Sedana Medical announces enrolment of first patient in US clinical program
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the first patient has been enrolled in the company’s US clinical studies. The two identical Phase III studies, INSPiRE-ICU 1 and 2, aim to confirm the efficacy and safety of inhaled sedation with isoflurane delivered via Sedaconda ACD and are expected to lead to a new drug application (NDA) filing at the US Food and Drug Administration (FDA) in the US.The studies will compare the safety and efficacy of sedation with inhaled isoflurane delivered via Sedaconda ACD or intravenous propofol in adult mechanically ventilated ICU