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."
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
CARMAT
Marcello 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
NewCap
Financial Communication
and Investor Relations
Dusan Oresansky
Emmanuel Huynh
Tel.: +33 (0)1 44 71 94 94
carmat@newcap.fr
Help employers find you! Check out all the jobs and post your resume.
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."
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
CARMAT
Marcello 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
NewCap
Financial Communication
and Investor Relations
Dusan Oresansky
Emmanuel Huynh
Tel.: +33 (0)1 44 71 94 94
carmat@newcap.fr
Help employers find you! Check out all the jobs and post your resume.
