Therapy Areas: Devices
Sedana Medical enrols first patient in US clinical studies
28 April 2022 -

Sedana Medical AB (publ) (SEDANA: FN Stockholm), a Sweden-based medtech and pharmaceutical company, announced on Thursday that it has enrolled its first patient in its United States clinical studies.

The two identical Phase III studies, INSPiRE-ICU 1 and 2, intend to confirm the efficacy and safety of inhaled sedation with isoflurane delivered through Sedaconda ACD and are expected to lead to a new drug application (NDA) filing at the US Food and Drug Administration (FDA).

The studies are to compare the safety and efficacy of sedation with inhaled isoflurane delivered through Sedaconda ACD or intravenous propofol in adult mechanically ventilated ICU patients.

The firm is planning a combination registration of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane) for sedation of mechanically ventilated intensive care patients in the United States. It is expecting the NDA submission in 2024 and a launch in early 2025.