Latest news with #Aeson®'
Business Wire
12-05-2025
- Business
- Business Wire
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
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 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. Stéphane Piat, Chief Executive Officer of CARMA, commented: 'The very strong momentum in the EFICAS study, which enrolment is now complete, reflects the quality and performance of our Aeson® artificial heart and its ability to address the unmet need expressed by healthcare professionals and patients. I am convinced that this study paves the way for strong sales development in Europe and beyond - particularly once its results will have been published, hopefully as soon as end of 2025. I am also very pleased that, by approving 21 additional implants, the French authorities enable patients in France to continue benefitting from our therapy beyond the EFICAS study. This is a strong sign of confidence in Aeson® artificial heart. Given the study design, we anticipate to be in a position to file for Aeson®'s reimbursement in France early next year, which could lead to coverage of our artificial heart by the French Social Security system during 2026. The EFICAS study is also important given our strategy to access the U.S. market, which we are expecting to achieve in 2028. I would like to thank all patients and healthcare professionals, as well as our teams for their contribution to this important step in Aeson®'s development.' 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 France 1. 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. EFICAS is key to support Aeson®'s commercial rollout in Europe 2 (through 'evidence-based medicine'), and secure its reimbursement in France, and is also expected to contribute to securing the Pre-Market Approval (PMA) in the United States, currently targeted for 2028 3. Given the 6-month post-implant follow-up of patients, CARMAT expects completing the EFICAS study (primary endpoint) early November 2025, which will be followed by the publication of its results. Approval obtained from French authorities for 21 additional Aeson® implants - and filing for reimbursement in France planned early 2026 As a reminder, the EFICAS study is partially funded by the French State (€13 million for 52 implants 4), through the 'Forfait Innovation' program. In order to allow patients in France to continue benefitting from Aeson® artificial heart after the completion of the 52 implants in the EFICAS study, the French authorities 5 have approved 21 additional implants, under financial terms equivalent to those of the 'Forfait Innovation. In parallel, CARMAT is taking all necessary steps to be in position to submit a reimbursement application (so-called 'LPPR') for Aeson® at the beginning of 2026, which could allow Aeson® to be covered by the French Social Security system during the same year. Disclaimer This press release and the information it contains do not constitute an offer to sell or subscribe, nor a solicitation of an offer to buy or subscribe, for CARMAT shares in any country. This press release may contain forward-looking statements regarding the Company's objectives and outlook. 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 (Autorité des marchés 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. The Company's forward-looking statements mentioned in this press release may not be achieved due to these elements or other risk factors and uncertainties, whether unknown or not considered material and specific by the Company as of today. 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).
Yahoo
03-04-2025
- Health
- Yahoo
CARMAT - Publication in the JACC(1): Heart Failure of the Initial Clinical Experience with Aeson® Total Artificial Heart in Cardiogenic Shock Patients Initially Placed on Extracorporeal Life Support
The retrospective analysis on 10 patients shows a 90% survival rate at 6 months, suggesting Aeson® as a therapeutic solution for these patients at risk of death in the short term. PARIS, April 03, 2025--(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 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 Support3", 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 at 6 months following Aeson® implant, with 5 patients successfully transplanted and 4 still on Aeson® support at that time. In addition, the analysis highlights that Aeson® improves kidney and liver recovery and allows for hospital discharge after a median hospital stay of 42 days, contributing to an improvement in functional capacity and overall health status of the patient while awaiting a heart transplant. Dr. Anne-Céline Martin, Cardiologist at Hôpital Européen Georges-Pompidou (Paris) and lead author of the article, commented: "Even for critically ill patients in refractory cardiogenic shock requiring temporary circulatory support, transitioning to the Aeson® total artificial heart has demonstrated highly promising results, with a 6-month survival rate of 90%. Moreover, thanks to Aeson®'s autoregulated and pulsatile flow, patients experienced a significant improvement in exercise capacity and quality of life, enabling them to face the challenge of a heart transplant." Aeson®: a promising solution for very high-risk patients initially placed on temporary extracorporeal life support Cardiogenic shock is an acute heart failure condition that poses a life-threatening risk to patients, with still high mortality rates (30% to 60%) despite advancements in treatment. In the most severe cases, extracorporeal life support can be used temporarily to stabilize patients; however, this approach is only viable for a short period of time (around ten days) due to the risk of complications. Heart transplant often remains the best option for these patients initially placed on extracorporeal life support. However, its access is limited by the lack of available human grafts, and by the sometimes too fragile health status of patients, who may present temporary contraindications to such a transplant. Aeson® is therefore emerging as a promising therapeutic solution for this population of patients at very high risk of death in the short term, enabling them to improve their state of health before they can benefit from a heart transplant. Over the past two years, around half of patients treated with Aeson® had previously been placed on extracorporeal life support. Stéphane Piat, Chief Executive Officer of CARMAT, concluded: "This new publication in a leading scientific journal validates the relevance and clinical value of our therapy, confirming that Aeson® can be used as a bridge to transplant even for the most critical patients, at risk of death in the short term. After several days on extracorporeal life support (ECMO), these patients have no other options but heart transplant or the implant of a total artificial heart if a human graft is not available or if a transplant can't be made immediately due to the patient's state of health. Our promising results bring hope to patients and their families. I am convinced that their dissemination within the medical community will drive an always broader adoption of Aeson® across Europe." *** 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 and follow us on LinkedIn. ●●● Name: CARMATISIN code: FR0010907956Ticker: ALCAR ●●● Disclaimer This press release and the information contained herein do not constitute an offer to sell or subscribe, nor a solicitation of an order to buy or subscribe to CARMAT shares in any country. This press release may contain forward-looking statements by the Company regarding its objectives and prospects. 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 (Autorité des marchés financiers) (the "AMF") under number D.24-0374, as updated by the amendment to the 2023 universal registration document filed with the AMF on September 17, 2024 under number D.24-0374-A01 (together, the "2023 Universal Registration Document"), which are 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 the end of May 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. The Company's forward-looking statements mentioned in this press release may not be achieved due to these elements or other risk factors and uncertainties, whether unknown or not considered material and specific by the Company as of today. 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). 1 Journal of the American College of Cardiology2 Also known as "ECMO" (Extra-Corporeal Membrane Oxygenation) or "ECLS" (Extra-Corporeal Life Support).3 View source version on Contacts CARMAT Stéphane Piat Chief Executive Officer Pascale d'Arbonneau Deputy Chief Executive Officer & Chief Financial OfficerTel.: +33 1 39 45 64 50contact@ NewCap Press Relations Nicolas Merigeau Arthur Rouillé Tel.: +33 1 44 71 94 98carmat@ NewCap Financial Communication& Investor Relations Dusan Oresansky Jérémy Digel Tel.: +33 1 44 71 94 92carmat@
Yahoo
17-02-2025
- Health
- Yahoo
CARMAT: Aeson® total artificial heart highlighted as a very promising solution for heart failure patients with pulmonary hypertension in The Journal of Heart and Lung Transplantation
Up to 25% of advanced heart failure patients suffer from pulmonary hypertension Aeson® could potentially become a standard treatment for these thousands of patients, both as a bridge-to-transplant and destination therapy PARIS, February 17, 2025--(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 the publication in The Journal of Heart and Lung Transplantation, of an article on the performance of Aeson® total artificial heart in treating heart failure patients with pulmonary hypertension. Study description and key findings The article, entitled "Precise Monitoring of Transpulmonic Resistance in Bridge to Transplant Patients Supported by The Aeson Total Artificial Heart1", features the results of a single-center study conducted at the University Medical Center of Astana (Kazakhstan) on 3 heart failure patients with pulmonary hypertension (PHT). One of Aeson®'s innovative features is its ability to estimate transpulmonic resistance (eTPR) in real time, based on embedded pressure sensors. This is useful for monitoring patients with PHT, an indication that often excludes them from heart transplant candidacy. Following the Aeson® implant, all three patients experienced improved functional capacity, as demonstrated by 6-minute walk distances test, and were discharged from hospital on the Aeson® respectively 68, 48 and 48 days after implant. Over time, their pulmonary hypertension indicators improved, rendering them eligible for heart transplant, which effectively took place after 243, 155 and 109 days respectively. Dr. Yuriy Pya, Cardiac Surgeon at University Medical Center of Astana and lead author of the study, stated: "In our experience with patients suffering from pulmonary hypertension, the Aeson® total artificial heart provided autoregulated blood flow to optimize patients' condition. Moreover, the non-invasive monitoring of pulmonary resistance with data generated by Aeson® has helped us to determine the best timing for a successful heart transplant in all cases." Aeson®: a very promising solution for heart failure patients with pulmonary hypertension Up to 25% of patients with advanced heart failure suffer from pulmonary hypertension, which represents several thousand patients in a difficult-to-treat situation, as they are mostly subject to a contra-indication to heart transplant. While left ventricular assist devices are often used in an attempt to relieve pulmonary hypertension, prolonged support may lead to onset of right heart failure. These patients face significant risks of morbidity and mortality, emphasizing the need for alternative strategies. Aeson®, providing balanced biventricular support and integrating pressure sensors for real-time blood flow regulation, could offer an innovative approach to the management of pulmonary hypertension in advanced heart failure patients, both as a viable bridge-to-transplant solution or, potential definitive therapy. Piet Jansen, Chief Medical Officer of CARMAT, concluded: "Pulmonary hypertension is a condition that can temporarily delay heart transplantation. This publication in a prestigious scientific journal highlights the potential of Aeson® to safely bridge patients with pulmonary hypertension to a heart transplant. The ability of the device to provide real-time hemodynamic monitoring and to facilitate clinical decision-making has led to improved outcomes for these high-risk heart transplant candidates. Although larger studies are needed to confirm these findings and establish standardized protocols for pulmonary hypertension management with Aeson®, our device represents an important advancement in mechanical circulatory support and a real hope for thousands of patients with this challenging condition." *** 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 and follow us on LinkedIn. ●●● Name: CARMATISIN code: FR0010907956Ticker: ALCAR ●●● 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). 1 View source version on Contacts CARMAT Stéphane Piat Chief Executive OfficerPascale d'Arbonneau Deputy Chief Executive Officer & Chief Financial OfficerTel.: +33 1 39 45 64 50contact@ Alize RP Press RelationsCaroline Carmagnol Tel.: +33 6 64 18 99 59carmat@ NewCap Financial Communication& Investor RelationsDusan Oresansky Jérémy Digel Tel.: +33 1 44 71 94 92carmat@ Sign in to access your portfolio
