Half of Enrolments Targeted in the EFICAS Study Reached by CARMAT
Regulatory News:
CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the “Company” or “CARMAT”), today announces that it has reached half of the enrolments targeted in the EFICAS study.
Continued momentum in the EFICAS study implants
The 26th Aeson implant recently carried out as part of the EFICAS study has enabled CARMAT to reach the half-way mark in the 52 recruitments targeted as part of this study carried out exclusively in France.
The continuing good momentum in implants testifies to the very encouraging spread of the therapy in France, and to its increasing adoption by the medical community. Of the 10 hospitals taking part in the study, 9 have already carried out at least one implant, and 8 at least two.
EFICAS is the largest study ever initiated by CARMAT. It is a key study both for obtaining reimbursement for Aeson in France, and for obtaining the “PMA” (marketing authorization for Aeson in the United States), which the Company anticipates for 2027 (subject in particular to the successful completion of the EFS study in the United States, the second cohort of which is anticipated to start in Q1 2025).
Significant scientific publications expected in 2025
The momentum in the EFICAS study allows the Company to anticipate the completion of the enrolment (52 patients) in the first half of 2025, and the publication of the study results1 at the end of 2025.
In addition, the Company anticipates in the first half of 2025, the publication in a scientific journal of the clinical results of Aeson in a cohort of 10 patients who have been on ECMO2 support prior to being implanted with Aeson. This publication aims to demonstrate the efficacy and safety of Aeson in high-risk patients.
CARMAT believes that these scientific publications will enable Aeson's clinical results to be widely disseminated within the medical community and will be a key factor for wider adoption of its therapy and for the Company's growth.
Stéphane Piat, Chief Executive Officer of CARMAT, comments: “EFICAS is an essential study for scientifically objectifying the clinical results of Aeson on a large sample of patients, and thus facilitating their dissemination within the medical community. If the final results of the study confirm their interim results, their publication at the end of 2025 should contribute to a significant acceleration in the adoption of Aeson by European physicians.