Update on the US Early Feasibility Study

November 26th 2020

  • Three US centers successfully trained in November
  • Commercial configuration of CARMAT prosthesis in final stage of approval by the FDA
  • First enrolment in the study postponed to Q1 2021, and completion of the enrolment of the study still expected by end-2021

Paris, November 26, 2020 – 7 am 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 EFS was fully approved by the US Food and Drug Administration (FDA) in February 2020 and 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.

In order to be able to use the “commercial configuration” of its artificial heart in the study, CARMAT submitted certain amendments to the FDA. The company believes that this latest version of the prosthesis should improve patient safety and quality of life. At this stage, thanks to a very constructive collaboration with the FDA, 8 amendments out of 9 have already been approved, and the last one should be approved in the coming weeks.

CARMAT is finalizing the study preparation with three US centers successfully trained in November at Pitt MIRM Centre for Preclinical Studies (Pittsburgh, Pennsylvania): VCU Health Pauley Heart Center (Richmond, Virginia), University of Louisville Jewish Hospital (Louisville, Kentucky), and Baylor University Medical Center (Dallas, Texas). All other steps necessary to start the EFS have already been taken.

In view of this, CARMAT now expects the first implants to be performed in Q1 2021 and the enrolment of the 10 patients to be completed by the end of 2021.

The Company confirms that its available resources[1] enable it to fund its activities through to Q3 2021.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “Despite the COVID-19 pandemic, we have been able to train the first three US centers selected for our Early Feasibility Study. They all went out of this experience very enthusiastic and committed to the success of this study. As we intend to use a new version of the CARMAT system, including features reinforcing the safety and the quality of life of patients, we had to submit amendments to supplement our initial dossier approved in February 2020. Based on ongoing discussions with the FDA, we expect to start to treat patients in the US with the new prosthesis in Q1 2021.”

[1] Including cash on-hand, €10m of ‘PGE’ Loan (loan guaranteed by the French State) drawn in November 2020, the last tranche (€10m) of the European Investment Bank Loan which can be drawn at any time until December 2021, and the non-dilutive financing of €13m granted by the French state to fund the EFICAS study (this amount will be perceived over the duration of the study); excluding the balance of the Kepler-Cheuvreux equity line, which can be used until September 27, 2021.

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