- Over 90 patients have received the Aeson® artificial heart
since the first implant in 2013, including 42 in 2024.
- 2024 Sales of €7 million (a 2.5-fold increase vs 2023).
- Cash burn reduced by over 20% vs 2023.
- 50 hospitals trained in Aeson® implants internationally1.
- Successful first “Aeson® User Meeting” and increasing
engagement from trained hospitals, supporting the anticipation of a
strong implants momentum in 2025.
- CARMAT expects to at least double its sales in 2025.
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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”), announces its 2024 annual sales2 and provides an
update on its development outlook.
Stéphane Piat, Chief Executive Officer of CARMAT, stated:
“With 42 implants of our Aeson® artificial heart and €7 million in
sales, i.e. 2.5 times higher than in 2023, we delivered a very
solid commercial performance in 2024, while reducing our cash burn
by over 20%.
All our operational indicators are trending positively,
reflecting increasing interest and growing adoption of our therapy
by hospitals: 60 centers are now trained on Aeson®, including 50
internationally for commercial implants, 43% of them have already
performed at least one implant, and among those, six have performed
at least four implants. In 2024, Aeson® was sold in four European
countries, namely Germany, Italy, Spain, and Poland - and, of
course, in France as part of the EFICAS study.
The first “User Meeting” we organized in November 2024, which
brought together nearly 100 experts in cardiology to share their
experience with Aeson®, was a tremendous success. It should prompt
many European hospitals to either take the step of performing a
first implant of our artificial heart or integrate it more broadly
into their clinical practice.
All this, combined with the strong momentum in our EFICAS study
in France, makes us optimistic about the future trajectory of our
implants, and allows us to anticipate doubling our sales in 2025,
at the very least.
A well-structured supply chain, calibrated to meet the demand,
distribution agreements already in place in nine countries, a
“field” team providing best-in-class support to hospitals, and key
scientific publications on Aeson® outcomes planned in 2025, will
support this momentum. We are therefore very well-positioned to
continue and accelerate our development in the coming months and
progressively establish Aeson® as a benchmark in the treatment of
advanced heart failure.”
Strong commercial performance in 2024 with 42 Aeson® implants
and sales multiplied by 2.5
The Company’s 2024 sales amount to €7 million, corresponding to
the sale of 42 Aeson® hearts, including 17 in a commercial set-up
(in Germany, Italy, Spain, and Poland) and 25 as part of the EFICAS
clinical study in France.
This performance represents a 2.5-fold increase in Aeson®
implants and sales vs 2023.
CARMAT’s activity showed strong momentum throughout the year,
with a monthly average number of implants of 3.5, rising to nearly
5 over the last four months of the year.
Continued strong recruitment momentum in the EFICAS
study
By the end of 2024, nearly 70% of the planned recruitments in
this study had been completed.
CARMAT anticipates completing EFICAS enrolment (i.e. a total of
52 patients) in the first half of 2025, paving the way for the
publication of its results3 at the end of 2025.
As a reminder, the EFICAS study is the largest study ever
initiated by CARMAT. It is key to facilitate a broader commercial
deployment of Aeson® (“evidence-based medicine”) and obtain its
reimbursement in France; and in order to secure the authorization
to market Aeson® in the United States (“PMA”), which the Company
anticipates in 2027-20284.
The EFICAS study is currently being conducted in 10 hospitals in
France5, among which 2 have already performed 7 implants each,
demonstrating a high level of satisfaction with the therapy among
healthcare professionals.
Increasing number and activity by hospitals trained in Aeson®
implants
At the end of 2024, 60 hospitals were trained in Aeson®
implants, including:
- 50 for commercial6 implants in Europe,
Israel and Saudi Arabia (+17 vs 2023), - 10 in France as part of
the EFICAS study (+2 vs 2023).
Among these trained centers7:
- 43% have performed at least one Aeson®
implant (compared to 30% at end-2023), - 27% have already performed
several implants (compared to 15% at end-2023), and - 6 hospitals
have performed 4 or more implants.
The positive evolution of these indicators reflects the growing
interest of hospitals in Aeson®, as well as their increasing
inclination, once trained, to carry out a first implant and then to
adopt the therapy by performing additional ones.
CARMAT anticipates the acceleration of this trend, as supported
by the results of a survey conducted by the Company among the 41
hospitals represented at the first “Aeson® European User Meeting8”
in late November 2024, indicating that 100% of them intend to
perform at least one implant in 2025, with 70% planning to perform
several implants.
Further geographical expansion
In 2024, Aeson® implants were performed in 5 countries (+2 vs
2023), namely Germany, Italy, Spain, and Poland in a commercial
set-up, and France as part of the EFICAS study.
In Europe, Germany is the largest market targeted commercially
by CARMAT. The Company also aims to establish significant recurring
activity in its three other active countries (Italy, Spain and
Poland), and to initiate commercial implants in additional
countries in Europe and the Middle East, where centers are already
trained.
To this end, distribution contracts are in place to facilitate
future sales in 9 countries (Poland, Switzerland, Greece, Israel,
Slovenia, Croatia, Bosnia, Serbia, and North Macedonia).
CARMAT will continue to rely on a hybrid commercial approach,
combining direct sales in certain countries, and support from
distributors in others, when this latter model is deemed more
appropriate.
Strong added-value services provided to hospitals in terms of
clinical support and funding of the therapy
Building on a commercial and clinical organization scaled to
support the growth in implants, CARMAT provides hospitals with
best-in-class training, clinical support before, during, and after
implantation, and also assist them in securing funding or
reimbursement for the therapy.
During the fourth quarter of 2024, CARMAT’s “field” team was
able to successfully support four implants in a single week, and
two implants in a single day.
All commercial implants of Aeson® have been appropriately
funded, either through standard public and/or private reimbursement
mechanisms specific to each country or region, or through specific
funding dedicated to innovation.
Reduction of more than 20% in cash burn9 associated to
operations and investment
In line with its objective, CARMAT reduced its operating and
investment cash burn by more than 20% in 2024 compared to 2023,
achieving an average monthly cash burn of less than €3.8 million
during the year.
The Company intends to carry-on with this reduction in 2025 and
beyond.
Outlook
Based on these promising results and indicators, as well as
feedback gathered during the first “Aeson® European User Meeting”,
CARMAT anticipates significant growth in Aeson® implants in 2025,
driven particularly by the combined effect of more trained
hospitals taking the step of performing their first implant, and an
increase in the average number of implants by centers having a
recurring activity.
The Company believes that this momentum will be further
strengthened by the publication, in the first quarter of 2025, of
the results of the clinical experience with Aeson® in patients
previously supported by ECMO10, and later in the year, by the
results of the EFICAS study.
CARMAT therefore expects to, at least, double its sales in 2025
compared to 2024.
As an indication, the Company estimates that its financial
breakeven can be achieved with circa 500 Aeson® implants per year.
This threshold is expected to be reached within a few years, based
on approximately 100 Aeson® “implanting” centers in Europe and the
Middle East, performing, on average, 5 implants a year.
The Company also continues to aim for the destination therapy
indication, which would enable patients to remain on long-term
Aeson® support without a subsequent heart transplant, as well as
for the commercial launch of Aeson® in the United States.
To this end, the Company plans, in 2025, to conduct the second
cohort of patients in its EFS11 study in the United States, and to
initiate a clinical study dedicated to patients not eligible for a
heart transplant, in Europe, in order to gain clinical experience
in destination therapy.
Based on its confirmed financial resources, CARMAT can fund its
activities until February 2025 and estimates its 12-month financial
needs in the range of €40 to €45 million. The Company is working
very actively to secure, in the short-term, additional financial
resources to extend its cash runway beyond February.
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 it contains do not
constitute an offer to sell or subscribe, or the solicitation of an
order to buy or subscribe, CARMAT shares in any country.
This press release may contain forward-looking statements about
the Company's objectives and prospects. These forward-looking
statements are based on the current estimates and expectations 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, as updated by an amendment
to the 2023 universal registration document filed with the AMF on
17 September 2024 under number D. 24-0374-A01 (together the ‘2023
Universal Registration Document’), and available on CARMAT's
website.
Readers' attention is particularly drawn to the fact that the
Company's current financing horizon is limited to February 2025 and
that, given its financing requirements and the dilutive instruments
in circulation, the Company's shareholders are likely to experience
significant dilution of their stake in the Company in the short
term. The Company is also 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
developments, changes in the competitive environment, regulatory
developments, industrial risks and all risks associated with
managing the Company's growth. The forward-looking statements
contained in this press release may not be achieved as a result of
these factors or other unknown risks and uncertainties or factors
that the Company does not currently consider material and
specific.
Aeson® is an active implantable medical device commercially
available in the European Union and other countries recognising the
CE mark. 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 with 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 benefit from 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's manual, patient's
manual and alarm booklet) must be read carefully to learn about the
characteristics of Aeson® and the information required for patient
selection and proper use (contraindications, precautions, side
effects) of Aeson®. In the United States, Aeson® is currently only
available as part of a feasibility clinical trial approved by the
Food & Drug Administration (FDA).
_____________________________ 1 Excluding the United States,
where 9 hospitals are trained as part of the EFS (Early Feasibility
Study) clinical trial, and France, where 10 centers are taking part
in the EFICAS study. 2 Unaudited data. 3 Results on 52 patients.
The primary endpoint of the study is support with Aeson® at 6
months or transplantation within 6 months, without disabling
stroke. 4 Subject in particular to the successful completion of the
EFS study in the United States, second cohort of which is planned
in 2025. 5 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. 6 Of which 21 in Germany, 9 in
Italy, 4 in Poland, 2 in Spain, 2 in Switzerland, 2 in Saudi Arabia
and 1 in Israel. 7 Cumulative data. 8 For further details, please
refer to the press release issued by the Company on November 26,
2024. 9 Unaudited data. 10 ECMO = Extracorporeal Membrane
Oxygenation. 11 EFS – Early Feasibility Study
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250108496565/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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