• PainChek receives FDA De Novo clearance for Adult App, opening $175m US long-term care market
• Contracted licences grow 15.4% to 115,770 globally, with 71,751 implemented
• PainChek Infant App sales commence in Australia, targeting $15bn global market

PainChek Ltd (ASX: PCK) has reported its quarterly activities and cashflow report for the quarter ended 30 September 2025. Key highlights include the company receiving FDA De Novo clearance for its PainChek Adult App, making it the first and only regulated medical device to assess pain in people living with moderate to severe dementia in the US long-term care market. This provides PainChek with immediate access to a $175m annual US market, with the potential to expand to a $582m annual opportunity including home care and hospital sectors. The company has signed its first US customer shortly after receiving FDA clearance and is building a strong sales pipeline, including attending major US industry events. In its core markets, PainChek has continued to grow its contracted licences, which now stand at 115,770 globally across over 1,900 aged care facilities, with an annual recurring revenue (ARR) of $5.6m once fully implemented. The company has also seen strong growth in its Infant App, with sales commencing in Australia and targeting a global $15bn annual market opportunity. PainChek has appointed a Head of Growth for the Infant App and is focused on optimising the product, onboarding, and marketing ahead of broader scaling activities.

PainChek's FDA De Novo clearance for its Adult App provides immediate access to a $175m annual US long-term care market, with the potential to expand to a $582m annual opportunity including home care and hospital sectors.

PainChek is strongly positioned for immediate commercial rollout in the US, bolstered by strategic partnerships with leading healthcare software providers. The company continues to see positive growth in its core markets and is focused on optimising its Infant App ahead of broader scaling activities.