CARMAT: Interim Results of the Feasibility Study Presented at the ESC Congress in London

Regulatory News:

CARMAT (Paris:ALCAR) (FR0010907956, ALCAR, PEA-PME eligible), 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 heart failure, announces the presentation of the interim results of the feasibility study at the European Society of Cardiology’s annual congress (ESC Congress 2015), held in London from August 29 to September 2, 2015.

These interim results, which were the subject of an article in the prestigious The Lancet medical journal in late July (First clinical use of a bioprosthetic total artificial heart: report of two cases), notably show the absence of hemolysis and thromboembolic events in the two patients studied. Indeed, the data collected reveals the formation of a thromboresistant layer on the surface of the CARMAT bioprosthesis implanted in the first patient.

"Before proof of concept, we already have substantial confidence in the confirmation of the advantages of the CARMAT heart. Its acquired hemocompatibility and the pulsatile way it operates make it possible to minimize the formation of blood clots, which are the main problem other ventricular assist devices face”, says Professor Alain Carpentier, co-founder of CARMAT and the inventor of the bioprosthesis, who is the author of the article published in The Lancet and who today presented the interim results in the "Devices for heart failure: the pipeline” session during a symposium devoted to heart failure.

Marcello Conviti, Chief Executive Officer of CARMAT, adds: "These interim results are a vindication of our development efforts, and give us reason to be confident regarding the pursuance of our trials on a broader patient population in order to ascertain in a statistically significant manner the advantages of the CARMAT artificial heart in the treatment of end-stage heart failure.”

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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, Professor Alain Carpentier, the Centre Chirurgical Marie Lannelongue, Truffle Capital, a leading European venture capital firm, and 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.15-0138 on March 16, 2015, 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

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