FDA APPROVAL!!!,, page-11

The thing is the market is slowly understanding what the possibilities for the company will be going forward. We need to see PCC take this and run.

FDA approval for PainChek’s Adult App would significantly enhance the company’s prospects, particularly in the U.S. and potentially in Japan, where its aging population presents a substantial market opportunity. Access to the U.S. aged care market, with 1.7 million residents and an estimated annual recurring revenue of US$85 million (AUD$130.2 million), would position PainChek as the first FDA-cleared pain assessment tool for dementia patients unable to self-report, providing a competitive advantage. This approval would also serve as a predicate for faster regulatory clearance of other products, like the PainChek Infant App, and enable expansion into U.S. home care and hospital settings, diversifying revenue streams. In Japan, with a population of 126 million and over 25% aged 65 or older, PainChek’s 2020 patent signals potential for future market entry, though regulatory clearance from Japan’s PMDA is still needed. The aging demographic and focus on quality aged care in Japan could align with PainChek’s technology, addressing the needs of millions with dementia or cognitive impairments.

The FDA clearance would also boost PainChek’s global credibility, facilitating partnerships and market penetration in regions like Japan, where healthcare providers and regulators value stringent approvals. Existing integrations, such as with PointClickCare (covering over 1 million U.S. and Canadian aged care beds), could be mirrored with Japanese care management systems post-regulatory approval. Revenue growth from these markets could help PainChek achieve profitability in the near term.

Who's excited?