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, announces that the first international implantation of its bioprosthetic artificial heart has been performed at the National Research Center for Cardiac Surgery (Astana, Kazakhstan) 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.

This implantation within the PIVOTAL study, performed by the team headed by Dr. Yuriy Pya, cardiac surgeon and Chairman of the center, went smoothly.

Stéphane Piat, CEO of CARMAT, says: “We congratulate the team at the National Research Center for Cardiac Surgery on their first implantation of our device, which was performed in excellent conditions in terms of both the surgical procedure and postoperative follow-up. As communicated at the time of the international expansion of the PIVOTAL study, we rely on centers of excellence in the field of implantable cardiac devices that have substantial patient enrollment capabilities and exemplary postoperative follow-up. The optimal strategy consists in undertaking the PIVOTAL study simultaneously in a number of medical centers each performing several implantations, in order to increase medical teams’ experience curve, minimize risks and comply with our ambitious roadmap towards CE marking.”

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.

As previously indicated, CARMAT will not provide individual updates regarding patients implantations, in accordance with good clinical practice. However, CARMAT will communicate during the study on the opening of new centers and the overall progression of enrollment.

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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 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 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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Name: CARMAT
ISIN code: FR0010907956
Ticker: ALCAR