View Future GrowthEBR Systems 過去の業績過去 基準チェック /06EBR Systemsの収益は年間平均-9.5%の割合で減少していますが、 Medical Equipment業界の収益は年間 増加しています。収益は年間13.6% 103.1%割合で 増加しています。主要情報-9.49%収益成長率62.36%EPS成長率Medical Equipment 業界の成長8.90%収益成長率103.14%株主資本利益率-579.56%ネット・マージン-1,389.24%前回の決算情報31 Mar 2026最近の業績更新更新なしすべての更新を表示Recent updatesお知らせ • Feb 12EBR Systems, Inc., Annual General Meeting, May 07, 2026EBR Systems, Inc., Annual General Meeting, May 07, 2026.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.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.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.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.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.収支内訳EBR Systems の稼ぎ方とお金の使い方。LTMベースの直近の報告された収益に基づく。収益と収入の歴史OTCPK:EBRC.Z 収益、費用、利益 ( )USD Millions日付収益収益G+A経費研究開発費31 Mar 264-55282531 Dec 252-49232430 Sep 251-45182530 Jun 250-43152531 Mar 250-42132631 Dec 240-41112730 Sep 240-41112830 Jun 240-40102931 Mar 240-3782831 Dec 230-3572730 Sep 230-3382530 Jun 230-33102331 Mar 230-33122131 Dec 220-33142130 Sep 220-36131830 Jun 220-40131631 Mar 220-40111531 Dec 210-40101330 Sep 210-3391130 Jun 210-2571031 Mar 210-2671231 Dec 200-2671331 Dec 191-25911質の高い収益: EBRC.Zは現在利益が出ていません。利益率の向上: EBRC.Zは現在利益が出ていません。フリー・キャッシュフローと収益の比較過去の収益成長分析収益動向: EBRC.Zは利益が出ておらず、過去 5 年間で損失は年間9.5%の割合で増加しています。成長の加速: EBRC.Zの過去 1 年間の収益成長を 5 年間の平均と比較することはできません。現在は利益が出ていないためです。収益対業界: EBRC.Zは利益が出ていないため、過去 1 年間の収益成長をMedical Equipment業界 ( 14.8% ) と比較することは困難です。株主資本利益率高いROE: EBRC.Zは現在利益が出ていないため、自己資本利益率 ( -579.56% ) はマイナスです。総資産利益率使用総資本利益率過去の好業績企業の発掘7D1Y7D1Y7D1YHealthcare 、過去の業績が好調な企業。View Financial Health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2026/05/24 21:34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
お知らせ • Feb 12EBR Systems, Inc., Annual General Meeting, May 07, 2026EBR Systems, Inc., Annual General Meeting, May 07, 2026.
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.
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.
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.
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.
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.