- 20 implants of the Aeson® artificial heart performed in the
first half of 2024
- Pace of 4 implants per month in the second quarter
- Half-year sales at €3.2 million, higher than the 2023 full-year
sales
- Unique safety and performance profile of Aeson® confirmed,
based on more than 70 implants made since inception
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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”), provides an update on its achievements over the
first half of 2024 and reiterates its confidence in its development
outlook.
Stéphane Piat, Chief Executive Officer of CARMAT,
comments: "Overall, our first-half achievements are very
positive. With sales of €3.2 million (i.e., 20 implants) in the
first 6 months of the year, we have already exceeded our 2023
annual sales; and the trajectory is extremely encouraging, with
twice as many implants in the second quarter as in the first.
With 14 implants since January 1st and a total of 25 since its
initiation, the momentum of our EFICAS study in France is
excellent. We expect to pass the halfway mark of the targeted 52
inclusions in the study very soon, which means we can anticipate
completing these inclusions in the first half of 2025. This
progress demonstrates that, once introduced to Aeson®, healthcare
professionals rapidly adopt the therapy, which is a positive signal
for our ongoing commercial development.
Building on these achievements, on a European network of 42
hospitals trained for commercial implants, on 3 commercially active
countries (Germany, Italy, and Poland) and 6 others now ready, as
well as on our growing and convincing clinical experience (70
implants carried out since the inception of CARMAT), I am confident
that our sales will continue to grow gradually, quarter after
quarter; and this, all the more as awareness around Aeson® is
growing, notably driven by spontaneous communication from many
centers that have implanted Aeson®.
I would like to thank our teams for their commitment and
determination, and all our shareholders, whose support make these
advances possible. More than ever, we remain resolutely committed
to making CARMAT a leader in the field of advanced heart
failure."
- Marked acceleration in sales
20 Aeson® implants were performed in the first half of 2024,
versus 3 in the first half of 2023. The pace of Aeson® implants
reached 4 per month in the second quarter of this year, doubling
from 2 hearts per month in the first quarter.
In the first 6 months of 2024, CARMAT generated sales of €3.2
million, already exceeding the annual sales for 2023 (€2.8
million).
Sales were achieved for the first time in Poland, bringing the
number of commercially active countries to 3 (Germany, Italy, and
Poland). A total of 9 hospitals implanted Aeson® for the first time
in 2024, including 4 in Germany, 3 in France and 2 in Poland.
This very positive trend reflects an encouraging spread of the
therapy across Europe.
- Excellent momentum in EFICAS study
Since the beginning of 2024, 14 Aeson® implants1 were made as
part of the EFICAS study in France, at a pace of more than 2
implants per month.
This brings the total number of Aeson® implants performed to
date in this study to 25, which paves the way for the imminent
completion of half of the targeted recruitments, i.e. 52 patients
in total.
All French centers taking part in the study (10 in total2) have
already referred patients, and 9 of them have performed at least
one implant. The hospitals of Lille, Rennes, and the Hôpital
Européen Georges Pompidou (HEGP) in Paris have each already carried
out 5 implantations, which reflects the marked satisfaction of
healthcare professionals with the therapy, as they become familiar
with Aeson® and identifying eligible patients.
CARMAT anticipates publishing the results of the EFICAS study in
the last quarter of 2025. The Company believes that this will lead
to a strong and sustained acceleration in the adoption of Aeson® in
Europe.
EFICAS is also a key study both for securing reimbursement for
Aeson® in France and obtaining the "PMA" (marketing authorization
in the United States issued by the FDA - Food & Drug
Administration), which the Company anticipates in 2027.
- Business development continues
In the first half of 2024, CARMAT trained 9 new hospitals for
Aeson® commercial implants, expanding its network to 42 centers in
14 different countries3. The Company is thus well on track to meet
its target of 50 trained hospitals by the end of 2024.
Of these 42 centers, three-quarters are active, having already
submitted patient scanners to CARMAT to assess patients’
eligibility for implantation.
In addition, 6 countries (Switzerland, Austria, Slovenia,
Croatia, Greece, and Israel) have now been activated and are
therefore ready to carry out implants. The Company plans to
activate more countries in Europe in the second half of the
year.
With over 70 patients implanted since inception, corresponding
to 27 patient-years, CARMAT benefits from substantial and
convincing clinical experience with Aeson®, which continues to
confirm the technology's unique performance and safety profile,
even though the Company tends to treat patients at an increasingly
severe stage of the disease.
Based on this promising set of clinical data, Aeson® benefits
from a growing reputation within the medical community,
particularly supported by a ripple effect between centers,
spontaneous positive communication from physicians and institutions
performing implants, and CARMAT's regular presence at medical and
scientific conferences and forums.
Building on this experience and visibility, as well as on the
on-going development of a very solid network of trained hospitals
across Europe (three-quarters of which are already active), the
Company is confident in the gradual spread of its technology in
Europe. This should be further strengthened, from the end of 2025,
by a key catalyst i.e. the publication of the results of the EFICAS
study, the largest ever conducted by CARMAT
For the second half of 2024, CARMAT anticipates that the
quarterly sales growth observed in the first part of the year will
continue to reach annual sales of around €14 million.
CARMAT’s cash runway currently extends to the end of September
2024, and the Company continues to work very actively on securing
the financial resources it needs to pursue its development beyond
this timeframe.
- Next financial press release
2024 Half-Year Results: September 30, 2024 (before stock market
opening)
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.
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, including those described in its
universal registration document filed with the Autorité des Marchés
Financiers (AMF) under number D.24-0374 and available on Carmat's
website.
Readers' attention is particularly drawn to the fact that the
Company's current cash runway is limited to the end of September
2024, the Company being subject to other risks 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 forward-looking statements
mentioned in this press release may not be achieved due to these
elements or other risk factors and uncertainties, unknown or not
considered material and important by the Company to date.
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 Data as of July 1, 2024 (included). 2 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 3 Germany, Italy, Poland, Switzerland, Israel, Slovenia,
Saudi Arabia, Serbia, Croatia, Austria, Denmark, Netherlands, Czech
Republic and Greece.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240708967380/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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