CARMAT Advances the Internationalization of the PIVOTAL Study and Obtains the Approval to Perform Implants in Denmark
February 20 2018 - 12:00PM
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 Heart Center of the Rigshospitalet hospital, Copenhagen,
Denmark.
The Heart Center of the Rigshospitalet is an internationally
recognized center for the diagnosis and treatment of all types of
heart diseases. It has developed a strong expertise in treating
advanced heart failure and has participated in front-line clinical
studies with innovative medical therapies and devices in this
field. The study will be conducted by Professor Finn Gustafsson, a
leading heart failure and transplantation cardiologist whose
research focuses on the use of invasive hemodynamics in
patients.
Finn Gustafsson, MD, PhD, Professor of Advanced Heart Failure
and Transplantation at the Heart Center and principal investigator
of the study, comments: “As advanced heart failure and
mechanical circulatory support is my main area of expertise, I am
excited to evaluate the CARMAT artificial heart for the treatment
of end-stage heart-failure patients. With its self-regulation and
hemocompatibility, this device could potentially offer a real
alternative to heart transplant.”
Stéphane Piat, CEO of CARMAT, adds: “I am delighted that,
shortly after Astana and Prague, the Heart Center of Copenhagen
becomes the third international center to take part in our PIVOTAL
study. The experience and enthusiasm of the teams makes us
confident in starting patient recruitment shortly. We continue to
pursue our strategy of creating a pool of highly specialized
centers particularly recognized for their know-how in LVAD1 studies
and we expect to include three more centers in the upcoming months.
This should allow us to sustain the patient enrollment pace in line
with our objective of finalizing the PIVOTAL study by the end of
this year.”
●●●
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 filed
with the Autorité des Marchés Financiers under number D.16-0200 on
March 22, 2017, and in an update to the Registration Document of
the Company filed with the AMF on December 4, 2017 under number
D.17-0200-A01, 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.
1 LVAD: Left Ventricular Assist Device
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version on businesswire.com: http://www.businesswire.com/news/home/20180220005329/en/
CARMATStéphane PiatChief Executive
OfficerorBenoît de la MotteChief Financial OfficerTel.: +33
1 39 45 64 50contact@carmatsas.comorAlize RPPress
RelationsCaroline CarmagnolTel.: +33 1 44 54 36
66carmat@alizerp.comorNewCapInvestor Relations
&Strategic CommunicationDusan OresanskyEmmanuel
HuynhTel.: +33 1 44 71 94 94carmat@newcap.fr
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