PainChek's AI app set to transform pain detection beyond words
FDA clearance forecast in October could make PainChek only US-approved pain assessment tool for dementia in aged care
As part of a product expansion PainChek launches Infant app in Australia to detect pain in babies aged 1-12 months
How can carers and medical professionals accurately assess pain in someone who can't reliably communicate? Available on smartphones and tablets, PainChek (ASX:PCK) has developed an app that uses AI facial recognition to analyse facial muscle movements and detect pain – even when it isn't obvious – designed for people with dementia or cognitive impairment who have limited communication.
Following a series of clinical studies in target markets PainChek has been regulatory-cleared in Australia, Canada, the EU, New Zealand, Singapore, Malaysia, and the UK.
CEO and managing director Philip Daffas told Stockhead US Food and Drug Administration (FDA) de novo (new device) clearance was expected in early October with PainChek set to be the only regulated product in the world's largest healthcare market to assess pain for people with dementia or cognitive impairment in aged care.
"PainChek has AI technology that assesses for nine facial expressions, known as action units, that indicate pain," he said.
"There's five other steps guiding the user such as a nurse to use their clinical judgement for other observations to indicate pain such as movement or sounds a person may be making.
"Its a cumulative score so the more indicators present the higher severity of pain with clinical observation key and AI good to pick up microfacial features indicating pain."
Daffas said the study for US FDA clearance had to be done across all American patient populations, providing further validation for the app, which had already undertaken more than 12 million pain assessments.
"In our FDA study we showed we could replicate it with different American populations from African Americans, Hispanic etc and the system worked well across all those groups," he said.
"The US is an initial US$100 million annual market opportunity for PainChek."
Borne out of technology from Curtin University
The technology started out of Western Australia's Curtin University School of Pharmacy with the idea coming from PainChek's now chief scientific officer Professor Jeff Hughes.
"He was doing rounds as a pharmacist in an aged care facility and thought they're not managing pain properly, particularly in people with dementia, and there must be a better way," Daffas said.
"He went to a PhD student at the university and told him he wanted a thesis on making a better pain assessment tool for people living with dementia who can't verbalise, which was the genesis of the product."
With extensive global experience in medical devices Daffas was contacted by a friend on the innovation board of Curtin University to evaluate the tool and see if it was commercially viable.
"I thought it had legs so started working with Jeff and the team and six months later there was an initiative in WA to take it out of the university and backdoor list it on the ASX through a mining stock going nowhere," Daffas said.
"They approached me to come on as CEO and managing director to get everything going and help raise the capital.
"We took the product out of the uni in October 2016 and it was a prototype with still a lot of work to be done including clinical studies and regulatory clearance but the genesis of the product was there."
It was originally called EPAT, which was the university's code name for the product standing for Electronic Pain Assessment Technology.
"When we got going the company and product name was switched to PainChek."
From Cochlear to PainChek – growing next ASX healthcare leader
Originally from the UK Daffas spent his entire career working with companies developing novel medical devices.
"I've worked in the UK, US, Germany and Australia – I've had a very patient wife and children," he said.
"The first job I stumbled into after finishing uni was with IVAC which was the first company to make an infusion pumps and innovators of electronic thermometers, now big products.
"I later worked for Roche Diagnostics in Germany, which were innovators in blood glucose monitoring to help people with diabetes manage the disease at home."
Daffas joined Aussie-grown global hearing implant leader Cochlear (ASX:COH) in the late 1990s.
"They had recently listed and weren't quite profitable and I came in to head up their European, Middle East and African business based out London," he said.
It was during his time at Cochlear and moving to Australia to head its global marketing that Daffas was inspired to establish an Australian medical device company.
"I developed this appetite to start something from scratch in Australia and take it to the world so when PainChek came up I thought this is the opportunity," he said.
Daffas said through his extensive experience he came to understand how medical devices were successfully developed from scratch.
"The model we follow for PainChek is very much a Cochlear model of establishing the product and validating it in the domestic market," he said.
"Secondly, we established a team in the UK, New Zealand and Canada in parallel which are recognised as high value markets.
"Only then once the product is established did we aim to enter much bigger markets like the US."
Daffas said he could make PainChek profitable tomorrow if he was merely focused on Australia, however his vision is to grow the company into the next ASX healthcare success story.
"We want to establish a new global brand like your Cochlear and ResMed (ASX:RMD) and to do that you must have shareholders who understand that is the journey and are supportive, which fortunately we do," he said.
Daffas said it took Cochlear 20 years to be profitable from when they started and he thinks PainChek will be profitable in around 10 years.
"We're eight down already and are on track to be profitable in the next two years."
PainChek in more than 30% of Australian aged care facilities
In Australia more than 30% of aged care facilities are using PainChek to manage pain in their residents.
"There are around 200,00 aged care beds in Australia and we have close to 70,000 beds under contract," Daffas said.
"In the UK we have about 40,000 beds."
Daffas said its revenue model is based on annual recurring revenue with the cost $50 per bed per annum.
"So in an aged care facility with 100 beds that is $5000 per year," he said.
"Our smallest customer has 50 beds and our largest has 7500 beds so our business model is ARR and we are up to about $5.5 million now and we're getting very strong retention rates."
Daffas said the market for PainChek was strong with a need to manage pain effectively in a growing dementia population.
"There's 150 million people living with dementia in the world and it is looking to double in next five years as we age and there is yet no cure," he said.
Taking guesswork out of infant pain
Any parent can relate to the angst of identifying if their baby is in pain. As part of its product expansion PainChek has launched its PainChek Infant app in Australia, which identifies and detects six facial action units indicative of pain in infants aged one month to 12 months.
It is now commercially available on the App Store for home use by parents.
"While the adult product is more B2B and sold into aged care, home care or hospitals for use by nurses, carers and clinicians the PainChek Infant app is more directed to parents," Daffas said.
"There are something like 400 million children who are pre-verbal in the world at any one time and there is 150 million babies born each year globally to first time parents.
He said PainChek Infant was an addition in the repertoire of tools for parents such as a baby monitor or digital thermometer.
"It doesn't tell the parent what is causing the pain just like a thermometer doesn't tell what is causing the fever," he said.
"It just shows there is clear indicators this baby is in pain or distress and often there's an overlap but it requires intervention whether cuddling the baby, giving medication or seeking medical advice."
Daffas said the company was also developing a product for toddlers aged one to three.
"With infants and toddlers it is just a three second analysis of the face and no other behaviour factors you need to observe," he said.
PainChek is also working on a research project with the West Australian government for a PainChek app to assess pain for children living with disabilities like cerebral palsy.
"That is a much more complex product," he said.
The PainChek share price is up ~45% YTD.

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