PainChek FDA De Novo submission update

PainChek Ltd (ASX:PCK) is making significant progress with its FDA de Novo submission for the PainChek Adult App. The company has completed the majority of the requirements for submission, with the Clinical Evaluation Report in its final stages. PainChek expects to provide a further update this month regarding the submission. The 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.

PainChek CEO's perspective on FDA de Novo submission

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. This clearance would also provide an important predicate for the PainChek Infant App and support the expansion of the Adult App into larger US markets, including home care and hospitals. Additionally, we hold a granted U.S. patent that will remain in place until 2038.

Summary of PainChek's FDA de Novo submission progress

PainChek Ltd (ASX:PCK) has made significant strides in completing the requirements for its FDA de Novo submission for the PainChek Adult App. The company's progress in the US Aged Care market, with the completion of the US-based clinical validation study data collection, marks a crucial step towards potential FDA clearance. The FDA clearance for the Adult app would not only be a major milestone for the Company but also pave the way for its expansion into larger US markets, including home care and hospitals. With existing partnerships and regulatory clearances in various countries, PainChek is well-positioned to penetrate the US and Northern American market. The potential FDA clearance holds the promise of substantial revenue and further solidifies PainChek's position as a leader in smart phone-based pain assessment and monitoring applications.