20.05.2013 17:45:00

Agreement with the Prince Sultan Cardiac Center in Riyadh, Kingdom of Saudi Arabia, 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 Prince Sultan Cardiac Center (PSCC) in Riyadh, Kingdom of Saudi Arabia, has agreed to participate into the first clinical implants of CARMAT bioprosthetic artificial heart.

"Prince Sultan Cardiac Center has established a worldwide reputation as a Center of Excellence for cardiac disease treatment and participated in prestigious international trials. 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 Antonio Calafiore, Head of the Department of Adult Cardiac Surgery at Prince Sultan Cardiac Center in Riyadh, Kingdom of Saudi Arabia, adds: "Cardiovascular disease has become a major cause of death in the Middle-East. As a leading treatment and research institution in the region, PSCC has already been involved in many first-in-man studies on innovative devices and has a large recruitment spanning all the Middle-East. We are eager and ready to implant a CARMAT bioprosthetic artificial heart, now that our ethical committee has granted its approval.”

Dr Hussein Al-Amri, Director of Medical Administration of the Prince Sultan Cardiac Center, states: "We are really glad of this opportunity to confirm PSCC leadership in the treatment of end-stage heart failure. This device will add value to the state-of-the-art armentorium we are already successfully using, such as mitral clips, coronary sinus devices, conventional surgery on valves and ventricles, and heart transplant. This new total artificial heart meets our expectations for patient’s quality of life: thanks to its biological components, it should reduce the need for lifelong anticoagulation.”

The patient selection process is being finalized and the training of the surgical and medical teams at PSCC has started. Implantations could start 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 fulfill. We now look forward to the start of our clinical trial.

About Prince Sultan Cardiac Center (PSCC)

Cardiac services started in 1979 at Riyadh Military Hospital. The center was crowned in May 1992 by a Decree of HRH the late, God Willing, Prince Sultan bin Abdulaziz, stating the establishing of Prince Sultan Cardiac Center to act as a specialized healthcare center to provide comprehensive cardiovascular services to all Armed Forces personnel, their dependents and other patients referred to the center for further evaluation and specialized treatment.

Vision - Prince Sultan Cardiac Center aspires to be the leader in providing specialized cardiovascular services in the Middle East, as an integrated medical center and specialized scientific authority in cardiology and cardiac surgery.

Mission - Prince Sultan Cardiac Center is committed to providing the highest standards of integrated healthcare services to all Saudi Armed Forces Personnel, their dependents and other eligible patients delivered by highly qualified human resources and utilizing the most advanced medical technologies in accordance with MSD Total Quality Management, and in line with International Standards.

For more information: www.pscc.med.sa

About Professor Antonio Calafiore

Prof. Calafiore is the Head of the Department of Adult Cardiac Surgery at Prince Sultan Cardiac Center in Riyadh, Kingdom of Saudi Arabia since May 2009. Prof. Calafiore was Professor of Cardiac Surgery and Head of Cardiac Surgery in Chieti, Italia, from 1985 to 2003, in Torino from 2003 to 2005, at the European Hospital in Rome in 2005 and 2006 and at the University of Catania from 2006 to 2009.

Prof. Calafiore is internationally recognized as an extremely talented and creative surgeon. He pioneered many innovative techniques such as off-pump coronary artery bypass grafting, left anterior small thoracotomy (LAST operation), the use of intermittent antegrade warm blood cardioplegia for myocardial preservation which is now referred to as "Calafiore technique”, multiple vessel revascularization on a beating heart, and left ventricular surgical remodeling. He is also the past President of the Italian Society of Cardiac Surgery and Member of the European Society of Thoracic and Cardiovascular Surgery, Society of Thoracic Surgeons and American Association of Thoracic Surgeons.

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 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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