CARMAT provided an update on the EFICAS study. To date, 20 patients have been implanted with the Aeson heart as part of the EFICAS study, 9 of them in the first 4 months of 2024. The EFICAS study is conducted exclusively in France, in 10 hospitals whose teams are fully trained and ready to carry out the implants.

To date, 8 hospitals have already enrolled patients in the study. The primary objective of the study is a minimum survival of 6 months on CARMAT support, without disabling stroke, or a successful heart transplant within the first 6 months. The study's interim success rate of 75%, which exceeds expectations, is very promising compared to previous CARMAT studies3 and existing therapies, given the poor state of health of the patients concerned.

In view of these advances, CARMAT confirms its target of completing the EFICAS study, with a total of 52 Aeson implants, in the first half of 2025. The EFICAS study is essential both for the reimbursement of Aeson in France and for obtaining PMA (marketing authorization in the United States, issued by the FDA), which the Company anticipates for 2027. Study data are also an important catalyst for the adoption of Aeson across Europe.