CARMAT Granted Approval to Conduct Study on its Artificial Heart

CARMAT SA, designer and developer of an advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, said the French National Authority for Health (HAS) has given its definitive approval to initiate a clinical study of the CARMAT device within the framework of the Forfait Innovation program.¹ 
 
Through this definitive approval, the HAS confirmed its positive opinion regarding the financing by special exemption of the CARMAT total artificial heart within the framework of the EFICAS study, a prospective, multicenter, non-randomized study, to be undertaken in France. The design of the study, which includes 52 patients to be implanted with the CARMAT heart as a bridge to a heart transplant, has been adjusted in accordance with the observations expressed by the HAS in the conditional approval  received by CARMAT in February. The primary endpoint of the study is the survival rate at 180 days after implantation without a disabling stroke or a successful cardiac transplantation within 180 days post-implant.
 
CARMAT has already received approval from the French National Agency for Medicine and Health Product Safety (ANSM) and the Île-de-France Patient Protection Committee (CPP) to undertake such a study. 
 
The company will now initiate budget discussions with the Ministry of Health and Solidarity.
 
Stéphane Piat, CEO of CARMAT, said: “We are delighted with this positive opinion from the HAS, received within a particularly complex context. The definitive eligibility of our device to the Forfait Innovation program now enables us to  open  budgetary  discussions pertaining to the EFICAS study aimed at facilitating the access of French patients suffering from end-stage biventricular heart failure to our cutting-edge technology.”
 
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, composed of the implantable bioprosthesis and its portable external power supply system to which it is connected, 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 CARMAT heart resulted from the medical expertise of Professor Alain 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.
 
Given its size, the use of highly biocompatible materials, its unique self-regulation system and its pulsatile nature, the CARMAT total artificial heart could, assuming the clinical trials are successful, potentially save the lives of thousands of patients each year with no risk of rejection and with a good quality of life.
 
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 euros.
 
Founders and shareholders of CARMAT include Matra Défense SAS (subsidiary of the Airbus Group); Professor Carpentier, the Centre Chirurgical Marie Lannelongue; Truffle Capital, a European venture capital firm; ALIAD (Air Liquide’s venture capital investor); CorNovum (an investment holding company held 50-50 by Bpifrance and the French State); the family offices of Pierre Bastid (Lohas) of Dr. Antonino Ligresti (Santé Holdings S.R.L.), of the Gaspard family (CorelyBelgium SPRL and Bratya SPRL) and of M. Pierre-Edouard Stérin (BAD 21 SPRL); and Groupe Therabel.

Reference
¹ The Forfait Innovation is granted by the Ministry of Health and Solidarity, following an initial eligibility assessment by the HAS (https://www.has-sante.fr/jcms/c_2035788/fr/forfait-innovation).