Information regarding the Feasibility study of the CARMAT bioprosthetic artificial heart

Regulatory News:

CARMAT (Paris:ALCAR)(FR0010907956, ALCAR), the designer and developer of the world's most advanced total artificial heart project, to provide a therapeutic alternative for patients suffering from end-stage heart failure, gives an update on its feasibility clinical trial.

A 4^th implantation of the CARMAT heart was performed on December 22^d , 2015 by La Pitié Salpêtrière University Hospital heart team on a 58 years old patient suffering from biventricular heart failure, its severity requiring extracorporeal life support (ECLS).

Pr. Pascal Leprince, Department Head, Cardiology Institute, La Pitié Salpêtrière Hospital, comments: "We were fully satisfied with the artificial heart sustained function. We know the risks associated with this type of procedure and, despite all of the team’s efforts, the patient died of medical complications not related to the prosthesis.”

This was the fourth and last implantation performed in the Feasibility study. During this trial, 21 months of cumulative clinical experience was generated with the CARMAT artificial heart. CARMAT is now preparing the Pivotal clinical trial.

Marcello Conviti, Chief Executive Officer of CARMAT, concludes: "CARMAT would like to pay tribute to the patient and convey their deepest condolences to the family and friends. This patient’s contribution to finding a solution to terminal heart failure has provided the medical and technical teams with a wealth of experience. CARMAT would also like to thank La Pitié Salpêtrière University Hospital team, who showed total commitment during this final implantation of the Feasibility clinical trial. The overall experience generated will allow us to finalize the necessary documentation to start the PIVOTAL clinical trial. We have confidence in the CARMAT heart’s ability to provide patients suffering from terminal heart failure with a real alternative to a heart transplant.”

The company would like to remind readers that, according to good clinical practice and subject to regulatory requirements or specific circumstances it does not plan to publish data of the trials before all the data have been analyzed.

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

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 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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