Reported Earnings • Mar 05
First half 2026 earnings released: AU$0.02 loss per share (vs AU$0.02 loss in 1H 2025) First half 2026 results: AU$0.02 loss per share (in line with 1H 2025). Revenue: AU$1.73m (up 4.5% from 1H 2025). Net loss: AU$4.70m (loss widened 49% from 1H 2025). Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has fallen by 15% per year, which means it is significantly lagging earnings. New Risk • Mar 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$7.1m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$7.1m free cash flow). Earnings have declined by 11% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding). Revenue is less than US$5m (AU$2.1m revenue, or US$1.5m). Market cap is less than US$100m (AU$35.5m market cap, or US$25.3m). New Risk • Feb 10
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Negative equity (-AU$1.1m). Earnings have declined by 3.2% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding). Revenue is less than US$5m (AU$3.4m revenue, or US$2.4m). Market cap is less than US$100m (AU$49.1m market cap, or US$34.7m). Announcement • Jan 28
PainChek Limited to Report Q2, 2026 Results on Jan 30, 2026 PainChek Limited announced that they will report Q2, 2026 results Pre-Market on Jan 30, 2026 Announcement • Dec 23
PainChek Limited has completed a Follow-on Equity Offering in the amount of AUD 7.446 million. PainChek Limited has completed a Follow-on Equity Offering in the amount of AUD 7.446 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 218,823,533
Price\Range: AUD 0.034
Discount Per Security: AUD 0.00204
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 176,471
Price\Range: AUD 0.034
Discount Per Security: AUD 0.00204
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing New Risk • Nov 28
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$7.72m (US$5.06m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Negative equity (-AU$1.1m). Earnings have declined by 3.2% per year over the past 5 years. Market cap is less than US$10m (AU$7.72m market cap, or US$5.06m). Minor Risks Shareholders have been diluted in the past year (28% increase in shares outstanding). Revenue is less than US$5m (AU$3.4m revenue, or US$2.2m). New Risk • Nov 05
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 14% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Negative equity (-AU$1.1m). Earnings have declined by 3.2% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). Revenue is less than US$5m (AU$3.4m revenue, or US$2.2m). Market cap is less than US$100m (AU$95.8m market cap, or US$62.1m). Announcement • Oct 29
PainChek Limited to Report Q1, 2026 Results on Oct 31, 2025 PainChek Limited announced that they will report Q1, 2026 results Pre-Market on Oct 31, 2025 Announcement • Oct 24
PainChek Limited, Annual General Meeting, Nov 26, 2025 PainChek Limited, Annual General Meeting, Nov 26, 2025. Location: at suite 401/35 lime street, sydney nsw 2000 Australia Reported Earnings • Aug 31
Full year 2025 earnings released: AU$0.004 loss per share (vs AU$0.006 loss in FY 2024) Full year 2025 results: AU$0.004 loss per share (improved from AU$0.006 loss in FY 2024). Revenue: AU$3.36m (up 26% from FY 2024). Net loss: AU$7.67m (loss narrowed 7.7% from FY 2024). Over the last 3 years on average, earnings per share has increased by 5% per year whereas the company’s share price has increased by 8% per year. New Risk • Aug 30
New major risk - Revenue and earnings growth Earnings have declined by 3.2% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 3.2% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (26% increase in shares outstanding). Revenue is less than US$5m (AU$3.0m revenue, or US$2.0m). Market cap is less than US$100m (AU$80.4m market cap, or US$52.6m). Announcement • Jul 29
PainChek Limited to Report Q4, 2025 Results on Jul 31, 2025 PainChek Limited announced that they will report Q4, 2025 results Pre-Market on Jul 31, 2025 Announcement • Jul 28
PainChek Limited has filed a Follow-on Equity Offering in the amount of AUD 7.5 million. PainChek Limited has filed a Follow-on Equity Offering in the amount of AUD 7.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 218,823,529
Price\Range: AUD 0.034
Discount Per Security: AUD 0.00204
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,764,706
Price\Range: AUD 0.034
Discount Per Security: AUD 0.00204
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing New Risk • Jun 05
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-AU$7.8m free cash flow). Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Revenue is less than US$5m (AU$3.0m revenue, or US$2.0m). Market cap is less than US$100m (AU$77.4m market cap, or US$50.4m). Announcement • Apr 29
PainChek Limited to Report Q3, 2025 Results on Apr 30, 2025 PainChek Limited announced that they will report Q3, 2025 results at 10:00 AM, AUS Eastern Standard Time on Apr 30, 2025 New Risk • Mar 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$7.8m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-AU$7.8m free cash flow). Minor Risks Shareholders have been diluted in the past year (26% increase in shares outstanding). Revenue is less than US$5m (AU$3.2m revenue, or US$2.0m). Market cap is less than US$100m (AU$54.2m market cap, or US$33.7m). New Risk • Feb 07
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 26% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Minor Risks Shareholders have been diluted in the past year (26% increase in shares outstanding). Revenue is less than US$5m (AU$2.7m revenue, or US$1.7m). Market cap is less than US$100m (AU$48.8m market cap, or US$30.7m). Announcement • Jan 30
PainChek Limited to Report Q2, 2025 Results on Jan 31, 2025 PainChek Limited announced that they will report Q2, 2025 results Pre-Market on Jan 31, 2025 New Risk • Jan 08
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (14% increase in shares outstanding). Revenue is less than US$5m (AU$2.7m revenue, or US$1.7m). Market cap is less than US$100m (AU$44.2m market cap, or US$27.5m). Announcement • Nov 25
PainChek Limited has filed a Follow-on Equity Offering in the amount of AUD 5.116441 million. PainChek Limited has filed a Follow-on Equity Offering in the amount of AUD 5.116441 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 200,159,320
Price\Range: AUD 0.025
Discount Per Security: AUD 0.0015
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 4,498,320
Price\Range: AUD 0.025
Discount Per Security: AUD 0.0015
Transaction Features: Rights Offering Announcement • Oct 28
PainChek Limited to Report Q4, 2024 Results on Oct 30, 2024 PainChek Limited announced that they will report Q4, 2024 results at 10:00 AM, AUS Eastern Standard Time on Oct 30, 2024 Announcement • Oct 25
PainChek Limited, Annual General Meeting, Nov 28, 2024 PainChek Limited, Annual General Meeting, Nov 28, 2024. Location: suite 401/35 lime street, sydney nsw 2000. Australia Reported Earnings • Aug 31
Full year 2024 earnings released: AU$0.006 loss per share (vs AU$0.006 loss in FY 2023) Full year 2024 results: AU$0.006 loss per share (in line with FY 2023). Revenue: AU$3.88m (up 98% from FY 2023). Net loss: AU$8.31m (loss widened 9.7% from FY 2023). Over the last 3 years on average, earnings per share has fallen by 2% per year but the company’s share price has fallen by 10% per year, which means it is performing significantly worse than earnings. Announcement • Jan 19
PainChek Limited Announces Change of Company Secretary PainChek Limited announce the appointment of Ms. Natalie Climo of Boardroom Pty Limited as Company Secretary, with effect from 19th January 2024. For the purposes of ASX Listing Rule 12.6, Ms. Climo will also be the primary person responsible for communications between the Company and ASX. Ms. Dadswell of Boardroom Pty Limited has notified the Board of her resignation as Company Secretary with effect from 19th January 2024. Announcement • Dec 05
PainChek Limited has completed a Follow-on Equity Offering in the amount of AUD 3.55 million. PainChek Limited has completed a Follow-on Equity Offering in the amount of AUD 3.55 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 104,954,788
Price\Range: AUD 0.027
Discount Per Security: AUD 0.00162
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 26,526,704
Price\Range: AUD 0.027
Discount Per Security: AUD 0.00162
Transaction Features: Subsequent Direct Listing Reported Earnings • Oct 01
Full year 2023 earnings released: AU$0.006 loss per share (vs AU$0.005 loss in FY 2022) Full year 2023 results: AU$0.006 loss per share (further deteriorated from AU$0.005 loss in FY 2022). Revenue: AU$1.96m (up 97% from FY 2022). Net loss: AU$7.57m (loss widened 32% from FY 2022). Over the last 3 years on average, earnings per share has increased by 15% per year but the company’s share price has fallen by 23% per year, which means it is significantly lagging earnings. New Risk • Sep 21
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 8.2% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$6.3m free cash flow). Earnings have declined by 5.7% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (8.2% increase in shares outstanding). Revenue is less than US$5m (AU$2.0m revenue, or US$1.3m). Market cap is less than US$100m (AU$56.1m market cap, or US$36.0m). Reported Earnings • Sep 01
Full year 2023 earnings released: AU$0.006 loss per share (vs AU$0.005 loss in FY 2022) Full year 2023 results: AU$0.006 loss per share (further deteriorated from AU$0.005 loss in FY 2022). Revenue: AU$3.14m (up 215% from FY 2022). Net loss: AU$7.57m (loss widened 32% from FY 2022). Over the last 3 years on average, earnings per share has increased by 14% per year but the company’s share price has fallen by 30% per year, which means it is significantly lagging earnings. Announcement • Aug 31
PainChek Limited, Annual General Meeting, Nov 22, 2023 PainChek Limited, Annual General Meeting, Nov 22, 2023. New Risk • Aug 30
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$6.0m free cash flow). Earnings have declined by 6.8% per year over the past 5 years. Revenue is less than US$1m (AU$1.4m revenue, or US$927k). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Market cap is less than US$100m (AU$40.2m market cap, or US$26.1m). New Risk • Aug 13
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$6.0m free cash flow). Earnings have declined by 6.8% per year over the past 5 years. Revenue is less than US$1m (AU$1.4m revenue, or US$929k). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Market cap is less than US$100m (AU$37.6m market cap, or US$24.4m). Reported Earnings • Mar 03
First half 2023 earnings released: AU$0.002 loss per share (vs AU$0.002 loss in 1H 2022) First half 2023 results: AU$0.002 loss per share (in line with 1H 2022). Revenue: AU$1.92m (up 462% from 1H 2022). Net loss: AU$3.11m (loss widened 70% from 1H 2022). Over the last 3 years on average, earnings per share has increased by 38% per year but the company’s share price has fallen by 35% per year, which means it is significantly lagging earnings. Announcement • Dec 21
PainChek Limited Announces Company Secretary Changes PainChek Ltd. announced the appointment of Lisa Dadswell as Company Secretary. Ms. Dadswell is an experienced Company Secretary and corporate governance professional; she is an Associate of the Governance Institute of Australia and has an Honours Degree in Law. The appointment follows the resignation of Sally McDow; the Board thanks Ms. McDow for her contribution. Board Change • Nov 16
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 5 non-independent directors. Non-Executive Director Cynthia Payne was the last director to join the board, commencing their role in 2022. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Oct 14
PainChek Limited, Annual General Meeting, Nov 23, 2022 PainChek Limited, Annual General Meeting, Nov 23, 2022. Agenda: To consider election of directions. Breakeven Date Change • Sep 01
Forecast to breakeven in 2025 The analyst covering PainChek expects the company to break even for the first time. New forecast suggests losses will reduce by 42% per year to 2024. The company is expected to make a profit of AU$2.10m in 2025. Average annual earnings growth of 76% is required to achieve expected profit on schedule. Announcement • Jul 05
Painchek Limited to Receive Govt Funding for Children's Disability App PainChek® Ltd. announced that a project to create a specific version of PainChek® for non-verbal children living with a disability has been recognised by the State Government of Western Australia through a $392,820 grant from the Future Health Research and Innovation Fund. The project was one of 17 awarded in the McGowan Government's inaugural Innovation Seed Fund 2022 with more than $8 million distributed under the program, focused on novel ideas that have the potential to improve the health and wellbeing of Western Australians. The project, known as `Detecting pain in kids who can't tell user it hurts: PainChek® for children with disabilities', is led by Associate Professor Jenny Downs, from Telethon Kids Institute on behalf of the Centre for Child Health Research, University of Western Australia along with PainChek's Professor Jeff Hughes. The grant is further validation and evidence of the need for technology-enabled tools, such as PainChek® for the assessment of pain in non-verbal children. As such the project addresses a significant unmet need and opens the opportunity to expand PainChek's market opportunities. PainChek® is already used in over 800 aged care facilities globally and has transformed pain management in residential aged care homes across both Australia and in the UK. PainChek Ltd. will hold the exclusive rights to utilise the arising IP to commercialise the new tool, and have global, non-revocable, exclusive and perpetual rights for future pain assessment tool development or refinement. Major Estimate Revision • Apr 27
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from AU$3.40m to AU$3.00m. EPS estimate unchanged from -AU$0.004 per share at last update. Healthcare Services industry in Australia expected to see average net income growth of 22% next year. Consensus price target down from AU$0.14 to AU$0.10. Share price fell 4.8% to AU$0.04 over the past week. Board Change • Apr 27
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 5 non-independent directors. Non-Executive Director Cynthia Payne was the last director to join the board, commencing their role in 2022. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Mar 30
PainChek Ltd Appoints Cynthia Payne as Non-Executive Director, Effective 30 March 2022 PainChek Ltd. announced the appointment of Ms. Cynthia Payne as a Non-Executive Director, effective 30 March 2022. Ms. Payne brings 30 years executive leadership experience as well as significant board and operational experience in residential and home aged care services in Australia. That experience includes over 16 years as CEO for a large private aged care Provider in NSW and before that head of operation manager for a large Not for Profit with home care, residential and retirement living portfolios. Major Estimate Revision • Mar 06
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from AU$0 to AU$0 per share. Revenue forecast of AU$3.40m unchanged since last update. Healthcare Services industry in Australia expected to see average net income growth of 31% next year. Consensus price target down from AU$0.24 to AU$0.14. Share price fell 4.8% to AU$0.04 over the past week. Breakeven Date Change • Mar 01
Forecast breakeven date pushed back to 2024 The analyst covering PainChek previously expected the company to break even in 2023. New forecast suggests losses will reduce by 40% per year to 2023. The company is expected to make a profit of AU$3.40m in 2024. Average annual earnings growth of 91% is required to achieve expected profit on schedule. Reported Earnings • Sep 01
Full year 2021 earnings released: AU$0.005 loss per share (vs AU$0.013 loss in FY 2020) Full year 2021 results: Net loss: AU$6.06m (loss narrowed 51% from FY 2020). Over the last 3 years on average, earnings per share has fallen by 11% per year but the company’s share price has only fallen by 4% per year, which means it has not declined as severely as earnings. Announcement • May 21
PainChek Limited Infant Achieves International Regulatory Clearances PainChek Ltd. (‘PainChek’ or ‘the Company’) announced it has received the necessary regulatory clearances including the CE Mark and UK MHRA that allow for sales and marketing of its PainChek Infant offering in Australia, Europe, UK, Canada, Singapore and New Zealand. The regulatory clearances follow completion of the PainChek's Infant Face-Only study, which demonstrated positive findings and is being peer-reviewed for publication. Findings from the study support the clinical indication for procedural pain assessment and PainChek infant is now cleared for use with infants aged between 1 month to 12 months. PainChek will now progress with launch plans for PainChek infant in these markets and will pursue opportunities in the key Hospital and Home Care markets, with potential users including children's hospitals, post-natal wards, parents and other healthcare professionals. With 400 million pre-verbal children¹ in the world, of which it is estimated 100 million are born to first time parents, PainChek Infant is now able to access a very large new market opportunity. The Company will also continue to expand the PainChek clinical applications and broaden the age ranges for Children's pain assessment through additional research and clinical studies including the existing study at the Royal Children's Hospital (RCH) in Melbourne. Existing clinical paper-based tools to assess pain for pre-verbal children, such as the FLACC2, have been available for some time, however they are rarely used in clinical practice with clinicians and nurses often relying on clinical observations to assess pain of which the infant's facial expressions are the most critical. High levels of exposure to painful face expressions can lead to observer bias, with some healthcare professionals showing an exaggerated underestimation of pain3. PainChek Infant's automated facial analysis addresses this problem. The PainChek infant Face-Only study was developed to test the feasibility of using PainChek Infant's face domain alone as an indicator of pain, and to evaluate it using video recordings of infants undergoing painful procedures. The study involved PainChek Infant face domain scores being compared with assessments conducted using the Revised Neonatal Facial Coding System (NFCS-R) and the Observer Visual Analogue Scale (ObsVAS). Both NFCS-R and ObsVAS are well known and validated scales used in assessing procedural pain in infants, such as vaccinations, finger and heel pricks, dressing changes or more invasive procedures such as biopsies. Findings from the study supported thevalidity and reliability of PainChek Infant for procedural pain assessment. Procedural pain represents a significant problem as it can have both short-term and long-term negative consequences on children's health if not managed effectively. Announcement • Jan 22
PainChek Limited Announces Successful Completion of Infant Face-Only Clinical Study PainChek Limited announced that the PainChek Infant Face-Only clinical study to support CE Mark and TGA regulatory clearance has been successfully completed with findings supporting the use of PainChek Infant for procedural pain assessment with infants. A publication detailing the findings of the study has been written and submitted to a scientific journal for peer review. PainChek is on schedule for Australian (TGA) and European (CE Mark) regulatory clearance of the PainChek® Infant product in Second Quarter calendar 2021 followed by market launch in these territories. The clinical study results will support these market launches. The PainChek Infant Face-Only study was developed to test the feasibility of using PainChek® Infant's face domain alone as an indicator of pain, and evaluate it using video recordings of infants undergoing painful procedures. The study, which received ethics approval from Curtin University, involved PainChek infant face domain scores being compared with assessments conducted using the Revised Neonatal Facial Coding System (NFCS-R) and the Observer Visual Analogue Scale (ObsVAS). Both NFCS-R and ObsVAS are well known and validated scales used in assessing procedural pain in infants, such as vaccinations, finger and heel pricks, dressing changes or more invasive procedures such as biopsies. Assessment of procedural pain occurs in various settings, from hospitals to home care environments.
Using the face only automatic assessment, PainChek Infant demonstrated effectiveness in procedural pain assessment, with comparison against the NFCS-R and ObsVAS demonstrating the psychometric properties of the technology i.e. validity, reliability and internal consistency. The findings showed that PainChek Infant (Face Only) has excellent correlation with NFCS-R and ObsVAS, and detailed results of the study will be made available following the peer-review and publication in a scientific journal. PainChek continues with next steps to broaden the clinical applications of PainChek Infant, including research at the Royal Children's Hospital (RCH) in Melbourne, which was put on hold due to COVID-19. Announcement • Aug 11
PainChek Ltd. announced that it expects to receive AUD 10 million in funding PainChek Ltd. (ASX:PCK) announced a private placement of 90,909,091 common shares at a price of AUD 0.11 per share for gross proceeds of AUD 10,000,000 on August 11, 2020. The transaction will include participation from professional and sophisticated investors under its existing 15% placement capacity under ASX Listing Rule 7.1 and from multiple existing and new offshore and Australian institutional investors as well as existing cornerstone shareholders. The transaction is expected to close on August 17, 2020.