Latest news with #CARMAT
Yahoo
a day ago
- Business
- Yahoo
In a Context of Critical Financial Situation, CARMAT Launches a Donation Campaign Open to All to Contribute to Its Funding and Continuation of Its Activities
Risk of insolvency as early as end of June 2025 Launch of a donation campaign open to all via the online platform To listen to CARMAT CEO's message,click here PARIS, June 20, 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 launch of a donation campaign open to all, to help fund its operations and continue its mission. Critical financial situation and risk of insolvency at the end of June 2025 In a separate press release published today (see the press release), CARMAT announced that it is currently in a critical financial situation and facing a risk of insolvency as early as the end of June 2025. The Company estimates its 12-month financial needs at approximately €35 million, including €3.5 million needed urgently before the end of June 2025, and an additional €4.5 million by the end of July 2025. Despite efforts that are still ongoing, the Company has not yet been able to secure the financing required to continue its operations. Launch of a donation campaign Against this backdrop, and while continuing its efforts to raise funds, particularly through potential capital increases, CARMAT is today launching a donation campaign open to all. This initiative aims to allow individuals and organizations who support CARMAT's mission and wish to contribute to the continuity of its operations to do so. Practical information on the donation campaign The campaign opens on Friday, June 20, 2025. Donations can only be made via the platform (available on this link). Should they experience issues, donors are invited to contact CARMAT at the following email address: donor@ Main risks associated with donations Potential donors' attention is drawn to the fact that donations made as part of this campaign are non-refundable and do not entail any equity stake in the Company. Donors will therefore not become creditors or shareholders of CARMAT through their donation. Donors should also be aware that there is no guarantee that the donations received as part as this campaign, even in combination with any potential capital increases or other financing solutions that the Company could secure, will be sufficient to prevent a default at the end of June 2025 or beyond. As such, a default of the Company remains possible, even in the very short term. Furthermore, donations made in the context of this campaign do not entitle donors to any tax benefits of any kind. CARMAT, one of the most innovative French medtech companies in the world A technological breakthrough: Aeson®, the world's first physiological artificial heart, to be both pulsatile, self-regulated, and highly hemocompatible Increasing adoption by the medical community: over 120 patients treated worldwide, including more than 70 over the past 18 months Recognition by experts worldwide: more than 60 hospitals trained across 17 countries A team of around 180 highly skilled and committed people Stéphane Piat, Chief Executive Officer of CARMAT, concludes: "After 30 years of research and with 120 patients treated, CARMAT's artificial heart is now the most advanced artificial heart in the world and the most credible solution to address the major challenge of advanced heart failure. This condition is currently the world's leading cause of death. As of today, heart transplantation remains the gold standard treatment, but human donor hearts are unfortunately not available in sufficient numbers, leaving thousands of patients without any solution every year. CARMAT's heart is therefore absolutely essential to fight this growing health crisis and bring hope to patients and their families. In order to continue its mission, CARMAT urgently needs €3.5 million by the end of June 2025, and approximately €35 million over the next 12 months. Failing that, we will most likely be forced to cease operations. Despite our best efforts in a highly deteriorated environment, we have not yet been able to secure the financing required to continue our mission. This is why we are today calling on everyone's generosity to help CARMAT continue saving lives." 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, 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 extends only until the end of June 2025, and that CARMAT is therefore facing a very high risk of default, including in the very short term. The Company is also exposed to other risks and uncertainties, such as its ability to implement its strategy, the pace of development of its production and sales, the progress and results of ongoing or planned clinical trials, technological developments, the competitive landscape, regulatory changes, industrial risks, and all risks related to the management of the Company's growth. Forward-looking statements mentioned in this press release may not be achieved due to these factors or other unknown risks and uncertainties, or risks that the Company does not currently consider to be material or 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). 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 RelationsNicolas Merigeau Arthur Rouillé Tel.: +33 1 44 71 94 98carmat@ NewCap Financial Communication & Investor RelationsDusan Oresansky Jérémy Digel Tel.: +33 1 44 71 94 92carmat@
Business Wire
a day ago
- Business
- Business Wire
In a Context of Critical Financial Situation, CARMAT Launches a Donation Campaign Open to All to Contribute to Its Funding and Continuation of Its Activities
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 launch of a donation campaign open to all, to help fund its operations and continue its mission. Critical financial situation and risk of insolvency at the end of June 2025 In a separate press release published today (see the press release), CARMAT announced that it is currently in a critical financial situation and facing a risk of insolvency as early as the end of June 2025. The Company estimates its 12-month financial needs at approximately €35 million, including €3.5 million needed urgently before the end of June 2025, and an additional €4.5 million by the end of July 2025. Despite efforts that are still ongoing, the Company has not yet been able to secure the financing required to continue its operations. Launch of a donation campaign Against this backdrop, and while continuing its efforts to raise funds, particularly through potential capital increases, CARMAT is today launching a donation campaign open to all. This initiative aims to allow individuals and organizations who support CARMAT's mission and wish to contribute to the continuity of its operations to do so. Practical information on the donation campaign The campaign opens on Friday, June 20, 2025. Donations can only be made via the platform (available on this link). Should they experience issues, donors are invited to contact CARMAT at the following email address: donor@ Main risks associated with donations Potential donors' attention is drawn to the fact that donations made as part of this campaign are non-refundable and do not entail any equity stake in the Company. Donors will therefore not become creditors or shareholders of CARMAT through their donation. Donors should also be aware that there is no guarantee that the donations received as part as this campaign, even in combination with any potential capital increases or other financing solutions that the Company could secure, will be sufficient to prevent a default at the end of June 2025 or beyond. As such, a default of the Company remains possible, even in the very short term. Furthermore, donations made in the context of this campaign do not entitle donors to any tax benefits of any kind. CARMAT, one of the most innovative French medtech companies in the world A technological breakthrough: Aeson ®, the world's first physiological artificial heart, to be both pulsatile, self-regulated, and highly hemocompatible Increasing adoption by the medical community: over 120 patients treated worldwide, including more than 70 over the past 18 months Recognition by experts worldwide: more than 60 hospitals trained across 17 countries A team of around 180 highly skilled and committed people Stéphane Piat, Chief Executive Officer of CARMAT, concludes: ' After 30 years of research and with 120 patients treated, CARMAT's artificial heart is now the most advanced artificial heart in the world and the most credible solution to address the major challenge of advanced heart failure. This condition is currently the world's leading cause of death. As of today, heart transplantation remains the gold standard treatment, but human donor hearts are unfortunately not available in sufficient numbers, leaving thousands of patients without any solution every year. CARMAT's heart is therefore absolutely essential to fight this growing health crisis and bring hope to patients and their families. In order to continue its mission, CARMAT urgently needs €3.5 million by the end of June 2025, and approximately €35 million over the next 12 months. Failing that, we will most likely be forced to cease operations. Despite our best efforts in a highly deteriorated environment, we have not yet been able to secure the financing required to continue our mission. This is why we are today calling on everyone's generosity to help CARMAT continue saving lives.' 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. 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 extends only until the end of June 2025, and that CARMAT is therefore facing a very high risk of default, including in the very short term. The Company is also exposed to other risks and uncertainties, such as its ability to implement its strategy, the pace of development of its production and sales, the progress and results of ongoing or planned clinical trials, technological developments, the competitive landscape, regulatory changes, industrial risks, and all risks related to the management of the Company's growth. Forward-looking statements mentioned in this press release may not be achieved due to these factors or other unknown risks and uncertainties, or risks that the Company does not currently consider to be material or 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).
Business Wire
a day ago
- Business
- Business Wire
CARMAT Announces Being in a Critical Financial Situation and at Risk of Insolvency as of End-June 2025
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 being in a critical financial situation and at risk of insolvency as early as the end of June 2025. Critical financial situation and risk of insolvency at the end of June 2025 When reporting its full-year 2024 results (press release dated April 29, 2025), on April 29, 2025, the Company had indicated that it was funded until mid-June 2025 and actively working on financing options to secure, in the short term, the resources needed to continue its operations beyond that date. Despite all its efforts, in a very challenging funding environment—particularly for small and mid-cap companies—the Company has not, to date, been able to secure such financing and will be in a situation of insolvency at the end of June 2025 unless it manages, before then, to secure additional cash of at least €3.5 million. More generally, based on its current business plan, the Company estimates its 12-month financial needs at approximately €35 million, including around €20 million by end-December 2025 (broken down into €8 million by end-July, an additional €4 million by end-September, and a further €8 million by end-December 2025). Next steps and launch of a donation campaign CARMAT continues to actively explore all financing options to ensure business continuity beyond June 2025. In parallel to this, the Company is today launching a donation campaign through an online platform, which is the subject of a separate press release (link to the press release). Press releases will be issued regularly to keep shareholders and the financial community informed of any developments regarding the Company's financial situation. 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. 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 extends only until the end of June 2025, and that CARMAT is therefore facing a very high risk of default, including in the very short term. The Company is also exposed to other risks and uncertainties, such as its ability to implement its strategy, the pace of development of its production and sales, the progress and results of ongoing or planned clinical trials, technological developments, the competitive landscape, regulatory changes, industrial risks, and all risks related to the management of the Company's growth. Forward-looking statements mentioned in this press release may not be achieved due to these factors or other unknown risks and uncertainties, or risks that the Company does not currently consider to be material or 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).
Business Wire
02-06-2025
- Business
- Business Wire
CARMAT Announces the First Commercial Implants of Its Aeson® Artificial Heart Outside the European Union
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 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, Pr Rabea 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. Those are the first Aeson® implants made in a commercial set-up outside the European Union. These implants bring to 5 the total number of countries 1 where commercial implants have been performed so far. They confirm the trust placed in the device by healthcare professionals, and the growing interest in the therapy. 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. 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).
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).
