Agreement with the Silesian Center for Heart Diseases in Zabrze, Poland, to perform implants of CARMAT’s bioprosthetic artificial heart

Regulatory News:

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced project of total artificial heart, reports today that the Silesian Center for Heart Diseases in Zabrze, Poland, has agreed to participate into the first clinical implants of CARMAT bioprosthetic artificial heart.

"The Silesian Center is known worldwide for its exceptional chronic heart failure program. We are extremely honored 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 Marian Zembala, Chairman, Department of Cardiac Surgery and Transplantation and Director of the Silesian Center for Heart Diseases comments: "It has been 30 years since the first successful heart transplantation was carried out in Zabrze. Since then, more than 1’000 heart transplantations, 70 combined heart and lungs transplantations and over 34’000 open heart surgeries have been performed, placing the Center in a leading position in Europe, from a research as well as from a clinical standpoint. We are really looking forward to explore all the potential benefits of the CARMAT bioprosthetic artificial heart for our patients and especially its unique features in terms of physiology and auto adaptation to patients’ needs.”

Prof. Alain Carpentier, co-founder and Scientific Director at CARMAT, adds: "I have been very pleased to learn that Prof. Zembala and the Silesian Center for Heart Diseases are willing to join us in the evaluation of the CARMAT bioprosthesis. As recognized experts in the field, they will be able to appreciate first-hand the unique features and remarkable performances of this prosthesis."

The study protocol and the patient selection process are being finalized. The training of the surgical and medical teams at the Silesian Centre 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 the Silesian Center for Heart Diseases (SCCS)

The Silesian Center for Heart Diseases in Zabrze welcomed its first patient in 1984 and is a modern, highly specialized heart center, recognized nationwide and internationally for its outstanding clinical and scientific achievements in cardiology and cardiothoracic surgery.

The Center offers the broadest possible spectrum of diagnostics, therapeutic and surgical treatment options for both congenital and acquired heart diseases. Patients presenting symptoms of acute coronary syndromes are treated immediately by well trained and experienced cardiologists ready to perform any kind of percutaneous intervention twenty four hours a day, seven days a week. In case of any difficulties cardiac surgeons are always on standby, prepared to take over.

Mission – To rescue, treat and give hope...

For more information: http://www.sccs.pl/en/

About Professor Marian Zembala

Prof. Zembala, MD PhD FESC, is chairman of the Department of Cardiac Surgery and Transplantation (since 1998) and the director of the Silesian Center for Heart Diseases (since 1993). He is national chief consultant in cardiac surgery (since 2011) and chairman of the Scientific Council of the Ministry of Health (since 2009). Prof. Zembala was an Adjunct Assistant Professor of Surgery and Deputy Head of the Department of Cardiac Surgery of the Medical University of Silesia in Katowice from 1985 to 1998. On the forefront of research, Prof. Zembala also completed several postdoctoral fellowships programs notably in Aachen, Germany (1999), in Brown Mills, New Jersey, USA (1998), in Utrecht, The Netherlands (1981-1985) and Leuven, Belgium (1980). He was also an alumnus of Professor Alain Carpentier’s course on mitral valve repair.

Prof. Zembala is internationally recognized for his clinical and surgical achievements. He introduced many innovative procedures in Poland, among others minimally invasive transcatheter aortic valve implantation, single-lung transplant in pulmonary hypertension patients, lung transplant, heart-and-lung transplant, heart-and-kidney transplant. He leads the largest mitral valve reconstruction program in Poland, the first and the largest in the country heart failure treatment program and heart and lung transplant program. Prof. Zembala was a President of the European Society for Cardiovascular and Endovascular Surgery (2010-2012; since 2008 - a member of the ESCVS Executive Committee). He is a member of the International Society for Heart and Lung Transplantation, the European Association for Cardio-Thoracic Surgery, the European Society of Cardiology, the Society of Thoracic Surgeons and the American Association of Thoracic Surgeons and the Editor-in-chief of the Polish Journal of Cardio-Thoracic Surgery.

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.