CARMAT Announces the Restart of Production and Confirms the Objective of Resuming Implants of its Aeson® Artificial Heart in October 2022
28 Mars 2022 - 6:00PM
Business Wire
Regulatory News:
CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and
developer of the world’s most advanced total artificial heart,
aiming to fulfill an unmet medical need by providing a therapeutic
alternative to people suffering from end-stage biventricular heart
failure, issues an update on its activities and outlook.
Restart of production and confirmation of the objective of
resuming implants in October 2022
Following the characterization of the quality defects on the two
components that were the root cause of issues affecting some of its
prostheses, CARMAT, in close collaboration with its suppliers,
defined the necessary corrective actions.
These actions have now been implemented within the production
processes of the relevant suppliers, and notably include additional
controls.
Given supply and production lead times for suppliers and at
CARMAT’s plant in Bois-d’Arcy, the Company can thus confirm that
new implantable prostheses will be available in October 2022.
At the same time, the Company is continuing its discussions with
the notified body (DEKRA) and the competent authorities (the ANSM
in France and the Food & Drug Administration in the United
States), whose authorization is required to resume implants.
These elements allow CARMAT to confirm its objective of a
resumption in commercial and clinical implants in October 2022.
Ongoing training for hospitals
Due to the lack of therapeutic solutions available to patients
with end-stage heart failure, CARMAT is seeing strong demand for
the Aeson® system from cardiologists, notably driven by positive
feedback from physicians who have already implanted the device.
CARMAT is thus continuing to train more hospitals, in Germany
and in other European countries, in order to be able to meet, to
the extent possible, this demand once the suspension of implants is
lifted.
Stéphane Piat, Chief Executive Officer of CARMAT,
concluded: “I would like to pay tribute to the strong
mobilization of CARMAT’s teams who, by providing our suppliers with
their assistance and expertise, have enabled the changes necessary
to improve the sturdiness and reliability of the components that
led to the incidents we experienced in 2021 to be rapidly
implemented within manufacturing processes. Thanks to this close
collaboration, the resumption of production, incorporating these
changes, is now effective.
This allows us, given our supply and production lead-times, to
confirm our objective of providing medical teams with implantable
prostheses from October 2022, thus enabling our implants to resume
at that time, subject of course to the approval of the notified
body DEKRA and the competent authorities with whom we are
continuing our constructive dialogue.
Given the lack of satisfactory therapeutic solutions addressing
advanced heart failure and the number of patients on a waiting list
for a heart transplant, we are receiving requests from many
physicians and are doing everything we can to be able to resume our
implants as soon as possible while continuing to prioritize the
health and safety of patients”.
●●●
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 more than 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.21-0076. 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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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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