PARIS--(BUSINESS WIRE)--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 announced the appointment of Thierry Dupoux as Senior Director of Quality Assurance.
Thierry Dupoux is a seasoned medical device professional with a strong and large expertise in Quality Assurance / Regulatory Affairs and R&D. Engineering Graduate from Ecole Centrale de Lyon (France), he has worked most of his career for Life Sciences companies such as General Electric where he became Supply Chain Quality & Compliance Manager for the plant of Buc (France) in his last position. In 2006, he joined Sorin Group, now named LivaNova, a world leader in Cardiac Surgery and Neuromodulation. Over the past 12 years at LivaNova, he held several senior positions in Quality Assurance, Regulatory Affairs and R&D. Prior to joining CARMAT, he was Vice President of Quality Assurance at LivaNova where he led the integration of the Quality Systems following the merger between Sorin Group and Cyberonics.
Thierry Dupoux, Senior Director of Quality Assurance of CARMAT, commented: “The device designed by CARMAT is a true engineering challenge that has no equivalent today. I am excited to join CARMAT to support the company in bringing this highly needed technology to the market as soon as possible. Advanced Heart Failure is one the most important issue that modern medicine has to face and CARMAT is clearly one of the few solutions for the foreseeable future.”
Stéphane Piat, Chief Executive Officer of CARMAT, added: “We are delighted to welcome Thierry, a seasoned manager in Quality Assurance and Regulatory Affairs in Cardiology, as Director of Quality Assurance. He has a broad and diverse experience with the European and US regulations, from established Multinationals to Mid-Cap companies, which is key to support us in obtaining the CE mark and moreover to get the IDE1 approval thanks to his long and successful experience with the FDA. His background and leadership will constitute a very important asset to our success. Thierry will work closely with Joëlle Monnier-Roulé, currently Director of Quality, who will now focus on the development of processes for our Quality Management System.”
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 (Babalia) and of Dr. Antonino Ligresti (Santé Holdings S.R.L.), Groupe Therabel as well as the thousands of institutional and individual shareholders who have placed their trust in CARMAT.
For more information: www.carmatsa.com
ISIN code: FR0010907956
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 registration document filed with the Autorité des Marchés Financiers under number D.18-0169 on March 22, 2018, as well as 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 IDE – Investigational Device Exemption