Sedana Medical AB (publ) announced that the company has submitted a Type II variation with the aim of including the paediatric population (3-17 years) into the existing Sedaconda®? indication for inhaled sedation of mechanically ventilated patients in Europe. The submission is based on the results of the IsoCOMFORT trial, a randomised active-controlled assessor-blinded study comparing the efficacy and safety of sedation with inhaled isoflurane, administered via the company's medical device Sedaconda ACD-S, with intravenous midazolam in mechanically ventilated patients 3 to 17 years old.

Sedana Medical's objective of the IsoCOMFort trial was two-fold: to secure extended data exclusivity and market protection for Sedaconda®? (isoflurane)'s main indication in adult patients and to obtain an approval for sedation of mechanically ventilated children in intensive care. In November, the European Medicines Agency's Paediatric Committee issued a positive opinion regarding the compliance with the company's Paediatric Investigation Plan.

This confirmed data exclusivity and market protection of Sedaconda (isoflurane) until 2031. Now, the Type II variation to extend the indication to include paediatric patients of 3-17 years has been submitted to the Reference Member State (RMS) Germany and 15 Concerned Member States (CMS) in Europe. Type II variation follow a standard procedure, which foresees a review period of 120 days plus a maximum of 150 days to answer questions.

Sedana Medical therefore expects End of Procedure in Third Quarter 2024, after which the national approval processes will follow. For the adult indication, those lasted between 1 and 2 months for the majority of countries.