PainChek's U.S. validation success

PainChek (ASX:PCK) has announced successful outcomes from its U.S. validation study for the PainChek Adult App. This achievement enables the company to proceed with an FDA De Novo submission anticipated in November 2024. The validation study involved 105 residents from nursing homes in Iowa and New York, demonstrating positive performance against the Abbey Pain Scale.

PainChek's strategic outlook

PainChek is advancing towards a significant milestone with its planned FDA De Novo submission in November 2024, following a successful U.S. validation study for its PainChek Adult App. The study, which involved 105 nursing home residents, showed positive results compared to the Abbey Pain Scale. The U.S. Aged Care market represents a substantial opportunity, being the world's largest with 1.7 million people in long-term care. PainChek aims for FDA clearance to expand its application into larger markets, including home care and hospitals, and to extend its use for infants. The company has established strategic partnerships, such as with PointClickCare, and plans to publish its validation data in peer-reviewed journals. With a U.S. patent valid until 2038, PainChek is poised for future market expansion.

Executive insights on PainChek's progress

The FDA De Novo submission is a major milestone for PainChek and positions us on the path to becoming the first FDA-cleared pain assessment tool for aged care residents with moderate to severe dementia.