French medical technology company CARMAT has received conditional approval from the U.S. Food and Drug Administration (FDA) to proceed with the second cohort of its Early Feasibility Study (EFS) for the Aeson artificial heart. The company expects to begin recruiting patients in the second half of 2025, marking a significant milestone in bringing this innovative technology to the U.S. market.
The Aeson device is designed as a total artificial heart for patients suffering from end-stage biventricular heart failure who are awaiting heart transplantation. This development addresses a critical unmet need in cardiac care, as the demand for donor hearts consistently exceeds available organs.
FDA Approval Details and Study Design
The EFS is structured as a feasibility study involving a total of 10 patients eligible for heart transplantation. The study's primary endpoint measures patient survival at 6 months post-implantation or successful heart transplantation within that timeframe.
The study design includes two successive cohorts. The first cohort of three patients was completed in Q3 2021. Following this initial phase, CARMAT implemented several enhancements to the Aeson device, which were subsequently submitted to the FDA for review.
"The authorization to initiate the second cohort of our Early Feasibility Study in the United States marks a very important milestone in CARMAT's journey," stated Stéphane Piat, Chief Executive Officer of CARMAT. "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."
The second cohort will include seven patients, with an interim report planned after the first three implants. Before initiating the study, CARMAT must obtain approvals from ethics committees and refresh the training of participating hospitals.
Technology and Market Potential
The Aeson artificial heart represents a significant advancement in cardiac device technology. It is described as the world's first physiological artificial heart that is highly hemocompatible, pulsatile, and self-regulated. The device features an ergonomic and portable external power supply system that remains continuously connected to the implanted prosthesis, offering patients improved quality of life and mobility.
Currently, the Aeson device is commercially available as a bridge to transplant in the European Union and other countries that recognize CE marking. The U.S. market represents the largest potential market for implantable cardiac devices globally, making this FDA approval particularly significant for CARMAT's growth strategy.
If the EFS yields positive results, CARMAT anticipates a potential commercial launch in the United States as early as 2028, subject to the quality of clinical outcomes and regulatory approvals.
Clinical Significance and Patient Impact
For patients with end-stage biventricular heart failure, particularly those classified as Intermacs 1-4 who cannot benefit from maximal medical therapy or a left ventricular assist device (LVAD), the Aeson artificial heart could provide a critical bridge to transplantation.
The device is specifically indicated for patients likely to benefit from a heart transplant within 180 days of implantation. Given the chronic shortage of donor hearts worldwide, this technology could potentially save thousands of lives annually by providing a viable alternative while patients await a suitable donor organ.
Company Background and Financial Outlook
Founded in 2008, CARMAT is based in the Paris region, with headquarters in Vélizy-Villacoublay and a production facility in Bois-d'Arcy. The company employs approximately 200 specialized professionals across various disciplines.
It's worth noting that CARMAT's current cash runway extends only to the end of May 2025, excluding a flexible equity financing line entered into with IRIS announced on March 27, 2025. This financial timeline aligns closely with the expected initiation of the second cohort study in H2 2025.
CARMAT is publicly traded on the Euronext Growth market in Paris under the ticker ALCAR.
Next Steps and Regulatory Path
While preparing for the second cohort study, CARMAT will also seek FDA approval for the most recent version of the Aeson device currently used in Europe. This would allow the company to utilize the latest iteration of the technology in the U.S. study.
The company must provide the FDA with a limited number of clarifications within 45 days, though this requirement does not have a suspensive effect on the approval to proceed with the study.
Successful completion of the EFS would position CARMAT to pursue further regulatory approvals necessary for commercial distribution in the United States, potentially opening access to this life-saving technology for American patients with advanced heart failure.
