CARMAT achieves a pivotal year in 2023 by reaching the milestone of 50 implants of the Aeson® artificial heart and presents its development prospects

• 50 patients have benefited from CARMAT’s Aeson® artificial heart since the first implant in 2013
• Aeson® becomes an essential breakthrough innovation in the treatment of advanced biventricular heart failure
• 41 hospitals in 12 countries are trained for implants[1], including 33 for commercial activity
• Turnover of €2.8m in 2023, marked by a substantial acceleration in sales in the fourth quarter, with 11 implants out of the 17 carried out during the year
• Sales of €14-20m anticipated in 2024
• Launch in the very short term of a capital increase to extend the cash runway beyond the end of January 2024 and partially finance the Company’s needs for the forthcoming 12-month period, estimated to a minimum of €50m

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Paris, January 15, 2024 – 7:00 am (CET)

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aimed at providing a therapeutic alternative for patients suffering from advanced biventricular heart failure (the “Company” or “CARMAT“), today announced that it has reached the milestone of 50 implants of its total artificial heart, and provides an update on its achievements and outlook.

Stéphane Piat, Chief Executive Officer of CARMAT, declares: « CARMAT celebrated its 15^th anniversary in 2023. The Company and its teams are extremely proud to have reached the milestone of 50 Aeson® implants since the first in December 2013. This milestone is a major success and is a testimony of the recognition of our therapy by leading names in cardiology.

Founded on the work of the icon of cardiac surgery, Professor Alain Carpentier, CARMAT aims to treat heart failure, a major health issue and the world’s leading cause of death, by replacing the diseased heart with a bioprosthetic artificial heart. The last 15 years have been a period of intense research and development, resulting in a breakthrough innovation that is unique in the field of cardiology. 2023 has been particularly structuring year for the Company, with a substantial acceleration in sales in the last quarter, a significant number of hospitals trained for implants, increased manufacturing capacity to meet demand, and a reinforcement of the Aeson® heart’s safety profile thanks, in particular, to software improvements, which represents a significant catalyst for our long-term ambition to make Aeson® a “destination therapy” device, i.e. enabling long-term patient support without subsequent heart transplantation.

Taken together, these advances provide a solid foundation for a sizable commercial roll-out, enabling CARMAT to achieve its ultimate goal of providing patients waiting for a human heart with a therapeutic solution and a good quality of life. We look forward to 2024 with confidence and are very determined to achieve our goals. »

[1] Excluding the United States, where 9 hospitals are trained as part of the EFS (early feasibility study) clinical trial.

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