Sedana Medical receives IND approval for US trials
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate phase III pivotal clinical trials with its Sedaconda products in the United States.Sedana Medical is aiming for a combination registration of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane) for sedation of mechanically ventilated intensive care patients. As previously announced, the company is planning to commence patient recruitment at the turn of Q1/Q2 2022, with the