PainChek has productive final FDA De Novo clearance meeting

• Successful final feedback review meeting with US FDA
• Submission of additional clinical study data expected by end of June 2025
• FDA commitment to final De Novo regulatory clearance decision within 75 days

PainChek Ltd has announced that it has completed a successful final feedback review meeting with the US FDA as the company targets De Novo regulatory clearance for its pain assessment and monitoring application. The meeting, held on 3rd June 2025, was a follow-up to a previous face-to-face meeting on 19 May 2025 and focused on addressing the FDA's final questions related to PainChek's recent US clinical trial results. The meeting was described as a positive two-way conversation, providing feedback and clarity for both parties. Based on the discussions, PainChek is now compiling additional information collected from the completed clinical study that addresses the FDA feedback. This submission is expected to be the final step in PainChek's US De Novo marketing clearance application and will be submitted prior to the end of June 2025. On receipt of the final PainChek submission, the FDA has committed to a final decision on De Novo regulatory clearance within 75 days, giving a projected potential clearance date of mid-to-late September 2025 or sooner. PainChek CEO Philip Daffas expressed confidence that the company will be in a position to launch a first version of the Adult App designed for the US market later this year, following the successful FDA meetings and ongoing communication.

PainChek remains confident that it will be in a position to launch a first version of the Adult App designed for the US market later this year, following the successful FDA meetings and ongoing communication.