital, a long-standing partner, for giving new
hope to a patient suffering from major comorbidities. We are
delighted with this world first for CARMAT, which demonstrates the
ability of Aeson® to address increasingly complex clinical
cases."
***
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
●●●
About the Marie-Lannelongue Hospital
The Marie-Lannelongue Hospital is a private health establishment
of collective interest (ESPIC) in sector 1 (with no out-of-pocket
expenses) specializing in the medical, surgical and minimally
invasive treatment of cardiac, pulmonary and vascular pathologies.
Recognized as a center of excellence in France and internationally,
it treats congenital heart malformations, diseases and tumors of
the thoracic cavity, pulmonary arterial hypertension and valvular
heart disease or coronary artery disease from newborns to adults.
The technical expertise of its teams, combined with cutting-edge
technology, make it one of the world's leading hospitals in
pediatric and adult cardiology and thoracic oncology.
The Marie-Lannelongue Hospital is currently being rebuilt in
Plessis-Robinson (in the western suburbs of Paris). The new
hospital is due to open in 2025.
For more information: www.hopitalmarielannelongue.fr
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' attention is drawn in particular to the
financing risk of the Company, whose cash runway currently extends
until early 2024. Readers and investors’ attention is also 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)
-------------
1 AP-HP GHU Pitié Salpêtrière, Hôpital Européen Georges
Pompidou, Rennes University Hospital, Strasbourg University
Hospital, Lyon University Hospital, Lille University Hospital,
Marie-Lannelongue Hospital and Montpellier University Hospital
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231211372356/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
Contacts Media Relations– Hôpitaux Saint-Joseph &
Marie-Lannelongue Fabienne Rouhier - presse@ghpsj.fr Alix
Fournier - presse@ghpsj.fr Tel.: +33 1 44 12 80 95
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