CARMAT Continues to Build on Its Momentum in the EFICAS Study and Reiterates Confidence in Its 2024 Outlook

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 provides an update on the EFICAS study and reiterates confidence in its 2024 outlook.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: "I'm very pleased with the progress of the EFICAS study, both in terms of the pace of inclusion and results observed to date.

With 20 patients implanted, we have already completed 38% of the planned inclusions (out of a total of 52), which once again underlines the very strong interest shown by French doctors and hospitals in the Aeson heart. Moreover, the interim results of the study are better than expected, although we are treating increasingly sick patients.

These achievements make us optimistic not only about the completion of the EFICAS study in the first half of 2025, but also about the growth potential of Aeson sales over the coming months.

I am also delighted to be able to rely on several of our reference shareholders who have already confirmed their intention to support CARMAT financially in the short term, which will enable us to focus on our objectives and our development.”

• EFICAS study on track

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 10¹ 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%², 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.