CARMAT PRESS RELEASE
CARMAT will benefit from the European SEED1program that supports innovative therapy developers seeking reimbursement
Paris, January 22, 2015
CARMAT (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 European SEED consortium has selected CARMAT's bioprosthetic autoregulated artificial heart as one of only ten companies Europe-wide.
The SEED Consortium, led by French HAS (Haute Autorité de Santé), is a project funded by the European Union in the framework of the EU Health Program; it is composed of 14 European agencies specialized in the field of Health Technology Assessment (HTA).
The aim of the SEED project is to conduct pilots on early dialogues between its member HTA agencies and developers of new health products (pharmaceuticals and medical devices) whose products are currently in the development stage before CE mark. CARMAT will benefit from one of the ten early dialogues planned (seven on drugs and three on medical devices).
Health technology assessment is a rigorous process that sometimes proves difficult to navigate for innovative companies. Early dialogues allow companies developing health products to meet with European HTA agencies in order to present their development plan for the product in question and allow agencies to ask specific questions relative to their plan.
The early dialogue process is organized around the submission of a dossier followed by a plenary discussion between the company developing the product and HTA agencies who are members of the SEED Consortium. A plenary discussion between CARMAT and HAS will be scheduled in the second quarter of 2015.
Marcello Conviti, Chief Executive Officer of CARMAT, comments: "We are honored to be one of the three European medical device projects selected for this program. This early dialogue strongly increases the likelihood that our production of data will conform to the requirements of the European HTA agencies and support the company's future reimbursement filings, thereby potentially decreasing the time to reimbursement for our bioprosthetic heart."
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AboutCARMAT:the world's most advanced total artificial heart project
Acredibleresponsetoend-stageheartfailure: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.
1SEED: Shaping European Early Dialogues for health technologies
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Theresultofcombiningtwotypesofuniqueexpertise: 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.
Imitatingthenaturalheart: 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.
AprojectleaderacknowledgedataEuropeanlevel: 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.
Stronglycommitted,prestigiousfoundersandshareholders:Airbus Group, Professor Alain Carpentier, the Centre ChirurgicalMarie 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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CARMATMarcello Conviti CEO
Patrick Coulombier
COO
Valérie Leroy
Director of Marketing
& Investor Relations
Tel.: +33 (0)1 39 45 64 50 contact@carmatsas.com
Alize RP
Press Relations
Caroline Carmagnol
Tel.: +33 (0)1 44 54 36 66 caroline@alizerp.com
Name: CARMAT
ISIN code: FR0010907956
Ticker: ALCAR
NewCapFinancial Communication and Investor Relations
Dusan Oresansky
Emmanuel Huynh
Tel.: +33 (0)1 44 71 94 94 carmat@newcap.fr
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