CARMAT announces updates in its governance

Paris, February 25, 2021 – 7:00 pm 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 announced the publication of the Company’s 2020 Universal Registration Document for the year ended December 31, 2020.

The document, filed with the French stock-market authority (Autorité des Marchés Financiers) on February 24, 2021, is available to the public free of charge upon request, as per current legal regulations; and on the Company’s website under the section Investors / Documentation / Regulated information, as well as on that of the AMF (www.amf-france.org).

It notably includes the2020 annual financial report, the report on corporate governance, the required information in relation to the share repurchase program, as well as the auditors’ reports and information on the fees paid to the statutory auditors in 2020.

First enrollment in the study expected in Q1 2021

Paris, February 10, 2021 – 5.45 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today provides an update on its early feasibility study (EFS) in the United States.

The FDA has granted CARMAT approval to use the new version of its artificial heart in the EFS. This new version includes certain improvements in the prosthesis and the wearable system based on clinical experience gained in the PIVOTAL study. The company believes that this latest version should further improve patient safety and quality of life.

In view of this, the Company confirms that it expects the first enrolments in the EFS in Q1 2021.

As a reminder, CARMAT obtained the approval from the Centers for Medicare & Medicaid Services (CMS) for the reimbursement of the device and associated services within the framework of this study in May 2020.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “We are pleased to provide this new version of our artificial heart, which is similar to our CE-marked product, to the US study centers. Despite the Covid-19 pandemic, we were able to train and initiate three of them before the end of 2020. These centers are now ready to enroll patients. We also intend to pursue the training and initiation of additional selected centers.”