PainChek locks in performance data for FDA submission, aiming to be first pain assessment app approved in US

It’s not often thought about but as we get older, our verbal capabilities deteriorate with age and for some, this can have a drastic impact on their health when unable to communicate the state of their wellbeing. Such issues for those who are non-verbal due to neurodegenerative diseases, however, may soon be solved for those in the US with health tech company PainChek (ASX: PCK) marking a milestone in its path towards gaining FDA approval for its innovative smartphone-based pain assessment and monitoring app.

PainChek recently completed the clinical validation data collection phase, crucial for the FDA de Novo submission of its Adult App, seeking to become the first smartphone-based pain assessment tool to be approved in the United States.

The clinical study, conducted across five aged care facilities in Iowa and New York, involved 105 participants. PainChek’s clinical research partners have now completed performance data analysis, with preliminary statistical findings being prepared for the final Clinical Evaluation Report. While the Company has not disclosed specific outcomes from the clinical report, it confirmed that essential components of its FDA submission – such as cyber security, software documentation, and device labelling – are also nearing completion.

PainChek’s submission to the FDA, anticipated by October 2024, positions the company to potentially tap into the vast US aged care market, which is home to 1.7 million residents in long-term care facilities. 

CEO Philip Daffas highlighted the financial potential of this market, estimating an annual recurring revenue of $85 million USD for PainChek based on projected US pricing.

“The FDA De Novo is a marketing pathway to classify novel medical device,” he said. 

“Should PainChek Adult successfully obtain FDA clearance, PainChek would be the first of its kind FDA-cleared pain assessment tool in the USA specifically designed for aged care residents with moderate to severe dementia who are unable to self-report their pain.

“This clearance would also provide an important predicate for the PainChek Infant App and support the expansion of the Adult App into larger US markets, including home care and hospitals. Additionally, we hold a granted US patent that will remain in place until 2038.” 

Revolutionising Pain Management in Aged Care

PainChek’s technology is designed to address a critical gap in aged care to assess pain in individuals who cannot verbally express it, such as those with dementia or other neurodegenerative diseases that impact speech. 

Traditional pain assessment tools rely heavily on self-reporting, which is often not possible for these patients. PainChek’s app, however, uses artificial intelligence to analyse facial expressions and other indicators of pain, providing an objective and consistent pain assessment.

The app’s ability to automate this process reduces subjectivity and unintentional bias, offering caregivers a consistent tool to assess pain levels, record trends, and create more informed care plans. The data is accessible via smartphones and tablets, making it a practical solution for time-poor carers and healthcare providers in aged care settings.

PainChek has already been regulatory cleared in multiple countries, including Australia, Canada, and the European Union. 

FDA approval would make PainChek the first of its kind in the US, opening the door to wider adoption not just in aged care, but also in home care settings and hospitals. The Company has already laid the groundwork for market penetration through partnerships with organisations such as PointClickCare, which gives PainChek access to over 1 million aged care beds across the US and Canada.

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Emily Maxwell

Emily Maxwell is a business writer at The Sentiment with interest in the tech, fintech and retail industries.

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