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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.”

Paris, September 16, 2021 – 6:30 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, today announces that it has received final approval from the Patient Protection Committee (CPP Ile-de-France XI) for the use of the commercial version of the Aeson® heart in the EFICAS study in France.

This agreement from the CPP Ile-de-France XI applies to the dossier submitted by CARMAT in the first half of 2021 and enables it to use the latest version of its Aeson® artificial heart in the EFICAS study.

This agreement paves the way for the start of this study, with recruitment expected to begin in the fourth quarter of 2021 in the first six centers that have expressed an interest in taking part in the trial (APHP Hôpital européen Georges-Pompidou, APHP-HU Pitié Salpêtrière, CHRU Lille, CHU Lyon, CHU Rennes and CHU Strasbourg).

As a reminder, CARMAT had already obtained the approvals of the French National Agency for Medicine and Health Product Safety (ANSM) and the French National Authority for Health (HAS) on the clinical protocol of this study, and benefits from €13 million in funding from the National Innovation Fund, granted by the French Ministry of Solidarity and Health, to partially finance it. 

The study will cover 52 implants in France and will allow CARMAT to collect both additional data on the efficacy and safety of its artificial heart, and medico-economic data to support the value proposition and reimbursement of the device, notably in France.

Stéphane Piat, Chief Executive Officer of CARMAT, stated: “I am pleased that the patient protection committee has agreed to the use of the most recent version of Aeson® in the EFICAS study. This medico-economic study is of major interest for our development in France as the data collected will in particular support our reimbursement application for Aeson® in our domestic market. I am also delighted that 6 of the most prestigious French cardiology hospitals have placed their trust in us and will allow French patients to benefit from our unique therapy.”

• 6 Aeson® artificial hearts marketed to date
• Enrollment of the first cohort of 3 patients in the EFS[1] in the USA finalized
• Cash position of €58 million at June 30, 2021, covering the Company’s activities through to mid-2022
• Videoconference with Stéphane Piat today at 5 pm Paris time

Paris, September 15, 2021 – 7:00 am CEST

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative to people suffering from end-stage biventricular heart failure, today reports its results for the first half of the year to June 30, 2021[2] and issues an update on its latest progress and main strategic objectives.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “Following the granting of CE marking in December 2020, CARMAT dedicated most of its resources to preparing the commercial launch in Europe, initiating the EFS in the US and strengthening its supply chain. Despite the constraints associated with the COVID-19 pandemic, CARMAT achieved key milestones: since July, 6 patients in leading German and Italian hospitals did benefit from Aeson®, the world’s first physiological artificial heart, in a commercial setting. CARMAT also successfully completed the enrollment of the first cohort of 3 patients in the EFS study, with some of the largest and renowned American cardiology centers such as Duke University Hospital, paving the way to the evaluation of our device in the US, the world’s largest medical device market. The very positive feedback regarding the implantations of Aeson® in both commercial and clinical trials settings is further demonstrating our confidence that our device represents a valid alternative to heart transplants. We anticipate that around a dozen European centers, primarily in Germany, will be commercially active by the end of 2021. In order to support this momentum, CARMAT has also been working on ramping up its production activities, which should allow the company to manufacture Aeson® prostheses at an increasing pace in order to appropriately supply hospitals that would like to offer our unique technology to their patients”.

[1] Early Feasibility Study

[2] First-half results were approved by the Board on September 13, 2021 and have been the subject of a limited review by the statutory auditors. The 2021 half-year financial report was published today and is available on the Company’s website.