PainChek (ASX:PCK) has announced significant progress in its quarterly update for the period ending September 30, 2024. The company has achieved key milestones, including the submission of a US FDA De Novo regulatory application. PainChek also reported achieving 100,000 contracted licenses globally, reflecting a 6% increase from the previous quarter.
PainChek (ASX:PCK) has made substantial progress in its latest quarterly update, achieving key milestones that align with its corporate strategy. Central to this progress is the submission of a US FDA De Novo application for its Adult App, which opens the door to the $100 million USD annual US market. PainChek has reached 100,000 global licenses, marking a 30% year-over-year increase, and launched its Infant App in Australia, targeting infants aged 1-12 months. Financially, PainChek reported customer receipts of $912,000 for the quarter and recognized revenue of $760,000, alongside cash reserves of $1.7 million. The company continues to expand in regions like Australia, New Zealand, the UK, and North America through strategic partnerships and is actively involved in research projects to validate its technology. Looking ahead, PainChek is exploring fundraising options and expects reduced cash outflows, setting the stage for continued growth and market penetration.
The submission of our De Novo application to the US FDA is a significant milestone for PainChek as we continue to expand our presence globally. Our achievements in license growth and the launch of the Infant App in Australia demonstrate our commitment to improving pain assessment and management worldwide.