CARMAT Accelerates the Internationalization of the PIVOTAL Study & Obtains the Approval to Perform Implants in the Czech Rep...
30 Octobre 2017 - 07:00AM
Business Wire
Regulatory News:
CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and
developer of the world’s most advanced total artificial heart
project, aiming to provide a therapeutic alternative for people
suffering from end-stage biventricular heart failure, today
announces it has received the approval to perform, within the
framework of the PIVOTAL study protocol approved by the ANSM
(French national agency for the safety of medicines and health
products), implants of its total artificial heart in patients at
the Institute for Clinical and Experimental Medicine (IKEM),
Prague, Czech Republic.
The IKEM is particularly recognized for its scientific research
and its pioneering role in adopting the latest innovations in the
field of medical devices. Its Department of Cardiovascular Surgery
is a leading unit in the field of cardiac surgery with the longest
tradition of end-stage heart failure therapy in the Czech Republic
with the first heart transplantation done in 1984. Nowadays it is
recognized as one of the leading centers in Central Europe given
its expertise in advanced heart failure therapies.
Professor Ivan Netuka, a Chair of the Department of
Cardiovascular Surgery, IKEM, comments: “At the year of the
50th anniversary of the first human heart transplantation, we are
particularly enthusiastic to join the mission of evaluating the
CARMAT artificial heart. The device offers an innovative approach
to the treatment of advanced heart failure given its unique
autonomous control and hemocompatibility features. We are delighted
to participate in the project which aims to address an unmet need
for patients suffering from severe and irreversible cardiac
conditions.”
Stéphane Piat, CEO of CARMAT, adds: “With the association
of the Czech Republic to our clinical strategy, we now have three
countries in our PIVOTAL study. Our goal is to access international
centers that have significantly contributed to the success of
clinical studies in the field of mechanical assistance. I am
therefore delighted to count on the support of the Astana and
Prague centers, which have been among the most active hospitals in
LVAD studies in Europe. These two new partnerships will enable us
to optimize the recruitment for our study, both qualitatively and
quantitatively. We have also initiated the administrative
procedures in 4 other countries in order to expand the network of
participating centers within the study in the upcoming months.”
●●●
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, 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.
Imitating the natural heart: given its size, the choice
of structural materials and its innovative physiological functions,
CARMAT’s total artificial heart could, assuming the necessary
clinical trials are successful, potentially benefit the lives of
thousands of patients a year with no risk of rejection and with a
good 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: Airbus Group (Matra Défense), 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 (ZAKA) and of Dr. Antonino Ligresti (Santé
Holdings S.R.L.) as well as the thousands of institutional and
individual shareholders who have placed their trust in CARMAT.
For more information: www.carmatsa.com
●●●
DisclaimerThis 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 Document de
Référence filed with the Autorité des Marchés Financiers under
number D.16-0200 on March 22, 2017 and 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
the ANSM, enroll patients, obtain satisfactory clinical results,
perform the clinical trials and tests required for CE marking and
to obtain the CE mark. CARMAT products are currently exclusively
used within the framework of clinical trials.
●●●
Name: CARMATISIN code:
FR0010907956Ticker: ALCAR
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version on businesswire.com: http://www.businesswire.com/news/home/20171029005009/en/
Stéphane PiatCEOBenoît de la MotteCFOTel.: +33
(0)1 39 45 64 50contact@carmatsas.comorAlize RPPress
RelationsCaroline Carmagnol, Tel.: +33 (0)144 54 36
66carmat@alizerp.comorNewCapInvestor Relations &
Strategic CommunicationDusan OresanskyEmmanuel
HuynhTel.: +33 (0)1 44 71 94 94carmat@newcap.eu
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