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EBR SYSTEMS INC-CDI

0.265

0.000

Volume:383.33K

Turnover:102.04K

Market Cap:224.03M

PE:-1.39

High:0.275

Open:0.275

Low:0.265

Close:0.265

52wk High:1.470

52wk Low:0.235

Shares:845.41M

Float Shares:37.49M

Volume Ratio:0.41

T/O Rate:1.02%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-0.190

EPS(LYR):-0.169

ROE:-102.51%

ROA:-28.46%

PB:2.26

PE(LYR):-1.57

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Overview Company News Filings

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

EBR Systems Chief Commercial Officer to Step Down

MT Newswires Live

EBR Systems Inc-Transition of Chief Commercial Officer

THOMSON REUTERS

EBR Systems (ASX:EBR) Shares Trail A Revenue Surge As Losses Deepen

Simply Wall St.

EBR Systems' Q2 Net Loss Widens, Net Sales Jump; Shares Gain 4%

MT Newswires Live

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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":"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","BK4585","LABU","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 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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":"sg","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":["BK7007","BK4588","BK4585","BK7095","EBR.AU","LABU","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":"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: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":["BK7007","EBR.AU"],"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":"hk","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":["BK7007","LABU","BK4585","EBR.AU","BK4588"],"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 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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":["EBR.AU","BK7007"],"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 Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2666630529?lang=en_us&edition=fundamental","pubTime":"2026-09-09 09:02","pubTimestamp":1788915728,"startTime":"0","endTime":"0","summary":"EBR Systems  said the US Food and Drug Administration  has completed its review of the company's cybersecurity risk assessment related to the February incident and determined that no field corrective action or recall of the WiSE System is warranted, according to a Wednesday filing with the Australian bourse.The incident was classified as a controlled risk under FDA postmarket cybersecurity guidance, with no evidence of any impact on the safety or performance of fielded WiSE cardiac resynchronization therapy systems, per the filing.The company continues its cybersecurity remediation efforts by strengthening credential controls, enhancing anti-phishing measures, expanding endpoint monitoring, hardening its products, and providing required updates to the FDA, the filing said.","market":"hk","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":["BK4097","BK4588","NTSK","IHAK","BK4585","HAKY","EBR.AU","TEKX","CIBR","BK7007","HACK","LABU","BUG"],"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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Live","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2665398020?lang=en_us&edition=fundamental","pubTime":"2026-09-07 09:21","pubTimestamp":1788744073,"startTime":"0","endTime":"0","summary":"EBR Systems  has secured International Organization for Standardization  13485 certification for its new Santa Clara manufacturing facility following an assessment by the BritishStandards Institution, marking a key milestone in the company's quality and operational capabilities, according to a Monday filing with the Australian bourse.The expanded facility's automated assembly machinery is expected to increase Wireless Stimulation Endocardially system production capacity by around 500%, while improving efficiency, reducing costs, and supporting the company's US commercial expansion, the filing said.The US Food and Drug Administration pre-approval inspection is scheduled for September, with facility approval anticipated by year-end, the filing added.The company's shares rose 4% 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":"1","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["ISO.AU","EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2662673544","title":"Host-Plus Reports Acquisition of EBR Systems Common Shares Worth $20.79 Million","url":"https://stock-news.laohu8.com/highlight/detail?id=2662673544","media":"Reuters","labels":["shareholding","insiderTrades","express"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2662673544?lang=en_us&edition=fundamental","pubTime":"2026-08-25 18:37","pubTimestamp":1787654253,"startTime":"0","endTime":"0","summary":"Host-Plus reports acquisition of EBR Systems common shares worth $20.79 millionHost-Plus Pty Ltd, a 10% owner of EBR Systems, increased its indirect stake via a purchase of 7,700,119 common shares.Tot","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:20260825:nNDL5VTK3c:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":"Host-Plus Reports Acquisition of EBR Systems Common Shares Worth $20.79 Million","news_tag":"shareholding,insiderTrades,express","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2662560203","title":"EBR Systems CCO Strandberg to Depart; CEO McCutcheon Takes over Commercial Duties During Search","url":"https://stock-news.laohu8.com/highlight/detail?id=2662560203","media":"Reuters","labels":["executive"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2662560203?lang=en_us&edition=fundamental","pubTime":"2026-08-25 02:08","pubTimestamp":1787594934,"startTime":"0","endTime":"0","summary":"EBR Systems CCO Strandberg to depart; CEO McCutcheon takes over commercial duties during searchEBR Systems’ Chief Commercial Officer Erik Strandberg will depart in the coming months.CEO John McCutcheo","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:20260824:nNDL7J6GcZ:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"executive","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2661688253","title":"EBR Systems Chief Commercial Officer to Step Down","url":"https://stock-news.laohu8.com/highlight/detail?id=2661688253","media":"MT Newswires Live","labels":["executive"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2661688253?lang=en_us&edition=fundamental","pubTime":"2026-08-21 08:21","pubTimestamp":1787271713,"startTime":"0","endTime":"0","summary":"EBR Systems  said Chief Commercial Officer Erik Strandberg will step down from his role in the coming months, according to a Friday filing with the Australian bourse.Chief Executive John McCutcheon will oversee the commercial organization while the company searches for a replacement, the filing added.","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://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"executive","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["EBR.AU","BK7007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2661307262","title":"EBR Systems Inc-Transition of Chief Commercial Officer","url":"https://stock-news.laohu8.com/highlight/detail?id=2661307262","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2661307262?lang=en_us&edition=fundamental","pubTime":"2026-08-21 06:38","pubTimestamp":1787265487,"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:20260820:nTUE2FJHHW: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":"2659150874","title":"EBR Systems (ASX:EBR) Shares Trail A Revenue Surge As Losses Deepen","url":"https://stock-news.laohu8.com/highlight/detail?id=2659150874","media":"Simply Wall St.","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2659150874?lang=en_us&edition=fundamental","pubTime":"2026-08-13 19:34","pubTimestamp":1786620895,"startTime":"0","endTime":"0","summary":"EBR Systems walked into this result with a bruised share price over the past three months and a market that has been sceptical of story stocks. Yet the stock sits at just A$0.30, while the company is now posting quarterly revenue above US$2.6 million and carrying a high price to sales multiple against peers. That clash between a low absolute share price and a rich revenue multiple is the real headline today. The market is trying to decide whether fast top line growth justifies the valuation...","market":"hk","thumbnail":"https://images.simplywall.st/asset/industry/6021000-choice1-main-header/1585186659638","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/6021000-choice1-main-header/1585186659638"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/au/healthcare/asx-ebr/ebr-systems-shares/news/ebr-systems-asxebr-shares-trail-a-revenue-surge-as-losses-de","rn_cache_url":null,"directOrigin":true},"property":["earning"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/au/healthcare/asx-ebr/ebr-systems-shares/news/ebr-systems-asxebr-shares-trail-a-revenue-surge-as-losses-de","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":"simplywall_highlight","symbols":["EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2658499942","title":"EBR Systems' Q2 Net Loss Widens, Net Sales Jump; Shares Gain 4%","url":"https://stock-news.laohu8.com/highlight/detail?id=2658499942","media":"MT Newswires Live","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2658499942?lang=en_us&edition=fundamental","pubTime":"2026-08-12 09:11","pubTimestamp":1786497081,"startTime":"0","endTime":"0","summary":"EBR Systems  reported a second-quarter net loss attributable to common stockholders of $0.35 per share, widening from a loss of $0.30 a year earlier, according to a Wednesday filing with the Australian bourse.Net sales for the June quarter were $2.6 million, up from $170,000 a year ago.The company attributed the higher quarterly loss to an increase in selling, general and administrative expenses, and an uptick in research and development expenses.EBR Systems ended the second quarter with cash, cash equivalents, restricted cash and marketable securities of $89.5 million.It ended March with cash, cash equivalents, restricted cash and marketable securities of $33.5 million, an earlier filing showed.The company's shares gained 4% in recent Wednesday trade.","market":"sg","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":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK7007","EBR.AU"],"isVideo":false,"video":null,"gpt_icon":0}],"pageSize":20,"totalPage":4,"pageCount":1,"totalSize":76,"code":"91000000","status":"200"}]}}