Sedana Medical AB (publ) (the "Company" or "Sedana Medical") announced on 19 January 2023 that Nasdaq Stockholm's listing committee had resolved to approve the Company's application for admission to trading of the Company's shares on Nasdaq Stockholm (the "Listing Change"). Today, 25 January 2023, trading in the Company's shares on Nasdaq Stockholm commences.
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the evaluation of isoflurane via the Sedaconda ACD-S device for sedation of mechanically ventilated patients in the intensive care (ICU) setting.
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.