FDA Approves Second Part of CARMAT’s Artificial Heart Study

CARMAT has received conditional approval from the U.S. Food and Drug Administration (FDA) to initiate the second cohort of its U.S. Early Feasibility Study (EFS) for the Aeson artificial heart.

“The authorization to initiate the second cohort of our Early Feasibility Study (EFS) in the United States, received from the FDA, marks a very important milestone in CARMAT’s journey. It reflects Aeson artificial heart’s quality and performance and its potential to address the unmet need expressed by healthcare professionals and patients around the world,” CARMAT CEO Stéphane Piat stated. “This authorization will allow U.S. patients to benefit from our therapy as early as the second half of 2025. It also represents a key step towards a potential commercial launch of Aeson in the United States, which—subject to factors including the quality of our clinical results—could occur from 2028. I would like to thank all our team for their contribution to this key achievement.”

The EFS study in the United States involves 10 patients eligible for heart transplant. The study’s primary endpoint is patient survival at six months after the artificial heart’s implantation, or a successful transplant within this timeframe. The study design includes two successive cohorts, the first of which (three patients) was completed in Q3 2021.

Once the first cohort was completed, CARMAT enhanced Aeson and submitted those changes to the FDA. All of these changes have now been FDA-reviewed and approved, allowing CARMAT to start recruiting patients in the second cohort.¹

This second cohort will include seven patients, with an interim report on the first three implants. CARMAT will now take all necessary steps—including obtaining approvals from ethics committees² and refreshing the training of participating hospitals—to initiate implants in the second half of this year.

Meanwhile, CARMAT will seek FDA approval of Aeson’s most recent version, currently used in Europe, for use in the EFS study. This second part of the EFS study represents an important step in the company’s U.S. market access strategy, since the United States is the world’s largest market for implantable cardiac devices.

CARMAT designs, manufactures, and markets the Aeson artificial heart. The company wants to make Aeson the first alternative to a heart transplant, thus providing a therapeutic solution to people suffering from end-stage biventricular heart failure who are facing a 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 a multidisciplinary team of about 200 highly specialized people. CARMAT is listed on the Euronext Growth market in Paris.

References
¹ In view of this, CARMAT is required, with no suspensive effect, to provide the FDA with a limited number of clarifications within 45 days.
² IRB – Institutional Review Board.