• PainChek granted De Novo classification by FDA for its PainChek Adult App
• FDA creates new product code 'SGB' recognizing PainChek as a medical device
• PainChek complies with Listing Rules, particularly Rule 3.1

PainChek Ltd has responded to an ASX Aware Letter regarding the recent movement in its share price. The company confirmed that it considers the information regarding the FDA granting a De Novo classification for its PainChek Adult App and the creation of a new product code 'SGB' formally recognizing PainChek as a medical device for pain assessment to be information that a reasonable person would expect to have a material effect on the price or value of its securities. PainChek became aware of this information on Tuesday, 7 October 2025 at 7.50 a.m. AEDT and requested a trading halt on the same date in order to have time to prepare an announcement, which was promptly released on 8 October 2025 without delay. The company confirms it is complying with the Listing Rules, particularly Rule 3.1, and that the response has been authorized and approved in accordance with its continuous disclosure policy.