CARMAT Achieves a Pivotal Year in 2023 by Reaching the Milestone of 50 Implants of the Aeson Artificial Heart and Presents Its Development Prospects - Seite 2

A therapy adopted by the medical community: 50 implants in 8 countries since inception

Since the first implant in December 2013, Aeson has spread widely through clinical trials and then commercially: 50 patients have benefited from the Aeson heart in 8 different countries³, bringing the cumulative experience to more than 19 patient-years. To date, 13 patients are living with the Aeson device.

Among the 17 implants carried out in 2023, 10 were part of the EFICAS clinical trial in 6 different hospitals in Paris, Lille, Lyon, Le Plessis-Robinson and Montpellier; and 7 in the commercial setting, internationally, in Germany and Italy.

Aeson, which is strongly supported by leading cardiologists in Europe and the United States, is becoming a reference solution for patients eligible for transplantation, waiting for an available human heart.

2023, a pivotal year particularly marked by the start of the commercial dynamic

Solid sales momentum since the last quarter of 2023

During the 2023 financial year, CARMAT generated sales⁴ of €2.8m, corresponding to the sale of 17 Aeson prostheses, including 11 in the last quarter, demonstrating solid early commercial dynamics (with a rate of around one implant per week achieved since the end of September), underpinned by CARMAT's ability to roll out its therapy on a large scale industrially and commercially.

33 hospitals in 11 different countries have been trained and are therefore ready to carry out Aeson implants on a commercial basis, and 8 French hospitals⁵ have also been trained for implants as part of the EFICAS clinical trial.

Manufacturing capacity increased to 500 hearts per year

In 2023, CARMAT has continued to invest in its industrial facilities, notably with the opening of its second production building in Bois-d'Arcy, enabling it to increase its manufacturing capacity to 500 hearts per year from early 2024, corresponding to potential annual sales of around €100m.

Enhanced Aeson reliability

In 2023, Aeson continued to confirm a safety profile that clearly sets it apart from all other mechanical circulatory support systems: since its inception, Aeson has not resulted in any gastrointestinal bleeding or disabling stroke.

At the end of the year, CARMAT also announced a software enhancement for Aeson, which significantly strengthens the safety profile of the device: from now on, for many potential malfunctions linked to the prosthesis's electronic components, the Aeson software will automatically 'correct' these faults by adapting the prosthesis's performance in an appropriate manner, so that the patient's support remains unaffected.