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PAINCHEK LTD

0.185

-0.015-7.50%

Volume:300.12K

Turnover:54.85K

Market Cap:38.63M

PE:-4.19

High:0.200

Open:0.200

Low:0.180

Close:0.200

52wk High:1.050

52wk Low:0.180

Shares:208.81M

Float Shares:151.37M

Volume Ratio:2.73

T/O Rate:0.20%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-0.044

EPS(LYR):-0.044

ROE:-8647.59%

ROA:-151.46%

PB:-34.71

PE(LYR):-4.19

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Overview Company News Filings

PainChek's Annual Recurring Revenue Grows to AU$4 Million as of January-End

MT Newswires Live

PainChek Says Independent Legal Opinion Confirms Its Device Qualifies For US Remote Therapeutic Monitoring Reimbursement Claims

MT Newswires Live

BRIEF-PainChek Secures First US Customer After FDA Clearance

Should FDA De Novo Clearance for Adult App Prompt a Rethink by PainChek (ASX:PCK) Investors?

Simply Wall St.

ASX Midday Sector Update: Healthcare Sector Up, Consumer Discretionary Falls

MT Newswires Live

BRIEF-Painchek Says FDA De Novo Grant Received For Pain Assessment App

BUZZ-Australia's PainChek Ltd hits over 5-year high after US FDA approves pain app

PainChek Ltd - FDA De Novo Grant Received for Pain Assessment App

THOMSON REUTERS

BRIEF-Painchek Seeks Trading Halt Pending FDA Clearance

PainChek Ltd - Seeks Trading Halt Pending FDA Clearance

THOMSON REUTERS

PainChek Says Scotland Care System Trial Confirmed Clinical Benefits from App Use, Shares Up 4%

MT Newswires Live

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Annual Recurring Revenue Grows to AU$4 Million as of January-End","url":"https://stock-news.laohu8.com/highlight/detail?id=2607064286","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2607064286?lang=en_us&edition=fundamental","pubTime":"2026-01-30 11:28","pubTimestamp":1769743716,"startTime":"0","endTime":"0","summary":"PainChek  said its annual recurring revenue grew to AU$4 million at the end of January with the implementation of licenses, and it anticipates an annual recurring revenue of AU$5.6 million after all licenses have been implemented, according to a Friday Australian bourse filing.The company also has a pipeline for about AU$1.9 million in annual recurring revenue under negotiation across US, Canada, UK, and Australia-New Zealand, the filing said.The company plans to continue negotiating with the Centers for Medicare & Medicaid Services in the US for an additional specific PainChek Current Procedural Terminology reimbursement code by April, per the filing.","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":["PCK.AU","BK7094"],"gpt_icon":0},{"id":"2607194774","title":"PainChek Says Independent Legal Opinion Confirms Its Device Qualifies For US Remote Therapeutic Monitoring Reimbursement Claims","url":"https://stock-news.laohu8.com/highlight/detail?id=2607194774","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2607194774?lang=en_us&edition=fundamental","pubTime":"2026-01-29 13:01","pubTimestamp":1769662880,"startTime":"0","endTime":"0","summary":"PainChek  said US healthcare law firm Nixon Law Group confirmed the PainChek device qualifies as a US Food and Drug Administration -regulated medical device for the purposes of Remote Therapeutic Monitoring  reimbursement claims in the US to the Centers for Medicare & Medicaid Services, according to a Thursday Australian bourse filing.The legal opinion confirmed that PainChek meets the statutory definition of a medical device under the US Federal Food, Drug, and Cosmetic Act and was granted De Novo classification by the FDA.Its device allows for assessing pain in non-verbal dementia patients in long-term care settings with musculoskeletal issues.The firm said it now operated two business models in the US, an existing business-to-business software-as-a-service offering to long-term care facilities, as well as a new RTM reimbursement model. It will formally launch its RTM initiative to customers and partners at HIMSS 2026 Global Health Conference in Las Vegas in March.","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":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK7094","PCK.AU","RTM"],"gpt_icon":0},{"id":"2575444043","title":"BRIEF-PainChek Secures First US Customer After FDA Clearance","url":"https://stock-news.laohu8.com/highlight/detail?id=2575444043","media":"Reuters","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2575444043?lang=en_us&edition=fundamental","pubTime":"2025-10-13 09:24","pubTimestamp":1760318680,"startTime":"0","endTime":"0","summary":"BRIEF-PainChek Secures First US Customer After FDA ClearanceOct 13 (Reuters) - PainChek Ltd PCK.AX:SECURES FIRST US CUSTOMER AFTER FDA CLEARANCEFurther company coverage: PCK.AX ((Reuters.Briefs@thomsonreuters.com;))","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:20251013:nFWN3VR2VD:1","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":null,"symbols":["BK7094","PCK.AU"],"gpt_icon":0},{"id":"2574439349","title":"Should FDA De Novo Clearance for Adult App Prompt a Rethink by PainChek (ASX:PCK) Investors?","url":"https://stock-news.laohu8.com/highlight/detail?id=2574439349","media":"Simply Wall St.","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2574439349?lang=en_us&edition=fundamental","pubTime":"2025-10-11 10:19","pubTimestamp":1760149152,"startTime":"0","endTime":"0","summary":"PainChek has received De Novo clearance from the US FDA for its Adult App, authorizing it as the first regulated medical device for pain assessment in individuals who cannot reliably self-report, including those with dementia, thus unlocking access to the US aged care market.\nThe clearance not only enables immediate US commercial rollout but also paves the way for expanded opportunities in international markets that recognize FDA data standards, such as Japan and Germany.\nWe'll now explore...","market":"us","thumbnail":"https://images.simplywall.st/asset/industry/9551730-choice1-main-header/1585186828574","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/9551730-choice1-main-header/1585186828574"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/au/healthcare/asx-pck/painchek-shares/news/should-fda-de-novo-clearance-for-adult-app-prompt-a-rethink","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/au/healthcare/asx-pck/painchek-shares/news/should-fda-de-novo-clearance-for-adult-app-prompt-a-rethink","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":["BK4211","BK7094","ISBC","PCK","PCK.AU"],"gpt_icon":0},{"id":"2573915442","title":"ASX Midday Sector Update: Healthcare Sector Up, Consumer Discretionary Falls","url":"https://stock-news.laohu8.com/highlight/detail?id=2573915442","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2573915442?lang=en_us&edition=fundamental","pubTime":"2025-10-08 10:52","pubTimestamp":1759891923,"startTime":"0","endTime":"0","summary":"Healthcare stocks advanced 0.5% at midday Wednesday.On Wall Street, the S&P 500 fell 0.4%, the Dow Jones index slipped 0.2%, and the Nasdaq index shed 0.7%.PainChek  was granted a De Novo classification by the US Food and Drug Administration for its PainChek pain assessment adult app. The US FDA created product code \"SGB,\" recognizing the app as a unique medical device for pain assessment.The FDA De Novo classification increases the potential for expedited regulatory approval in Japan as well as other global markets, such as Brazil and the United Arab Emirates, that accept FDA approval to facilitate abbreviated market entry.On the flip side, the consumer discretionary sector fell 1.7%, as Australian stocks continued to decline.Peter Warren Automotive Holdings  said that Chief Financial Officer Victor Cuthell plans to retire in June 2026. The company has initiated a process to identify a successor and ensure a smooth transition.","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":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["XLV","PWR.AU","BK7094","PCK.AU","BK4137","XBI","BK4581","BK4585","HCSG","BK7143","LABU","BK4588"],"gpt_icon":0},{"id":"2573918694","title":"BRIEF-Painchek Says FDA De Novo Grant Received For Pain Assessment App","url":"https://stock-news.laohu8.com/highlight/detail?id=2573918694","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2573918694?lang=en_us&edition=fundamental","pubTime":"2025-10-08 09:27","pubTimestamp":1759886871,"startTime":"0","endTime":"0","summary":"BRIEF-Painchek Says FDA De Novo Grant Received For Pain Assessment AppOct 8 (Reuters) - PainChek Ltd PCK.AX:FDA DE NOVO GRANT RECEIVED FOR PAIN ASSESSMENT APPFurther company coverage: PCK.AX ((Reuters.Briefs@thomsonreuters.com;))","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:20251008:nFWN3VO2NB:1","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":null,"symbols":["PCK.AU","BK7094"],"gpt_icon":0},{"id":"2573990363","title":"BUZZ-Australia's PainChek Ltd hits over 5-year high after US FDA approves pain app","url":"https://stock-news.laohu8.com/highlight/detail?id=2573990363","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2573990363?lang=en_us&edition=fundamental","pubTime":"2025-10-08 08:45","pubTimestamp":1759884305,"startTime":"0","endTime":"0","summary":"BUZZ-Australia's PainChek Ltd hits over 5-year high after US FDA approves pain app** Shares of Australia's PainChek Ltd PCK.AX rise as much as 31.3% to A$0.105, their highest level since mid-August 2020** Stock posts its biggest intraday pct gain since early-October 2023** Medical technology firm says U.S. FDA granted De Novo classification for its PainChek Adult App** PainChek Adult App is a smartphone-based pain assessment tool designed for individuals who cannot self-report pain, such as those with moderate to severe dementia** De Novo classification refers to regulatory pathway used by the FDA to evaluate and approve novel medical devices that do not have an existing legally marketed equivalent** Nearly 18.5 million shares change hands, 4.9x the 30-day average volume ** Stock has risen 186.2% this year, including session gains ","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:20251008:nL3N3VP00T:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["PCK.AU","BK7094"],"gpt_icon":0},{"id":"2573723992","title":"PainChek Ltd -  FDA De Novo Grant Received for Pain Assessment App","url":"https://stock-news.laohu8.com/highlight/detail?id=2573723992","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2573723992?lang=en_us&edition=fundamental","pubTime":"2025-10-08 08:00","pubTimestamp":1759881604,"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:20251008:nFWN3VO2NB: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":["BK7094","PCK.AU"],"gpt_icon":0},{"id":"2573498900","title":"BRIEF-Painchek Seeks Trading Halt Pending FDA Clearance","url":"https://stock-news.laohu8.com/highlight/detail?id=2573498900","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2573498900?lang=en_us&edition=fundamental","pubTime":"2025-10-07 06:24","pubTimestamp":1759789472,"startTime":"0","endTime":"0","summary":"BRIEF-Painchek Seeks Trading Halt Pending FDA ClearanceOct 7 (Reuters) - PainChek Ltd PCK.AX:SEEKS TRADING HALT PENDING FDA CLEARANCEFurther company coverage: PCK.AX ((Reuters.Briefs@thomsonreuters.com;))","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:20251006:nFWN3VN2FL: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":null,"symbols":["BK7094","PCK.AU"],"gpt_icon":0},{"id":"2573989003","title":"PainChek Ltd - Seeks Trading Halt Pending FDA Clearance","url":"https://stock-news.laohu8.com/highlight/detail?id=2573989003","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2573989003?lang=en_us&edition=fundamental","pubTime":"2025-10-07 06:23","pubTimestamp":1759789438,"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:20251006:nFWN3VN2FL: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":["PCK.AU","BK7094"],"gpt_icon":0},{"id":"2568367451","title":"PainChek Says Scotland Care System Trial Confirmed Clinical Benefits from App Use, Shares Up 4%","url":"https://stock-news.laohu8.com/highlight/detail?id=2568367451","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2568367451?lang=en_us&edition=fundamental","pubTime":"2025-09-17 12:06","pubTimestamp":1758081996,"startTime":"0","endTime":"0","summary":"PainChek (ASX:PCK) said the PainChek Adult App was trialed in the Scottish care system in a Scottish government-funded pilot, and an independent evaluation confirmed clinical benefits in using the app","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":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK7094","PCK.AU"],"gpt_icon":0}],"pageSize":20,"totalPage":1,"pageCount":1,"totalSize":11,"code":"91000000","status":"200"}]}}