15.05.2013 18:38:00

Agreement with St Pierre University Hospital, in Brussels, Belgium, to Perform Implantations of CARMAT’s Bioprosthetic Artificial Heart

Regulatory News :

CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced project of total artificial heart, reports today that St Pierre University Hospital, in Brussels, Belgium, has agreed to participate into the first clinical implantations of CARMAT’s bioprosthetic artificial heart.

"St Pierre University Hospital is a leading teaching and research institution in Belgium. We are extremely honoured of its agreement to be included in the first clinical trial of our breakthrough bioprosthetic artificial heart” says Marcello Conviti, Chief Executive Officer of CARMAT.

Professor Didier de Cannière, Chief of CV surgery at St Pierre University Hospital comments: " The lack of donors and the stringent requirements to be eligible for heart transplantation leave too many patients without hope for treatment. CARMAT’s bioprosthetic artificial heart could definitely fill a gap in the treatment of end-stage heart failure. We are very proud to take part in CARMAT’s bioprosthetic artificial heart project, and our team is very excited to start working on the first implantations.

The study protocol and the patient selection process are being finalized. The training of the surgical and medical teams at St Pierre University Hospital has started. Implantations could begin following the completion of the training.

"This is a major milestone for CARMAT, its employees, its partners and its shareholders, concludes Marcello Conviti, as well as recognition from the international scientific community of the unmet needs our unique project aims to fulfil.

About St Pierre University Hospital
St-Pierre University Hospital is a center of excellence with top-ranked services in Cardiovascular Disease, Children's Health, Digestive Diseases, Gynecology and Obstetrics, Infectious Diseases and Ophtalmological Surgery to name but a few. All of these services include both surgical and non-surgical treatment of medical conditions, with a truly unique expertise and focus on minimally invasive, multidisciplinary approaches.

Saint-Pierre University Hospital is a teaching hospital affiliated with the two top medical schools (French and Flemish branches) of Brussels University, Université Libre de Bruxelles and Vrije Universiteit Brussel. Health teaching, research and services to the community are three essential and complementary areas which Saint-Pierre University Hospital is involved in and which it is continuously striving to develop further.

For more information: http://www.stpierre-bru.be/en/index.html

About Professor Didier de Cannière
Prof. de Cannière is the Chief of the Department of Cardiac Surgery at St Pierre University Hospital in Brussels, Belgium, since his recent return from the United States where he was Professor of Surgery (Miller School of Medicine, University of Miami), and Director of the Institute of Surgical Innovation and Head of the Department of Minimally Invasive and Robotics Cardio-Thoracic Surgery at the University of Miami from 2010 to 2013. (please refer to http://www.youtube.com/watch?v=p_ZlxSIz6hk and to http://www.youtube.com/watch?v=sJz-6_kmkiw ). Prior to this tenure, he was Head of Department of the Erasme Academic Hospital and University Tivoli ULB from 2004 to 2010.

Since his Ph.D. thesis on the pulsatile hemodynamics of the right ventricle in 1996, he has remained at the forefront of research for innovative cardiovascular disease treatment. Prof. de Cannière has served as principal investigator in several international multicentric trials, more recently in the field of heart valve development and stem cell transplantation, and is a pioneer in minimally invasive and robotic cardiac surgery. Prof. de Cannière co-led the the course on Minimally invasive mitral valve repair (ECMICS) endorsed by the European Society of Cardiovascular Surgery (ESCVS) where more than 200 surgical groups were trained, and then helped develop these innovative techniques at the University of Miami. Prof. de Cannière has published over 50 peer-reviewed scientific publications in renowned journals such as Circulation, the Annals of Thoracic Surgery, the Journal of Thoracic and CardioVascular Surgery, the American Heart Journal, Cardiovascular research, etc., has performed surgery on invitation in more than 10 different countries on 4 continents and was Guest Faculty in over 20 congresses worldwide in the past three years. He served also in the board of Directors of the International Society of Minimally Invasive Cardiac Surgery (ISMICS 1999-2002 ) and in the Board of the European Society for Cardio-Vascular Surgery. He kicked off a program of open heart cardiac surgery in Yaoundé Cameroon (http://missioncameroun.skyrock.com). He is currently focused on developing alternative approaches to the treatment of structural heart disease.

About CARMAT: the world’s most advanced total artificial heart project.

The only credible response for all cases of end-stage heart failure, which is a real public health issue: CARMAT’s aim is to be able to 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. Indeed, this disease currently affects over 100 million patients in developed countries. 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 heart failure.

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 EADS, 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 upcoming clinical trials are successful, potentially benefit the lives of tens of thousands of patients a year whilst ensuring there is no risk of rejection and providing them with an unparalleled 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 OSEO; a total of €33 million.

Strongly committed, prestigious founders and shareholders: Truffle Capital, a leading European venture capital firm, EADS, the Fondation Alain Carpentier, the Centre Chirurgical Marie Lannelongue, 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 registered with the Autorité des Marchés Financiers under number R.12-044 on September 12, 2012 and the Note d’Opération that was approved with visa no. 11-308 on July 11, 2011, 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.

Name: CARMAT
ISIN code: FR0010907956
Ticker: ALCAR

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