CARMAT

Continuing Progress in Line with the Objective of Obtaining CE Marking in 2019

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 biventricular heart failure, today announced an update on the progress of the PIVOTAL study and the latest developments regarding its market access strategy.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “We are ramping up our project on all of its strategic routes and are gradually meeting the key milestones that bring us closer each day to meeting our objective of obtaining a CE mark for the CARMAT total artificial heart in 2019. From a clinical perspective, we have carried out one third of the implantations foreseen within the framework of the PIVOTAL study. This sustained enrollment rate validates the pertinence of our international clinical strategy implemented in highly-specialized medical facilities. It also takes on its full meaning given the performances of the surgical teams, who have been able to substantially reduce the operating time, confirming that the implantation of the CARMAT heart is highly controlled and reproducible. These clinical breakthroughs are closely correlated to our industrial development and justify our decision to open a new manufacturing site in Bois-d’Arcy, near Paris. This new site will enable us to produce the prostheses required for the clinical trials and the subsequent commercial phase in compliance with certified processes that meet the demands of industrial production. Lastly, as our project aims to address the issue of heart failure on a global scale, we are delighted to see our discussions with the U.S. FDA progressing towards the initiation of an early feasibility study in the United States, a market with substantial potential for CARMAT”.

• Acceleration in the pace of recruitment for the PIVOTAL study

The PIVOTAL study follows the feasibility study undertaken by CARMAT on 4 patients. It corresponds to the second phase of the clinical trials required to compile the CE marking clinical dossier. Within the framework of this study, CARMAT is planning to implant its bioprosthesis in approximately twenty patients with end-stage biventricular heart failure whose health state is more stable than that of the patients included in the feasibility study. This study’s endpoint is to show the survival of the implanted patients at 6 months and thus validate the CARMAT system’s safety, efficacy and performances.