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Business Wire
a day ago
- 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
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
12-03-2025
- Health
- Yahoo
Man lives for 100 days with artificial titanium heart in new trial
An Australian man lived for 100 days with an artificial titanium heart while he awaited a donor transplant, the longest period to date of someone with the technology. The patient, a man in his 40s who declined to be identified, received the implant during surgery at St. Vincent's Hospital Sydney last November. In February, he became the first person worldwide to leave hospital with the device, which kept him alive until a heart donor became available earlier this month. According to a statement issued Wednesday by St Vincent's Hospital, Monash University and BiVACOR, the US-Australian company behind the device, the man, who had severe heart failure, was 'recovering well.' The ability of the device to sustain him for so long is being celebrated as a sign the artificial heart could potentially offer a long-term option for people suffering heart failure. The device is still being trialed and has not yet been approved for general use. BiVACOR's founder, Australian bioengineer Daniel Timms, who invented the device following his father's death from heart disease, said it was 'exhilarating to see decades of work come to fruition.' 'The entire BiVACOR team is deeply grateful to the patient and his family for placing their trust in our Total Artificial Heart,' he said in the statement. 'Their bravery will pave the way for countless more patients to receive this lifesaving technology.' The BiVACOR Total Artificial Heart (TAH) has a single moving part, a levitated rotor that's held in place by magnets. As the name suggests, it's constructed from titanium and there are no valves or mechanical bearings that may be susceptible to wear. It pumps blood to the body and the lungs, replacing both ventricles of a failing heart. Cardiovascular diseases are the leading cause of death globally killing around 18 million people each year, according to the World Health Organization. The long-term ambition is to use the device to save more people who languish on waiting lists for suitable donors. According to the US Health Department, about 3,500 people received heart transplants in 2024. Around 4,400 joined the waiting list the same year. Professor Chris Hayward, from the Victor Chang Cardiac Research Institute, said the BiVACOR heart ushered in 'a whole new ball game for heart transplants.' 'Within the next decade we will see the artificial heart becoming the alternative for patients who are unable to wait for a donor heart or when a donor heart is simply not available,' said Hayward, who is overseeing the Australian patient's recovery and was involved in preparing the device for clinical trials. The device has already been tested in the Food and Drug Administration's Early Feasibility Study in the United States, which saw five patients successfully implanted with the device. The first was last July, when a 58-year-old man suffering end-stage heart failure received the implant during surgery at Texas Medical Center. It kept him alive for eight days until a donor was available. Four other patients followed in the study, which examined the safety and performance of the device, while they waited for a donor transplant. It's hoped the trial will expand to 15 patients. The Australian implant was the first in a series planned by Monash University's Artificial Heart Frontiers Program, a 50 million Australian dollar ($31 million) program to develop and commercialize three devices to treat heart failure.
