Sedana Medical completes patient recruitment for pediatric IsoCOMFORT study
Sedana Medical AB (publ) (SEDANA: FN Stockholm) announces that the last patient has been recruited for its pediatric phase III clinical study in Europe (IsoCOMFORT). Assuming positive study results, the company expects approval of the pediatric indication in Q4 2023 or Q1 2024 within Europe, enabling data exclusivity/market protection for the adult indication until 2031.The IsoCOMFORT study compares the efficacy and safety of Sedana Medical’s pharmaceutical Sedaconda (isoflurane), administered via the company’s medical device Sedaconda ACD, with intraveneous midazolam for sedation of