CARMAT announces the first commercial implants of its Aeson® artificial heart outside the European Union

Paris, December 23, 2021 – 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, announces the completion of investigations on its prostheses.

Following the occurrence of a quality issue affecting some of its prostheses, CARMAT had announced, on December 3, 2021, the voluntary and temporary suspension of implants of its Aeson® artificial heart. The company has subsequently carried out a very rigorous investigation of the situation.

This investigation, which is now complete, has enabled the root causes of the quality issue to be identified, and the changes required to prevent its reoccurrence to be determined.

The outcome of the investigation will now be shared with the notified body (DEKRA) and the competent authorities (specifically the ANSM in France and the Food & Drug Administration in the United States), starting from this week. The discussions with DEKRA and the competent authorities are expected to take a few weeks and lead to an agreed schedule to resume implants.

The company plans to provide a further update in January 2022, including a web conference, the date of which will be communicated in due course.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “After more than 2 weeks of in-depth investigation, I am glad that our teams were able to identify the root causes of the quality issue that occurred, and to propose corrective actions. Given the significant unmet need for patients suffering from end-stage biventricular heart failure who cannot benefit from a heart transplant, and the strong demand for Aeson® from many doctors and hospitals, we will now work diligently with all regulatory stakeholders in order to resume implants as soon as possible while keeping quality and patient safety as our top priorities”.

Paris, October 21, 2021 – 6:00 pm CEST

                    
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, announced today that Ladenburg Thalmann, a leading U.S. investment bank, hosted a web conference on October 20, 2021 on the Aeson^® artificial heart, with the participation of surgeons from Duke University Hospital and the Jewish Hospital of Louisville who have performed the first Aeson^® implants in the United States in recent months as part of the Early Feasibility Study (EFS).
 
Speakers at the conference included:

• Stéphane Piat, Chief Executive Officer of CARMAT;
• Dr. Piet Jansen, Chief Medical Officer of CARMAT;
• Dr. Carmelo Milano, cardiac surgeon at Duke University Hospital;
• Dr. Mark Slaughter, cardiac surgeon at UofL Health – Jewish Hospital & University of Louisville. 

You can access the replay of this web conference by clicking on this link.     

The procedure was performed at UofL Health – Jewish Hospital by University of Louisville physicians in the first cohort of the U.S. Early Feasibility Study

Paris, September 21, 2021 – 7:00 am CEST

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, announces the first implant of its bioprosthetic artificial heart, Aeson®, in a female recipient.

The implant procedure was performed by a team led by Dr. Mark S. Slaughter, Professor and Chair of the Department of Cardiovascular and Thoracic Surgery at the University of Louisville and UofL Physician at Jewish Hospital, Louisville, Kentucky, within the framework of the first cohort of 3 patients of the U.S. Early Feasibility Study (EFS). The recipient is a 57-year-old woman who was suffering from severe biventricular heart failure and had undergone cardiac surgery several years before.

Mark S. Slaughter, MD, heart surgeon at UofL Health – Jewish Hospital and University of Louisville, and principal investigator of the study, stated: “The Aeson® artificial heart is compact enough to fit inside smaller chest cavities, more frequently found in women, which gives hope to a wider variety of men and women waiting for a heart transplant and increases the chances for success. With our second Aeson® implant within one month, we are quickly gaining experience, including patients who underwent previous cardiac surgery, and continue to be impressed by the performance of the device.”

Stéphane Piat, Chief Executive Officer of CARMAT, concluded: “This 3^rd implant in the US was a landmark event not only because it allowed us to finalize the enrollment of the first cohort of patients of the EFS, but very importantly because it is the first time ever that our device has helped a woman suffering from heart failure. This achievement confirms that the size limitations for adults are minimal, which makes us very confident in Aeson®’s potential to become a therapy of choice for a broad patient population.”