Sedana Medical AB (publ) announced that all 235 randomized patients have been recruited for its INSPiRE-ICU 1 phase III clinical trial in the United States. Concurrently, the identical INSPiRE-ICU 2 trial is nearing completion, with 23 of 235 randomized patients remaining. The company anticipates topline results from both trials in the second half of 2024, with a planned New Drug Application (NDA) submission in the first quarter of 2025.

INSPiRE-ICU 1 and 2 are two identical randomized phase III trials, aiming to confirm the efficacy and safety for sedation with isoflurane delivered via Sedana Medical's unique medical device Sedaconda ACD. The primary endpoint is the proportion of time spent at adequate depth of sedation, compared with intravenous sedation using propofol. In addition, several important secondary endpoints are being studied, including opioid use, time to wake-up, cognitive recovery and spontaneous breathing.

The first patient was included in April 2022, and 31 highly reputed clinics in the United States are involved in the two trials. The design of the US studies is similar to the Sedaconda study (SED001) successfully performed in Europe in 2017-2019, which resulted in market approval in 2021.