CARMAT's Aeson device gains momentum in Europe as a bridge-to-transplant solution

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the “CARMAT”), provides an update on Aeson^® artificial heart’s uptake as a bridge to transplant in Europe.

Growing adoption of Aeson^® as a bridge-to-transplant solution in Europe

By the end of October 2024, 30 patients had successfully undergone heart transplant after being supported by the Aeson^® artificial heart, confirming the ability of the device to provide physiological support tailored to each patient, enabling them to approach heart transplant in optimal physical condition when a human graft becomes available.

Out of these 30 transplants carried out in 7 different countries (including 16 in France and 5 in Germany), 16 have been performed since the beginning of 2024, demonstrating a clear acceleration in the adoption of Aeson^® as a bridge-to-transplant solution in Europe.

These 30 patients benefited from Aeson^® support for an average of 156 days before transplant (the maximum duration recorded being 308 days).

As a reminder, the Aeson^® artificial heart is CE marked for the “bridge to transplant” indication. It can therefore be marketed in Europe (and in other countries recognizing the CE marking) for this indication, and more specifically in patients suffering from 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 receive a heart transplant within 180 days of implantation.

Strong interest in Aeson^® from the medical community

At the end of November 2024, CARMAT organizes the first ‘Aeson^® European User Meeting’. This event will enable more than 100 European leaders in the field of cardiology to share their experience with the Aeson^® artificial heart. The event will focus on case studies and feedback from the various stakeholders managing patients (cardiologists, surgeons, anesthetists, intensive care specialists, etc.), with a view to better identifying patients who could benefit from Aeson^®, and enhancing the level of expertise of the centers. It will thus mark an important step towards wider adoption of the device, and better management of patients suffering from advanced biventricular heart failure.

This event is part of the intensification, over the course of 2024, of the information and training effort around Aeson^®, including in particular CARMAT’s participation in about ten key conferences attended by several hundred participants. This testifies to the growing interest shown by healthcare professionals in this innovative device, and to the critical need for effective solutions to treat patients who frequently find themselves at a therapeutic standstill.

Ultimate goal: Get the ‘destination therapy’ indication

Building on its growing and extremely encouraging experience in the bridge-to-transplant indication, CARMAT continues to ultimately aim for the ‘destination therapy’ (‘DT’) indication, which would enable patients to live sustainably under Aeson^® support without subsequent heart transplant.

To this end, CARMAT confirms that it plans to resume its PIVOTAL study in Europe in the second half of 2025, on a cohort of patients not eligible to transplant.

Approval in ‘DT’ would be decisive in meeting the critical challenge of the graft shortage, given that only 5% of patients in need of a transplant can currently benefit from it. As such, the DT indication represents the largest addressable market opportunity in cardiology. CARMAT estimates that obtaining this indication could take a few years.

The growing success of our Aeson^® artificial heart as a bridge to transplant solution demonstrates the impact of this innovation on the lives of patients suffering from advanced heart failure. With 30 patients successfully bridged to transplant thanks to Aeson^®, including 16 since the beginning of the year, our device continues to prove that it has the potential to become a first-line solution to save patients at the ultimate stage of the disease. As we look ahead to the first Aeson^® user meeting, which will bring together over 100 European experts, we are proud to see the medical community becoming increasingly committed to the adoption of our technology. Together, we can make Aeson^® a new benchmark in the treatment of advanced biventricular heart failure.”

Stéphane Piat, Chief Executive Officer, CARMAT