The implant, performed at the Azienda
Ospedaliera dei Colli hospital in Naples, Italy, represents the
first sale for CARMATand paves the way for the Company’s commercial
development
Regulatory News:
CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and
developer of the world’s most advanced total artificial heart,
aiming to provide a therapeutic alternative for people suffering
from end-stage biventricular heart failure, today announces the
first implant of its Aeson® bioprosthetic artificial heart in a
commercial setting.
First commercial implant and first sale in CARMAT’s
history
This implant of the Aeson® artificial heart was performed by the
team headed by heart surgeon Dr. Ciro Maiello at the Azienda
Ospedaliera dei Colli hospital in Naples, one of the hospitals with
the greatest experience in the field of artificial hearts in
Italy.
This implant represents the first sale ever recorded by CARMAT
since it was created in 2008. It is a major milestone that opens-up
a new chapter in the Company’s development.
Commercial development prospects
In accordance with its strategy, in 2021, CARMAT intends to
focus its Aeson® artificial heart marketing efforts on Germany, and
address one or two other EU countries, including Italy, in a more
opportunistic way.
Since it obtained CE marking for its artificial heart as a
bridge to transplant in December 2020, the Company has initiated
very active and constructive talks, from a scientific and medical
as well as contractual perspectives, notably with the twenty most
active German hospitals in the field of mechanical assistance.
These discussions have confirmed both the extent of the patient
population which could benefit from the Aeson® heart and the
medical community’s keen interest in a therapy understood to be
truly innovative and providing patients with unique benefits.
This assessment has been confirmed by the cardiac surgery teams
at Duke University Hospital in the United States, who recently
estimated1 the number of new cases of heart failure in that country
at 100,000 per year, with only 3,000 to 4,000 of these patients
currently able to benefit from a heart transplant, concluding that
a substantial portion of the remaining 96,000 patients could
potentially benefit from CARMAT’s solution.
At this stage, 5 German hospitals have already been trained by
CARMAT and are currently screening patients for an implant. A
number of patient files are currently being analyzed by these
hospitals with the support of CARMAT, whose teams will remain
mobilized throughout the summer to ensure the continuity of the
commercial launch of the Aeson® artificial heart.
The Company expects around a dozen medical centers to be trained
and commercially active by the end of 2021, primarily in
Germany.
CARMAT will provide a comprehensive update on its schedule
and main strategic objectives when it publishes its half-year
results on September 15, 2021.
The terms of this communication will be specified at a later
date.
Prof. Marisa De Feo, Director of the Department of General
Cardiac Surgery and Transplantation at Azienda Ospedaliera dei
Colli, declared: “We are pleased to be the first center in the
world to implant the Aeson® total artificial heart in a commercial
setting. The surgery has been performed by Dr. Ciro Maiello and Dr.
Cristiano Amarelli without any particular difficulty thanks to the
excellent preparation and cooperation between our department and
the specialists from CARMAT. The patient is recovering well and,
thanks to the combination of the main features of the device -
pulsatility, hemocompatibility and selfregulation - we believe that
he will experience a rapid transition to outpatient management. I
would also like to take the opportunity to thank the entire
Department of Cardiac Surgery and the Azienda Ospedaliera dei Colli
for continuing innovating in the domain of transplantation and
mechanical assistance, and the Campania Region for supporting our
program.”
Stéphane Piat, Chief Executive Officer of CARMAT, added:
“The first commercial implant of the Aeson® heart is a major
milestone in CARMAT’s history. It paves the way for a large number
of patients to gradually access our therapy, and is the culmination
of many years of work for our teams and our partners. The feedback
we are receiving, both within the framework of our clinical trials,
notably very recently in the United States, and in our discussions
with European hospitals as part of Aeson®’s commercialization,
makes us very confident that our Aeson® artificial heart is a “game
changer” and offers unique benefits to patients, compared to all
existing therapies. I would like to thank the teams at the Naples
hospital for their trust and commitment, and can assure you that
our teams are as mobilized as ever to enable other patients,
notably in Germany, to benefit from our therapy in the coming
weeks.”
About CARMAT: the world’s most advanced total artificial
heart project
A credible response to end-stage heart failure: CARMAT
aims to eventually provide a response to a major public health
issue associated with heart disease, the world’s leading cause of
death: chronic and acute heart failure. By pursuing the development
of its total artificial heart, Aeson®, composed of the implantable
bioprosthesis and its portable external power supply system to
which it is continuously connected, CARMAT intends to overcome the
well-known shortfall in heart transplants for the tens of thousands
of people suffering from irreversible end-stage heart failure, the
most seriously affected of the 20 million patients with this
progressive disease in Europe and the United States.
The result of combining two types of unique expertise:
the medical expertise of Professor Carpentier, known throughout the
world for inventing Carpentier-Edwards® heart valves, which are the
most used in the world, and the technological expertise of Airbus
Group, world aerospace leader.
The first physiologic heart replacement therapy: given
the use of highly biocompatible materials, its unique
self-regulation system and its pulsatile nature, the CARMAT total
artificial heart could, assuming a successful clinical development,
potentially save the lives of thousands of patients each year with
no risk of rejection and with an enhanced quality of life.
A project leader acknowledged at a European level: with
the backing of the European Commission, CARMAT has been granted the
largest subsidy ever given to an SME by Bpifrance; a total of €33
million.
Strongly committed, prestigious founders and
shareholders: Matra Défense SAS (subsidiary of the Airbus
Group), Professor Alain Carpentier, the Centre Chirurgical Marie
Lannelongue, Truffle Capital, a leading European venture capital
firm, ALIAD (Air Liquide’s venture capital investor), CorNovum (an
investment holding company held 50-50 by Bpifrance and the French
State), the family offices of Pierre Bastid (Lohas), of Dr.
Antonino Ligresti (Santé Holdings S.R.L.), of the Gaspard family
(Corely Belgium SPRL and Bratya SPRL) and of M. Pierre-Edouard
Stérin (BAD 21 SPRL), Groupe Therabel as well as the thousands of
institutional and individual shareholders who have placed their
trust in CARMAT.
CARMAT's history in brief:
- 2008: creation of CARMAT
- 2010: Initial public offering (Euronext Growth Paris)
- 2013: 1st implant of the artificial heart in human as part of a
clinical feasibility study conducted in France
- 2016: start of the PIVOTAL study in France, then in Europe, on
approx. 20 patients with the aim of obtaining CE marking
- December 2020: obtaining CE marking in the "bridge to
transplant" indication, allowing the heart to be marketed under the
trade name Aeson® in Europe and in other countries that recognize
this marking.
- July 2021:
- 1st human implant within the framework of an early feasibility
study in the United States;
- 1st sale in Europe.
For more information: www.carmatsa.com
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 contains forward‐looking
statements that relate to the Company’s objectives. Such
forward‐looking statements are based solely on the current
expectations and assumptions of the Company’s management and
involve risk and uncertainties. Potential risks and uncertainties
include, without limitation, whether the Company will be successful
in implementing its strategies, whether there will be continued
growth in the relevant market and demand for the Company’s
products, new products or technological developments introduced by
competitors, and risks associated with managing growth. 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.
No guarantee can be given as to any of the events anticipated by
the forward-looking statements, which are subject to inherent
risks, including those described in the Universal registration
document filed with the Autorité des Marchés Financiers on February
24, 2021 under number D.21-0076 as well as changes in economic
conditions, the financial markets or the markets in which CARMAT
operates. In particular, no guarantee can be given concerning the
Company’s ability to finalize the development, validation and
industrialization of the prosthesis and the equipment required for
its use, to manufacture the prostheses, satisfy the requirements of
competent authorities, enroll patients, obtain satisfactory
clinical results, perform the clinical trials and achieve
commercial objectives.
Aeson® is an active implantable medical device commercially
available in Europe ONLY, CARMAT SA., CE0344. The Aeson® TAH is
intended to replace ventricles of 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 LVAD and are likely to
undergo heart transplant in the 180 days following device
implantation. The decision to implant and the surgical procedure
must be executed by Health Care professionals trained by the
manufacturer. Carefully read the documentation (clinician manual,
patient manual & alarm booklet) for characteristics and
information necessary for patient selection and good use
(contraindications, precautions, side effects).
In the USA, Aeson® is currently exclusively available within the
framework of clinical trials.
1 Source: Virtual press conference held by Duke University
Hospital on July 15, 2021, following the first implantation of the
Aeson® heart in the United States within the framework of the EFS
(Early Feasibility Study).
Name: CARMAT ISIN code:
FR0010907956 Ticker: ALCAR
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version on businesswire.com: https://www.businesswire.com/news/home/20210718005018/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 Investor Relations & Strategic Communication
Dusan Oresansky Quentin Massé Tel.: +33 1 44 71 94 94
carmat@newcap.eu
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