October 26th 2022
French National Agency for Medicine and Health Product Safety and Patient Protection Committee have provided approval to resume Aeson® implants within the framework of the EFICAS study
Paris, October 26, 2022 – 7 am CEST
CARMAT (FR0010907956, ALCAR), the designer and developer of Aeson®, the world’s most advanced total artificial heart, designed to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announced today that it has been granted the necessary regulatory approvals from the French National Agency for Medicine and Health Product Safety (“ANSM”) and the Patient Protection Committee (CPP Ile-de-France XI) to restart the EFICAS Clinical Study.
The study will include 52 transplant-eligible patients in France and will allow CARMAT to collect both additional data on the efficacy and safety of its artificial heart, and medico-economic data to support the value proposition and reimbursement of the device, notably in France.
Ahead of the restart, four centres have undergone refresher trainings on the product and clinical protocol and are ready to screen patients (APHP-HU Pitié Salpêtrière, CHRU Lille, CHU Rennes and CHU Strasbourg).
As a reminder, CARMAT benefits from a funding of €13 million from the French National Innovation Fund, to partially finance this study.
Given this approval, which follows the recently announced green light to resume commercial implants as well, CARMAT confirms its intention to resume implants in Europe in the near future, at a gradual pace in line with the rebuilding of its prostheses inventory.
Stéphane Piat, Chief Executive Officer of CARMAT, said: “This approval is very positive news for French patients who will now be able to benefit from Aeson® as part of the EFICAS study that we will shortly be initiating in France. This study is also instrumental for the Company as it will allow us to collect essential medico-economic data to support the reimbursement of our therapy, notably in France. Our teams are working hard to build prostheses inventory to support the resumption of our implants in Europe.”