PainChek targets US aged care market

PainChek (ASX:PCK), a company known for developing smartphone-based pain assessment applications, has taken a significant step in its US market strategy by submitting an FDA De Novo clearance application for its Adult App. This application aims to enter the US aged care market, the largest globally, presenting a substantial revenue opportunity.

PainChek's strategic US market entry

PainChek has submitted an FDA De Novo application for its Adult App, a crucial move in entering the US market, especially targeting the aged care sector. The US long-term care market, home to 1.7 million residents, offers a potential annual revenue of $85 million USD for PainChek. If approved, the app would be the first FDA-cleared tool for assessing pain in dementia patients in aged care. This clearance would not only allow rapid market penetration but also pave the way for expanding into other segments, like home care and hospitals. PainChek's technology, which uses AI for pain assessment, has received regulatory clearance in several countries and is backed by clinical validation. The company plans to continue building its presence through strategic partnerships and scientific contributions.

Executive insights on FDA submission

The submission of our FDA De Novo application for the PainChek Adult App marks a pivotal step towards our US market entry strategy. With our successful validation study, we are confident in our technology's ability to transform pain assessment for aged care residents with dementia.