PainChek (ASX:PCK) has applied for Food and Drug Administration (FDA) De Novo approval for its new PainChek Adult App.
The application comes hot on the heels of completion of a U.S.-based validation study.
A green light from the FDA would signify a win along the company’s U.S. expansion journey. The company projects annual recurring revenue of around US$85 million ($130.2 million) from the long tail aged care sector. The market currently has 1.7 million residents housed across the country.
PainChek’s wider U.S. market entry approach already incudes its Infant app and diversification into the home and hospital care market segments.
“The FDA De Novo is a marketing pathway to classify novel medical devices. Should PainChek Adult successfully obtain FDA regulatory clearance, PainChek would be the first of its kind FDA-cleared pain assessment tool in the USA,” says Philip Daffas, CEO of PainChek.
PainChek’s collaboration with PointClickCare and other providers is expected to fast track their rapid market expansion across North America.
These partnerships are providing integration access to approximately 1,000,000 aged care beds in the USA and Canada.
PainChek says it will share validation data in peer-reviewed journals and present findings at US medical conferences in 2025.
PainChek develops pain assessment technologies. The company’s principal activities are the development and commercialisation of mobile medical device applications that provide pain assessment for individuals that are unable to communicate with their carers.
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