View ValuationEBR Systems 향후 성장Future 기준 점검 2/6EBR Systems은 연간 수입과 매출이 각각 15.4%와 44.9% 증가할 것으로 예상되고 EPS는 연간 11.5%만큼 감소할 것으로 예상됩니다.핵심 정보15.4%이익 성장률-11.51%EPS 성장률Medical Equipment 이익 성장14.7%매출 성장률44.9%향후 자기자본이익률n/a애널리스트 커버리지Low마지막 업데이트20 May 2026최근 향후 성장 업데이트업데이트 없음모든 업데이트 보기Recent 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.공시 • 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.공시 • 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.공시 • 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.공시 • 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)공시 • 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 0.04공시 • 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.공시 • 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.공시 • 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.공시 • 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).공시 • 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 Listing공시 • 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.공시 • Feb 13EBR Systems, Inc., Annual General Meeting, May 29, 2024EBR Systems, Inc., Annual General Meeting, May 29, 2024, at 16:00 Pacific Daylight.공시 • 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.공시 • 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).공시 • 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 Listing공시 • 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.공시 • 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.이익 및 매출 성장 예측CHIA:EBR - 애널리스트 향후 추정치 및 과거 재무 데이터 (USD Millions)날짜매출이익자유현금흐름영업현금흐름평균 애널리스트 수12/31/202877-34-39-36412/31/202743-52-54-53412/31/202616-56-57-5643/31/20264-55-67-60N/A12/31/20252-49-57-53N/A9/30/20251-45-51-49N/A6/30/20250-43-47-46N/A3/31/2025N/A-42-45-45N/A12/31/2024N/A-41-42-41N/A9/30/2024N/A-41-40-40N/A6/30/2024N/A-40-38-38N/A3/31/2024N/A-37-35-35N/A12/31/2023N/A-35-33-33N/A9/30/2023N/A-33-31-31N/A6/30/2023N/A-33-31-31N/A3/31/2023N/A-33-32-31N/A12/31/2022N/A-33-31-30N/A9/30/2022N/A-36-30-29N/A6/30/2022N/A-40-29-28N/A3/31/2022N/A-40-26-25N/A12/31/2021N/A-40-23-22N/A9/30/2021N/A-33-19-18N/A6/30/2021N/A-25-15-15N/A3/31/2021N/A-26-17-16N/A12/31/2020N/A-26-18-18N/A12/31/20191-25N/A-21N/A더 보기애널리스트 향후 성장 전망수입 대 저축률: EBR 향후 3년 동안 수익성이 없을 것으로 예상됩니다.수익 vs 시장: EBR 향후 3년 동안 수익성이 없을 것으로 예상됩니다.고성장 수익: EBR 향후 3년 동안 수익성이 없을 것으로 예상됩니다.수익 대 시장: EBR 의 수익(연간 44.9%)이 Australian 시장(연간 6.1%)보다 빠르게 성장할 것으로 예상됩니다.고성장 매출: EBR 의 수익(연간 44.9%)은 연간 20%보다 빠르게 증가할 것으로 예상됩니다.주당순이익 성장 예측향후 자기자본이익률미래 ROE: EBR의 자본 수익률이 3년 후 높을 것으로 예상되는지 판단하기에 데이터가 부족합니다.성장 기업 찾아보기7D1Y7D1Y7D1YHealthcare 산업의 고성장 기업.View Past Performance기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/05/22 18:36종가2026/05/22 00:00수익2026/03/31연간 수익2025/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델에 대한 자세한 내용은 당사의 Github 페이지에서 확인하실 수 있습니다. 또한 보고서 활용 방법에 대한 가이드와 YouTube 튜토리얼도 제공합니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스EBR Systems, Inc.는 5명의 분석가가 다루고 있습니다. 이 중 4명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Chris SavageBell PotterJohn HesterBell PotterMartyn JacobsBell Potter2명의 분석가 더 보기
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.
공시 • 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.
공시 • 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.
공시 • 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.
공시 • 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)
공시 • 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
공시 • 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.
공시 • 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.
공시 • 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.
공시 • 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).
공시 • 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
공시 • 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.
공시 • Feb 13EBR Systems, Inc., Annual General Meeting, May 29, 2024EBR Systems, Inc., Annual General Meeting, May 29, 2024, at 16:00 Pacific Daylight.
공시 • 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.
공시 • 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).
공시 • 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
공시 • 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.
공시 • 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.