19.01.2015 02:01:16

The patient who received a CARMAT bioprosthetic heart in Nantes on August 5, 2014 has been discharged home

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 heart failure, announces that the patient implanted at the Nantes University Hospital last August has been discharged from the hospital and has returned home.

The company has received approval from the competent authorities to include the portable power and alert system1 in the protocol of the ongoing first-in-man study, thus making it available to all patients of this trial.

The patient was discharged home after training in the management of this silent electric portable system. It is the lightest of any system currently available for powering a total artificial heart and provides patients with mobility and autonomy in excellent conditions.

Professor Alain Carpentier, co-founder of CARMAT and inventor of the Company’s self-regulated bioprosthetic artificial heart, says: "After years of suffering, a new year and a new life have started for this patient. His courage, trust and his family’s support were decisive in the success of this implantation. We express our deep appreciation to the medico-surgical teams and medical staff of the Nantes University Hospital2, whose experience and commitment have contributed to the patient’s impressive rehabilitation.

In full agreement with the Nantes University Hospital team and CARMAT, the patient has requested that his identity remain confidential and his privacy respected, in accordance with the regulations governing this ongoing clinical trial.

Marcello Conviti, Chief Executive Officer of CARMAT, concludes: "We allocated a significant part of our teams and resources to the development of the portable device in 2014. This system is a symbol of our will to enable patients to return to as normal a life as possible. Our greatest reward has been the patient’s joy at not only reclaiming a level of activity that was unthinkable just a few months ago thanks to the bioprosthesis, but more importantly being able to live a real life at home with family and friends.

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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, Professor Alain Carpentier, the Centre Chirurgical Marie Lannelongue, Truffle Capital, a leading European venture capital firm, and the thousands of institutional and individual shareholders who have placed their trust in CARMAT.

For more information: www.carmatsa.com

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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 filed with the Autorité des Marchés Financiers under number D.14-0145 on March 17, 2014 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. CARMAT products are currently exclusively used within the framework of clinical trials. They are not available outside these trials or for sale.

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1 For further information about the portable system, please refer to the 6th Shareholder Newsletter.

2 CARMAT wholeheartedly thanks Daniel Duveau, professor emeritus, Jean-Christian Roussel, university professor and hospital practitioner - heart surgeon and principal investigator, Jean-Noël Trochu, university professor and hospital practitioner - cardiologist and head of the Nantes University Hospital’s Thorax Institute and Nervous System Department, Dr. Jean-Pierre Gueffet, hospital practitioner - cardiologist and co-investigator, Dr. Michel Treilhaud, hospital practitioner - anesthetist-resuscitator, Dr. Philippe Bizouarn, hospital practitioner - anesthetist-resuscitator, and all the department’s cardiology, heart surgery, anesthesia-resuscitation, healthcare and physiotherapy teams. CARMAT would also like to thank professor Christian Latrémouille, heart surgeon at the Georges Pompidou European Hospital in Paris, for the technical assistance provided to the Nantes team.

Name: CARMAT
ISIN code: FR0010907956
Ticker: ALCAR

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