Sedana Medical AB (publ) announces that the European Medicines Agency's Paediatric Committee has issued a positive opinion regarding the compliance with the company's Paediatric Investigation Plan. This confirms data exclusivity and market protection for Sedana Medical's Sedaconda® (isoflurane) until 2031. In 2021, Sedana Medical's proprietary pharmaceutical Sedaconda (isoflurane) received its first market authorization in Europe for administration via the medical device Sedaconda ACD for inhaled sedation of mechanically ventilated patients in intensive care.

As part of the approval, Sedana Medical could obtain eight years of data exclusivity and two additional years of market protection, provided that the company would comply with the agreed Paediatric Investigation Plan. The Paediatric Committee of the European Medicines Agency has now confirmed that all elements of the Paediatric Investigation Plan, including the clinical trial IsoCOMFORT, were performed in compliance with the agreed plan and all timelines have been respected accordingly.