Regulatory News:
CARMAT (Paris:ALCAR):
Videoconference in English with Stéphane
Piat at 8 pm CET today. To participate, please register
by clicking on this link
CARMAT (FR0010907956, 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.
Positive feedback from physicians on Aeson® since its
commercial launch in July 2021
Subsequent to getting the CE marking in the BTT indication1 in
December 2020, the Company started generating the first sales in
its history from July 2021, with the implants of 7 Aeson® hearts,
including 5 in Germany and 2 in Italy.
To date, four patients are being supported by Aeson®, either
within the framework of clinical trials or because they have been
implanted in a commercial set-up. Three of these four patients are
awaiting a heart transplant.
In response to the strong interest in Aeson® shown by hospitals
and encouraged by the positive feedback received from surgeons who
have implanted its device, the Company continues training more
hospitals, notably in Germany, to allow for a strong resumption in
sales once the suspension of implants is lifted.
Resumption of implants anticipated in October 2022
Following the occurrence of quality issues affecting some of its
prostheses, CARMAT took, on December 2, 2021, the decision to
voluntarily suspend all Aeson® implants.
A rigorous investigation concluded that quality defects on two
distinct components of the prosthesis were the root cause of these
issues.
Corrective actions aimed at preventing such defects have been
defined and are currently being integrated within manufacturing
processes. Given the time required to fully implement these
actions, and production lead-times, CARMAT estimates that new
prostheses should be available by October 2022.
At the same time, the Company is continuing its discussions with
the notified body (DEKRA) and the competent authorities
(specifically the ANSM in France and the Food & Drug
Administration in the United States), whose authorization is
required to resume implants respectively on a commercial basis, and
within the framework of clinical trials.
In view of this, CARMAT anticipates to be in a position to
resume its commercial and clinical implants in October 2022.
Based on this schedule, CARMAT confirms that it has the
necessary financial resources to finance its activities through to
July 2022.
Stéphane Piat, Chief Executive Officer of CARMAT,
commented: “As we have consistently said, the production of
such an innovative and sophisticated device as Aeson® remains a
challenge, and quality issues are not unusual in our industry,
especially in phases of production ramp-up. I am satisfied that our
teams have been able to rapidly identify the root causes of the
quality issues that have occurred, and to define the changes that
should be made to the manufacturing processes to avoid these issues
arising again. This experience will be very helpful for the
future.
In parallel, we are continuing our very constructive discussions
with our notified body, DEKRA, and the regulatory authorities.
There is strong interest and demand from hospitals for our
therapy. Feedback from surgeons who have implanted the CARMAT heart
is positive, and our clinical trials continue to demonstrate
Aeson®’s superiority compared to other therapies addressing
advanced biventricular heart failure.
I have the utmost confidence in Aeson®’s potential to become,
over the coming years, the benchmark treatment in advanced
biventricular heart failure, and that it will offer patients a
genuine quality of life. I also firmly believe that implants will
grow at a sustained rate once they resume in the fourth quarter of
this year”.
Join a video conference with Stéphane Piat today at 8:00 pm
CET
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***
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).
1 Bridge To Transplant
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version on businesswire.com: https://www.businesswire.com/news/home/20220131005603/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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