View Financial HealthEBR Systems 배당 및 자사주 매입배당 기준 점검 0/6EBR Systems 배당금을 지급한 기록이 없습니다.핵심 정보n/a배당 수익률-31.3%자사주 매입 수익률총 주주 수익률-31.3%미래 배당 수익률0%배당 성장률n/a다음 배당 지급일n/a배당락일n/a주당 배당금n/a배당 성향n/a최근 배당 및 자사주 매입 업데이트업데이트 없음모든 업데이트 보기Recent updates공시 • Feb 12EBR Systems, Inc., Annual General Meeting, May 07, 2026EBR Systems, Inc., Annual General Meeting, May 07, 2026.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.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.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.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.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.지급의 안정성과 성장배당 데이터 가져오는 중안정적인 배당: 과거에 EBRC.Z 의 주당 배당금이 안정적이었는지 판단하기에는 데이터가 부족합니다.배당금 증가: EBRC.Z 의 배당금 지급이 증가했는지 판단하기에는 데이터가 부족합니다.배당 수익률 vs 시장EBR Systems 배당 수익률 vs 시장EBRC.Z의 배당 수익률은 시장과 어떻게 비교되나요?구분배당 수익률회사 (EBRC.Z)n/a시장 하위 25% (US)1.4%시장 상위 25% (US)4.2%업계 평균 (Medical Equipment)2.2%분석가 예측 (EBRC.Z) (최대 3년)0%주목할만한 배당금: 회사가 최근 지급을 보고하지 않았기 때문에 하위 25%의 배당금 지급자에 대해 EBRC.Z 의 배당 수익률을 평가할 수 없습니다.고배당: 회사가 최근 지급을 보고하지 않았기 때문에 배당금 지급자의 상위 25%에 대해 EBRC.Z 의 배당 수익률을 평가할 수 없습니다.주주 대상 이익 배당수익 보장: 배당금 지급이 수익으로 충당되는지 확인하기 위해 EBRC.Z 의 지급 비율을 계산하기에는 데이터가 부족합니다.주주 현금 배당현금 흐름 범위: EBRC.Z 에서 지급을 보고하지 않았기 때문에 배당 지속 가능성을 계산할 수 없습니다.높은 배당을 제공하는 우량 기업 찾기7D1Y7D1Y7D1YUS 시장에서 배당이 강한 기업.View Management기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/05/24 19:40종가2026/05/22 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
공시 • Feb 12EBR Systems, Inc., Annual General Meeting, May 07, 2026EBR Systems, Inc., Annual General Meeting, May 07, 2026.
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.
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.
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.
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.
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.