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EBR SYSTEMS INC-CDI

0.155

+0.01510.71%

Volume:7.12M

Turnover:1.08M

Market Cap:131.04M

PE:-0.82

High:0.165

Open:0.140

Low:0.140

Close:0.140

52wk High:1.470

52wk Low:0.130

Shares:845.41M

Float Shares:37.49M

Volume Ratio:1.08

T/O Rate:18.98%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-0.189

EPS(LYR):-0.167

ROE:-102.51%

ROA:-28.46%

PB:1.33

PE(LYR):-0.93

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Overview Company News Filings

EBR Systems Says Q3 Implant Volumes Below Forecast Amid Commercial Leadership Transition; Shares Fall 36%

MT Newswires Live

Australia's EBR Systems Hits Record Low on Weak Third-Quarter Revenue Outlook

EBR Systems Forecasts Q3 2026 Revenue of Us$2.4 MLN to Us$2.5 MLN

EBR Systems - Expects Q3 2026 Revenue of Us$2.43m-Us$2.53m Based on Preliminary Unaudited Results

THOMSON REUTERS

EBR Systems Says US FDA Completes Inspection of New California Facility; Shares Up 4%

MT Newswires Live

EBR Systems Inc-CMS Finalises Increased Inpatient Reimbursement for Wise

THOMSON REUTERS

EBR Systems Plans FDA Label Update for WiSE System in Q4

MT Newswires Live

EBR Systems - Announces Its Plan to Submit a Changes Being Effected (Cbe) Premarket Approval (Pma) Supplement to FDA in Q4 2026

THOMSON REUTERS

EBR Systems Says US FDA Begins Pre-Approval Inspection of California Manufacturing Facility

MT Newswires Live

EBR Systems Inc - FDA Initiates Inspection of New Manufacturing Facility

THOMSON REUTERS

EBR Systems - Continues to Expect FDA Approval of New Facility by Year End

THOMSON REUTERS

Australia's EBR Systems Heads for Worst Week in Nearly Two Months After US FDA Risk Assessment

EBR Systems Says FDA Finds No Need for WiSE System Recall After Cybersecurity Incident

MT Newswires Live

EBR Systems - Continues Cybersecurity Remediation and Hardening Activities

THOMSON REUTERS

EBR Systems Inc - Ebr Provides Update on FDA Review of Cybersecurity Incident

THOMSON REUTERS

EBR Systems - FDA Agrees no Field Corrective Action or Recall for Wise System

THOMSON REUTERS

EBR Systems - no Evidence of Impact to Wise Crt System Safety or Performance

THOMSON REUTERS

EBR Systems Secures ISO Certification for New US Manufacturing Facility; Shares Up 4%

MT Newswires Live

Host-Plus Reports Acquisition of EBR Systems Common Shares Worth $20.79 Million

EBR Systems CCO Strandberg to Depart; CEO McCutcheon Takes over Commercial Duties During Search

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Systems Says Q3 Implant Volumes Below Forecast Amid Commercial Leadership Transition; Shares Fall 36%","url":"https://stock-news.laohu8.com/highlight/detail?id=2674847854","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2674847854?lang=en_us&edition=fundamental","pubTime":"2026-10-12 09:04","pubTimestamp":1791767098,"startTime":"0","endTime":"0","summary":"EBR Systems  completed 40 commercial implants of its WiSE wireless cardiac pacing device for heart failure in the third quarter, down from 46 in the second quarter, bringing total implants across the pilot phase and limited market release to 157, according to a Monday filing with the Australian bourse.The company said third-quarter implant volumes were below forecast, particularly in September, possibly due to a commercial leadership transition, the implementation of a refocused commercial execution strategy, and additional field training requirements.\"The correction in commercial strategy back to focus on deeper utilization in accounts versus starting many new accounts has not yet shown up in current volumes but is expected to do so once fully implemented,\" EBR Systems said.The company expects to report third-quarter revenue in the range of $2.4 million to $2.5 million, compared with $2.6 million in the second quarter.Its shares fell 36% in recent Monday trade.","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2674842336","title":"Australia's EBR Systems Hits Record Low on Weak Third-Quarter Revenue Outlook","url":"https://stock-news.laohu8.com/highlight/detail?id=2674842336","media":"Reuters","labels":["dataReport","express"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2674842336?lang=en_us&edition=fundamental","pubTime":"2026-10-12 08:21","pubTimestamp":1791764468,"startTime":"0","endTime":"0","summary":"BUZZ-Australia's EBR Systems hits record low on weak third-quarter revenue outlook** Shares of Australia's EBR SystemsEBR.AXfall as much as 36.2% to a record low of A$0.15** Cardiac pacing device maker expects Q3 revenue of $2.43 mln to $2.53 mln, down from $2.6 mln reported in previous quarter** EBR adds Q3 implant volumesmissesits prior forecast, particularly in September** YTD stock down 80.6%","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20261012:nL4N45X06Z:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"dataReport,express","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2674841554","title":"EBR Systems Forecasts Q3 2026 Revenue of Us$2.4 MLN to Us$2.5 MLN","url":"https://stock-news.laohu8.com/highlight/detail?id=2674841554","media":"Reuters","labels":["express"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2674841554?lang=en_us&edition=fundamental","pubTime":"2026-10-12 06:16","pubTimestamp":1791756994,"startTime":"0","endTime":"0","summary":"Oct 12 (Reuters) - EBR Systems Inc::*EXPECTS Q3 2026 REVENUE OF US$2.43M-US$2.53M BASED ON PRELIMINARY UNAUDITED RESULTS*Further company coverage: EBR.AX* ((Reuters.briefs@thomsonreuters.com))((Reuter","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20261011:nRSDbVRc4s:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"express","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2674841870","title":"EBR Systems - Expects Q3 2026 Revenue of Us$2.43m-Us$2.53m Based on Preliminary Unaudited Results","url":"https://stock-news.laohu8.com/highlight/detail?id=2674841870","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2674841870?lang=en_us&edition=fundamental","pubTime":"2026-10-12 06:01","pubTimestamp":1791756100,"startTime":"0","endTime":"0","summary":null,"market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20261011:nFWN45V15M:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2670055400","title":"EBR Systems Says US FDA Completes Inspection of New California Facility; Shares Up 4%","url":"https://stock-news.laohu8.com/highlight/detail?id=2670055400","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2670055400?lang=en_us&edition=fundamental","pubTime":"2026-09-28 10:22","pubTimestamp":1790562130,"startTime":"0","endTime":"0","summary":"EBR Systems  said the US Food and Drug Administration  has completed its inspection of the company's new California manufacturing facility, according to a Monday filing with the Australian bourse.The inspection was carried out in relation to the company's pre-market approval supplement to add the facility as a manufacturing site for the WiSE System, its lead-less left ventricular endocardial pacing device designed for cardiac resynchronization therapy in heart failure patients, the filing said.The US FDA investigator issued a Form FDA 483 listing two routine observations, which the company has \"promised to correct.\"Facility approval is anticipated by year-end, per the filing.EBR Systems shares rose 4% in morning trade Monday.","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["LABU","EBR.AU","BK4585","BK7007","BK4588"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2669383981","title":"EBR Systems Inc-CMS Finalises Increased Inpatient Reimbursement for Wise","url":"https://stock-news.laohu8.com/highlight/detail?id=2669383981","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2669383981?lang=en_us&edition=fundamental","pubTime":"2026-09-21 07:07","pubTimestamp":1789945660,"startTime":"0","endTime":"0","summary":null,"market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260920:nTUE7DGSQQ:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2667462017","title":"EBR Systems Plans FDA Label Update for WiSE System in Q4","url":"https://stock-news.laohu8.com/highlight/detail?id=2667462017","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2667462017?lang=en_us&edition=fundamental","pubTime":"2026-09-16 07:31","pubTimestamp":1789515117,"startTime":"0","endTime":"0","summary":"EBR Systems  plans to submit a changes being effected  premarket approval supplement to the US Food and Drug Administration  in the fourth quarter to proactively update the WiSE System's commercial labelling, with greater emphasis on echo-induced pacing risks and mitigation strategies, according to a Wednesday filing with the Australian bourse.The company said it met with the FDA to discuss the plan, responded to the regulator's questions, and secured agreement on the proposed approach, per the filing.The CBE pathway will enable labelling safety enhancements to be implemented during the review process, helping support patient safety as commercial rollout of the WiSE System expands, the filing added.","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4588","LABU","EBR.AU","BK7095","BK4585","BK7007","CBE.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2667244627","title":"EBR Systems - Announces Its Plan to Submit a Changes Being Effected (Cbe) Premarket Approval (Pma) Supplement to FDA in Q4 2026","url":"https://stock-news.laohu8.com/highlight/detail?id=2667244627","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2667244627?lang=en_us&edition=fundamental","pubTime":"2026-09-16 06:37","pubTimestamp":1789511863,"startTime":"0","endTime":"0","summary":null,"market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260915:nFWN4570SE:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2667691420","title":"EBR Systems Says US FDA Begins Pre-Approval Inspection of California Manufacturing Facility","url":"https://stock-news.laohu8.com/highlight/detail?id=2667691420","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2667691420?lang=en_us&edition=fundamental","pubTime":"2026-09-15 07:56","pubTimestamp":1789430215,"startTime":"0","endTime":"0","summary":"EBR Systems  said the US Food and Drug Administration  started its pre-approval inspection of the company's new manufacturing facility in Santa Clara, California, marking a key step in the regulatory process, according to a Tuesday filing with the Australian bourse.The company still anticipates receiving US FDA approval for the facility by the end of the year, the filing added.","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["EBR.AU","BK4588","BK4585","LABU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2667691341","title":"EBR Systems Inc - FDA Initiates Inspection of New Manufacturing Facility","url":"https://stock-news.laohu8.com/highlight/detail?id=2667691341","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2667691341?lang=en_us&edition=fundamental","pubTime":"2026-09-15 07:24","pubTimestamp":1789428264,"startTime":"0","endTime":"0","summary":null,"market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260914:nFWN4560ID:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2667269134","title":"EBR Systems - Continues to Expect FDA Approval of New Facility by Year End","url":"https://stock-news.laohu8.com/highlight/detail?id=2667269134","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2667269134?lang=en_us&edition=fundamental","pubTime":"2026-09-15 07:24","pubTimestamp":1789428264,"startTime":"0","endTime":"0","summary":null,"market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260914:nFWN4560ID:2","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2666545351","title":"Australia's EBR Systems Heads for Worst Week in Nearly Two Months After US FDA Risk Assessment","url":"https://stock-news.laohu8.com/highlight/detail?id=2666545351","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2666545351?lang=en_us&edition=fundamental","pubTime":"2026-09-11 13:17","pubTimestamp":1789103859,"startTime":"0","endTime":"0","summary":"BUZZ-Australia's EBR Systems heads for worst week in nearly two months after US FDA risk assessment** Shares of Australia's EBR SystemsEBR.AXon track for a weekly loss of about 7.1%, their worst weekly performance in nearly two months** In current session, stock down as much as 5.5% to A$0.260, hitting lowest level since August 3** Earlier this week, the wireless cardiac pacing system provider said the U.S. Food and Drug Administration classified a cybersecurity incident as \"Controlled Risk\"** The company disclosed in February that a cybersecurity breach resulted in unauthorized access to personal information** EBR said it has implemented cybersecurity enhancements and system-hardening measures to mitigate future risks** YTD, stock down 69%","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260911:nL4N4530DN:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2666630529","title":"EBR Systems Says FDA Finds No Need for WiSE System Recall After Cybersecurity Incident","url":"https://stock-news.laohu8.com/highlight/detail?id=2666630529","media":"MT Newswires 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FDA, the filing said.","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["CIBR","BK7007","HACK","BK4588","IHAK","TEKX","BK4585","HAKY","LABU","BK4097","NTSK","BUG","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2666790308","title":"EBR Systems - Continues Cybersecurity Remediation and Hardening Activities","url":"https://stock-news.laohu8.com/highlight/detail?id=2666790308","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2666790308?lang=en_us&edition=fundamental","pubTime":"2026-09-09 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