Marketing Authorisation Application for CT001 submitted to the European Medicines Agency for acute pain management in children

• Proveca has submitted a Paediatric Use Marketing Authorisation (PUMA) application for CT001 (ketamine/sufentanil nasal spray) to the EMA
• The validation process has been completed
• The review process will now be initiated and potential approval expected in 2026

Copenhagen, Denmark - 14 August 2025 - Cessatech A/S (“Cessatech”) and Proveca Ltd (“Proveca”) today announce that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for CT001 (a prescription only medicine), confirming that the submission is complete and that the formal scientific review has started. This event marks a significant milestone in Proveca’s and Cessatech’s mission to bring an innovative treatment candidate to paediatric patients in Europe.

CT001 is being developed for acute pain management in children aged 1-17 years with the goal of addressing a clear unmet medical need where current options are limited and inconsistent in meeting patient and caregiver expectations. If approved, CT001 has the potential to become the first and only nasal treatment specifically designed for the management of moderate to severe acute pain in children aged 1-17 years. PUMA is a type of application to the EMA to get a medicine approved specifically for use in children, across the EU.

Comments from Proveca CEO, Simon Bryson
“We are very pleased to have submitted this PUMA application to the EMA for this innovative, new medicine to manage acute pain in children aged 1-17. Proveca and Cessatech signed the exclusive licensing agreement less than 12 months ago, and in this time the team have successfully completed the CMC and clinical programmes and prepared the marketing authorisation dossier for EU registration. This is a significant milestone, and we look forward to bringing this new treatment to paediatric patients.”

Comments from Cessatech CEO, Jes Trygved
“The EMA application of the CT001 MAA is a proud moment for the team and all of our partners. It reflects years of rigorous clinical development and close collaboration with investigators, regulators and advisors. We believe CT001 can make a meaningful difference for patients facing acute pain, an area where the unmet need remains high. It is amazing that we can submit the application just a few months after the top-line results of the last study, with thanks also to Proveca for their immense effort.”