CARMAT Achieves a Pivotal Year in 2023 by Reaching the Milestone of 50 Implants of the Aeson Artificial Heart and Presents Its Development Prospects

Regulatory News:

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. »

A unique technological breakthrough: since 2008, 15 years of innovation to serve patients

The fruit of 15 years of research and the convergence of several cutting-edge technologies, the Aeson artificial heart is a unique device, that aims to "replicate" as closely as possible the functioning of a human heart.

The only device in the world to be pulsatile, hemocompatible and self-regulated, Aeson saves lives and offers patients a better quality of life².

An "intelligent" device, Aeson adapts blood flow in real time and manages differentiated flows between the right and left parts of the heart, depending on the patient's needs and activity; and does so without risk of rejection, without heavy drug regiment, and with a safety profile superior to that of all other comparable devices.