CARMAT Announces the Opening of Its New Production Facility in Bois-d'Arcy, France

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 the opening of its second production facility ("BDA2") in Bois-d'Arcy, in the immediate vicinity of the Company's first production facility ("BDA1").

The works have now been completed, and the entire facility has been reviewed by the notified body DEKRA, which in mid-November 2023 approved it for the production of the Aeson total artificial heart.

This 1,500 m² building, which meets the highest medical device production standards, will enable CARMAT to significantly increase its capacity in terms of:

• assembly of the electronic parts of the Aeson heart,
• microbiological testing of the product and the manufacturing process,
• receiving and checking incoming components,
• storage and shipping.

Combined with the extension of the clean room which is currently being completed in the "BDA1" facility, the opening of the "BDA2" facility will enable the Company to reach an annual production capacity of 500 hearts by early 2024, as planned.

Stéphane Piat, Chief Executive Officer of CARMAT, comments: "The opening of our new production facility is a major achievement, and I would like to thank all the teams who have worked relentlessly to ensure that it is delivered on schedule before the end of 2023. Today, with the historical "BDA1" facility and this new "BDA2" facility, we have a high-performance manufacturing tool that is certified to produce up to 500 hearts per year from 2024. In line with our strategic plan, we will further develop our industrial set-up over the next few years, to reach an annual production capacity of 1,000 Aeson hearts by 2027."

***

About CARMAT

CARMAT is a French MedTech that designs, manufactures and markets the Aeson artificial heart. The Company’s ambition is to make Aeson the first alternative to a heart transplant, and thus provide a therapeutic solution to people suffering from end-stage biventricular heart failure, who are facing a well-known shortfall in available human grafts. The world’s first physiological artificial heart that is highly hemocompatible, pulsatile and self-regulated, Aeson could save, every year, the lives of thousands of patients waiting for a heart transplant. The device offers patients quality of life and mobility thanks to its ergonomic and portable external power supply system that is continuously connected to the implanted prosthesis. Aeson is commercially available as a bridge to transplant in the European Union and other countries that recognize CE marking. Aeson is also currently being assessed within the framework of an Early Feasibility Study (EFS) in the United States. Founded in 2008, CARMAT is based in the Paris region, with its head offices located in Vélizy-Villacoublay and its production site in Bois-d’Arcy. The Company can rely on the talent and expertise of a multidisciplinary team of circa 200 highly specialized people. CARMAT is listed on the Euronext Growth market in Paris (Ticker: ALCAR / ISIN code: FR0010907956).