- PainChek (PCK) has received CE Mark and UK MHRA clearances to start selling and marketing an offshoot of its pain recording app, PainChek Infant
- The PainChek Infant app is a pain assessment and monitoring system that records a short video of the infant’s face and analyses the images that indicate pain
- Now, the clearances will allow the company to launch into markets across Australia, Europe, UK, Canada, Singapore and New Zealand
- Findings from the study are being peer-reviewed for publication
- The company plans to expand the PainChek clinical applications and broaden the age ranges for children’s pain assessment through additional research and clinical studies
- Shares are trading in the grey at 6.5 cents apiece
PainChek (PCK) has received the necessary CE Mark and UK MHRA clearances to start selling and marketing an offshoot of its pain recording app, PainChek Infant.
The company developed the world-first pain assessment and monitoring app, PainChek, that records a short video of a person’s face and analyses the images that indicate pain.
Since establishing the initial PainChek Adult App, the company conducted an infant-based study to test the feasibility of using PainChek’s Infant face domain alone as an indicator of pain and to evaluate video recordings of infants undergoing painful procedures.
Being granted the CE Mark and the UK MHRA regulatory clearances follows completion of the study which demonstrated positive findings and is being peer-reviewed for publication.
The clearances will allow the company to launch into markets across Australia, Europe, UK, Canada, Singapore and New Zealand
In particular, PainChek Infant has been cleared for use with infants aged between one and twelve months old, allowing the company to pursue opportunities in the hospital and home care markets.
Specifically, the company said users could include children’s hospitals, post-natal wards, parents and other healthcare professionals.
Additionally, PainChek believes there is a large opportunity for PainChek infant to tap into the pre-verbal market, noting around 400 million pre-verbal children in the world.
PainChek said paper-based tools used to assess pain for pre-verbal children such as FLACC — face, legs, activity, cry, consolability — are rarely used in clinical practice and high levels of exposure to painful face expressions can lead to observer bias leading to underestimation of pain.
CEO Philip Daffas commented on the ability of the app.
“The PainChek Infant App is unique in that it completes a micro-facial analysis through a 3 second video assessment and provides the carer with an instant result in relation to the infant’s pain severity level.”
Looking forward, the company plans to expand the PainChek clinical applications and broaden the age ranges for children’s pain assessment through additional research and clinical studies including an existing study at the Royal Children’s Hospital in Melbourne.
Shares are trading in the grey at 6.5 cents apiece at 9:55am AEST.