February 12th 2020
Paris, February 12, 2020 – 7.00 am CET
CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today reports its annual results for the year ending December 31, 2019[1], and presents its 2020 development prospects.
Stéphane Piat, Chief Executive Officer of CARMAT, said: “2019 was a crucial year for CARMAT, as we were able to successfully strengthen all strategic pillars of our project: the manufacturing system, the quality of the bioprosthesis that is continuing to fulfill its role within the PIVOTAL study in line with expectations, and the Company’s financial structure. Firstly, we completed the transfer of all our manufacturing activities to the Bois-d’Arcy site, where the production of prostheses resumed in May following the implementation of the final technical adjustments. This had a direct effect on the PIVOTAL study that was then able to gradually resume thanks to the approvals received from the health authorities in Denmark, the Czech Republic and Kazakhstan. The 12th patient of the study was thus able to benefit from the new prosthesis in December, enabling us to reach over 7 years of cumulative support to date within the framework of the study. At the same time, we continued our very constructive discussions with the FDA that led, in September, to the conditional approval being granted to undertake a feasibility study in the United States. Since then, we have responded to all remaining questions and recently obtained the full approval of the FDA that will enable us to accelerate discussions with the 7 chosen American medical centers, but also with the Centers for Medicare & Medicaid Services (CMS) to obtain coverage of the costs of the study, for which enrollment could begin during the fourth quarter of 2020. Lastly, we significantly strengthened our financial structure through a €60 million private placement with investors who share our long-term vision. These funds have provided us with a financial visibility through to mid-2021 and the necessary resources to continue achieving various milestones of our project, notably including our key objective of obtaining CE marking in 2020.”
[1] Annual accounts were approved by the Board of Directors on February 10, 2020. Audit procedures relative to these accounts have been carried out, and the auditor’s report is currently being prepared.