PainChek (ASX:PCK), developer of the world’s first smart phone-based pain assessment and monitoring application, has progressed the US Food and Drug Administration De Novo (FDA De Novo) submission for the Company’s PainChek Adult App.
- Majority of requirements for submission complete – Clinical Evaluation Report in final stages
- PainChek expects to provide a further update this month regarding the submission
- US Aged Care market is the world’s largest – 1.7 million people in long-term aged care
- Potential FDA clearance for the Adult app would be a major milestone for the Company and provides a predicate for PainChek’s use with infants and in other market segments
Philip Daffas, CEO of PainChek, said “The US Aged Care market is the largest in the world where 1,700,000 people reside in these long-term care facilities, with a potential gross annual recurring revenue value of around $85,000,000 USD for PainChek based on our projected US pricing. The FDA De Novo is a marketing pathway to classify novel medical devices. 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.”