French medical technology company CARMAT has reported significant growth in the first quarter of 2025, with a record 16 implants of its Aeson® artificial heart performed across three European countries. This performance represents a 140% increase compared to the same period in 2024, generating quarterly sales of €2.4 million.
The company's flagship product, Aeson®, is the world's most advanced total artificial heart designed to provide a therapeutic alternative for patients suffering from end-stage biventricular heart failure who face limited access to donor hearts.
"We have delivered a solid first quarter, in line with our objectives," said Stéphane Piat, Chief Executive Officer of CARMAT. "The beginning of 2025 has confirmed 2024 positive momentum in terms of implants, with 16 implants carried out in the first quarter, at a pace of more than 5 implants per month."
EFICAS Clinical Trial Nears Completion
The EFICAS clinical trial in France has reached a critical milestone with 94% of patient recruitment completed. Thirteen implants were performed in Q1 2025 as part of this study, bringing the total to 49 patients out of the targeted 52. The company expects to complete enrollment "very shortly."
Results from this pivotal study, anticipated by the end of 2025, will be instrumental in securing reimbursement approval in France, which CARMAT projects could occur by late 2026. The trial has also facilitated the development of specialized surgical expertise, with Lille University Hospital emerging as a center of excellence after performing 10 implants, while three other French hospitals have each conducted 7 procedures.
"This study represents a major driver for the adoption of our therapy in France and internationally as well, once study results are obtained at the end of the year," Piat noted.
U.S. Market Entry Progress
CARMAT is in the final stages of discussions with the U.S. Food and Drug Administration (FDA) regarding authorization to initiate the second cohort of its Early Feasibility Study (EFS). This next phase will involve seven patients and represents a crucial step toward accessing the American market, which is the world's largest for implantable cardiac devices.
The company anticipates receiving FDA approval to resume implants in the second half of 2025, potentially setting the stage for a commercial launch in the United States around 2028.
Enhanced Version of Aeson® in Development
Looking ahead, CARMAT is focusing on its long-term support goal, which would allow patients to remain on Aeson® support indefinitely, potentially eliminating the need for subsequent heart transplantation in some cases.
"We should be in a position to make an enhanced version of our artificial heart available by the end of 2025, which will enable the Company to progress towards a new phase of its development and gradually unlock the full potential of its therapy," Piat explained.
This enhanced version is expected to broaden access to Aeson® in European markets, particularly in countries like Germany where transplant waiting times can be extensive. However, the company acknowledges that securing regulatory approval for destination therapy indication could take several years.
Financial Position and Leadership Changes
CARMAT has taken steps to strengthen its financial flexibility, completing a €9.7 million fundraising in January 2025 and implementing an equity financing line with IRIS Capital Investment in March 2025, providing potential access to up to €7.9 million. The company's current cash runway extends to the end of May 2025, and management is actively exploring additional financing solutions.
In a significant leadership transition, Professor Christian Latrémouille has been appointed Medical Director effective April 1, 2025, succeeding Dr. Piet Jansen, who is retiring after more than 15 years with the company. Latrémouille, a cardiac surgery specialist and University Professor, has been involved with Aeson® since its inception and joined CARMAT in 2021 as Director of Surgical Affairs.
Clinical Impact and Market Potential
The Aeson® artificial heart represents a potentially life-saving innovation for patients with end-stage heart failure. The device is designed to be highly hemocompatible, pulsatile, and self-regulated, offering patients improved quality of life through its ergonomic and portable external power supply system.
Currently, Aeson® is commercially available as a bridge to transplant in the European Union and other countries that recognize CE marking. The company has performed a total of 108 Aeson® implants since the first procedure in 2013, with 58 of these occurring in just the last 15 months—demonstrating accelerating clinical adoption.
Recent scientific publications in renowned journals have further validated the technology, which CARMAT believes will drive additional adoption of the therapy. The company aims to double its sales in 2025, building on the momentum established in the first quarter.
For patients with advanced biventricular heart failure who face limited donor organ availability, Aeson® offers a critical therapeutic option that could save thousands of lives annually as the technology continues to advance and gain wider acceptance.
