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).
Business Wire
29-04-2025
- Business
- Business Wire
CARMAT Announces Its 2024 Annual Results
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 its annual results for the year ending December 31, 2024 1. 2024 annual results Revenues of €7.0 million, corresponded to the sale of 17 Aeson® artificial hearts for commercial implants (Germany, Italy, Spain, and Poland) and to the sale of 25 Aeson® artificial hearts in the EFICAS clinical trial in France. As a result of a tight cost control, the operating loss for 2024 was contained at €49.2 million, showing a slight improvement over the prior year (-€52.5 million). In 2024, CARMAT has dedicated most of its efforts and resources to: - commercial development in Europe; - pursuing the EFICAS clinical study in France; - implementing actions required to resume the Early Feasibility Study (EFS) in the United States; - strengthening and optimizing its supply chain; - reinforcing its financial structure. Taking into account net financial expense (-€3.2 million), non-recurring items (-€0.6 million), and research tax credit (+€1.7 million), the net loss for 2024 stood at €51.4 million, improving by €2.5 million compared to 2023. For 2024 key developments, readers are kindly invited to refer to the dedicated press release issued on January 8, 2025, and to subsequent press releases available on the Company's website: Cash position and financial structure Cash and cash runway As of December 31, 2024, CARMAT's cash position stood at €4.7 million (vs. €8.0 million at end 2023), reflecting the following cash flows: The Company reduced its combined operating and investing cash burn by 23% in 2024 (-€13.7 million vs. 2023). This translated into monthly cash burn of €3.7 million in 2024, compared to €4.9 million per month in 2023. In terms of financing in 2024, the Company: - carried out three capital increases for a total gross amount of €42.8 million (€16.5 million in January, €16.0 million in May, and €10.3 million in September); - received the final €0.3 million tranche of a €1.4 million grant (CAP23) awarded to CARMAT under the 'Plan de Relance pour l'industrie – Secteurs Stratégiques' call for projects; - secured €2.5 million via the equity financing line signed on July 5, 2024 with Vester Finance; - paid €0.7 million in interest due on its loans (EIB loan and government-backed loans), or 'PGEs'). In addition, the Company raised a further €9.7 million 2 in gross proceeds post-year-end, on January 31, 2025. On March 26, 2025, CARMAT also signed a new equity financing line with IRIS Capital Investment ("IRIS") for a maximum of 9,000,000 shares (approximately 15% of its capital) over 24 months 3. Based on these developments, the Company believes that its available secured financial resources should allow it to fund its operations until mid-June 2025, under its current business plan. Net financial debt On March 22, 2024, the Company reached an agreement with all its financial creditors (European Investment Bank 'EIB', BNP Paribas 'BNPP', and Bpifrance 'BPI') on new loan repayment terms 4. As a result of this agreement, CARMAT's net financial debt stood at €53.1 million at December 31, 2024, broken down as follows: * Due within 12 months Expand The Company's financial liabilities include: - outstanding principal and accrued interest on the EIB loan for a total of €24.8 million 5; - outstanding principal and accrued interest on the two PGEs (government-backed loans) for a total of €9.5 million; 6 - as well as accrued interest on repayable advances: €9.9 million from Bpifrance, and €0.1 million from the 'France 2030' plan. Short-term financial liabilities mainly relate to repayments due under the PGEs in 2025. * ** The 2024 financial statements were approved by the Board of Directors on April 25, 2025, on a going concern basis. Audit procedures by the Company's statutory auditor have been completed and his report is in the process of being issued. The Company expects to publish its 2024 Universal Registration Document (including the annual financial report) as soon as the audit report is received, anticipated by no later than April 30, 2025. As of the date of this press release, available cash and cash equivalents are not sufficient to fund CARMAT's operations over the next 12 months. Based on its current business plan, the Company estimates its cash runway to mid-June 2025, with 12-month funding needs of approximately €35 million. CARMAT is actively exploring various financing options to secure the resources required to continue its activities beyond June 2025. More specifically, the Company believes—based on its current discussions with potential investors—that it should be in a position to carry out a new capital increase by mid-June 2025, extending its cash runway by several months. CARMAT believes that its recent progress (2.5-fold increase in sales between Q1 2024 and Q1 2025, imminent completion of EFICAS patient enrolment, conditional FDA approval in April 2025 to initiate the second EFS cohort in the U.S., and recent peer-reviewed scientific publications) should facilitate this operation. However, the Company cannot guarantee that the necessary financing will be secured. This creates a significant degree of uncertainty that could impact the Company's ability to continue as a going concern. If CARMAT is unable to obtain the required funding, applying standard French accounting rules and assumptions for going concern may no longer be appropriate for valuing its assets and liabilities. *** 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 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 The 2024 annual financial statements were approved by the Board of Directors on April 25, 2025. Audit procedures by the Company's statutory auditor have been completed and his report is in the process of being issued. The Company expects to publish its 2024 Universal Registration Document (including the annual financial report) as soon as the audit report is received, anticipated by no later than April 30, 2025. 2 Refer to the dedicated press release issued by the Company on January 31, 2025. 3 Refer to the dedicated press release issued by the Company on March 27, 2025. 4 Refer to the dedicated press release issued by the Company on March 22, 2024. 5 Including Tranche 1 of the EIB loan, currently being equitized. 6 PGEs contracted with BNP Paribas for one, and with Bpifrance for the other. Expand
Yahoo
14-04-2025
- Business
- Yahoo
CARMAT Receives FDA Conditional Approval to Initiate the Second Cohort of the EFS Study in the United States
Recruitment of the second cohort expected to begin in H2 2025 PARIS, April 14, 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 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. Stéphane Piat, Chief Executive Officer of CARMAT, stated: "The authorization to initiate the second cohort of our Early Feasibility Study (EFS) in the United States, received from the FDA, marks a very important milestone in CARMAT's journey. 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 our 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 our clinical results—could occur from 2028. I would like to thank all our team for their contribution to this key achievement." Conditional approval to initiate the second cohort of the EFS study in the United States The EFS study in the United States is a feasibility study involving a total of 10 patients eligible for heart transplant. The study's primary endpoint is patient survival at 6 months post-Aeson® implant, or a successful transplant within this timeframe. The study design includes two successive cohorts. The first cohort of 3 patients was completed in Q3 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 H2 2025 CARMAT will now take all necessary steps - including obtaining approvals from ethics committees2 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 world in the field of implantable cardiac devices. 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 In view of this, CARMAT is required, with no suspensive effect, to provide the FDA with a limited number of clarifications within 45 days.2 IRB – Institutional Review Board. 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@ 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@ Sign in to access your portfolio
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
27-03-2025
- Business
- Yahoo
CARMAT announces the implementation of a flexible equity financing line with IRIS Capital Investment
PARIS, March 27, 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"), announces the implementation of a flexible equity financing line with IRIS Capital Investment ("IRIS"), for a maximum of 9,000,000 shares (i.e., approximately 15% of its current share capital), over a 24-month period. Stéphane Piat, Chief Executive Officer of CARMAT, comments: "I am very pleased with the implementation of this financing line with IRIS Capital Investment, which, based on our current share price, provides us with a potential total financing amount of approximately €7.9 million over the next 24 months, and thus offers substantial room for manoeuvre that we can start benefitting from immediately. In parallel, we are actively working on securing additional funding to ensure the long-term development of our Company and our sales growth. Following a strong start this year, we are determined to progressively establish Aeson® as a reference solution for patients suffering from advanced biventricular heart failure — today in Europe, and within a few years in the United States." Pursuant to the terms of the agreement signed on March 26, 2025 between the Company and IRIS, the latter has undertaken to subscribe up to 9,000,000 new ordinary shares of the Company, over a 24-month period, at its own initiative and subject to the conditions set out in the appendix to this press release. The main purpose of this financing is to strengthen CARMAT's equity and to contribute to the funding of its working capital requirements, particularly to support the development of its sales and the completion of its EFICAS clinical trial in France. Based on the current share price1, the Company could receive a total gross amount of €7.9 million should it make full use of this financing line (although this amount is not guaranteed). The financing line has been structured via the issuance of warrants giving the right to subscribe new ordinary shares of the Company (the "Warrants"), exclusively for the benefit of IRIS2. This issuance was decided by the Board of Directors of the Company on March 26, 2025, pursuant to the delegation granted by the combined shareholders' meeting of the Company held on December 30, 2024, under its 6th resolution, and in accordance with the provisions of Article L. 225-138 of the French Commercial Code. The main characteristics of the Warrants (in particular their exercise conditions) are described in the appendix to this press release. CARMAT controls the exercise schedule of the Warrants, having the option to suspend, reactivate or terminate this financing agreement at any time without penalty, but also the right to set a maximum number of Warrants that can be exercised over a given period. In addition, the number of new shares issued upon exercise of the Warrants during each calendar quarter cannot exceed 15% of the volume of CARMAT shares traded on the Euronext Growth market of Euronext Paris during that quarter, unless expressly agreed by the Company. The issuance of the Warrants does not give rise to the publication of a prospectus subject to the approval of the French Financial Markets Authority (AMF) nor to the publication of an information document subject to filing with the AMF. The number of shares issued and admitted to trading under this agreement will be disclosed on the Company's website. The flexible equity financing line implemented with IRIS only partially finances CARMAT's estimated funding needs over the next 12 months, amounting to c. €35 million based on its current business plan. In this context, the Company is actively exploring various additional financing options and is particularly holding discussions with several financial stakeholders which could support it over the long term. However, it should be noted that, to date, there is no guarantee that such discussions will ultimately lead to any financial support for the Company, regardless of the amount, nor that they will materialize before the end of the Company's current cash runway, i.e. end of May 20253. *** 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 of Euronext 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 is the subject of this press release). 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. Furthermore, the AMF (French Financial Markets Authority) encourages companies that implement equity lines or other staggered capital increases to, in particular, include the following standard warning: CARMAT is implementing an equity financing line in the form of warrants to subscribe new ordinary shares with IRIS. After receiving the shares issued upon exercise of the Warrants, IRIS does not intend to remain a shareholder of the Company. The shares resulting from the exercise of the Warrants will generally be sold on the market at short notice, which can exert significant downward pressure on the share price. Shareholders may suffer a loss of their invested capital due to a significant decrease in the value of the Company's shares, as well as significant dilution due to the large number of shares issued to IRIS. Investors are advised to exercise great caution before deciding to invest in CARMAT securities. Investors are also invited to review the risk factors relating to this transaction, as set out in this press release. 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). Key terms and conditions of the financing line entered into with IRIS Main characteristics of the Warrants Investor/Subscriber IRIS, a French single-member limited liability company (société à responsabilité limitée unipersonnelle) with a share capital of €400,000, having its registered office at 5, villa Houssay, 92200 Neuilly-sur-Seine, registered with the Nanterre Trade and Companies Register under number 753.471.853. Number of Warrants 9 million Warrants, subscribed by the Investor on March 26, 2025. Subscription price €0.0001 per Warrant, representing a total subscription amount of €900. Term Upon expiry of a 24-month period starting this day, as may be extended in the cases set out below (the "Commitment Period"), any unexercised Warrants shall automatically lapse. Furthermore, any unexercised Warrants may be repurchased at any time by the Company for cancellation, for a lump sum of €1, at the request of the Company or the Investor (in the latter case, only upon occurrence of an event of default – see below). Exercise price of a Warrant The exercise price of a Warrant is equal to 95% of the lowest VWAP observed over the twenty-five (25) trading days immediately preceding the exercise date of the relevant Warrant. However, it is specified that in any case, the exercise price of the concerned Warrant may in no case be less than (i) the minimum price set by the Company's Board of Directors, namely 95% of the volume-weighted average price on the trading day immediately preceding the date of exercise of the Warrant concerned, (ii) the minimum price set by the combined shareholders' meeting of the Company held on December 30, 2024, i.e., 70% of the VWAPs of the five most recent trading sessions preceding the exercise date of the relevant Warrant, or (iii) the nominal value of the Company's shares. The discount granted enables the Investor, acting as a financial intermediary and not intending to remain a shareholder of the Company, to ensure the subscription of the shares despite potential financial markets volatility. IRIS will nevertheless not be able to exercise the Warrants if the exercise price of these Warrants, as calculated above, is lower than a floor price freely set by the Company at any time (currently €0.81). Other Conditions for Exercising the Warrants The Warrants are exercisable from today until their cancellation or lapse, as described above. The Company controls the exercise schedule of the Warrants, as it can at any time define the maximum number of new ordinary shares that can be subscribed for by exercising the Warrants during a given period. Furthermore, the number of these new shares cannot exceed, during a calendar quarter, 15% of the volume of CARMAT shares traded on the Euronext Growth market of Euronext Paris during that quarter, unless expressly agreed by the Company. The exercise of each Warrant by the Investor is also subject to other conditions set out in the issuance agreement (exercise price above the floor price set by the Company, no event of default or material adverse change, listing of the Company's shares, share closing price above a certain threshold, etc.). Suspension and reactivation Extension of the Commitment Period The Company may suspend and reactivate the exercise of the Warrants at any time without penalty. Likewise, in the event of an event of default (see below), the exercise of the Warrants shall remain suspended until such event of default has been remedied. The Commitment Period will be extended to reflect any suspensions and reactivations requested by the Company, up to a maximum additional period of 6 months. Ratio Each Warrant entitles its holder to subscribe for one new ordinary share of the Company (subject to standard legal or contractual adjustments). Events of default Events of default include, in particular, the Company's failure to comply with its obligations under the issuance agreement, failure to perform any of its contractual obligations, delisting of the Company's shares, or the occurrence of a material adverse change. No financial covenants apply. New shares The new ordinary shares of the Company issued upon exercise of the Warrants will carry current dividend rights. They will rank pari passu with the existing ordinary shares and will be admitted to trading on the Euronext Growth market of Euronext Paris. The Company will publish the number of shares issued under this financing line on its website. Transfer The Warrants may not be transferred without the prior written consent of the Company, except in the case of a transfer to an affiliate of the Investor. Potential dilution – Maximum number of shares The Warrants entitle the holder to subscribe for a maximum of 9,000,000 new ordinary shares of the Company, representing approximately 15% of its current share capital* (on a non-diluted basis). If this maximum number of shares was to be effectively issued, the stake of a shareholder holding 1% of the Company's share capital prior to the implementation of the financing line would decrease to 0.87%. To the best of the Company's knowledge, the share capital breakdown before and after the exercise of all the Warrants will be as follows: Before IRIS financing line After IRIS financing line To the best of the Company's knowledge Nb. of shares % Nb. of shares % Lohas SARL (Pierre Bastid) 10,742,930 18.3% 10,742,930 15.8% Sante Holdings SRL (Dr Antonino Ligresti) 10,689,320 18.2% 10,689,320 15.8% Corely Belgium SPRL 880,000 1.5% 880,000 1.3% Therabel Invest 741,706 1.3% 741,706 1.1% Airbus Group 670,640 1.1% 670,640 1.0% Pr. Alain Carpentier & Family 491,583 0.8% 491,583 0.7% Ass. Recher. Scientif. Fondation A. Carpentier 115,000 0.2% 115,000 0.2% Stéphane Piat (CEO) 553,402 0.9% 553,402 0.8% Cornovum 458,715 0.8% 458,715 0.7% Treasury shares 876,582 1.5% 876,582 1.3% Free float 32,629,669 55.4% 41,629,669 61.4% Total 58,849,547 100.0% 67,849,547 100.0% * As of the date of this press release, the Company has a share capital of €2,353,981.88 divided into 58,849,547 shares, including 58,817,806 ordinary shares. Provision of Company shares A share loan agreement has been entered into between the Investor and the Company to cover any default or delay in the delivery of shares in connection with the implementation of the issuance agreement. The use of a portion of the Company's treasury shares for this purpose was authorized by the combined shareholders' meeting of the Company held on May 30, 2024. General principles of the financing line Structuring/arrangement fee and other commissions Penalty clause None. Similar operations carried out over the last 24 months The financing line agreed with IRIS takes over from the previous financing line set up in July 2024. The Company has also issued and may issue in the future share warrants to IQEQ Management as part of the implementation of the equitisation announced on March 22, 2024. Conflict of interest To the Company's knowledge, the implementation of the financing line does not create any conflict of interest for its officers or corporate representatives. Risks associated with the financing line The sale on the market by IRIS — which does not intend to remain a shareholder of the Company — of shares issued by the Company under the financing line may impact the volatility and liquidity of the stock and exert downward pressure on the Company's share price. The Company's shareholders may also experience significant dilution as a result of the use of the financing line. The total amount of funds raised under the financing line is not guaranteed, as the exercise of the Warrants depends, in particular, on the fulfillment of the conditions described above. The public's attention is drawn to the risk factors relating to the Company and its business, as described in Chapter 2 of the 2023 Universal Registration Document filed with the French Financial Markets Authority (Autorité des marchés financiers) (the "AMF") on April 30, 2024 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"), available free of charge on the websites of CARMAT ( and the AMF ( The occurrence of all or some of these risks could have an adverse effect on the Company's business, financial situation, results, development or outlook. 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 equity financing line entered into with IRIS, which is the subject of this press release). 1 Closing price on March 26, 2025, i.e., €0.879. 2 The latter being part of the category defined by the combined shareholders' meeting of the Company held on December 30, 2024, under its 6 resolution, namely: "natural persons, companies or investment funds, French or foreign, whether shareholders or not of the Company, investing on a regular basis, or having invested more than €1 million over the past 36 months prior to the issue concerned, in the life sciences or technology sectors." 3 Cash runway excluding the equity financing line entered into with IRIS, the proceeds of which by the end of May 2025 cannot be determined with certainty. 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@ 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@
