Sedana Medical reports topline results from phase 3 paediatric IsoCOMFORT study
Sedana Medical AB (publ) today announces that the primary endpoint of its Phase 3 IsoCOMFORT study was met in the full analysis set, but was not met in the per-protocol analysis. The completion of the trial extends the company’s data exclusivity of the adult indication to 2031. The approval of the paediatric indication will be subject to regulatory review.IsoCOMFORT was 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