EFICAS Study Results Confirm the Clinical Performance of the Aeson® Total Artificial Heart as a Bridge-to-Transplant Therapy

• The study’s primary endpoint was achieved in 72.7% of the 55 patients implanted between December 2022 and May 2025.

• This rate was significantly above the historical benchmark of 38% established for earlier generations of total artificial hearts.

• Published in the prestigious European Heart Journal, these results represent a key milestone in supporting the reimbursement process for Aeson® in France and, ultimately, its routine clinical use in the bridge-to-transplant indication.

• The study’s key data were presented in a Late-Breaking Science session on August 31, 2026, at ESC Congress 2026 in Munich.

VÉLIZY-VILLACOUBLAY, France--(BUSINESS WIRE)--CARMAT SAS¹, designer and developer of the world’s most advanced total artificial heart (the “Company” or “CARMAT SAS” or “CARMAT”), aiming to provide a therapeutic alternative for patients suffering from advanced biventricular heart failure, today announces the publication of the results of the EFICAS clinical study in the prestigious European Heart Journal (EHJ), as well as their presentation during a scientific session at the ESC (European Society of Cardiology) Congress, held in Munich from August 28 to 31, 2026.

EFICAS: the largest clinical study conducted with Aeson® and a key milestone towards reimbursement in France

EFICAS (NCT04475393) is a prospective, multicentre study conducted at ten leading French hospital centres². It is the largest clinical study conducted with Aeson® to date, and its results are key to the device’s reimbursement process in France.

The published analysis covers 55 patients implanted between December 2022 and May 2025, with a median age of 56 years and a severely compromised clinical status. In particular, 49% of patients were classified as INTERMACS profiles 1 or 2, with profile 1 corresponding to critical cardiogenic shock and profile 2 to progressive decline despite medical support. In addition, 36% were receiving VA-ECMO extracorporeal circulatory support at the time of implant.

The study’s composite primary endpoint was met in patients who were alive at 180 days while supported by Aeson® or had undergone heart transplantation before 180 days, without disabling stroke or device malfunction requiring reoperation, device replacement or urgent transplantation.

Robust results confirming Aeson®’s clinical efficacy and supporting the reimbursement process

The primary endpoint was achieved in 40 of the 55 patients, representing 72.7% (95% CI: 57.1–85.1), a result significantly above the prespecified historical benchmark of 38% established for earlier total artificial hearts (p<0.0001). At 180 days, 96% of patients had remained free from disabling stroke, 76% had been discharged from hospital, and 92% of surviving patients were classified as NYHA class I or II, corresponding to no limitation or only mild limitation of ordinary physical activity under this functional classification of heart failure³.

Among patients evaluable at six months, functional recovery was also demonstrated by a median improvement of 305 metres in the 6-minute walk test (p<0.0002) and a 40-point improvement in the EQ-5D quality-of-life score (p<0.0001). No haemolysis was observed, and major bleeding events were limited to the first 30 postoperative days.

In the study population, Aeson® met its primary endpoint while demonstrating a favourable safety profile, confirming the clinical performance previously observed in the bridge-to-transplant indication in patients who are not eligible for an LVAD (left ventricular assist device). These results provide robust clinical evidence supporting the use of Aeson® in this indication and help support the reimbursement process for the device in France, a necessary step towards its broader adoption in routine clinical practice. As a reminder, 122 patients have received Aeson® since its first implant.

Publication in the European Heart Journal and strong interest from the medical community

The results of the EFICAS study have been published in the article entitled “Auto-regulated bioprosthetic total artificial heart as bridge to transplantation: the EFICAS study” in the European Heart Journal, an internationally renowned scientific journal and the official journal of the European Society of Cardiology (ESC), with a 2025 Impact Factor of 45.6.

The key EFICAS results also generated strong interest among healthcare professionals when they were presented by Professor André Vincentelli during a Late-Breaking Science session at ESC Congress 2026 in Munich on August 31, 2026.

Professor André Vincentelli, Head of Cardiac Surgery at the Heart & Lung Institute of Lille University Hospital and lead author of the article, commented: “Patients suffering from advanced biventricular heart failure or major structural heart abnormalities are not eligible for left ventricular assist device support. For these patients, heart transplantation often remains the only option but unfortunately cannot systematically be offered to everyone due to the shortage of donor hearts. The results achieved with the Aeson® total artificial heart in the EFICAS study provide the medical community, for the first time, with robust and objective clinical data on its performance. We already had encouraging clinical experience with Aeson®; EFICAS now confirms this experience on a solid scientific basis, and we hope these results will contribute to supporting its use in routine clinical practice.”

Dr Anne-Céline Martin, cardiologist at Hôpital Européen Georges-Pompidou and co-author of the article, added: “For cardiologists managing these critically ill patients, the objective goes beyond survival: it is also about enabling them to recover sufficiently to leave hospital and regain a degree of independence. In the EFICAS study, more than three-quarters of patients had been discharged from hospital by 180 days, with significant improvements in walking capacity and quality of life. Management with Aeson® relies on a multidisciplinary approach involving cardiologists, surgeons, anaesthesiologists and intensivists, as well as rehabilitation teams. For such severely ill patients with very limited therapeutic options, these results represent a major step forward.”

Pierre Bastid, Chief Executive Officer of CARMAT SAS, concluded: “The publication of the EFICAS results in the European Heart Journal, a leading international scientific journal, together with their presentation in a Late Breaking Session at ESC Congress 2026, represents important recognition of the work carried out with the ten French investigating centres. I would like to congratulate and thank all the clinical teams and acknowledge the commitment of the patients and their families, without whom these results would not have been possible. They illustrate the contribution our innovation can make to cardiology and reinforce our determination to continue working alongside the medical community to improve the management of patients with advanced heart failure.”

About CARMAT SAS

CARMAT SAS is a French MedTech company that designs, manufactures and markets the Aeson® artificial heart. The Company aims to establish Aeson® as the first alternative to heart transplantation and thereby provide a therapeutic solution for patients suffering from advanced biventricular heart failure who face the well-known shortage of available human donor hearts. As the world’s first physiological artificial heart to be highly haemocompatible, pulsatile and autoregulated, Aeson® could save thousands of patients awaiting heart transplantation each year. The device provides patients with quality of life and mobility through an ergonomic and portable external power supply system that remains permanently connected to the implanted prosthesis. Aeson® has obtained CE Marking under Regulation (EU) 2017/745 on medical devices (MDR – Medical Devices Regulation). To date, 122 Aeson® implants have been performed worldwide.

CARMAT SAS is based in the Paris region, with its headquarters in Vélizy-Villacoublay and a production site in Bois-d’Arcy. Following its restructuring, the Company relies on the expertise of a multidisciplinary team of approximately 90 people.

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¹ CARMAT SAS carries on the historical activities of CARMAT SA, which was placed into judicial liquidation in January 2026.
² Lille University Hospital, AP-HP Hôpital Européen Georges Pompidou, Pitié-Salpêtrière University Hospital, Dijon University Hospital, Hospices Civils de Lyon, Marie-Lannelongue Hospital, Rennes University Hospital, Montpellier University Hospital, Nantes University Hospital and Strasbourg University Hospital.
³ NYHA: functional classification of heart failure ranging from class I (no limitation of ordinary physical activity) to class IV (symptoms even at rest).