EBR Systems（EBR）株式概要EBRシステムズ社は、ワイヤレス組織刺激用の埋め込み型システムを開発している。 詳細EBR 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2/6配当金0/6報酬当社が推定した公正価値より91.5%で取引されている 収益は年間44.88%増加すると予測されています リスク分析キャッシュランウェイが1年未満である 現在は利益が出ておらず、今後3年間で利益が出る見込みはない 過去1年間で株主の希薄化が進んだ 意味のある収益がありません ( $4M )すべてのリスクチェックを見るEBR Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueAU$Current PriceAU$0.49191.2% 割高 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-69m25m2016201920222025202620282031Revenue US$25.4mEarnings US$3.4mAdvancedSet Fair ValueView all narrativesEBR Systems, Inc. 競合他社Austco HealthcareSymbol: ASX:AHCMarket cap: AU$125.5mSomnoMedSymbol: ASX:SOMMarket cap: AU$120.5mOptiscan ImagingSymbol: ASX:OILMarket cap: AU$114.9mEMVision Medical DevicesSymbol: ASX:EMVMarket cap: AU$155.2m価格と性能株価の高値、安値、推移の概要EBR Systems過去の株価現在の株価AU$0.4952週高値AU$1.4852週安値AU$0.49ベータ0.591ヶ月の変化-18.18%3ヶ月変化-36.94%1年変化-58.92%3年間の変化-58.23%5年間の変化n/aIPOからの変化-52.40%最新ニュースBoard Change • May 20Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • May 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • Feb 12EBR Systems, Inc., Annual General Meeting, May 07, 2026EBR Systems, Inc., Annual General Meeting, May 07, 2026.Board Change • Dec 24Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • Nov 07EBR Systems Achieves First Enrollments in the WiSE-Up Study for Heart Failure PatientsEBR Systems, Inc. announced the first patient enrollments in the WiSE®? System Utilization & Performance (WiSE-UP) Study. The first two patients were treated at St. Bernards Heart & Vascular Center in Arkansas by Dr. Devi Nair, a globally recognized electrophysiologist. This milestone marks an important step forward in advancing cardiac resynchronization therapy (CRT) for patients with heart failure with the addition of LVEP. Sponsored by EBR Systems, the WiSE-UP Study is a prospective, observational post-approval study designed to evaluate real-world outcomes in patients treated with the FDA-approved WiSE System, which delivers left ventricular endocardial pacing (LVEP) for CRT. The study will follow more than 300 patients across 50 centers over five years, generating both short- and long-term performance data to inform future clinical practice.Board Change • Aug 18Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.最新情報をもっと見るRecent updatesBoard Change • May 20Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • May 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • Feb 12EBR Systems, Inc., Annual General Meeting, May 07, 2026EBR Systems, Inc., Annual General Meeting, May 07, 2026.Board Change • Dec 24Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • Nov 07EBR Systems Achieves First Enrollments in the WiSE-Up Study for Heart Failure PatientsEBR Systems, Inc. announced the first patient enrollments in the WiSE®? System Utilization & Performance (WiSE-UP) Study. The first two patients were treated at St. Bernards Heart & Vascular Center in Arkansas by Dr. Devi Nair, a globally recognized electrophysiologist. This milestone marks an important step forward in advancing cardiac resynchronization therapy (CRT) for patients with heart failure with the addition of LVEP. Sponsored by EBR Systems, the WiSE-UP Study is a prospective, observational post-approval study designed to evaluate real-world outcomes in patients treated with the FDA-approved WiSE System, which delivers left ventricular endocardial pacing (LVEP) for CRT. The study will follow more than 300 patients across 50 centers over five years, generating both short- and long-term performance data to inform future clinical practice.Board Change • Aug 18Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • Jun 30EBR Systems, Inc. Announces Executive ChangesEBR Systems, Inc. announced that the company has appointed Mr. Kobe Li as the Australian Company Secretary, effective June 30, 2025. Mr. Brendan Case has resigned as Company Secretary. Kobe is an experienced company secretary for a number of ASX listed companies. He has previously worked at the ASX as a Senior Advisor in the Listings Compliance team and is a member of the Governance Institute of Australia.お知らせ • May 23EBR Systems, Inc. has filed a Follow-on Equity Offering.EBR Systems, Inc. has filed a Follow-on Equity Offering. Security Name: Cash Depository Interest Security Type: Depositary Receipt (Common Stock)お知らせ • May 22EBR Systems, Inc. has completed a Follow-on Equity Offering in the amount of AUD 55.9 million.EBR Systems, Inc. has completed a Follow-on Equity Offering in the amount of AUD 55.9 million. Security Name: Cash Depository Interest Security Type: Depositary Receipt (Common Stock) Securities Offered: 55,900,000 Price\Range: AUD 1 Discount Per Security: AUD 0.04お知らせ • Apr 17FDA Approves WiSE System, World's First and Only Leadless Left Ventricular Endocardial Pacing (LVEP) Device for CRTEBR Systems, Inc. has received FDA approval of the WiSE®? System, which marks a significant leap forward in the treatment of heart failure. Unlike conventional CRT, the WiSE System is the first and only to deliver leadless left ventricular endocardial pacing (LVEP), that closely aligns with the heart's natural conduction pathway. The endocardial approach represents a more physiological method of resynchronization and allows electrophysiologists to treat patients that are not able to receive lead-based devices. This advancement offers a pioneering treatment option for patients who have limited access to conventional CRT therapies. Conventional CRT leaves too many heart failure patients behind. The WiSE System was designed for them. It allows physicians to help these key patient populations: Patients with challenging anatomy where the LV lead could not be implanted; Patients with acute or chronic LV lead failure; Patients with high procedural risk for LV lead placement; Patients with leadless pacemakers who need CRT, yet are often poor candidates for conventional upgrades. In short: WiSE brings CRT to more patients than ever before. Backed by Data. Reimagining Delivery of CRT. The SOLVE-CRT trial has delivered promising results for heart failure patients. The WiSE System offers hope to those who have tried other therapies without success and were told no further options existed-- until now; 16.4% reduction in LV end-systolic volume (LVESV--a key marker of reverse remodeling (p=0.003); Shorter QRS durations by an average of 39ms-- an indicator of electrical resynchronization; Over 55% improved at least one NYHA class and another 40% remained stable. The WiSE System syncs with existing pacing devices--pacemakers, ICDs, or CRTs--using a subcutaneous ultrasound Transmitter to power an ultra-compact Electrode implanted in the LV. No leads. No lead navigation. Just endocardial pacing that's more physiologic, from the inside out.お知らせ • Apr 15EBR Systems, Inc. Announces US Food and Drug Administration Approval of EBR's WiSE CRT SystemEBR Systems, Inc. announced the US Food and Drug Administration (FDA) approval of EBR's WiSE cardiac resynchronisation therapy ("CRT") System. The FDA has issued an approval letter authorizing the commercial marketing of EBR's WiSE CRT System in the US. The FDA approval of the WiSE CRT System was supported by the submission of five comprehensive modules as part of the Premarket Approval ("PMA") application, the completion of a Pre-Approval Inspection (PAI) of EBR's manufacturing facilities in January 2025 with no form FDA 483 observations, and the resolution of any queries that arose from the FDA's review of the submitted modules. Securing FDA approval for the WiSE CRT System is a transformative moment, marking transition from clinical development to commercialization. With FDA approval in hand, EBR is well-positioned to bring innovative solution to market, delivering real impact to patients and servicing a significant unmet need. The FDA approved indications for use are as follows: The WiSE CRT System is indicated for adult patients who are at least 22 years of age, are indicated for cardiac resynchronization therapy (CRT), have an existing implanted right ventricular pacing system, and are in one of the following two categories: Patients in whom previous coronary sinus lead implantation was unsuccessful or where an implanted lead has been turned off - referred to as "pre previously untreatable." Patients with previously implanted pacemakers or ICD's in whom standard CRT upgrade is not advisable due to known relative contraindications for CS lead or CRT device implantation, referred to as "high-risk upgrades." EBR SYSTEMS, INC. Chronic lead failure: patients with inactive or malfunctioning left-heart CRT leads High-risk upgrade: patients who have existing pacing systems, including leadless pacemakers, who need an upgrade to biventricular pacing due to heart failure progression and are not candidates for CRT coronary sinus lead placement. Medtronic's Micra leadless pacemaker has been qualified for use with WiSE CRT. The FDA approval letter was received by EBR via email at 10:47am PDT on 11 April 2025 (3:47am AEST on 12 April 2025) in line with the Company's expectation of obtaining approval on or before 13 April 2025. With FDA approval secured, EBR will launch the WiSE CRT System in phases. A limited market release is planned for 2025, with sales expected during the second half of the year, ramping towards full commercial distribution during 2026. The initial phase of the rollout will concentrate on high-volume centers, specifically those involved in previous clinical trials, aimed at gathering early user experience and facilitating wider adoption. The company will concurrently conduct a post-approval study, which is an FDA requirement as a condition of approval. As a result of the FDA's Breakthrough Device Designation, EBR expects to qualify for two reimbursement schemes: New Technology Add-on Payment (NTAP - inpat patients) and Transitional Pass-Through payment (TPT - outpatients). This strategic rollout ensures the WiSE CRT System are introduced with the right clinical support, training, and infrastructure in place.お知らせ • Feb 19EBR Systems, Inc., Annual General Meeting, May 29, 2025EBR Systems, Inc., Annual General Meeting, May 29, 2025.Board Change • Feb 04Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • Dec 24Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • Nov 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • Oct 25EBR Systems, Inc. to Report Q3, 2024 Results on Nov 13, 2024EBR Systems, Inc. announced that they will report Q3, 2024 results Pre-Market on Nov 13, 2024New Risk • Sep 30New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 19% This is considered a minor 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 Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$42m net loss in 2 years). Shareholders have been diluted in the past year (19% increase in shares outstanding).お知らせ • Sep 20EBR Systems, Inc. has filed a Follow-on Equity Offering in the amount of AUD 50.002187 million.EBR Systems, Inc. has filed a Follow-on Equity Offering in the amount of AUD 50.002187 million. Security Name: CHESS Depositary Insterests Security Type: Depositary Receipt (Common Stock) Securities Offered: 45,568,852 Price\Range: AUD 0.82 Discount Per Security: AUD 0.0492 Security Name: CHESS Depositary Insterests Security Type: Depositary Receipt (Common Stock) Securities Offered: 15,409,424 Price\Range: AUD 0.82 Discount Per Security: AUD 0.0492 Transaction Features: Rights Offering; Subsequent Direct Listingお知らせ • Sep 05EBR Systems, Inc. 1 CDI TO 1 SHARE OF COM STK to be Deleted from OTC EquityEBR Systems, Inc. 1 CDI TO 1 SHARE OF COM STK will be deleted from OTC Equity effective September 04, 2024, due to inactive security.New Risk • Sep 04New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 2.8% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$42m net loss in 2 years).Buy Or Sell Opportunity • Aug 05Now 23% undervalued after recent price dropOver the last 90 days, the stock has fallen 6.0% to AU$1.03. The fair value is estimated to be AU$1.33, however this is not to be taken as a buy recommendation but rather should be used as a guide only.Buy Or Sell Opportunity • Apr 24Now 22% overvalued after recent price riseOver the last 90 days, the stock has risen 24% to AU$0.91. The fair value is estimated to be AU$0.74, however this is not to be taken as a sell recommendation but rather should be used as a guide only.Buy Or Sell Opportunity • Apr 24Now 22% overvalued after recent price riseOver the last 90 days, the stock has risen 24% to AU$0.91. The fair value is estimated to be AU$0.74, however this is not to be taken as a sell recommendation but rather should be used as a guide only.Buy Or Sell Opportunity • Apr 05Now 25% overvalued after recent price riseOver the last 90 days, the stock has risen 45% to AU$0.92. The fair value is estimated to be AU$0.74, however this is not to be taken as a sell recommendation but rather should be used as a guide only.お知らせ • Feb 13EBR Systems, Inc., Annual General Meeting, May 29, 2024EBR Systems, Inc., Annual General Meeting, May 29, 2024, at 16:00 Pacific Daylight.お知らせ • Oct 26EBR Systems, Inc. Announces Positive Results from First-In-Human Fully Leadless CRT in the US, Published in the Journal of the American College of CardiologyEBR Systems, Inc. announced that positive results from the first completely leadless cardiac resynchronization therapy (CRT) in the United States have been published in The Journal of the American College of Cardiology (JACC). The positive results published in JACC are based on a 1-year follow-up of the first-in-human implantation in the US of totally leadless CRT pacing utilizing the Micra leadless pacing system in the right ventricle in conjunction with EBR's investigational WiSE®? CRT Electrode in the left ventricle of the heart. At 12-months, the patient showed improved heart failure symptoms (NYHA Class III to II), no recurrent heart failure-related hospitalization, a reduction in QRS duration, and an improvement in left ventricle from 30% to 65%. This first use in the US of the WiSE CRT System as a first-line therapy is a future market expansion opportunity for EBR. The initial addressable market of $2.6 billion is focused on treating patients who had previously failed CRT and by treating new CRT patients, the addressable market could increase to $6.8 billion. Based on the patient's health complications and risks, the implantation of EBR's investigational Wi SE CRT System alongside Medtronic's Micra received requisite approval from the Institutional Review Board (IRB) and U.S. Food and Drug Administration (FDA) on compassionate grounds. The Journal of theAmerican College of Cardiology (J ACC) is a prestigious, peer-reviewed medical journal dedicated to the field of cardiology. As a leading publication in the cardiovascular sciences, JACC provides a platform for the dissemination of research, clinical studies, and breakthroughs in cardiovascular medicine. The WiSE®? CRT System has the potential to offer a new treatment option for patients including the 3 million heart failure patients worldwide who were previously untreatable by conventional CRT, and potentially, the 64 million heart failure patients across the globe.お知らせ • Sep 13Ebr Systems, Inc. Announces Chief Financial Officer ChangesEBR Systems, Inc. announced the appointment of Mr. Gary Doherty as Chief Financial Officer of the Company, effective as of 11 September 2023. Mr. Doherty will replace EBR's current CFO, Frank Hettmann, and will help drive the Company forward with proven international experience across technology, healthcare, finance, and operations. Gary has a proven track record of developing high performing finance functions in international medical device corporations across his 30-year career. Prior to joining EBR, Mr. Doherty was the Chief Financial Officer at Acutus Medical, a medical technology company specialising in cardiac arrhythmia and atrial fibrillation treatment. He was responsible not only for the financial operations of the business which included leading a successful public offering but also played a pivotal role securing distribution agreements with strategic partners to accelerate global expansion and drive commercialisation. Before that, Gary served as Group Plant Controller for 12 years for Volcano Corporation (Nasdaq:VOLC), a company specialising in the development, manufacture, and distribution of medical products. Gary holds a Bachelor of Science degree in Business Administration from the San Diego State University. Current CFO, Frank Hettmann, has agreed to stay with the Company until 30 November 2023, to help Gary transition to the CFO role.New Risk • Jul 07New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 11% This is considered a minor 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 Earnings are forecast to decline by an average of 6.3% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$39m net loss in 3 years). Shareholders have been diluted in the past year (11% increase in shares outstanding).お知らせ • Jul 07EBR Systems, Inc. has completed a Follow-on Equity Offering in the amount of AUD 30 million.EBR Systems, Inc. has completed a Follow-on Equity Offering in the amount of AUD 30 million. Security Name: CHESS Depositary Interest Security Type: Depositary Receipt (Common Stock) Securities Offered: 5,494,506 Price\Range: AUD 0.91 Discount Per Security: AUD 0 Security Name: CHESS Depositary Interest Security Type: Depositary Receipt (Common Stock) Securities Offered: 27,472,527 Price\Range: AUD 0.91 Discount Per Security: AUD 0.0546 Transaction Features: Subsequent Direct Listingお知らせ • May 23Ebr Systems' Pivotal Solve-Crt Trial Meets EndpointsEBR Systems, Inc. has met its primary safety and efficacy endpoints in its pivotal SOLVE-CRT trial of the WiSE®? Cardiac Resynchronization Therapy (CRT) System. EBR Systems' WiSE®? system is on track to submit a Premarket Approval (PMA) application to the Food and Drug Administration (FDA) in early 2024 after successfully achieving primary and secondary endpoints in its pivotal trial which ended early due to success. The FDA has granted the WiSE CRT System a Breakthrough Device designation, which supports a priority of the WiSE CRT System. SOLVE-CRT was an international, multicenter clinical trial designed to enrol up to 300 patients in randomized and single-arm parts. The study was conducted across 43 sites in the US, 10 in Australia, and 15 centers in the United Kingdom, Germany, France, Italy, and the Netherlands. SOLVE- CRT was powered for an interim analysis such that if the primary efficacy and safety were met with 183 patients at the 6-month follow-up, the study could be declined a success and be halted early. The study was led by Co-Principal Investigators, Drs Jagmeet P. Singh, MD, DPhil, Professor of Medicine at Harvard Medical School, Director, Massachusetts General Hospital, Boston, MA; and Mary Norine (Minnow) Walsh, MD, Medical Director, Ascension St. Vincent Heart Center, Indianapolis, IN. The SOLVE-CRT trial results were presented by Dr. Singh at the Heart Rhythm Society (HRS) 2023 annual meeting, the largest gathering of heart rhythm professionals globally. The inclusion of the presentation in the Late Breaking Clinical Trials session during the premier global electrophysiology conference underpins the importance of EBR's SOLVE-CRT study within the cardiovascular field, with the aim to materially improve patient outcomes.お知らせ • Feb 01EBR Systems, Inc., Annual General Meeting, May 23, 2023EBR Systems, Inc., Annual General Meeting, May 23, 2023, at 09:00 AUS Eastern Standard Time.Board Change • Jan 11Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Bronwyn Evans was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.Board Change • Nov 16Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Bronwyn Evans was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.Board Change • Oct 11Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Bronwyn Evans was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.株主還元EBRAU Medical EquipmentAU 市場7D-13.9%2.7%-0.4%1Y-58.9%-44.3%2.9%株主還元を見る業界別リターン: EBR過去 1 年間で-44.3 % の収益を上げたAustralian Medical Equipment業界を下回りました。リターン対市場: EBRは、過去 1 年間で2.9 % のリターンを上げたAustralian市場を下回りました。価格変動Is EBR's price volatile compared to industry and market?EBR volatilityEBR Average Weekly Movement11.9%Medical Equipment Industry Average Movement10.6%Market Average Movement10.5%10% most volatile stocks in AU Market17.5%10% least volatile stocks in AU Market4.4%安定した株価: EBR 、 Australian市場と比較して、過去 3 か月間で大きな価格変動はありませんでした。時間の経過による変動: EBRの 週次ボラティリティ ( 12% ) は過去 1 年間安定しています。会社概要設立従業員CEO（最高経営責任者ウェブサイト2003135John McCutcheonwww.ebrsystemsinc.comEBRシステムズ社は、ワイヤレス組織刺激用の植え込み型システムを開発している。同社はWiSE心臓再同期療法システムを提供しており、これはワイヤーやリード線を使用することなく心臓のリズム状態を修正するために心内膜組織に刺激を与えることができる植え込み型心臓ペーシングシステムであり、SOLVE-CRTは治験用機器として認可されている。同社は2003年に設立され、カリフォルニア州サニーベールに本社を置いている。もっと見るEBR Systems, Inc. 基礎のまとめEBR Systems の収益と売上を時価総額と比較するとどうか。EBR 基礎統計学時価総額AU$220.77m収益（TTM）-AU$77.59m売上高(TTM)AU$5.58m39.5xP/Sレシオ-2.8xPER（株価収益率EBR 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EBR 損益計算書（TTM）収益US$3.98m売上原価US$3.31m売上総利益US$674.00kその他の費用US$55.95m収益-US$55.28m直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益（EPS）-0.12グロス・マージン16.94%純利益率-1,389.24%有利子負債／自己資本比率430.3%EBR 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2026/05/22 19:39終値2026/05/22 00:00収益2026/03/31年間収益2025/12/31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本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、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。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EBR Systems, Inc. 4 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。5 アナリスト機関Chris SavageBell PotterJohn HesterBell PotterMartyn JacobsBell Potter2 その他のアナリストを表示
Board Change • May 20Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • May 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Feb 12EBR Systems, Inc., Annual General Meeting, May 07, 2026EBR Systems, Inc., Annual General Meeting, May 07, 2026.
Board Change • Dec 24Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Nov 07EBR Systems Achieves First Enrollments in the WiSE-Up Study for Heart Failure PatientsEBR Systems, Inc. announced the first patient enrollments in the WiSE®? System Utilization & Performance (WiSE-UP) Study. The first two patients were treated at St. Bernards Heart & Vascular Center in Arkansas by Dr. Devi Nair, a globally recognized electrophysiologist. This milestone marks an important step forward in advancing cardiac resynchronization therapy (CRT) for patients with heart failure with the addition of LVEP. Sponsored by EBR Systems, the WiSE-UP Study is a prospective, observational post-approval study designed to evaluate real-world outcomes in patients treated with the FDA-approved WiSE System, which delivers left ventricular endocardial pacing (LVEP) for CRT. The study will follow more than 300 patients across 50 centers over five years, generating both short- and long-term performance data to inform future clinical practice.
Board Change • Aug 18Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • May 20Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • May 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Feb 12EBR Systems, Inc., Annual General Meeting, May 07, 2026EBR Systems, Inc., Annual General Meeting, May 07, 2026.
Board Change • Dec 24Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Nov 07EBR Systems Achieves First Enrollments in the WiSE-Up Study for Heart Failure PatientsEBR Systems, Inc. announced the first patient enrollments in the WiSE®? System Utilization & Performance (WiSE-UP) Study. The first two patients were treated at St. Bernards Heart & Vascular Center in Arkansas by Dr. Devi Nair, a globally recognized electrophysiologist. This milestone marks an important step forward in advancing cardiac resynchronization therapy (CRT) for patients with heart failure with the addition of LVEP. Sponsored by EBR Systems, the WiSE-UP Study is a prospective, observational post-approval study designed to evaluate real-world outcomes in patients treated with the FDA-approved WiSE System, which delivers left ventricular endocardial pacing (LVEP) for CRT. The study will follow more than 300 patients across 50 centers over five years, generating both short- and long-term performance data to inform future clinical practice.
Board Change • Aug 18Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Jun 30EBR Systems, Inc. Announces Executive ChangesEBR Systems, Inc. announced that the company has appointed Mr. Kobe Li as the Australian Company Secretary, effective June 30, 2025. Mr. Brendan Case has resigned as Company Secretary. Kobe is an experienced company secretary for a number of ASX listed companies. He has previously worked at the ASX as a Senior Advisor in the Listings Compliance team and is a member of the Governance Institute of Australia.
お知らせ • May 23EBR Systems, Inc. has filed a Follow-on Equity Offering.EBR Systems, Inc. has filed a Follow-on Equity Offering. Security Name: Cash Depository Interest Security Type: Depositary Receipt (Common Stock)
お知らせ • May 22EBR Systems, Inc. has completed a Follow-on Equity Offering in the amount of AUD 55.9 million.EBR Systems, Inc. has completed a Follow-on Equity Offering in the amount of AUD 55.9 million. Security Name: Cash Depository Interest Security Type: Depositary Receipt (Common Stock) Securities Offered: 55,900,000 Price\Range: AUD 1 Discount Per Security: AUD 0.04
お知らせ • Apr 17FDA Approves WiSE System, World's First and Only Leadless Left Ventricular Endocardial Pacing (LVEP) Device for CRTEBR Systems, Inc. has received FDA approval of the WiSE®? System, which marks a significant leap forward in the treatment of heart failure. Unlike conventional CRT, the WiSE System is the first and only to deliver leadless left ventricular endocardial pacing (LVEP), that closely aligns with the heart's natural conduction pathway. The endocardial approach represents a more physiological method of resynchronization and allows electrophysiologists to treat patients that are not able to receive lead-based devices. This advancement offers a pioneering treatment option for patients who have limited access to conventional CRT therapies. Conventional CRT leaves too many heart failure patients behind. The WiSE System was designed for them. It allows physicians to help these key patient populations: Patients with challenging anatomy where the LV lead could not be implanted; Patients with acute or chronic LV lead failure; Patients with high procedural risk for LV lead placement; Patients with leadless pacemakers who need CRT, yet are often poor candidates for conventional upgrades. In short: WiSE brings CRT to more patients than ever before. Backed by Data. Reimagining Delivery of CRT. The SOLVE-CRT trial has delivered promising results for heart failure patients. The WiSE System offers hope to those who have tried other therapies without success and were told no further options existed-- until now; 16.4% reduction in LV end-systolic volume (LVESV--a key marker of reverse remodeling (p=0.003); Shorter QRS durations by an average of 39ms-- an indicator of electrical resynchronization; Over 55% improved at least one NYHA class and another 40% remained stable. The WiSE System syncs with existing pacing devices--pacemakers, ICDs, or CRTs--using a subcutaneous ultrasound Transmitter to power an ultra-compact Electrode implanted in the LV. No leads. No lead navigation. Just endocardial pacing that's more physiologic, from the inside out.
お知らせ • Apr 15EBR Systems, Inc. Announces US Food and Drug Administration Approval of EBR's WiSE CRT SystemEBR Systems, Inc. announced the US Food and Drug Administration (FDA) approval of EBR's WiSE cardiac resynchronisation therapy ("CRT") System. The FDA has issued an approval letter authorizing the commercial marketing of EBR's WiSE CRT System in the US. The FDA approval of the WiSE CRT System was supported by the submission of five comprehensive modules as part of the Premarket Approval ("PMA") application, the completion of a Pre-Approval Inspection (PAI) of EBR's manufacturing facilities in January 2025 with no form FDA 483 observations, and the resolution of any queries that arose from the FDA's review of the submitted modules. Securing FDA approval for the WiSE CRT System is a transformative moment, marking transition from clinical development to commercialization. With FDA approval in hand, EBR is well-positioned to bring innovative solution to market, delivering real impact to patients and servicing a significant unmet need. The FDA approved indications for use are as follows: The WiSE CRT System is indicated for adult patients who are at least 22 years of age, are indicated for cardiac resynchronization therapy (CRT), have an existing implanted right ventricular pacing system, and are in one of the following two categories: Patients in whom previous coronary sinus lead implantation was unsuccessful or where an implanted lead has been turned off - referred to as "pre previously untreatable." Patients with previously implanted pacemakers or ICD's in whom standard CRT upgrade is not advisable due to known relative contraindications for CS lead or CRT device implantation, referred to as "high-risk upgrades." EBR SYSTEMS, INC. Chronic lead failure: patients with inactive or malfunctioning left-heart CRT leads High-risk upgrade: patients who have existing pacing systems, including leadless pacemakers, who need an upgrade to biventricular pacing due to heart failure progression and are not candidates for CRT coronary sinus lead placement. Medtronic's Micra leadless pacemaker has been qualified for use with WiSE CRT. The FDA approval letter was received by EBR via email at 10:47am PDT on 11 April 2025 (3:47am AEST on 12 April 2025) in line with the Company's expectation of obtaining approval on or before 13 April 2025. With FDA approval secured, EBR will launch the WiSE CRT System in phases. A limited market release is planned for 2025, with sales expected during the second half of the year, ramping towards full commercial distribution during 2026. The initial phase of the rollout will concentrate on high-volume centers, specifically those involved in previous clinical trials, aimed at gathering early user experience and facilitating wider adoption. The company will concurrently conduct a post-approval study, which is an FDA requirement as a condition of approval. As a result of the FDA's Breakthrough Device Designation, EBR expects to qualify for two reimbursement schemes: New Technology Add-on Payment (NTAP - inpat patients) and Transitional Pass-Through payment (TPT - outpatients). This strategic rollout ensures the WiSE CRT System are introduced with the right clinical support, training, and infrastructure in place.
お知らせ • Feb 19EBR Systems, Inc., Annual General Meeting, May 29, 2025EBR Systems, Inc., Annual General Meeting, May 29, 2025.
Board Change • Feb 04Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • Dec 24Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • Nov 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Oct 25EBR Systems, Inc. to Report Q3, 2024 Results on Nov 13, 2024EBR Systems, Inc. announced that they will report Q3, 2024 results Pre-Market on Nov 13, 2024
New Risk • Sep 30New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 19% This is considered a minor 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 Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$42m net loss in 2 years). Shareholders have been diluted in the past year (19% increase in shares outstanding).
お知らせ • Sep 20EBR Systems, Inc. has filed a Follow-on Equity Offering in the amount of AUD 50.002187 million.EBR Systems, Inc. has filed a Follow-on Equity Offering in the amount of AUD 50.002187 million. Security Name: CHESS Depositary Insterests Security Type: Depositary Receipt (Common Stock) Securities Offered: 45,568,852 Price\Range: AUD 0.82 Discount Per Security: AUD 0.0492 Security Name: CHESS Depositary Insterests Security Type: Depositary Receipt (Common Stock) Securities Offered: 15,409,424 Price\Range: AUD 0.82 Discount Per Security: AUD 0.0492 Transaction Features: Rights Offering; Subsequent Direct Listing
お知らせ • Sep 05EBR Systems, Inc. 1 CDI TO 1 SHARE OF COM STK to be Deleted from OTC EquityEBR Systems, Inc. 1 CDI TO 1 SHARE OF COM STK will be deleted from OTC Equity effective September 04, 2024, due to inactive security.
New Risk • Sep 04New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 2.8% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$42m net loss in 2 years).
Buy Or Sell Opportunity • Aug 05Now 23% undervalued after recent price dropOver the last 90 days, the stock has fallen 6.0% to AU$1.03. The fair value is estimated to be AU$1.33, however this is not to be taken as a buy recommendation but rather should be used as a guide only.
Buy Or Sell Opportunity • Apr 24Now 22% overvalued after recent price riseOver the last 90 days, the stock has risen 24% to AU$0.91. The fair value is estimated to be AU$0.74, however this is not to be taken as a sell recommendation but rather should be used as a guide only.
Buy Or Sell Opportunity • Apr 24Now 22% overvalued after recent price riseOver the last 90 days, the stock has risen 24% to AU$0.91. The fair value is estimated to be AU$0.74, however this is not to be taken as a sell recommendation but rather should be used as a guide only.
Buy Or Sell Opportunity • Apr 05Now 25% overvalued after recent price riseOver the last 90 days, the stock has risen 45% to AU$0.92. The fair value is estimated to be AU$0.74, however this is not to be taken as a sell recommendation but rather should be used as a guide only.
お知らせ • Feb 13EBR Systems, Inc., Annual General Meeting, May 29, 2024EBR Systems, Inc., Annual General Meeting, May 29, 2024, at 16:00 Pacific Daylight.
お知らせ • Oct 26EBR Systems, Inc. Announces Positive Results from First-In-Human Fully Leadless CRT in the US, Published in the Journal of the American College of CardiologyEBR Systems, Inc. announced that positive results from the first completely leadless cardiac resynchronization therapy (CRT) in the United States have been published in The Journal of the American College of Cardiology (JACC). The positive results published in JACC are based on a 1-year follow-up of the first-in-human implantation in the US of totally leadless CRT pacing utilizing the Micra leadless pacing system in the right ventricle in conjunction with EBR's investigational WiSE®? CRT Electrode in the left ventricle of the heart. At 12-months, the patient showed improved heart failure symptoms (NYHA Class III to II), no recurrent heart failure-related hospitalization, a reduction in QRS duration, and an improvement in left ventricle from 30% to 65%. This first use in the US of the WiSE CRT System as a first-line therapy is a future market expansion opportunity for EBR. The initial addressable market of $2.6 billion is focused on treating patients who had previously failed CRT and by treating new CRT patients, the addressable market could increase to $6.8 billion. Based on the patient's health complications and risks, the implantation of EBR's investigational Wi SE CRT System alongside Medtronic's Micra received requisite approval from the Institutional Review Board (IRB) and U.S. Food and Drug Administration (FDA) on compassionate grounds. The Journal of theAmerican College of Cardiology (J ACC) is a prestigious, peer-reviewed medical journal dedicated to the field of cardiology. As a leading publication in the cardiovascular sciences, JACC provides a platform for the dissemination of research, clinical studies, and breakthroughs in cardiovascular medicine. The WiSE®? CRT System has the potential to offer a new treatment option for patients including the 3 million heart failure patients worldwide who were previously untreatable by conventional CRT, and potentially, the 64 million heart failure patients across the globe.
お知らせ • Sep 13Ebr Systems, Inc. Announces Chief Financial Officer ChangesEBR Systems, Inc. announced the appointment of Mr. Gary Doherty as Chief Financial Officer of the Company, effective as of 11 September 2023. Mr. Doherty will replace EBR's current CFO, Frank Hettmann, and will help drive the Company forward with proven international experience across technology, healthcare, finance, and operations. Gary has a proven track record of developing high performing finance functions in international medical device corporations across his 30-year career. Prior to joining EBR, Mr. Doherty was the Chief Financial Officer at Acutus Medical, a medical technology company specialising in cardiac arrhythmia and atrial fibrillation treatment. He was responsible not only for the financial operations of the business which included leading a successful public offering but also played a pivotal role securing distribution agreements with strategic partners to accelerate global expansion and drive commercialisation. Before that, Gary served as Group Plant Controller for 12 years for Volcano Corporation (Nasdaq:VOLC), a company specialising in the development, manufacture, and distribution of medical products. Gary holds a Bachelor of Science degree in Business Administration from the San Diego State University. Current CFO, Frank Hettmann, has agreed to stay with the Company until 30 November 2023, to help Gary transition to the CFO role.
New Risk • Jul 07New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 11% This is considered a minor 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 Earnings are forecast to decline by an average of 6.3% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$39m net loss in 3 years). Shareholders have been diluted in the past year (11% increase in shares outstanding).
お知らせ • Jul 07EBR Systems, Inc. has completed a Follow-on Equity Offering in the amount of AUD 30 million.EBR Systems, Inc. has completed a Follow-on Equity Offering in the amount of AUD 30 million. Security Name: CHESS Depositary Interest Security Type: Depositary Receipt (Common Stock) Securities Offered: 5,494,506 Price\Range: AUD 0.91 Discount Per Security: AUD 0 Security Name: CHESS Depositary Interest Security Type: Depositary Receipt (Common Stock) Securities Offered: 27,472,527 Price\Range: AUD 0.91 Discount Per Security: AUD 0.0546 Transaction Features: Subsequent Direct Listing
お知らせ • May 23Ebr Systems' Pivotal Solve-Crt Trial Meets EndpointsEBR Systems, Inc. has met its primary safety and efficacy endpoints in its pivotal SOLVE-CRT trial of the WiSE®? Cardiac Resynchronization Therapy (CRT) System. EBR Systems' WiSE®? system is on track to submit a Premarket Approval (PMA) application to the Food and Drug Administration (FDA) in early 2024 after successfully achieving primary and secondary endpoints in its pivotal trial which ended early due to success. The FDA has granted the WiSE CRT System a Breakthrough Device designation, which supports a priority of the WiSE CRT System. SOLVE-CRT was an international, multicenter clinical trial designed to enrol up to 300 patients in randomized and single-arm parts. The study was conducted across 43 sites in the US, 10 in Australia, and 15 centers in the United Kingdom, Germany, France, Italy, and the Netherlands. SOLVE- CRT was powered for an interim analysis such that if the primary efficacy and safety were met with 183 patients at the 6-month follow-up, the study could be declined a success and be halted early. The study was led by Co-Principal Investigators, Drs Jagmeet P. Singh, MD, DPhil, Professor of Medicine at Harvard Medical School, Director, Massachusetts General Hospital, Boston, MA; and Mary Norine (Minnow) Walsh, MD, Medical Director, Ascension St. Vincent Heart Center, Indianapolis, IN. The SOLVE-CRT trial results were presented by Dr. Singh at the Heart Rhythm Society (HRS) 2023 annual meeting, the largest gathering of heart rhythm professionals globally. The inclusion of the presentation in the Late Breaking Clinical Trials session during the premier global electrophysiology conference underpins the importance of EBR's SOLVE-CRT study within the cardiovascular field, with the aim to materially improve patient outcomes.
お知らせ • Feb 01EBR Systems, Inc., Annual General Meeting, May 23, 2023EBR Systems, Inc., Annual General Meeting, May 23, 2023, at 09:00 AUS Eastern Standard Time.
Board Change • Jan 11Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Bronwyn Evans was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
Board Change • Nov 16Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Bronwyn Evans was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
Board Change • Oct 11Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Bronwyn Evans was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
