• Final US FDA submission completed for PainChek Adult App clearance
• Regulatory clearance decision expected within 75 days, by late September to early October
• Established US partner agreements in place to support rapid commercialization

PainChek Ltd has announced that it has completed its final submission to the US FDA for De Novo regulatory clearance of the PainChek Adult App as a medical device. The company expects a final decision on the clearance within 75 days, potentially by late September to early October 2025, or sooner. Following a meeting with the FDA in early June 2025, the final submission provides additional information collected from PainChek's recent US clinical trial that addresses specific feedback from the regulator. The US is the largest healthcare market in the world, with 2.9 million people living in its skilled nursing and assistive living sectors, where currently there is no regulatory cleared pain assessment medical device for people living with moderate to severe dementia. Based on projected PainChek pricing, this initial market opportunity exceeds $100M USD per annum.On successful receipt of the initial De Novo clearance, the company's intent is to pursue additional clearances to also enter the larger US home care, hospital, and infant markets. PainChek has already established US client relationships, appointed a US Head of Business Development, and secured major integration and reseller partner agreements in the region, which will provide an excellent springboard for rapid US market commercial success upon FDA clearance.

Upon successful FDA clearance, PainChek plans to rapidly commercialize the PainChek Adult App in the US market, leveraging its established partner agreements and relationships.