CARMAT Announces the Certification of Its New Automated Manufacturing Site in Bois-d’Arcy For the Production of up to 800 U...
29 Août 2018 - 6:00PM
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
announced the certification of its new manufacturing site situated
in Bois-d’Arcy, near Paris. In line with the schedule, the recently
opened automated site is perfectly aligned with CARMAT’s strategic
transformation into an industrial company.
The newly available space will allow the production of up to 800
units per year at full capacity to meet the demands of
industrial-pace manufacturing as well as the enrollment ramp up in
the ongoing PIVOTAL study. Furthermore, this facility will enable
the use of new tools, such as robots, to assemble hybrid membranes
on the device and a fully-automated software station to set up the
prosthesis parameters. This project has been conducted by a
dedicated team with the aim to implement best industrial practices
in regards to the organization, processes, and IT systems for
maximum efficiency and quality.
Stéphane Piat, Chief Executive Officer of CARMAT,
commented: “We are delighted to announce the certification of
our new manufacturing site based in Bois-d’Arcy, near Paris, which
is a true accomplishment as we have achieved it in less than a year
from the start of the building construction. CARMAT will now be
able to manufacture products in both Vélizy and Bois-d’Arcy. In
line with our strategy, the new automated site will enable CARMAT
to become an industrial company with the ability to manufacture up
to 800 units a year at full capacity in order to support the
demand. Thanks to new processes, we will increase production
throughput and more importantly, reinforce the quality of our
prostheses to better serve patients across the world.”
●●●
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
●●●
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
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20180829005521/en/
CARMATStéphane PiatChief Executive
OfficerBenoît de la MotteChief Financial OfficerTel.: +33 1
39 45 64 50contact@carmatsas.comorAlize RPPress
RelationsCaroline CarmagnolNajette ChaibTel.: +33 1
44 54 36 66carmat@alizerp.comorNewCapInvestor Relations
&Strategic CommunicationDusan OresanskyAlexia
FaureTel.: +33 1 44 71 94 94carmat@newcap.eu
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