The 5 successful transplants performed during
the PIVOTAL study point to the efficacy of the CARMAT heart for
patients waiting for a graft
Regulatory News:
CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and
developer of the world’s most advanced total artificial heart,
aiming to provide a therapeutic alternative for people suffering
from end-stage biventricular heart failure, announces the
publication ahead of printing of the bridge-to-transplant
experience performed during the PIVOTAL study in the Journal of
Heart and Lung Transplantation, the most recognized peer-reviewed
journal in the field of transplantation.
The article entitled “Initial
bridge-to-transplant experience with a bioprosthetic autoregulated
artificial heart” analyzed data from seven
transplant-eligible patients enrolled in the PIVOTAL study by the
surgical teams in Prague (Czech Republic) and Nur-Sultan
(Kazakhstan).
The five patients who were discharged from hospital with the
CARMAT device after a median duration of 48 days all recovered to
an optimal condition for receiving a donor heart. They received
donor hearts after median support of 243 days on the CARMAT device
in predominantly outpatient follow-up. The CARMAT device explant
procedure and the subsequent heart transplant procedure were
uneventful in all five cases.
All transplanted patients were successfully discharged after the
transplant with an 80% survival rate at 12 months, as one patient
developed pneumonia followed by a debilitating ischemic stroke ten
weeks after the transplant and passed away on day 110.
As a reminder, the primary endpoint of the PIVOTAL study
corresponds to a 6-month survival with the bioprosthesis or a
successful heart transplant within 6 months post-implant.
Ivan Netuka, MD, PhD, Chair of the Department of
Cardiovascular Surgery at the Institute for Clinical and
Experimental Medicine, Prague, and the first author of the
publication, comments: “The accumulated experience suggests
that a successful bridging to heart transplant by using the CARMAT
device is feasible and may also offer several substantial
advantages. Indeed, the fully pulsatile biventricular support,
along with a low incidence of adverse events, keep patients in a
favorable condition for the transplant procedure to optimize the
post-transplant outcomes. Furthermore, as there were minimal tissue
adhesions observed around the device, the explant procedure was
shorter while mitigating the bleeding risk. Last but not least, the
shape and size of the device resemble that of a natural heart, and
thus leave sufficient space for the transplanted donor heart.”
Stéphane Piat, Chief Executive Officer of CARMAT,
concludes: “We are glad that this excellent
bridge-to-transplant data was accepted in such a respected
peer-reviewed publication as the Journal of Heart and Lung
Transplantation. I would like to congratulate the teams in Prague
and Nur-Sultan for their tenacity and substantial involvement in
our PIVOTAL study. To date, 13 patients have received our device
within the framework of the study, and this successful experience
on five of them shows that our prosthesis could become a credible
therapeutic solution for a number of transplant-eligible patients
who are on waiting lists for a donor heart.”
●●●
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, composed of the implantable
bioprosthesis and its portable external power supply system to
which it is connected, 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.
The first physiological artificial heart: given its size,
the use of highly biocompatible materials, its unique
self-regulation system and its pulsatile nature, the CARMAT total
artificial heart could, assuming the clinical trials are
successful, potentially save the lives of thousands of patients
each 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: Matra Défense SAS (subsidiary of the Airbus
Group), 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 (Lohas), of Dr.
Antonino Ligresti (Santé Holdings S.R.L.), of the Gaspard family
(Corely Belgium SPRL and Bratya SPRL) and of M. Pierre-Edouard
Stérin (BAD 21 SPRL), 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: CARMAT ISIN code:
FR0010907956 Ticker: 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 Universal registration
document filed with the Autorité des Marchés Financiers on March
13, 2020 under number D.20-0126 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/20200806005701/en/
CARMAT Stéphane Piat Chief Executive Officer
Pascale d’Arbonneau Chief Financial Officer Tel.: +33 1
39 45 64 50 contact@carmatsas.com
Alize RP Press Relations
Caroline Carmagnol
Tel.: +33 6 64 18 99 59 carmat@alizerp.com
NewCap Investor Relations & Strategic
Communication
Dusan Oresansky Emmanuel Huynh
Tel.: +33 1 44 71 94 94 carmat@newcap.eu
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