15.05.2013 19:02:00

Agreement with the University Medical Centre, in Ljubljana, Slovenia, 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 University Medical Centre, in Ljubljana, Slovenia, has agreed to participate into the first clinical implants of CARMAT bioprosthetic artificial heart.

"The Ljubljana University Medical Centre is internationally renowned for leading innovation in cardiovascular surgery. 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 Borut Geršak, Head of the Department of Cardiovascular Surgery at the Ljubljana University Medical Centre comments: "The Ljubljana University Medical Centre is the only heart transplant center in Slovenia and our transplant activity has been steadily growing year on year, as well as our waiting list. We are therefore acutely aware of the need for a destination therapy that would alleviate the complications of current treatments. This is why we have been on the forefront of innovation in the treatment of end-stage heart failure. The CARMAT’s artificial heart carries promises we are eager to trial in the interest of Central Europe patients.”

The study protocol and the patient selection process are being finalized. The training of the surgical and medical teams at the Ljubljana University Medical 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 Ljubljana University Medical Centre (Ljubljana UMC)

The Ljubljana University Medical Centre (Ljubljana UMC) is Ljubljana's hospital centre and the largest hospital centre in Slovenia. It was officially opened on 29 November 1975, has over 2000 beds and 7000 employees, and performs over 100 000 in-patient admissions per year, making it one of the largest hospitals centers in Central Europe. It is the main training base for the Faculty of Medicine in Ljubljana, which is housed nearby. The Ljubljana UMC has a large transplant activity, steadily increasing by over 20% each year.

Mission – Our principal aim is to provide quality care to patients from Slovenia and other European countries. The UMCL's organization and activities are geared at continuous improvement of our services, development and introduction of new methods of treatment, and transfer of knowledge to younger generations of health professionals. Our major objectives are to acquire European accreditation, implement a comprehensive system of quality assurance, and achieve international quality standards. We have close contacts with similar institutions in the European Union. Our wish is to create a favourable working environment for our employees and provide quality professional care to our patients.

For more information: http://www.kclj.si/ang/index.php

About Professor Borut Geršak

Prof. Borut Geršak was first admitted to study nuclear engineering at the Massachusetts Institute of Technology (in Cambridge, MA), but soon changed his mind and graduated in 1991 at the Ljubljana Medical Faculty as a specialist surgeon. Since 2006, he has been the head of the Department of Cardiovascular Surgery at the University Medical Center, Ljubljana, Slovenia. Prof. Geršak’s work represents a great contribution to cardiac surgery in Slovenia and worldwide. He introduced heart-valve surgery on a beating heart, and was the first in Slovenia and among the first in the world to perform marginal artery bypass surgery on a beating heart without cardiopulmonary bypass in 1997, as well as the endoscopic aortic valve surgery and tricuspid valve surgeries on a beating heart, which he demonstrated in many European countries and in the US. In recent years, Prof. Geršak has focused on the surgical treatment of end-stage heart failure and the use of mechanical heart support, the use of biological heart valves and tissue engineering, and the use of computer technology in cardiovascular surgery, the latest’s as one of the coordinators of the European project Augmented Reality in Surgery.

He is one of the founders of the Slovenian Surgeons’ Association and has served as a member of many international surgical societies and associations such as the European Association for Cardio-Thoracic Surgery, the International Society for Minimally Invasive Cardiothoracic Surgery and the Society of Thoracic Surgeons. He is also a member of the editorial boards of several international journals.

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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