- The implantation of 50% of the total
number of planned patients marks the end of the first leg of the
PIVOTAL study
- Appointment of Pr. Ivan Netuka and Pr.
Finn Gustafsson as respectively Principal Investigator and
Co-Principal Investigator of the second leg of the study
- Study pace in line with the objective
of finalizing patient enrollment before end-2018
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
provided an update on the progress of the PIVOTAL study.
Stéphane Piat, Chief Executive Officer of CARMAT, says:
“I am thrilled to announce that we have enrolled the 10th patient
in the PIVOTAL study necessary for the obtention of the CE marking
of the CARMAT total artificial heart. This marks the end of the
first leg of the study and will allow us to start the second leg
right away. The second part of the study includes 10 additional
patients which we believe should be enough to file for CE marking.
Thanks to the knowledge accumulated in treating the first 10
patients we are confident to further improve patient outcome in the
next cohort. In order to support us in this mission, I am proud to
announce that Pr. Ivan Netuka, Professor of Cardiac Surgery and
Chairman of the Department of Cardiovascular Surgery at IKEM in
Prague, has accepted to be the Principal Investigator of the second
leg of the study and that Pr. Finn Gustafsson, Professor of
Cardiology at Rigshospitalet hospital in Copenhagen, will support
him as Co-Principal Investigator. Naturally, Pr. Christian
Latrémouille, Professor of Cardiac Surgery and Chairman of the
Department of Cardiac Surgery at the European Hospital
Georges-Pompidou in Paris, will continue to support us with his
invaluable experience of the CARMAT heart implantations. With the
three international centers already active and those that should
join shortly, we confirm our objective to reach 20 implanted
patients by year-end.”
- Completion of the first leg of the
PIVOTAL study
The PIVOTAL study, authorized in France, Kazakhstan, the Czech
Republic, and Denmark, is required to compile the Company’s CE
marking clinical dossier. Within the framework of this study,
CARMAT expects to implant its bioprosthesis in approximately twenty
patients with end-stage biventricular heart failure.
The PIVOTAL study is divided into two consequent parts (“legs”)
with a cohort of approximately 10 patients each. The primary
endpoint of the study is survival on a Carmat device at 180 days
post-implant or survival to cardiac transplantation if occurring
before 180 days post-implant.
To date, 10 patients have been implanted with the device,
marking enrollment completion of the first leg of the study. The
success of surgical procedures has been maintained at 100%,
confirming a soundly acquired know-how and a strong expertise of
the surgical teams in all participating centers.
- Appointment of a Principal and
Co-Principal Investigator for the second leg of the study
Following the completion of the first part of the PIVOTAL study,
CARMAT has appointed Pr. Ivan Netuka, Professor of Cardiac Surgery
and Chairman of the Department of Cardiovascular Surgery at IKEM,
Prague (Czech Republic) as Principal Investigator of the second leg
of the study and Pr. Finn Gustafsson, Professor of Cardiology at
Rigshospitalet hospital, Copenhagen (Denmark), as Co-Principal
Investigator. The outstanding experience of the two leading experts
in their respective field will contribute to a sustained
high-quality patient management for the upcoming implantations of
the CARMAT TAH within the final part of the study before filing for
the CE marking. Pr. Christian Latrémouille, who has been at the
very beginning of the clinical evaluation of the CARMAT device,
will continue to support all the investigating centers.
Pr. Ivan Netuka, comments: “I feel distinctly privileged
by the unique opportunity to have already participated in the first
leg of the PIVOTAL study. As stated by CARMAT, the learning curve
is accelerating and I anticipate a broadening of our patient
population while standardizing patient management protocols, which
is another key element of the clinical study. I am convinced that
our initial positive experience and gained confidence in the device
performance will further facilitate the dynamics of patient
enrollment.”
Pr. Finn Gustafsson, adds: “Advanced Heart Failure is a
fast growing disease for which there are limited treatment options
available today and I am excited to be involved in this project
that might change the way we treat our patients in the future.”
In order to maintain the sustained implantation rate, CARMAT
should shortly expand the network of investigating centers to new
countries and expects to finalize the PIVOTAL study implantations
by the end of 2018.
- Ongoing progress in the CE marking
process
The CE marking process with certification body, DEKRA, is
progressing according to plan with all technical modules already
completed. The last module, related to the clinical data, will be
completed with the outcomes of the PIVOTAL study in order to be
submitted to DEKRA for validation, with the aim to obtain CE
marking for CARMAT TAH in 2019.
●●●
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 (Babalia) and of Dr. Antonino
Ligresti (Santé Holdings S.R.L.), Groupe Therabel as well as the
thousands of institutional and individual shareholders who have
placed their trust in CARMAT.
For more information: www.carmatsa.com
●●●
Name: CARMATISIN code:
FR0010907956Ticker: 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 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
registration document filed with the Autorité des Marchés
Financiers under number D.18-0169 on March 22, 2018, 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180711005717/en/
CARMATStéphane PiatChief Executive
OfficerBenoît de la MotteChief Financial Officer+33 1 39 45
64 50contact@carmatsas.comorAlize RPPress
RelationsCaroline CarmagnolNajette Chaib+33 1 44 54
36 66carmat@alizerp.comorNewCapInvestor Relations &
Strategic CommunicationDusan OresanskyEmmanuel
Huynh+33 1 44 71 94 94carmat@newcap.fr
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