Carmat Opens New Production Facility in France

CARMAT has opened its second production facility (BDA2) in Bois-d’Arcy, France, in the immediate vicinity of its first production facility (BDA1).
 
The entire facility has been reviewed by the notified body DEKRA, which approved it last fall for production of the Aeson total artificial heart. Aeson is an active implantable device intended to replace the heart’s ventricles in patients with advanced heart failure. It is an electro-hydraulically driven device whose shape corresponds to that of a human heart. Once the Aeson Heart is connected, it replicates the action of a native heart, providing mechanical circulatory support and restoring normal blood flow to the body.

Commercially available only in Europe, Aeson is indicated as a bridge to transplantation in patients with end-stage biventricular heart failure (Intermacs classes 1-4) who cannot benefit from maximal medical therapy or a left ventricular assist device (LVAD) and who are likely to benefit from a heart transplant within 180 days of implantation. Aeson is exclusively available in the United States only in clinical trials.

CARMAT’s second 1,500-square meter building meets the highest medical device production standards and will enable the French firm to significantly increase its capacity in terms of: assembly of Aeson’s electronic parts, manufacturing, microbiological testing,  receiving/checking incoming components, storage, and shipping.
 
Combined with the cleanroom extension—currently being completed in BDA1—the BDA2 facility will enable CARMAT to reach an annual production capacity of 500 hearts, possibly this year.
 
“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,” CARMAT CEO Stéphane Piat said. “…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.”
 
CARMAT is a French medtech firm that designs, manufactures, and markets the Aeson artificial heart. The company aims 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 the lives of thousands of patients annually 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 employs about 200 highly specialized workers. CARMAT is listed on the Euronext Growth market in Paris.