PARIS--(BUSINESS WIRE)--Regulatory News:
CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces the first implantation of its bioprosthetic artificial heart in the Czech Republic, in accordance with the protocol of the PIVOTAL study approved by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM, the French national agency for the safety of medicines and health products) and in compliance with local authorizations.
The implantation was performed by the team of Prof. Ivan Netuka, Chair of the Department of Cardiovascular Surgery at the Institute for Clinical and Experimental Medicine (IKEM) in Prague. IKEM is the second international medical centre to initiate the CARMAT bioprosthesis implantations besides Astana, Kazakhstan. Moreover, the Company is pursuing the administrative procedures in a number of other European countries.
The strategy to expand the PIVOTAL study internationally is supported by a network of centers specialized in conducting clinical trials of cardiac devices for the European market. It also aims to accelerate patient recruitment, in line with the schedule of the PIVOTAL study, with completion expected by the end of 2018.
The aim of this study, which would involve approximately twenty patients suffering from end-stage biventricular heart failure, is to evaluate the system’s safety and performance. The study results will be included in the clinical module of the CE marking file.
In accordance with good clinical practice and subject to regulatory obligations or specific circumstances, CARMAT will not provide individual updates on patients’ implantations or their health condition. However, it is planning to communicate on the general progress of the CE Marking process or when major milestones in the PIVOTAL study are reached, such as the opening of new centers and the overall progression of patient recruitment.
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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 (ZAKA) and of Dr. Antonino Ligresti (Santé Holdings S.R.L.) as well as the thousands of institutional and individual shareholders who have placed their trust in CARMAT.
For more information: www.carmatsa.com
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Disclaimer
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 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.
Name: CARMAT
ISIN code: FR0010907956
Ticker:
ALCAR
