CARMAT Anticipates Implants of Its Aeson Artificial Heart to Resume in October 2022

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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, issues an update on its activities and outlook.

Positive feedback from physicians on Aeson since its commercial launch in July 2021

Subsequent to getting the CE marking in the BTT indication¹ in December 2020, the Company started generating the first sales in its history from July 2021, with the implants of 7 Aeson hearts, including 5 in Germany and 2 in Italy.

To date, four patients are being supported by Aeson, either within the framework of clinical trials or because they have been implanted in a commercial set-up. Three of these four patients are awaiting a heart transplant.

In response to the strong interest in Aeson shown by hospitals and encouraged by the positive feedback received from surgeons who have implanted its device, the Company continues training more hospitals, notably in Germany, to allow for a strong resumption in sales once the suspension of implants is lifted.

Resumption of implants anticipated in October 2022

Following the occurrence of quality issues affecting some of its prostheses, CARMAT took, on December 2, 2021, the decision to voluntarily suspend all Aeson implants.

A rigorous investigation concluded that quality defects on two distinct components of the prosthesis were the root cause of these issues.

Corrective actions aimed at preventing such defects have been defined and are currently being integrated within manufacturing processes. Given the time required to fully implement these actions, and production lead-times, CARMAT estimates that new prostheses should be available by October 2022.

At the same time, the Company is continuing its discussions with the notified body (DEKRA) and the competent authorities (specifically the ANSM in France and the Food & Drug Administration in the United States), whose authorization is required to resume implants respectively on a commercial basis, and within the framework of clinical trials.

In view of this, CARMAT anticipates to be in a position to resume its commercial and clinical implants in October 2022.

Based on this schedule, CARMAT confirms that it has the necessary financial resources to finance its activities through to July 2022.