CARMAT Achieves the Milestone of 100 Implants of Its Aeson® Total Artificial Heart

PARIS–(BUSINESS WIRE)–Regulatory News:

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 “Company” or “CARMAT”), today announces that it has passed the milestone of 100 implants of its Aeson® artificial heart.

Symbolic milestone of 100 Aeson® artificial heart implants passed

The 99th and 100th implants were successfully performed on Friday, February 7, 2025, at the Lille and Dijon university hospitals. They were carried out simultaneously, respectively by the teams of Prof. Vincentelli and Prof. Bouchot, as part of the EFICAS clinical study in France.

View the animation marking the 100th implant of Aeson®
by clicking here

Significant acceleration in pace of implants since 2024

The first 50 implants had been performed over 10 years, between 2013 (the year of Aeson® first human implant) and the end of 2023.

Since early 2024, the pace of implants has accelerated sharply leading to 50 additional implants performed in just over a year.

This acceleration reflects the growing deployment of the therapy across Europe, as well as the satisfaction and adherence of healthcare professionals, who gradually integrate Aeson® into their therapeutic arsenal and clinical practice.

This highly encouraging momentum supports CARMAT’s ambition to double sales in 2025, and gradually establish Aeson® as a benchmark therapy for the treatment of advanced heart failure.

Stéphane Piat, Chief Executive Officer of CARMAT, comments: “About a year ago, we announced the milestone of 50 Aeson® implants. Today, we are delighted to announce the 100th implant, demonstrating that Aeson® meets a real therapeutic need. I would like to thank all healthcare professionals who are working with us on this extraordinary project, as well as the CARMAT teams for their unwavering commitment. My thoughts also go to the patients and their families, to whom Aeson® brings real hope. Together, we contribute to shaping the future of advanced heart failure treatment, with our innovative artificial heart.”

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About CARMAT

CARMAT is a French MedTech that designs, manufactures and markets the Aeson^® artificial heart. The Company’s ambition is to make Aeson^® the first alternative to a heart transplant, and thus provide a therapeutic solution to people suffering from end-stage biventricular heart failure, who are facing a well-known shortfall in available human grafts. The world’s first physiological artificial heart that is highly hemocompatible, pulsatile and self-regulated, Aeson^® could save, every year, the lives of thousands of patients 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 can rely on the talent and expertise of a multidisciplinary team of circa 200 highly specialized people. CARMAT is listed on the Euronext Growth market in Paris (Ticker: ALCAR / ISIN code: FR0010907956).

For more information, please go to www.carmatsa.com and follow us on LinkedIn.

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Name: CARMAT
ISIN code: FR0010907956
Ticker: ALCAR

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Disclaimer

This press release and the information it contains do not constitute an offer to sell or subscribe, or the solicitation of an order to buy or subscribe, CARMAT shares in any country.

This press release may contain forward-looking statements about the Company’s objectives and prospects. These forward-looking statements are based on the current estimates and expectations of the Company’s management and are subject to risk factors and uncertainties, including those described in its universal registration document filed with the Autorité des Marchés Financiers (AMF) under number D.24-0374, as updated by an amendment to the 2023 universal registration document filed with the AMF on 17 September 2024 under number D. 24-0374-A01 (together the ‘2023 Universal Registration Document’), and available on CARMAT’s website.

Readers’ attention is particularly drawn to the fact that the Company’s current financing horizon is limited until mid-May 2025 and that, given its financing requirements and the dilutive instruments in circulation, the Company’s shareholders are likely to experience significant dilution of their stake in the Company in the short term. The Company is also subject to other risks and uncertainties, such as the Company’s ability to implement its strategy, the pace of development of CARMAT’s production and sales, the pace and results of ongoing or planned clinical trials, technological developments, changes in the competitive environment, regulatory developments, industrial risks and all risks associated with managing the Company’s growth. The forward-looking statements contained in this press release may not be achieved as a result of these factors or other unknown risks and uncertainties or factors that the Company does not currently consider material and specific.

Aeson® is an active implantable medical device commercially available in the European Union and other countries recognising the CE mark. The Aeson® total artificial heart is intended to replace the ventricles of the native heart and is indicated as a bridge to transplant in patients with 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 benefit from a heart transplant within 180 days of implantation. The decision to implant and the surgical procedure must be carried out by healthcare professionals trained by the manufacturer. The documentation (clinician’s manual, patient’s manual and alarm booklet) must be read carefully to learn about the characteristics of Aeson® and the information required for patient selection and proper use (contraindications, precautions, side effects) of Aeson®. In the United States, Aeson® is currently only available as part of a feasibility clinical trial approved by the Food & Drug Administration (FDA).