May 6th 2024
Paris, May 6, 2024 – 7.00 am CEST
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.”
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[1] 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 studies[3] 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.
Bolstered by the clinical results of the EFICAS study, the progression in implants over the first 4 months of 2024, and its solid base of 39 hospitals trained in commercial implants, CARMAT reiterates its sales forecast of around €14 million for 2024.
Given its cash position and business plan, the Company’s financial horizon currently extends to the end of May 2024, and CARMAT estimates its 12-month financing requirement at around €45 million.
The Company is working very actively on strengthening its equity, with the already-confirmed participation of some of its reference shareholders, enabling it to extend its financial horizon in the short-term.
[1] AP-HP GHU Pitié Salpêtrière, Hôpital Européen Georges Pompidou, CHU de Rennes, CHU de Strasbourg, Hospices Civils de Lyon, CHRU de Lille, Hôpital Marie-Lannelongue, CHU de Montpellier, CHU de Nantes and CHU de Dijon.
[2] Among the 8 patients who have already crossed the 6-month threshold.
[3] CE-marked PIVOTAL study: 73% success rate on 15 patients.