공시 • Aug 07
Carmat SA to Report First Half, 2025 Results on Oct 31, 2025 Carmat SA announced that they will report first half, 2025 results on Oct 31, 2025 공시 • Jun 02
CARMAT Announces the First Commercial Implants of Its Aeson Artificial Heart Outside the European Union CARMAT announced the first implants of its Aeson® artificial heart in a commercial set-up, outside the European Union (EU). Two implants of Aeson® artificial heart were performed during the week commencing May 26, 2025 in Israel. The first one was carried out at Hadassah Ein Kerem Hospital in Jerusalem by a team led by Pr Offer Amir, Prabea Asleh and Dr Amit Korach, respectively director of the Heart Institute, director of heart failure unit and director of the cardiac surgery department at Hadassah Medical Center. The second one was carried out at Sheba Medical Center in Ramat Gan (Tel Aviv), by a team led by Dr Jeff Morgan, Dr Leonid Sternik, Dr Alex Fardman and Dr Eyal Nachum, respectively head of mechanical support unit, director of cardiac surgery department, heart failure cardiologist and cardiac transplant surgeon. These implants bring to 5 the total number of countries1 where commercial implants have been performed so far. 공시 • May 12
CARMAT Completes Enrolment in the EFICAS Clinical Study and Receives Approval from French Authorities for 21 Additional Aeson®? Implants, While Awaiting Potential Reimbursement of the Device in France CARMAT announced the completion of enrolment of the 52 patients planned in the EFICAS study, and the approval from the French authorities to perform 21 additional Aeson®? implants, while awaiting potential reimbursement of the device in France. Enrolment completed in the EFICAS study: Initiated in November 2022, the EFICAS clinical study is the largest ever one conducted by CARMAT. It involves 52 patients eligible for a heart transplant and is carried out across 10 hospitals in France1. The primary endpoint of EFICAS is patient survival at 6 months post-Aeson®? implant, without disabling stroke, or a successful heart transplant within that period. These forward-looking statements are based on the current estimates and anticipations of the Company's management and are subject to risk factors and uncertainties, including those described in its Universal Registration Document filed with the French Financial Markets Authority (Autorite des march financiers) (the "AMF") under number D.25-0345 (the "2024 Universal Registration Document"), available free of charge on the websites of CARMAT and the AMF). Readers' attention is particularly drawn to the fact that the Company's current cash runway is limited to mid-June 2025 (excluding the flexible equity financing line entered into with IRIS, which was announced on March 27, 2025). The Company is also subject to other risks and uncertainties, such as its ability to implement its strategy, the pace of development of its production and sales, the pace and results of ongoing or planned clinical trials, technological evolution and competitive environment, regulatory changes, industrial risks, and all risks associated with the Company's growth management. Aeson®? is an active implantable medical device commercially available in the European Union and other countries recognizing the CE mark. 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).1 CHRU Lille, AP-HP Hopital Europeen Georges Pompidou, GHU Pitie Salpetriere, CHU Dijon, Hospices Civils de Lyon, Hopital Marie-Lannelongue, CHURennes, Chief Executive Officer of CARMA, commented that, by approving 21 additional implants, the French authorities enable patients in France to continue benefitting from therapy beyond the EFICAS study. This is a strong sign of confidence in Aeson®? artificial heart. Given the study design, company anticipate to be in a position to file for Aeson®?'s reimbursement in France early next year, which could lead to coverage of artificial heart by the French Social Security system during 2026. The EFICAS study is also important given strategy to access the U.S. market, which are expecting to achieve in 2028. 공시 • Apr 15
Carmat SA Receives FDA Conditional Approval to Initiate the Second Cohort of the EFS Study in the United States Carmat SA announced that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to initiate the second cohort of its Early Feasibility Study (EFS) with Aeson®? artificial heart in the United States. 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. This authorization will allow U.S. patients to benefit from 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 clinical results-- could occur from 2028. Conditional approval to initiate the second cohort of the EFS study in the United States is a feasibility study involving a total of 10 patients eligible for heart transplant. The study design includes two successive cohorts. The first cohort of 3 patients was completed in Third Quarter 2021. Following the completion of this initial cohort, CARMAT implemented enhancements to Aeson®?, which were submitted to the FDA. All of these changes have now been reviewed and approved by the FDA, allowing CARMAT to start recruiting patients in the second cohort1. This second cohort will include a total of 7 patients, with an interim report on the first 3 implants. Initiation of the second cohort expected in Second half of 2025. CARMAT will now take all necessary steps - including obtaining approvals from ethics committees and refreshing the training of participating hospitals - with the objective to initiate implants in the second half of 2025. Meanwhile, CARMAT will seek the FDA to approve Aeson®?'s most recent version, currently used in Europe, in order to be able to use it in the EFS study. This second part of the EFS study represents an important step in the Company's US market access strategy, the United States being the largest market in the field of implantable cardiac devices. 공시 • Apr 04
CARMAT Announces the Publication of the Results of the Initial Clinical Experience with Aeson in Cardiogenic Shock Patients Previously on Temporary Extracorporeal Life Support CARMAT announced the publication of the results of the initial clinical experience with Aeson® in cardiogenic shock patients previously on temporary extracorporeal life support2, in the JACC: Heart Failure. Study characteristics and key findings: 90% survival rate at 6 months, recovery of renal and hepatic function, improvement in functional capacity. The article, entitled "Initial Experience with Aeson® Total Artificial Heart in Cardiogenic Shock Patients on Extracorporeal Life Support", features the results of a retrospective analysis conducted in seven hospitals across France and Germany between November 2022 and April 2024. The analysis is about 10 patients with refractory cardiogenic shock, who were initially stabilized on extracorporeal life support (ECLS) for a median duration of 9 days before receiving an Aeson®? total artificial heart. The analysis reports a 90% survival rate at6 months following Aeson®? implant, with 5 patients successfully transplanted and 4 still on Aeson® support at that time. 공시 • Jan 31
Carmat SA, Annual General Meeting, Jun 26, 2025 Carmat SA, Annual General Meeting, Jun 26, 2025. 
