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PainChek (ASX:PCK) has updated the market on the progress of its De Novo submission to the US FDA for its flagship app in aged care settings.
The company reported on Wednesday the FDA’s overall Clinical Evaluation Report (CER) drawing from the application is in its final stages with a “majority of requirements for submission [now] complete.”
PainChek believes it will be in a position to provide a second update later this month.
Its submission to the FDA ultimately acts, if approved, to allow PainChek to take its smartphone-based pain assessment and monitoring app into the aged care setting in the US, which it noted has the world’s largest addressable market – 1.7M people in long-term care.
This, PainCheck added, would be a “predicate” for the app’s use in infants and “in other market segments.”
PainChek already has an infant pain assessment app approved in multiple world markets, but, not the US. With its goal to enter the aged care market in the US, the company is specifically eyeing dementia patients who are unable to self-report.
Despite all of this, the company noted on Wednesday it cannot offer any guarantee that the app will be approved once the CER is handed down.
“The FDA De Novo [application] is a marketing pathway to classify novel medical devices,” PainChek CEO Philip Daffas 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.”
PCK last traded at 3cps.
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