- 50 patients have benefited from CARMAT's Aeson® artificial
heart since the first implant in 2013
- Aeson® becomes an essential breakthrough innovation in the
treatment of advanced biventricular heart failure
- 41 hospitals in 12 countries are trained for implants1,
including 33 for commercial activity
- Turnover of €2.8m in 2023, marked by a substantial acceleration
in sales in the fourth quarter, with 11 implants out of the 17
carried out during the year
- Sales of €14-20m anticipated in 2024
- Launch in the very short term of a capital increase to extend
the cash runway beyond the end of January 2024 and partially
finance the Company's needs for the forthcoming 12-month period,
estimated to a minimum of €50m
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Regulatory News:
CARMAT (FR0010907956, ALCAR), designer and developer of the
world's most advanced total artificial heart, aimed at providing a
therapeutic alternative for patients suffering from advanced
biventricular heart failure (the "Company" or
"CARMAT"), today announced that it has reached the milestone
of 50 implants of its total artificial heart, and provides an
update on its achievements and outlook.
Stéphane Piat, Chief Executive Officer of CARMAT,
declares: « CARMAT celebrated its 15th anniversary in 2023. The
Company and its teams are extremely proud to have reached the
milestone of 50 Aeson® implants since the first in December 2013.
This milestone is a major success and is a testimony of the
recognition of our therapy by leading names in cardiology.
Founded on the work of the icon of cardiac surgery, Professor
Alain Carpentier, CARMAT aims to treat heart failure, a major
health issue and the world's leading cause of death, by replacing
the diseased heart with a bioprosthetic artificial heart. The last
15 years have been a period of intense research and development,
resulting in a breakthrough innovation that is unique in the field
of cardiology. 2023 has been particularly structuring year for the
Company, with a substantial acceleration in sales in the last
quarter, a significant number of hospitals trained for implants,
increased manufacturing capacity to meet demand, and a
reinforcement of the Aeson® heart’s safety profile thanks, in
particular, to software improvements, which represents a
significant catalyst for our long-term ambition to make Aeson® a
"destination therapy" device, i.e. enabling long-term patient
support without subsequent heart transplantation.
Taken together, these advances provide a solid foundation for a
sizable commercial roll-out, enabling CARMAT to achieve its
ultimate goal of providing patients waiting for a human heart with
a therapeutic solution and a good quality of life. We look forward
to 2024 with confidence and are very determined to achieve our
goals. »
A unique technological breakthrough: since 2008, 15 years of
innovation to serve patients
The fruit of 15 years of research and the convergence of several
cutting-edge technologies, the Aeson® artificial heart is a unique
device, that aims to "replicate" as closely as possible the
functioning of a human heart.
The only device in the world to be pulsatile, hemocompatible and
self-regulated, Aeson® saves lives and offers patients a better
quality of life2.
An "intelligent" device, Aeson® adapts blood flow in real time
and manages differentiated flows between the right and left parts
of the heart, depending on the patient's needs and activity; and
does so without risk of rejection, without heavy drug regiment, and
with a safety profile superior to that of all other comparable
devices.
A therapy adopted by the medical community: 50 implants in 8
countries since inception
Since the first implant in December 2013, Aeson® has spread
widely through clinical trials and then commercially: 50 patients
have benefited from the Aeson® heart in 8 different countries3,
bringing the cumulative experience to more than 19 patient-years.
To date, 13 patients are living with the Aeson® device.
Among the 17 implants carried out in 2023, 10 were part of the
EFICAS clinical trial in 6 different hospitals in Paris, Lille,
Lyon, Le Plessis-Robinson and Montpellier; and 7 in the commercial
setting, internationally, in Germany and Italy.
Aeson®, which is strongly supported by leading cardiologists in
Europe and the United States, is becoming a reference solution for
patients eligible for transplantation, waiting for an available
human heart.
2023, a pivotal year particularly marked by the start of the
commercial dynamic
Solid sales momentum since the last
quarter of 2023
During the 2023 financial year, CARMAT generated sales4 of
€2.8m, corresponding to the sale of 17 Aeson® prostheses, including
11 in the last quarter, demonstrating solid early commercial
dynamics (with a rate of around one implant per week achieved since
the end of September), underpinned by CARMAT's ability to roll out
its therapy on a large scale industrially and commercially.
33 hospitals in 11 different countries have been trained and are
therefore ready to carry out Aeson® implants on a commercial basis,
and 8 French hospitals5 have also been trained for implants as part
of the EFICAS clinical trial.
Manufacturing capacity increased to 500
hearts per year
In 2023, CARMAT has continued to invest in its industrial
facilities, notably with the opening of its second production
building in Bois-d'Arcy, enabling it to increase its manufacturing
capacity to 500 hearts per year from early 2024, corresponding to
potential annual sales of around €100m.
Enhanced Aeson® reliability
In 2023, Aeson® continued to confirm a safety profile that
clearly sets it apart from all other mechanical circulatory support
systems: since its inception, Aeson® has not resulted in any
gastrointestinal bleeding or disabling stroke.
At the end of the year, CARMAT also announced a software
enhancement for Aeson®, which significantly strengthens the safety
profile of the device: from now on, for many potential malfunctions
linked to the prosthesis's electronic components, the Aeson®
software will automatically 'correct' these faults by adapting the
prosthesis's performance in an appropriate manner, so that the
patient's support remains unaffected.
Strong growth outlook starting as early as 2024
Given the decisive steps taken in 2023, and the sales trends
seen in recent months, the Company is confident in the continued
momentum of its implants and the successful deployment of its
strategic roadmap.
CARMAT's key objectives for 2024 are:
- Sales of c. €14m to €20m; - Around fifty
hospitals trained for commercial implants by the end of the year; -
Around thirty implants carried out as part of the EFICAS study in
France; - A cash burn reduction (operations and capital
expenditure) of around 20% compared to 20236.
The Company is also maintaining its objective of submitting its
PMA7 application to the FDA8 by the end of 2026, which would enable
it to start marketing Aeson® in the United States in 2027. It also
confirms its objective of reaching breakeven in 2027.
A "destination therapy" objective
CARMAT's ultimate goal is to offer not only a temporary solution
("bridge to transplant") for transplant-eligible patients waiting
for a human graft, but also a "definitive" solution for patients
who are not eligible for a transplant, who would therefore remain
under the support of the CARMAT device over the long term, commonly
referred to as "destination therapy (DT)".
Given the unique characteristics of Aeson®, in particular its
confirmed biocompatibility profile, and its constantly improving
safety profile, CARMAT believes that its artificial heart is today
the only existing device with the potential to become a
"destination" bi-ventricular mechanical circulatory support
solution. This indication represents a huge additional market
potential worldwide.
Based in particular on the data that it will have accumulated
through its clinical trials, and in "real life" as part of the
follow-up of commercially implanted patients, CARMAT believes it
can reasonably obtain this destination therapy indication within a
few years, and thus be in a position to offer a solution to
thousands of patients currently at a therapeutic impasse.
Extending the cash runway: forthcoming launch of a capital
increase
Based solely on its current financial resources, CARMAT
currently has a cash-runway until the end of January 2024. Based on
its current business plan, the Company estimates that it will have
to secure around €50m9 in current financing over the next 12
months.
In this respect, CARMAT plans to launch a capital increase in
the very near future, which should enable it to extend its
financial horizon beyond the end of January 2024. Terms of this
transaction will be published in a dedicated press release.
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 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. 23-0323. Readers' attention is drawn in particular to the
financing risk of the Company, whose cash runway currently extends
until the end of January 2024. Readers and investors’ attention is
also 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 Excluding the United States,
where 9 hospitals are trained as part of the EFS (early feasibility
study) clinical trial. 2 Aeson® is currently commercially available
in the European Union for the "bridge to transplant" (BTT)
indication, i.e. while waiting for a heart transplant. 3 France,
Germany, Italy, Denmark, Czech Republic, Netherlands, USA,
Kazakhstan 4 Unaudited data. Out of the 17 sales made in 2023, 10
were made in France as part of the EFICAS study, and 7 in a
commercial set-up in Germany and Italy. 5 AP-HP CHU Pitié
Salpêtrière, Hôpital Européen Georges Pompidou, CHU in Rennes, CHU
in Strasbourg, Hospices Civils in Lyon, CHRU in Lille, Hôpital
Marie-Lannelongue and CHU in Montpellier. 6 Estimated cash burn for
2024 of around €50m 7 Authorization to market Aeson® in the United
States. 8 Food & Drug Administration in the USA. 9 to which
€15m would have to be added to repay the first tranche (principal
and interests) of the loan contracted with the European Investment
Bank (EIB), due on 31/01/2024, should the conditional agreement in
principle reached with the EIB not be transformed into a final
agreement or not implemented (see the Company's press release of
January 12, 2024 for further details on the terms and conditions of
this conditional agreement in principle).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240114909315/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
Carmat (EU:ALCAR)
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