Sedana Medical seeks US FDA approval to begin phase III trials with Sedaconda products
Sedana Medical AB (publ), a pioneer medtech and pharmaceutical company, announces that the company has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA), with the aim to commence its 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 inhaled sedation of mechanically ventilated patients in intensive care. Provided that the IND is approved, the company is planning to commence patient recruitment at the turn of Q1/Q2 2022, with the objective to obtain US approval in 2024.
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