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, today announces that CARMAT’s Board of Directors has decided to co-opt Jean-Luc Lemercier and Dr. Michael Mack as independent directors, thus replacing Marcello Conviti and André-Michel Ballester, who have stood down, for the remainder of their mandates, i.e. until the conclusion of the Shareholders’ Meeting called to rule on the Company’s 2021 annual accounts. Subject to the approval of these co-optations by the next Shareholders’ Meeting, CARMAT’s 8-member Board of Directors will thus have four independent directors.

Mr. Jean-Luc Lemercier, 60 years, has been the Vice-President Transcatheter Heart Valve EMEA at Edwards Lifesciences since 2008. A graduate of Claude Bernard Lyon 1 University’s pharmacy faculty, he has over 20 years of experience and acknowledged leadership in the medical device industry. During his career, Mr. Lemercier has held a number of strategic positions in cardiology sector, notably at Johnson & Johnson Cordis (1996-2008), where he created and headed, among other activities, the Structural Heart Disease division.

Michael Mack, MD, 70 years, is an internationally recognized American cardiac surgeon with long standing expertise in the introduction of innovative medical devices and procedures in cardiovascular disease. He is the author of more than 500 scientific publications and has received the Presidential Citation of the American College of Cardiology and the Transcatheter Cardiovascular Therapeutics (TCT) Lifetime Achievement Award. He is currently the Director of the Cardiovascular Service Line for the Baylor Scott & White Health in Dallas (Texas), a Director of the American Board of Thoracic Surgery and a member of the FDA MDEpiNet Advisory Committee1. Dr. Mack is a graduate of Boston College (Massachusetts), St. Louis University (Missouri) and the University of Texas Southwestern Medical School in Dallas (Texas).

Jean-Claude Cadudal, Chairman of CARMAT’s Board of Directors, says: “We are delighted to welcome these two world-class experts to CARMAT’s Board of Directors. Their arrival further confirms the appeal and potential of our disruptive technology in the treatment of end-stage biventricular heart failure. Their respective areas of expertise in the industrial and medical fields represent major assets to continue defining the Company’s strategic orientations. I would also like to take this opportunity to thank Marcello Conviti and André-Michel Ballester, whose contribution and commitment to CARMAT’s development have been exemplary, and wish them every success in their future endeavors.”

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About Dr. Michael Mack

Michael Mack MD, is an internationally recognized American cardiac surgeon with long standing expertise in the introduction of innovative medical devices and procedures in cardiovascular disease. He is currently the Director of the Cardiovascular Service Line for the Baylor Scott & White Health in Dallas, TX, US. Dr. Mack is the Past president of numerous professional societies including the Society of Thoracic Surgeons (STS) 2011, Thoracic Surgery Foundation for Research and Education (TSFRE) 2009-2011, the Southern Thoracic Surgical Association (STSA) 2009 and the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS) 2000.

He is an honorary member of the German Society for Thoracic and Cardiovascular Surgery and the Indian Association of Cardiovascular and Thoracic Surgery and has received the Presidential Citation of the American College of Cardiology and the Transcatheter Cardiovascular Therapeutics (TCT) Lifetime Achievement Award.

He is on the Steering Committee of the Cardiothoracic Surgery Network (CTSN) of the NIH and is a member of the American College of Cardiology (ACC) Board of Trustees, the ACC Interventional Scientific Council and the STS/ACC National Transcatheter Valve Therapy (TVT) Registry Steering Committee. He is a member of the FDA MDEpiNet Advisory Committee. He is currently a Director of the American Board of Thoracic Surgery. He is the author of more than 500 scientific publications.
Dr. Mack is a graduate of Boston College (Massachusetts), St. Louis University (Missouri), University of Minnesota, and the University of Texas Southwestern Medical School in Dallas (Texas).

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

Name: CARMAT
ISIN code: FR0010907956
Ticker: ALCAR

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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.16-0221 on March 29, 2016 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.

1 The Medical Device Epidemiology Network Initiative (MDEpiNet) is part of the Epidemiology Research Program (ERP) at the FDA’s Center for Devices and Radiological Health (CDRH). The initiative is a collaborative program through which CDRH and external partners share information and resources to enhance our understanding of the safety and effectiveness of medical devices after they are marketed.