- PIVOTAL study recruitment pace
accelerating with 30% of the total number of planned patients
implanted
- Opening of the new Bois-d’Arcy site for
the large-scale production of prostheses
- Pre-submission of an early feasibility
study request with the U.S. FDA in order to initiate implants in
the United States
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 an update on the progress of the PIVOTAL study and the
latest developments regarding its market access strategy.
Stéphane Piat, Chief Executive Officer of CARMAT, says:
“We are ramping up our project on all of its strategic routes and
are gradually meeting the key milestones that bring us closer each
day to meeting our objective of obtaining a CE mark for the CARMAT
total artificial heart in 2019. From a clinical perspective, we
have carried out one third of the implantations foreseen within the
framework of the PIVOTAL study. This sustained enrollment rate
validates the pertinence of our international clinical strategy
implemented in highly-specialized medical facilities. It also takes
on its full meaning given the performances of the surgical teams,
who have been able to substantially reduce the operating time,
confirming that the implantation of the CARMAT heart is highly
controlled and reproducible. These clinical breakthroughs are
closely correlated to our industrial development and justify our
decision to open a new manufacturing site in Bois-d’Arcy, near
Paris. This new site will enable us to produce the prostheses
required for the clinical trials and the subsequent commercial
phase in compliance with certified processes that meet the demands
of industrial production. Lastly, as our project aims to address
the issue of heart failure on a global scale, we are delighted to
see our discussions with the U.S. FDA progressing towards the
initiation of an early feasibility study in the United States, a
market with substantial potential for CARMAT”.
- Acceleration in the pace of
recruitment for the PIVOTAL study
The PIVOTAL study follows the feasibility study undertaken by
CARMAT on 4 patients. It corresponds to the second phase of the
clinical trials required to compile the CE marking clinical
dossier. Within the framework of this study, CARMAT is planning to
implant its bioprosthesis in approximately twenty patients with
end-stage biventricular heart failure whose health state is more
stable than that of the patients included in the feasibility study.
This study’s endpoint is to show the survival of the implanted
patients at 6 months and thus validate the CARMAT system’s safety,
efficacy and performances.
CARMAT has received the necessary regulatory authorizations to
conduct this study in France and three other countries: Kazakhstan,
the Czech Republic, and Denmark. This broadening of the study to
include leading international facilities in the conduct of clinical
trials on circulatory support devices targeting the European market
has helped significantly accelerate patient enrollment in the
study.
To date, the number of implantations already performed
represents 30% of the study’s planned total.
The surgical procedure boasts a 100% success rate, and operating
time has been cut by approximately 21% compared with the first
implantations, showing both a substantial improvement in surgical
teams’ learning curve and good reproducibility of the surgery as
the study progresses.
The patients treated in the PIVOTAL study have a more stable
clinical profile than those involved in the feasibility study, as
illustrated by the 100% survival rate at 1 month compared with 75%
previously.
In order to further accelerate the implantation rate, CARMAT is
planning to expand the network of investigation centers to 3
additional countries and is expecting to end PIVOTAL study
implantations this year.
- Major progress in the CE marking
process
The CE marking process undertaken by CARMAT with certification
body DEKRA aims to validate the CARMAT heart’s compliance with
European regulatory requirements. Within this framework, in 2017
CARMAT delivered more than half of the CE marking dossier’s
modules, notably those concerning all the technical aspects. The
Company is continuing to supplement the dossier with reliability
data from prostheses operating continuously on test benches.
Following the PIVOTAL study, the clinical results will complete
the final module of the CE marking dossier that will be submitted
to DEKRA for validation, aiming to obtain CE marking in 2019.
- Industrialization and market-access
strategy
CARMAT has opened its new, automated assembly plant in
Bois-d’Arcy, near Paris. This site will meet the demands of
industrial-pace production and the Company will launch, once the
technical teams have been transferred, the manufacturing of
prostheses to accompany the ramping up of enrollment in the PIVOTAL
study. The opening of this automated site is perfectly in line with
CARMAT’s strategic transformation process into an industrial
company. This complex project is being steered by a dedicated team
and aims to implement best industrial practices in terms of
organization, processes, and IT systems for maximum efficiency and
quality.
Simultaneously, CARMAT is preparing for the marketing phase in
close collaboration with partners who are experts in the market
positioning and reimbursement of medical devices.
- Clinical development in the United
States
The discussions between the Company and the FDA, the U.S. health
authority, have led to the pre-submission of a dossier for an Early
Feasibility Study (EFS). Once the FDA has the final application,
and assuming the regulator and patient protection committee give a
positive response, CARMAT will be able to initiate a first
feasibility study in the United States. This feasibility study
would be followed by a PIVOTAL study prior to the device being
marketed on the US market.
●●●
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/20180404006060/en/
CARMATStéphane PiatChief Executive
OfficerorBenoît 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 OresanskyEmmanuel
HuynhTel.: +33 1 44 71 94 94carmat@newcap.fr
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