CARMAT Announces the Certification of Its New Automated Manufacturing Site in Bois-d’Arcy For the Production of up to 800 Units a Year at Full Capacity

Regulatory News:

CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world's most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced the certification of its new manufacturing site situated in Bois-d’Arcy, near Paris. In line with the schedule, the recently opened automated site is perfectly aligned with CARMAT’s strategic transformation into an industrial company.

The newly available space will allow the production of up to 800 units per year at full capacity to meet the demands of industrial-pace manufacturing as well as the enrollment ramp up in the ongoing PIVOTAL study. Furthermore, this facility will enable the use of new tools, such as robots, to assemble hybrid membranes on the device and a fully-automated software station to set up the prosthesis parameters. This project has been conducted by a dedicated team with the aim to implement best industrial practices in regards to the organization, processes, and IT systems for maximum efficiency and quality.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “We are delighted to announce the certification of our new manufacturing site based in Bois-d’Arcy, near Paris, which is a true accomplishment as we have achieved it in less than a year from the start of the building construction. CARMAT will now be able to manufacture products in both Vélizy and Bois-d’Arcy. In line with our strategy, the new automated site will enable CARMAT to become an industrial company with the ability to manufacture up to 800 units a year at full capacity in order to support the demand. Thanks to new processes, we will increase production throughput and more importantly, reinforce the quality of our prostheses to better serve patients across the world.”

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About CARMAT: the world’s most advanced total artificial heart project

A credible response to end-stage heart failure: CARMAT aims to eventually provide a response to a major public health issue associated with heart disease, the world’s leading cause of death: chronic and acute heart failure. By pursuing the development of its total artificial heart, CARMAT intends to overcome the well-known shortfall in heart transplants for the tens of thousands of people suffering from irreversible end-stage heart failure, the most seriously affected of the 20 million patients with this progressive disease in Europe and the United States.