This company listing is no longer activeThis company may still be operating, however this listing is no longer active. Find out why through their latest events.See Latest EventsCarmat（CXT）株式概要Carmat SAは、末期二心室性心不全患者用の全人工心臓をフランス国内外で設計・開発している。 詳細CXT ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長2/6過去の実績0/6財務の健全性0/6配当金0/6報酬収益は年間58.53%増加すると予測されています リスク分析意味のある時価総額がありません ( €6M )マイナスの株主資本 過去5年間で収益は年間6.3%減少しました。 過去1年間で株主の希薄化は大幅に進んだ +2 さらなるリスクすべてのリスクチェックを見るCXT Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.NEW496,135 membersJoin community and earn perksGain real feedbackFrom our editorial team, personally. Not silence.Grow your followingReal investors. The kind who actually invest, not scroll past.Unlock free accessFree premium subscription for consistent and quality authors.Learn moreCreate NarrativeBLINROAG496,135 investors already sharing narrativesYour Fair Value€Current Price€0.04997.8% 割安 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-80m74m2016201920222025202620282031Revenue €73.5mEarnings €9.7mAdvancedSet Fair ValueView all narrativesCarmat SA 競合他社aap ImplantateSymbol: XTRA:AAQ1Market cap: €22.0mGeratherm MedicalSymbol: XTRA:GMEMarket cap: €14.4mNanoReproSymbol: XTRA:NN6Market cap: €26.6mgraceNTSymbol: DUSE:0GMMarket cap: €226.6k価格と性能株価の高値、安値、推移の概要Carmat過去の株価現在の株価€0.04952週高値€1.2252週安値€0.049ベータ1.11ヶ月の変化0%3ヶ月変化-27.94%1年変化-94.79%3年間の変化-99.53%5年間の変化-99.84%IPOからの変化-99.79%最新ニュースお知らせ • Aug 07Carmat SA to Report First Half, 2025 Results on Oct 31, 2025Carmat SA announced that they will report first half, 2025 results on Oct 31, 2025お知らせ • Jun 02CARMAT Announces the First Commercial Implants of Its Aeson Artificial Heart Outside the European UnionCARMAT 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.お知らせ • May 12CARMAT 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 FranceCARMAT 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.お知らせ • Apr 15Carmat SA Receives FDA Conditional Approval to Initiate the Second Cohort of the EFS Study in the United StatesCarmat 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.お知らせ • Apr 04CARMAT Announces the Publication of the Results of the Initial Clinical Experience with Aeson in Cardiogenic Shock Patients Previously on Temporary Extracorporeal Life SupportCARMAT 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.お知らせ • Jan 31Carmat SA, Annual General Meeting, Jun 26, 2025Carmat SA, Annual General Meeting, Jun 26, 2025.最新情報をもっと見るRecent updatesお知らせ • Aug 07Carmat SA to Report First Half, 2025 Results on Oct 31, 2025Carmat SA announced that they will report first half, 2025 results on Oct 31, 2025お知らせ • Jun 02CARMAT Announces the First Commercial Implants of Its Aeson Artificial Heart Outside the European UnionCARMAT 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.お知らせ • May 12CARMAT 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 FranceCARMAT 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.お知らせ • Apr 15Carmat SA Receives FDA Conditional Approval to Initiate the Second Cohort of the EFS Study in the United StatesCarmat 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.お知らせ • Apr 04CARMAT Announces the Publication of the Results of the Initial Clinical Experience with Aeson in Cardiogenic Shock Patients Previously on Temporary Extracorporeal Life SupportCARMAT 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.お知らせ • Jan 31Carmat SA, Annual General Meeting, Jun 26, 2025Carmat SA, Annual General Meeting, Jun 26, 2025.お知らせ • Jan 30+ 1 more updateCarmat SA to Report Fiscal Year 2024 Results on Apr 29, 2025Carmat SA announced that they will report fiscal year 2024 results at 9:00 AM, Central European Standard Time on Apr 29, 2025お知らせ • Dec 26Carmat 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.お知らせ • Nov 13Carmat Provides an Update on Aeson® Artificial Heart’s Uptake as A Bridge to Transplant in EuropeCarmat 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.お知らせ • Jul 12Carmat SA Ordinary Shares to Be Deleted from OTC EquityCarmat SA Ordinary Shares (France) will be deleted from OTC Equity effective July 11, 2024, due to Inactive Security.Board Change • Jun 26Insufficient new directorsNo 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.お知らせ • Jun 25Carmat SA Announces Board ChangesCarmat 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 27New major risk - Shareholder dilutionThe 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).お知らせ • May 18+ 1 more updateCarmat SA has filed a Follow-on Equity Offering in the amount of €62.57559 million.Carmat SA has filed a Follow-on Equity Offering in the amount of €62.57559 million. Security Name: Shares Security Type: Common Stock Securities Offered: 20,858,530 Price\Range: €3お知らせ • May 06+ 1 more updateCARMAT Continues to Build on Its Momentum in the EFICAS StudyCARMAT provided an update on the EFICAS study. To date, 20 patients have been implanted with the Aeson heart as part of the EFICAS study, 9 of them in the first 4 months of 2024. The EFICAS study is conducted exclusively in France, in 10 hospitals whose teams are fully trained and ready to carry out the implants. To date, 8 hospitals have already enrolled patients in the study. The primary objective of the study is a minimum survival of 6 months on CARMAT support, without disabling stroke, or a successful heart transplant within the first 6 months. The study's interim success rate of 75%, which exceeds expectations, is very promising compared to previous CARMAT studies3 and existing therapies, given the poor state of health of the patients concerned. In view of these advances, CARMAT confirms its target of completing the EFICAS study, with a total of 52 Aeson implants, in the first half of 2025. The EFICAS study is essential both for the reimbursement of Aeson in France and for obtaining PMA (marketing authorization in the United States, issued by the FDA), which the Company anticipates for 2027. Study data are also an important catalyst for the adoption of Aeson across Europe.Reported Earnings • May 05Full year 2023 earnings releasedFull 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.お知らせ • Apr 24CARMAT Provides Revenue Guidance for the Year 2024CARMAT 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 16New minor risk - Market cap sizeThe 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).お知らせ • Feb 06+ 2 more updatesCarmat SA to Report Fiscal Year 2023 Results on Apr 24, 2024Carmat SA announced that they will report fiscal year 2023 results on Apr 24, 2024Breakeven Date Change • Jan 19Forecast to breakeven in 2026The 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.お知らせ • Jan 18Carmat SA announced that it expects to receive €15.000002 million in fundingCarmat 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.お知らせ • Jan 15Carmat Sa Provides Earnings Guidance for the Year 2024Carmat 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 31Forecast to breakeven in 2026The 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.お知らせ • Dec 28Carmat Announces Software Enhancement Which Significantly Improves the Safety Profile of Its Aeson®? Artificial HeartCARMAT 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.お知らせ • Dec 12CARMAT Announces the First Implant of the Aeson® Artificial Heart in a Patient Suffering from a Cardiac TumorCARMAT 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.お知らせ • Oct 23CARMAT Presented Its Progress on the EFICAS Clinical Study at the 36th Journées de La Pitié in ParisCARMAT 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.お知らせ • Oct 17Carmat 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 SACarmat 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 06New minor risk - Market cap sizeThe 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 05New major risk - Financial positionThe 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 28First half 2023 earnings releasedFirst 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.お知らせ • Sep 27Carmat SA Provides Sales Guidance for the Fourth Quarter 2023Carmat 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 06New minor risk - ProfitabilityThe 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 06No longer forecast to breakevenThe 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 09No longer forecast to breakevenThe 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.お知らせ • Jan 05+ 2 more updatesCarmat SA to Report Fiscal Year 2022 Results on Feb 23, 2023Carmat SA announced that they will report fiscal year 2022 results on Feb 23, 2023お知らせ • Jan 04Carmat Announces the First Implantation of Aeson® Within the Framework of the Eficas Clinical Study in FranceCarmat 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.お知らせ • Oct 26Carmat SA Receives Regulatory Approvals to Resume its Clinical Study in FranceCarmat 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.お知らせ • Oct 25CARMAT Receives the Necessary Regulatory Approvals to Resume Aeson Commercial ImplantsCARMAT, 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 27Insufficient new directorsNo 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.お知らせ • Apr 13Carmat SA announced that it expects to receive €36.46431 million in funding from a group of investorsCarmat 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 02Insufficient new directorsNo 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.お知らせ • Dec 23CARMAT Announces the Completion of Its Investigations on Previously Identified Quality IssuesCARMAT 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.お知らせ • Aug 27CARMAT Announces a New Commercial Implant of Its Aeson® Artificial Heart at University Medical Center Schleswig-holstein in Kiel, GermanyCARMAT 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.お知らせ • Jul 15CARMAT Announces the First Human Implant of Its Total Artificial Heart in the United StatesCARMAT (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.お知らせ • Feb 11CARMAT Receives U.S. Food and Drug Administration Approval to Use the New Version of Its Artificial Heart in the U.S. Early Feasibility StudyCARMAT 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 11New 90-day high: €34.30The 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.お知らせ • Feb 01CARMAT Appoints Professor Christian Latrémouille as Director of Surgical AffairsCARMAT 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.お知らせ • Jan 19+ 2 more updatesCarmat SA to Report Fiscal Year 2020 Results on Feb 10, 2021Carmat SA announced that they will report fiscal year 2020 results Pre-Market on Feb 10, 2021Is New 90 Day High Low • Dec 30New 90-day high: €30.55The 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.お知らせ • Dec 25Carmat SA Receives the CE Marking for Its Total Artificial HeartCarmat 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 11New 90-day high: €24.35The 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.お知らせ • Nov 26CARMAT Provides Update on the US Early Feasibility StudyCARMAT 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 19New 90-day high: €22.75The 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 29New 90-day low: €17.80The 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 11New 90-day high: €20.40The 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.お知らせ • Sep 22Carmat SA to Report First Half, 2020 Results on Sep 09, 2020Carmat SA announced that they will report first half, 2020 results on Sep 09, 2020Is New 90 Day High Low • Sep 21New 90-day high: €20.35The 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.株主還元CXTDE Medical EquipmentDE 市場7D0%1.6%-0.5%1Y-94.8%-25.4%0.3%株主還元を見る業界別リターン: CXT過去 1 年間で-25.4 % の収益を上げたGerman Medical Equipment業界を下回りました。リターン対市場: CXTは、過去 1 年間で0.3 % のリターンを上げたGerman市場を下回りました。価格変動Is CXT's price volatile compared to industry and market?CXT volatilityCXT Average Weekly Movementn/aMedical Equipment Industry Average Movement6.3%Market Average Movement5.3%10% most volatile stocks in DE Market12.7%10% least volatile stocks in DE Market2.7%安定した株価: CXTの株価は、 German市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間のCXTのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト2008153Stephane Piatwww.carmatsa.comCarmat SA社は、末期二心室性心不全患者のための全人工心臓の設計・開発をフランス国内外で行っている。同社の製品には、進行した心不全を患う患者において、本来の心臓の心室を置換することを目的とした能動的植込み型医療機器であるAesonが含まれる。同社は2008年に設立され、フランスのVélizy-Villacoublayに本社を置いている。もっと見るCarmat SA 基礎のまとめCarmat の収益と売上を時価総額と比較するとどうか。CXT 基礎統計学時価総額€6.15m収益（TTM）-€51.39m売上高(TTM)€7.34m0.8xP/Sレシオ-0.1xPER（株価収益率CXT は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計CXT 損益計算書（TTM）収益€7.34m売上原価€43.69m売上総利益-€36.34mその他の費用€15.05m収益-€51.39m直近の収益報告Dec 31, 2024次回決算日該当なし一株当たり利益（EPS）-0.83グロス・マージン-494.88%純利益率-699.82%有利子負債／自己資本比率-168.5%CXT の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2025/12/23 23:18終値2025/09/25 00:00収益2024/12/31年間収益2024/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社のGitHubページでご覧いただけます。また、レポートの活用方法に関するガイドやYouTubeのチュートリアルも用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Carmat SA 1 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。4 アナリスト機関Romain ZanaBNP ParibasMaxim JacobsEdison Investment ResearchArnaud DesprePortzamparc BNP Paribas1 その他のアナリストを表示
お知らせ • Aug 07Carmat SA to Report First Half, 2025 Results on Oct 31, 2025Carmat SA announced that they will report first half, 2025 results on Oct 31, 2025
お知らせ • Jun 02CARMAT Announces the First Commercial Implants of Its Aeson Artificial Heart Outside the European UnionCARMAT 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.
お知らせ • May 12CARMAT 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 FranceCARMAT 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.
お知らせ • Apr 15Carmat SA Receives FDA Conditional Approval to Initiate the Second Cohort of the EFS Study in the United StatesCarmat 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.
お知らせ • Apr 04CARMAT Announces the Publication of the Results of the Initial Clinical Experience with Aeson in Cardiogenic Shock Patients Previously on Temporary Extracorporeal Life SupportCARMAT 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.
お知らせ • Jan 31Carmat SA, Annual General Meeting, Jun 26, 2025Carmat SA, Annual General Meeting, Jun 26, 2025.
お知らせ • Aug 07Carmat SA to Report First Half, 2025 Results on Oct 31, 2025Carmat SA announced that they will report first half, 2025 results on Oct 31, 2025
お知らせ • Jun 02CARMAT Announces the First Commercial Implants of Its Aeson Artificial Heart Outside the European UnionCARMAT 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.
お知らせ • May 12CARMAT 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 FranceCARMAT 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.
お知らせ • Apr 15Carmat SA Receives FDA Conditional Approval to Initiate the Second Cohort of the EFS Study in the United StatesCarmat 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.
お知らせ • Apr 04CARMAT Announces the Publication of the Results of the Initial Clinical Experience with Aeson in Cardiogenic Shock Patients Previously on Temporary Extracorporeal Life SupportCARMAT 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.
お知らせ • Jan 31Carmat SA, Annual General Meeting, Jun 26, 2025Carmat SA, Annual General Meeting, Jun 26, 2025.
お知らせ • Jan 30+ 1 more updateCarmat SA to Report Fiscal Year 2024 Results on Apr 29, 2025Carmat SA announced that they will report fiscal year 2024 results at 9:00 AM, Central European Standard Time on Apr 29, 2025
お知らせ • Dec 26Carmat 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.
お知らせ • Nov 13Carmat Provides an Update on Aeson® Artificial Heart’s Uptake as A Bridge to Transplant in EuropeCarmat 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.
お知らせ • Jul 12Carmat SA Ordinary Shares to Be Deleted from OTC EquityCarmat SA Ordinary Shares (France) will be deleted from OTC Equity effective July 11, 2024, due to Inactive Security.
Board Change • Jun 26Insufficient new directorsNo 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.
お知らせ • Jun 25Carmat SA Announces Board ChangesCarmat 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 27New major risk - Shareholder dilutionThe 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).
お知らせ • May 18+ 1 more updateCarmat SA has filed a Follow-on Equity Offering in the amount of €62.57559 million.Carmat SA has filed a Follow-on Equity Offering in the amount of €62.57559 million. Security Name: Shares Security Type: Common Stock Securities Offered: 20,858,530 Price\Range: €3
お知らせ • May 06+ 1 more updateCARMAT Continues to Build on Its Momentum in the EFICAS StudyCARMAT provided an update on the EFICAS study. To date, 20 patients have been implanted with the Aeson heart as part of the EFICAS study, 9 of them in the first 4 months of 2024. The EFICAS study is conducted exclusively in France, in 10 hospitals whose teams are fully trained and ready to carry out the implants. To date, 8 hospitals have already enrolled patients in the study. The primary objective of the study is a minimum survival of 6 months on CARMAT support, without disabling stroke, or a successful heart transplant within the first 6 months. The study's interim success rate of 75%, which exceeds expectations, is very promising compared to previous CARMAT studies3 and existing therapies, given the poor state of health of the patients concerned. In view of these advances, CARMAT confirms its target of completing the EFICAS study, with a total of 52 Aeson implants, in the first half of 2025. The EFICAS study is essential both for the reimbursement of Aeson in France and for obtaining PMA (marketing authorization in the United States, issued by the FDA), which the Company anticipates for 2027. Study data are also an important catalyst for the adoption of Aeson across Europe.
Reported Earnings • May 05Full year 2023 earnings releasedFull 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.
お知らせ • Apr 24CARMAT Provides Revenue Guidance for the Year 2024CARMAT 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 16New minor risk - Market cap sizeThe 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).
お知らせ • Feb 06+ 2 more updatesCarmat SA to Report Fiscal Year 2023 Results on Apr 24, 2024Carmat SA announced that they will report fiscal year 2023 results on Apr 24, 2024
Breakeven Date Change • Jan 19Forecast to breakeven in 2026The 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.
お知らせ • Jan 18Carmat SA announced that it expects to receive €15.000002 million in fundingCarmat 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.
お知らせ • Jan 15Carmat Sa Provides Earnings Guidance for the Year 2024Carmat 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 31Forecast to breakeven in 2026The 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.
お知らせ • Dec 28Carmat Announces Software Enhancement Which Significantly Improves the Safety Profile of Its Aeson®? Artificial HeartCARMAT 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.
お知らせ • Dec 12CARMAT Announces the First Implant of the Aeson® Artificial Heart in a Patient Suffering from a Cardiac TumorCARMAT 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.
お知らせ • Oct 23CARMAT Presented Its Progress on the EFICAS Clinical Study at the 36th Journées de La Pitié in ParisCARMAT 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.
お知らせ • Oct 17Carmat 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 SACarmat 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 06New minor risk - Market cap sizeThe 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 05New major risk - Financial positionThe 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 28First half 2023 earnings releasedFirst 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.
お知らせ • Sep 27Carmat SA Provides Sales Guidance for the Fourth Quarter 2023Carmat 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 06New minor risk - ProfitabilityThe 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 06No longer forecast to breakevenThe 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 09No longer forecast to breakevenThe 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.
お知らせ • Jan 05+ 2 more updatesCarmat SA to Report Fiscal Year 2022 Results on Feb 23, 2023Carmat SA announced that they will report fiscal year 2022 results on Feb 23, 2023
お知らせ • Jan 04Carmat Announces the First Implantation of Aeson® Within the Framework of the Eficas Clinical Study in FranceCarmat 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.
お知らせ • Oct 26Carmat SA Receives Regulatory Approvals to Resume its Clinical Study in FranceCarmat 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.
お知らせ • Oct 25CARMAT Receives the Necessary Regulatory Approvals to Resume Aeson Commercial ImplantsCARMAT, 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 27Insufficient new directorsNo 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.
お知らせ • Apr 13Carmat SA announced that it expects to receive €36.46431 million in funding from a group of investorsCarmat 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 02Insufficient new directorsNo 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.
お知らせ • Dec 23CARMAT Announces the Completion of Its Investigations on Previously Identified Quality IssuesCARMAT 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.
お知らせ • Aug 27CARMAT Announces a New Commercial Implant of Its Aeson® Artificial Heart at University Medical Center Schleswig-holstein in Kiel, GermanyCARMAT 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.
お知らせ • Jul 15CARMAT Announces the First Human Implant of Its Total Artificial Heart in the United StatesCARMAT (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.
お知らせ • Feb 11CARMAT Receives U.S. Food and Drug Administration Approval to Use the New Version of Its Artificial Heart in the U.S. Early Feasibility StudyCARMAT 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 11New 90-day high: €34.30The 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.
お知らせ • Feb 01CARMAT Appoints Professor Christian Latrémouille as Director of Surgical AffairsCARMAT 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.
お知らせ • Jan 19+ 2 more updatesCarmat SA to Report Fiscal Year 2020 Results on Feb 10, 2021Carmat SA announced that they will report fiscal year 2020 results Pre-Market on Feb 10, 2021
Is New 90 Day High Low • Dec 30New 90-day high: €30.55The 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.
お知らせ • Dec 25Carmat SA Receives the CE Marking for Its Total Artificial HeartCarmat 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 11New 90-day high: €24.35The 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.
お知らせ • Nov 26CARMAT Provides Update on the US Early Feasibility StudyCARMAT 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 19New 90-day high: €22.75The 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 29New 90-day low: €17.80The 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 11New 90-day high: €20.40The 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.
お知らせ • Sep 22Carmat SA to Report First Half, 2020 Results on Sep 09, 2020Carmat SA announced that they will report first half, 2020 results on Sep 09, 2020
Is New 90 Day High Low • Sep 21New 90-day high: €20.35The 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.
