December 23rd 2020
Paris, December 23, 2020 – 11 am CET
CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces that it has received the CE marking for its total artificial heart.
The CE marking was granted on December 22, 2020 to CARMAT’s total artificial heart system as a bridge to transplant in patients suffering from end-stage biventricular heart failure (Intermacs Classes 1-4) who are not amenable to maximal medical therapy or the LVAD[1] and who are likely to undergo heart transplant in the 180 days following implantation.
The CE marking allows the company to market its total artificial heart system in all countries that recognize this certification, including all the countries of the European Union.
A virtual press conference with Stéphane Piat, Chief Executive Officer of the company, is scheduled on January 6, 2021 at 10 am. Further details will follow in due time.
Stéphane Piat, Chief Executive Officer of CARMAT, says: “The CE Marking is great news for patients and a major milestone for CARMAT. As early as January, we will accelerate the ramp-up of our manufacturing activities and intensify discussions with our core target customers in order to achieve a smooth commercial launch during the second quarter of 2021, and thus offer a solution to many patients waiting for a heart transplant. The CE marking definitely opens-up a new and very promising chapter for the Company. I am also particularly proud of our employees who have shown exceptional commitment and resilience during these very special times and of course of I would like to thank all our shareholders who have supported us for many years. I will be happy to share further details on our launch plan during a press-conference that will take place on January 6, 2021.”
Listing of the CARMAT share will resume at the opening of the stock market on December 24, 2020.
[1] LVAD: Left Ventricular Assist Device