- EFICAS study reaches the milestone of 20 implants
- Interim study results above expectations
- Confirmation of short-term financial support from several key
shareholders
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 provides an update on the EFICAS study and
reiterates confidence in its 2024 outlook.
Stéphane Piat, Chief Executive Officer of CARMAT,
commented: "I'm very pleased with the progress of the EFICAS
study, both in terms of the pace of inclusion and results observed
to date.
With 20 patients implanted, we have already completed 38% of the
planned inclusions (out of a total of 52), which once again
underlines the very strong interest shown by French doctors and
hospitals in the Aeson® heart. Moreover, the interim results of the
study are better than expected, although we are treating
increasingly sick patients.
These achievements make us optimistic not only about the
completion of the EFICAS study in the first half of 2025, but also
about the growth potential of Aeson® sales over the coming
months.
I am also delighted to be able to rely on several of our
reference shareholders who have already confirmed their intention
to support CARMAT financially in the short term, which will enable
us to focus on our objectives and our development.”
To date, 20 patients have been implanted with the Aeson® heart
as part of the EFICAS study, 9 of them in the first 4 months of
2024.
The EFICAS study is conducted exclusively in France, in 101
hospitals whose teams are fully trained and ready to carry out the
implants. To date, 8 hospitals have already enrolled patients in
the study.
The primary objective of the study is a minimum survival of 6
months on CARMAT support, without disabling stroke, or a successful
heart transplant within the first 6 months.
The study's interim success rate of 75%2, which exceeds
expectations, is very promising compared to previous CARMAT
studies3 and existing therapies, given the poor state of health of
the patients concerned.
In view of these advances, CARMAT confirms its target of
completing the EFICAS study, with a total of 52 Aeson® implants, in
the first half of 2025.
The EFICAS study is essential both for the reimbursement of
Aeson® in France and for obtaining PMA (marketing authorization in
the United States, issued by the FDA), which the Company
anticipates for 2027.
Study data are also an important catalyst for the adoption of
Aeson® across Europe.
Bolstered by the clinical results of the EFICAS study, the
progression in implants over the first 4 months of 2024, and its
solid base of 39 hospitals trained in commercial implants, CARMAT
reiterates its sales forecast of around €14 million for 2024.
Given its cash position and business plan, the Company's
financial horizon currently extends to the end of May 2024, and
CARMAT estimates its 12-month financing requirement at around €45
million.
The Company is working very actively on strengthening its
equity, with the already-confirmed participation of some of its
reference shareholders, enabling it to extend its financial horizon
in the short-term.
***
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, nor a solicitation of an
order to buy or subscribe to CARMAT shares in any country. This
press release may contain forward-looking statements by the company
regarding its objectives and prospects. These forward-looking
statements are based on the current estimates and anticipations of
the company's management and are subject to risk factors 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,
technological evolution and competitive environment, regulatory
changes, industrial risks, and all risks associated with the
company's growth management. The company's objectives mentioned in
this press release may not be achieved due to these elements or
other risk factors and uncertainties.
The Company's material and specific risks are those described in
its universal registration document filed with the Autorité des
Marchés Financiers (AMF) under number D.24-0374. Readers'
attention is particularly drawn to the fact that the Company's
current financing horizon is limited to the end of May 2024.
Readers' and investors' attention is also drawn to the fact that
other risks, unknown or not considered material and specific, may
or may not exist.
Aeson® is an active implantable medical device commercially
available in the European Union and other countries recognizing 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 for patients suffering from 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 undergo a heart transplant within 180 days of
implantation. 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 carefully read to understand the
features of Aeson® and the information necessary for patient
selection and proper use (contraindications, precautions, side
effects). In the United States, Aeson® is currently exclusively
available as part of an Early Feasibility Study approved by the
Food & Drug Administration (FDA).
_________________________ 1 AP-HP GHU Pitié Salpêtrière, Hôpital
Européen Georges Pompidou, CHU de Rennes, CHU de Strasbourg,
Hospices Civils de Lyon, CHRU de Lille, Hôpital Marie-Lannelongue,
CHU de Montpellier, CHU de Nantes and CHU de Dijon. 2 Among the 8
patients who have already crossed the 6-month threshold. 3
CE-marked PIVOTAL study: 73% success rate on 15 patients.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240505918790/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)
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