PainChek (ASX: PCK) is set to submit a De Novo application to the U.S. Food and Drug Administration (FDA) for its Adult smartphone app, following positive results from a recent U.S. clinical validation study. The study, conducted across five sites in Iowa and New York, involved 105 nursing home residents and compared the PainChek app's pain assessments with those of the Abbey Pain Scale, a standard tool for patients with dementia, cognitive impairments, or communication difficulties.
The preliminary results and statistical analysis aligned with previous observational pain tool studies, supporting the app's efficacy in assessing pain in individuals unable to clearly articulate their needs. The company plans to include the validation data, along with necessary documentation such as cybersecurity and software paperwork and device labeling, in its FDA submission, expected in November. The FDA's review period is anticipated to last around 150 days.
Beyond the regulatory pathway, PainChek intends to submit the validation data for publication in a peer-reviewed journal and present it at U.S. medical conferences, as part of its strategy for entering the U.S. market. According to PainChek CEO Philip Daffas, FDA approval would enable the company to address the significant U.S. aged care market, which includes 1.7 million residents in long-term care facilities. This represents a potential gross annual recurring revenue of approximately US$85 million for the PainChek app.
"Should PainChek Adult obtain FDA clearance, it would become the first approved pain assessment tool in the US specifically designed for aged care residents with moderate to severe dementia who are unable to self-report their pain," Mr. Daffas stated. He also noted that this clearance would provide a precedent for the PainChek Infant app and facilitate expansion into larger markets, including home care and hospitals.
PainChek is strategically positioned to penetrate the North American market through existing partnerships with companies like PointClickCare, which provides integration access to over 1 million aged care beds across the U.S. and Canada. The PainChek app, available on smartphones and tablets, combines an artificial intelligence (AI) pain assessment tool with a numerical rating scale, enabling accurate and consistent pain assessment for patients with reduced ability to self-report pain. The device has already received regulatory clearance in Australia, Canada, the European Union, New Zealand, Singapore, Malaysia, and the UK. To date, PainChek has been used in over 1,600 aged care facilities worldwide, recording more than 7 million digital pain assessments by nurses, carers, and clinicians.
