Friday, December 24, 2021
Sedana Medical AB 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 objective to obtain US approval in 2024.
"We are concluding the year with another important milestone towards the registration of our Sedaconda products in the United States. With the IND approval, we can keep our ambitious timelines for initiating our pivotal clinical trials. The US market represents our largest commercial opportunity, and we are looking forward to bringing our products to intensive care patients in the US," said Johannes Doll, CEO of Sedana Medical.