Sedana Medical Announces Enrolment Of First Patient

84

Sedana Medical AB recently announced 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 patients.

“Our clinical trials INSPiRE-ICU 1 and 2 are strategically significant as they will form the basis of our NDA submission in the United States, which represents our largest commercial opportunity. We are excited about reaching this important milestone and are looking forward to bringing our products to intensive care patients in the US” said Johannes Doll, CEO of Sedana Medical.

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 in the United States. Assuming rapid enrolment of patients and successful trials, Sedana Medical continues to expect the NDA submission in 2024 and a launch in early 2025.

Source

LEAVE A REPLY

Please enter your comment!
Please enter your name here