February 23rd 2023
Paris, February 23, 2023 – 7 am CET
CARMAT (FR0010907956, ALCAR), designer and developer of Aeson®, the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure, today announces its annual results for the year ending December 31, 2022 and confirms its 2023 objectives.
Stéphane Piat, Chief Executive Officer of CARMAT, said: “Thanks to the efforts of the whole CARMAT team, we have achieved our main objective for 2022: resuming implantations of our Aeson® artificial heart in the fourth quarter, as previously announced.
In order to address the strong interest of healthcare professionals in our therapy, we are confident in our ability to gradually increase our production volumes over the coming months, with an acceleration in the second half of the year, and initiate the commercial success of our artificial heart as early as 2023.
At the same time, we will deploy the EFICAS study in France, the largest clinical study ever initiated by the Company, which will enable us to confirm the efficacy and safety of our therapy, but also to collect essential medico-economic data for reimbursement, notably in France.
Furthermore, we carry-on working with the FDA to resume our Early Feasibility Study in the United States, a key step on the road to obtaining the marketing approval (‘PMA’) for Aeson® in this country.
We are also actively reviewing all funding options to extend our cash runway beyond July 2023, and are confident in our ability to do so despite a challenging external environment.
2023 will be a pivotal year to position Aeson® as the benchmark treatment for advanced heart failure”.