Announcement • Aug 07
Carmat SA to Report First Half, 2025 Results on Oct 31, 2025 Carmat SA announced that they will report first half, 2025 results on Oct 31, 2025 Announcement • Jun 02
CARMAT Announces the First Commercial Implants of Its Aeson Artificial Heart Outside the European Union CARMAT announced 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, Prabea 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. These implants bring to 5 the total number of countries1 where commercial implants have been performed so far. Announcement • May 12
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 CARMAT announced 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. 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 France1. 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. 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 (Autorite des march 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. Aeson®? is an active implantable medical device commercially available in the European Union and other countries recognizing the CE mark. 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 CHRU Lille, AP-HP Hopital Europeen Georges Pompidou, GHU Pitie Salpetriere, CHU Dijon, Hospices Civils de Lyon, Hopital Marie-Lannelongue, CHURennes, Chief Executive Officer of CARMA, commented that, by approving 21 additional implants, the French authorities enable patients in France to continue benefitting from therapy beyond the EFICAS study. This is a strong sign of confidence in Aeson®? artificial heart. Given the study design, company anticipate to be in a position to file for Aeson®?'s reimbursement in France early next year, which could lead to coverage of artificial heart by the French Social Security system during 2026. The EFICAS study is also important given strategy to access the U.S. market, which are expecting to achieve in 2028. Announcement • Apr 15
Carmat SA Receives FDA Conditional Approval to Initiate the Second Cohort of the EFS Study in the United States Carmat SA announced 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. 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 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 clinical results-- could occur from 2028. Conditional approval to initiate the second cohort of the EFS study in the United States is a feasibility study involving a total of 10 patients eligible for heart transplant. The study design includes two successive cohorts. The first cohort of 3 patients was completed in Third Quarter 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 Second half of 2025. CARMAT will now take all necessary steps - including obtaining approvals from ethics committees 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 field of implantable cardiac devices. Announcement • Apr 04
CARMAT Announces the Publication of the Results of the Initial Clinical Experience with Aeson in Cardiogenic Shock Patients Previously on Temporary Extracorporeal Life Support CARMAT announced 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 Support", 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 at6 months following Aeson®? implant, with 5 patients successfully transplanted and 4 still on Aeson® support at that time. Announcement • Jan 31
Carmat SA, Annual General Meeting, Jun 26, 2025 Carmat SA, Annual General Meeting, Jun 26, 2025. Announcement • Dec 26
Carmat SA (ENXTPA:ALCAR) announces an Equity Buyback for 2,000,000 shares, for €0.000001 million. Carmat SA (ENXTPA:ALCAR) announces a share repurchase program. Under the program, the company will repurchase 2,000,000 shares for €0.000001 million. The purpose of repurchase program is financial restructuring. The repurchases shares will be used for repayment of its financial debt. Announcement • Nov 13
Carmat Provides an Update on Aeson® Artificial Heart’s Uptake as A Bridge to Transplant in Europe Carmat provided an update on Aeson® artificial heart’s uptake as a bridge to transplant in Europe. By the end of October 2024, 30 patients had successfully undergone heart transplant after being supported by the Aeson® artificial heart, confirming the ability of the device to provide physiological support tailored to each patient, enabling them to approach heart transplant in optimal physical condition when a human graft becomes available. Out of these 30 transplants carried out in 7 different countries1 (including 16 in France and 5 in Germany), 16 have been performed since the beginning of 2024, demonstrating a clear acceleration in the adoption of Aeson® as a bridge-to-transplant solution in Europe. These 30 patients benefited from Aeson® support for an average of 156 days before transplant (the maximum duration recorded being 308 days). As a reminder, the Aeson® artificial heart is CE marked for the “bridge to transplant” indication. It can therefore be marketed in Europe (and in other countries recognizing the CE marking) for this indication, and more specifically in patients suffering from 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 receive a heart transplant within 180 days of implantation. At the end of November 2024, CARMAT organizes the first ‘Aeson® European User Meeting’. This event will enable more than 100 European leaders in the field of cardiology to share their experience with the Aeson® artificial heart. The event will focus on case studies and feedback from the various stakeholders managing patients (cardiologists, surgeons, anaesthetists, intensive care specialists, etc.), with a view to better identifying patients who could benefit from Aeson®, and enhancing the level of expertise of the centres. It will thus mark an important step towards wider adoption of the device, and better management of patients suffering from advanced biventricular heart failure. This event is part of the intensification, over the course of 2024, of the information and training effort around Aeson®, including in particular CARMAT’s participation in about ten key conferences attended by several hundred participants. This testifies to the growing interest shown by healthcare professionals in this innovative device, and to the critical need for effective solutions to treat patients who frequently find themselves at a therapeutic standstill. Building on its growing and extremely encouraging experience in the bridge-to-transplant indication, CARMAT continues to ultimately aim for the ‘destination therapy’ (‘DT’) indication, which would enable patients to live sustainably under Aeson® support without subsequent heart transplant. To this end, CARMAT confirms that it plans to resume its PIVOTAL study in Europe in the second half of 2025, on a cohort of patients not eligible to transplant. Approval in ‘DT’ would be decisive in meeting the critical challenge of the graft shortage, given that only 5% of patients in need of a transplant can currently benefit from it. As such, the DT indication represents the largest addressable market opportunity in cardiology. CARMAT estimates that obtaining this indication could take a few years. Announcement • Jul 12
Carmat SA Ordinary Shares to Be Deleted from OTC Equity Carmat SA Ordinary Shares (France) will be deleted from OTC Equity effective July 11, 2024, due to Inactive Security. Board Change • Jun 26
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Honorary President Alain Carpentier was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Jun 25
Carmat SA Announces Board Changes Carmat SA announces the appointment of Mr. Pierre Bastid, Director, as Chairman of the Board of company, replacing Mr. Alexandre Conroy, who has resigned for personal reasons and the retirement of Mr. André Muller, Director, following his appointment as CEO of Idorsia. A seasoned industrialist and entrepreneur, Mr. Pierre Bastid knows the company very well, having served on its Board as a director since 2018. He is also one of the Company's main shareholders via the LOHAS and Les Bastidons entities, which he controls, and which together hold 13.5% of the Company's share capital. Since taking a stake in CARMAT back in 2016, Mr. Pierre Bastid has participated in each of the capital increases carried out by the Company. Following these changes, CARMAT's Board of Directors, now chaired by Pierre Bastid, consists of 10 members, including 5 independent. New Risk • May 27
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 52% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Negative equity (-€27m). Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€14m net loss in 3 years). Revenue is less than US$5m (€3.8m revenue, or US$4.2m). Reported Earnings • May 05
Full year 2023 earnings released Full year 2023 results: Revenue: €12.6m (up €12.1m from FY 2022). Net loss: €53.9m (flat on FY 2022). Revenue is forecast to grow 49% p.a. on average during the next 3 years, compared to a 6.8% growth forecast for the Medical Equipment industry in Germany. Announcement • Apr 24
CARMAT Provides Revenue Guidance for the Year 2024 CARMAT provided revenue guidance for the year 2024. The Company anticipates a substantial gradual sales growth over the year, and revenue of around €14 million for 2024. New Risk • Mar 16
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €91.8m (US$99.9m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Negative equity (-€8.7m). Revenue is less than US$1m (€910k revenue, or US$991k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€22m net loss in 3 years). Share price has been volatile over the past 3 months (9.9% average weekly change). Shareholders have been diluted in the past year (26% increase in shares outstanding). Market cap is less than US$100m (€91.8m market cap, or US$99.9m). Breakeven Date Change • Jan 19
Forecast to breakeven in 2026 The 5 analysts covering Carmat expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €22.1m in 2026. Average annual earnings growth of 46% is required to achieve expected profit on schedule. Announcement • Jan 18
Carmat SA announced that it expects to receive €15.000002 million in funding Carmat SA announced a private placement for a gross proceeds of €15,000,002.01 on January 17, 2024. The company will issue 3,759,399 shares at issue price €3.99 per share for a gross proceeds €15,000,002.01. Announcement • Jan 15
Carmat Sa Provides Earnings Guidance for the Year 2024 Carmat SA provided earnings guidance for the year 2024. For the period, the company expects Sales of €14 Million to €20 Million. Breakeven Date Change • Dec 31
Forecast to breakeven in 2026 The 6 analysts covering Carmat expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €22.1m in 2026. Average annual earnings growth of 45% is required to achieve expected profit on schedule. Announcement • Dec 28
Carmat Announces Software Enhancement Which Significantly Improves the Safety Profile of Its Aeson®? Artificial Heart CARMAT announced a software enhancement which significantly improves the safety profile of its Aeson®? artificial heart. The prosthesis software will now be able to detect on a real time basis, signals of possible Aeson®? faults. The software will then immediately adapt the control of the prosthesis so that its performance is not affected, and the patient's support is not impacted. These changes, developed and tested by CARMAT's research teams, will first be deployed on all hearts currently implanted in patients, as part of a software update for which a field safety notice is published. It will then be embedded into the Aeson®? production process, after getting the appropriate regulatory approvals. Announcement • Dec 12
CARMAT Announces the First Implant of the Aeson® Artificial Heart in a Patient Suffering from a Cardiac Tumor CARMAT announced the first implantation of the Aeson® heart in a patient suffering from a cardiac tumor. The patient implanted was suffering from a tumor invading the heart mass, responsible for rhythmic and restrictive cardiopathy, which eluded standard medical treatment. Only complete surgical removal of the heart could be considered as a hope of treatment. It is in this context that the Aeson® total artificial heart was implanted for the first time in the world in this type of indication. The implant was carried out at the Marie-Lannelongue Hospital in Plessis-Robinson (in the western suburbs of Paris) by the teams of Professor Julien Guihaire, cardiac surgeon, and Professor Elie Fadel, thoracic surgeon. The implant was performed as part of the CARMAT's EFICAS study, which aims to gather additional data on the efficacy and safety of its Aeson® artificial heart, as well as medico-economic data to support the value proposition of the prosthesis, and in particular the reimbursement of the device in France. Eight French cardiology centers1 are now involved in the EFICAS study, which will include a total of 52 patients. To date, enrolment of the first cohort of 10 patients has been finalized, and the study is on track for completion in 2025. Announcement • Oct 23
CARMAT Presented Its Progress on the EFICAS Clinical Study at the 36th Journées de La Pitié in Paris CARMAT announced that it has presented its progress on the EFICAS clinical trial at the 36th “Journées de La Pitié” national conference on heart and lung transplantation and circulatory assistance, organized by the cardiology institute of the Pitié Salpêtrière hospital from October 18 to 20, 2023 in Paris. EFICAS is a prospective study designed to include 52 patients eligible for transplants, currently enrolled by a network of 6 French cardiology centers. It will enable CARMAT to gather additional data on the efficacy and safety of its artificial heart, as well as medico-economic data to support the value proposition of the prosthesis, and in particular the reimbursement of the device in France. The primary objective of the study is 180-day post-implantation survival without disabling stroke, or successful heart transplant within 180 days of implantation. Announcement • Oct 17
Carmat SA announced that it has received €6.999991 million in funding from Lohas S.à R.L., Sante Holdings S.R.L., Therabel Healthcare Investment SA Carmat SA announced a private placement of 1,944,442 common shares at an issue price of €3.60 per share for the gross proceeds of €7,000,000 on October 16, 2023. The transaction included participation from returning investors Lohas S.à R.L., Sante Holdings S.R.L. and Therabel Healthcare Investment SA. New Risk • Oct 06
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €93.5m (US$99.0m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€57m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Negative equity (-€8.7m). Revenue is less than US$1m (€910k revenue, or US$964k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€1.2m net loss in 3 years). Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (€93.5m market cap, or US$99.0m). New Risk • Oct 05
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€57m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€57m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Negative equity (-€8.7m). Revenue is less than US$1m (€910k revenue, or US$957k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€1.2m net loss in 3 years). Shareholders have been diluted in the past year (16% increase in shares outstanding). Reported Earnings • Sep 28
First half 2023 earnings released First half 2023 results: Net loss: €26.7m (loss widened 2.7% from 1H 2022). Revenue is forecast to grow 53% p.a. on average during the next 3 years, compared to a 6.3% growth forecast for the Medical Equipment industry in Germany. Announcement • Sep 27
Carmat SA Provides Sales Guidance for the Fourth Quarter 2023 Carmat SA announced that the company is at a crucial time where they do expect a strong sales momentum going forward, so starting fourth quarter 2023. So sales forecast, they do their best to meet at least the 4 million. New Risk • Sep 06
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: €54m Forecast net loss in 3 years: €15m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (€477k revenue, or US$511k). Minor Risks Less than 1 year of cash runway based on current free cash flow (-€56m). Currently unprofitable and not forecast to become profitable over next 3 years (€15m net loss in 3 years). Shareholders have been diluted in the past year (16% increase in shares outstanding). Breakeven Date Change • Sep 06
No longer forecast to breakeven The 5 analysts covering Carmat no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €24.5m in 2025. New consensus forecast suggests the company will make a loss of €14.9m in 2025. Breakeven Date Change • Mar 09
No longer forecast to breakeven The 5 analysts covering Carmat no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €24.5m in 2025. New consensus forecast suggests the company will make a loss of €12.0m in 2025. Announcement • Jan 04
Carmat Announces the First Implantation of Aeson® Within the Framework of the Eficas Clinical Study in France Carmat SA aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announced the first implantation of its Aeson® artificial heart within the framework of the EFICAS clinical study in France. On October 26, 2022, CARMAT announced that it had received the necessary regulatory approvals to resume the EFICAS clinical study. The first Aeson® implantation within the framework of this study was performed during the last week of December 2022 by Prof. André Vincentelli and his team at Lille Regional University Hospital. In addition to the Lille hospital, five other medical centers take part in this study: Pitié Salpêtrière University Hospital and Georges Pompidou European Hospital in Paris, Rennes University Hospital, Strasbourg University Hospital and Lyon University Hospital (Hospices Civils de Lyon). This prospective study will involve a total of 52 patients eligible for a heart transplant in France and will allow CARMAT to collect both additional data on the efficacy and safety of its artificial heart and medico-economic data to support its value proposition and the device’s reimbursement, notably in France. The study’s primary endpoint is survival for 180 days after implantation of the device without a disabling stroke, or a successful heart transplant within 180 days of implantation. Announcement • Oct 26
Carmat SA Receives Regulatory Approvals to Resume its Clinical Study in France Carmat SA announced that it has been granted the necessary regulatory approvals from the French National Agency for Medicine and Health Product Safety (“ANSM”) and the Patient Protection Committee (CPP Ile-de-France XI) to restart the EFICAS Clinical Study. study will include 52 transplant-eligible patients in France and will allow CARMAT to collect both additional data on the efficacy and safety of its artificial heart, and medico-economic data to support the value proposition and reimbursement of the device, notably in France. Ahead of the restart, four centres have undergone refresher trainings on the product and clinical protocol and are ready to screen patients (APHP-HU Pitié Salpêtrière, CHRU Lille, CHU Rennes and CHU Strasbourg). As a reminder, CARMAT benefits from a funding of €13 million from the French National Innovation Fund, to partially finance this study. Given this approval, which follows the recently announced green light to resume commercial implants as well, CARMAT confirms its intention to resume implants in Europe in the near future, at a gradual pace in line with the rebuilding of its prostheses inventory. Announcement • Oct 25
CARMAT Receives the Necessary Regulatory Approvals to Resume Aeson Commercial Implants CARMAT, the designer and developer of Aeson, designed to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announced that it has been granted the necessary regulatory approvals to resume implants in a commercial setting. After review of CARMAT filings, DEKRA has provided notified body approval of all the changes implemented by the Company in response to the quality issues that led it to voluntarily and temporarily suspend all Aeson implants at the end of 2021. This approval allows CARMAT to resume implants of its Aeson artificial heart in a commercial setting, within the European Union and other countries that recognize CE Marking. Following this approval, CARMAT intends to resume sales in Europe in the near future at a gradual pace in line with the rebuilding of the prostheses inventory. CARMAT will provide additional update when it is in a position to resume clinical trials in France, Europe and the United States. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. 1 highly experienced director. Honorary President Alain Carpentier was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Apr 13
Carmat SA announced that it expects to receive €36.46431 million in funding from a group of investors Carmat SA announced a private placement of 3,646,431 shares at an issue price of €10 per share for gross proceeds of €36,464,310 on April 12, 2022. The transaction will include participation from new investors CorNovum SAS, Groupe Therabel, Alain Carpentier Foundation Scientific Research Association, Prof. Alain Carpentier, returning investors Matra Défense S.A.S. for €10,000,000, Lohas S.à R.L. for €3,000,000, Corely Belgium Sprl for for €700,000, BRATYA SPRL for €700,000, Sante Holdings S.R.L. for €3,000,000 and BAD 21 SPRL for €600,000. The securities to be issued will have a hold period of 180 days. Board Change • Apr 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. 1 highly experienced director. Honorary President Alain Carpentier was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Dec 23
CARMAT Announces the Completion of Its Investigations on Previously Identified Quality Issues CARMAT announced the completion of investigations on its prostheses. Following the occurrence of a quality issue affecting some of its prostheses, CARMAT had announced, on December 3, 2021, the voluntary and temporary suspension of implants of its Aeson® artificial heart. The company has subsequently carried out a very rigorous investigation of the situation. This investigation, which is now complete, has enabled the root causes of the quality issue to be identified, and the changes required to prevent its reoccurrence to be determined. The outcome of the investigation will now be shared with the notified body (DEKRA) and the competent authorities (specifically the ANSM in France and the Food & Drug Administration in the United States), starting from this week. The discussions with DEKRA and the competent authorities are expected to take a few weeks and lead to an agreed schedule to resume implants. The company plans to provide a further update in January 2022, including a web conference, the date of which will be communicated in due course. Announcement • Aug 27
CARMAT Announces a New Commercial Implant of Its Aeson® Artificial Heart at University Medical Center Schleswig-holstein in Kiel, Germany CARMAT announced the third implant of its Aeson® bioprosthetic artificial heart in a commercial setting. This new commercial implant of the Aeson® device was performed by Prof. Assad Haneya and his team of the Department of Cardiovascular Surgery at University Medical Center Schleswig-Holstein (UKSH) in Kiel (Director: Prof. Jochen Cremer). With 14,000 employees in over 85 clinics and institutes, UKSH is one of the medical care centers in Europe and the first training provider in Schleswig-Holstein. UKSH in Kiel is recognized as one of Germany’s leading heart centers with a history of thoracic transplantation for several decades. It provides maximum medical care in this federal state and guarantees medical-technical care at the level, especially for patients who require highly differentiated diagnosis and therapy. Announcement • Jul 15
CARMAT Announces the First Human Implant of Its Total Artificial Heart in the United States CARMAT (FR0010907956, ALCAR), announces the first implantation of its bioprosthetic artificial heart, Aeson®, in the United States within the framework of the Early Feasibility Study (EFS). The implant procedure was performed by a team led by Dr. Jacob N. Schroder and Dr. Carmelo A. Milano, heart surgeons at Duke University Hospital, in Durham (North Carolina). Duke University Hospital is rated as one of the best in the United States for its outstanding care and ground-breaking research, especially in cardiology and heart surgery. It is the first U.S. hospital to implant Aeson® within the framework of the EFS. Three additional U.S. centers are fully trained and are currently screening patients for the study. In accordance with the study protocol approved by the FDA, 10 transplant-eligible patients are expected to be enrolled in this trial. The primary study endpoint is patient survival at 180 days post-implant or a successful cardiac transplantation within 180 days post-implant. It is a staged study with a progress report of the first 3 patients after 60 days, before the enrollment of the next 7 patients. Announcement • Feb 11
CARMAT Receives U.S. Food and Drug Administration Approval to Use the New Version of Its Artificial Heart in the U.S. Early Feasibility Study CARMAT provides an update on its early feasibility study in the United States. The U.S. Food and Drug Administration has granted CARMAT approval to use the new version of its artificial heart in the EFS. This new version includes certain improvements in the prosthesis and the wearable system based on clinical experience gained in the PIVOTAL study. The company believes that this latest version should further improve patient safety and quality of life. In view of this, the company confirms that it expects the first enrolments in the EFS in First Quarter 2021. As a reminder, CARMAT obtained the approval from the Centers for Medicare & Medicaid Services (CMS) for the reimbursement of the device and associated services within the framework of this study in May 2020. Is New 90 Day High Low • Feb 11
New 90-day high: €34.30 The company is up 72% from its price of €20.00 on 12 November 2020. The German market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 22% over the same period. Announcement • Feb 01
CARMAT Appoints Professor Christian Latrémouille as Director of Surgical Affairs CARMAT announced the appointment of Professor Christian Latrémouille as Director of Surgical Affairs. Before joining CARMAT, Christian was, since 2017, Head of the Cardiovascular Surgery Department at the Georges Pompidou European Hospital in Paris. Is New 90 Day High Low • Dec 30
New 90-day high: €30.55 The company is up 54% from its price of €19.86 on 01 October 2020. The German market is up 9.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 9.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Dec 25
Carmat SA Receives the CE Marking for Its Total Artificial Heart Carmat SA announces that it has received the CE marking for its total artificial heart. The CE marking was granted on December 22, 2020 to CARMAT’s total artificial heart system as a bridge to transplant in patients suffering from end-stage biventricular heart failure (Intermacs Classes 1-4) who are not amenable to maximal medical therapy or the LVAD1 and who are likely to undergo heart transplant in the 180 days following implantation. The CE marking allows the company to market its total artificial heart system in all countries that recognize this certification, including all the countries of the European Union. Is New 90 Day High Low • Dec 11
New 90-day high: €24.35 The company is up 28% from its price of €19.02 on 11 September 2020. The German market is up 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 13% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Nov 26
CARMAT Provides Update on the US Early Feasibility Study CARMAT provides an update on its early feasibility study (EFS) in the United States. The EFS was fully approved by the US Food and Drug Administration (FDA) in February 2020 and CARMAT obtained the approval from the Centers for Medicare & Medicaid Services (CMS) for the reimbursement of the device and associated services within the framework of this study in May 2020. In order to be able to use the “commercial configuration” of its artificial heart in the study, CARMAT submitted certain amendments to the FDA. The company believes that this latest version of the prosthesis should improve patient safety and quality of life. At this stage, due to a very constructive collaboration with the FDA, 8 amendments out of 9 have already been approved, and the last one should be approved in the coming weeks. CARMAT is finalizing the study preparation with three US centers successfully trained in November at Pitt MIRM Centre for Preclinical Studies (Pittsburgh, Pennsylvania): VCU Health Pauley Heart Center (Richmond, Virginia), University of Louisville Jewish Hospital (Louisville, Kentucky), and Baylor University Medical Center (Dallas, Texas). All other steps necessary to start the EFS have already been taken.
In view of this, CARMAT now expects the first implants to be performed in First Quarter 2021 and the enrolment of the 10 patients to be completed by the end of 2021. The Company confirms that its available resources1 enable it to fund its activities through to third quarter of 2021. Is New 90 Day High Low • Nov 19
New 90-day high: €22.75 The company is up 17% from its price of €19.48 on 21 August 2020. The German market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Oct 29
New 90-day low: €17.80 The company is down 4.0% from its price of €18.54 on 30 July 2020. The German market is down 5.0% over the last 90 days, indicating the company outperformed over that time. However, it underperformed the Medical Equipment industry, which is down 1.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Oct 11
New 90-day high: €20.40 The company is up 8.0% from its price of €18.92 on 13 July 2020. The German market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Sep 22
Carmat SA to Report First Half, 2020 Results on Sep 09, 2020 Carmat SA announced that they will report first half, 2020 results on Sep 09, 2020 Is New 90 Day High Low • Sep 21
New 90-day high: €20.35 The company is up 1.0% from its price of €20.10 on 23 June 2020. The German market is up 5.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Medical Equipment industry, which is flat over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.