Sedana Medical is aiming for a US combination registration of the medical device Sedaconda ACD and isoflurane for sedation of mechanically ventilated intensive care patients. The primary endpoint measured the percentage of time spent at targeted depth of sedation, comparing patients receiving isoflurane via the company’s proprietary Sedaconda ACD medical device with patients receiving intravenous sedation using propofol.

The primary endpoint was met with the non-inferiority margin agreed with the FDA, and non-inferiority versus propofol was established. The safety profile of isoflurane was in line with expectations from previous studies and long-established clinical use in ICUs in Europe.

High-level results for INSPiRE-ICU 2 are expected in early 2025.

“We are very pleased that our first US trial, in a country previously not familiar with inhaled sedation, demonstrated non-inferiority compared to a standard of care treatment that has been used for decades. We would like to thank all the participating investigators and study sites for their support and commitment.” said Peter Sackey, Chief Medical Officer of Sedana Medical.

“With more than 2 million mechanically ventilated patients treated in US intensive care units each year, we see a tremendous opportunity to make a meaningful difference in these patients’ lives. We look forward to receiving the full results from our US clinical program and progressing towards our NDA submission.” said Johannes Doll, CEO and President of Sedana Medical.

The high-level results of INSPiRE-ICU 1 mark the first element of a comprehensive data set, including the full analyses of all end points for both INSPiRE-ICU 1 and INSPiRE-ICU 2, as well as the long-term follow-up of both studies. The FDA will make their assessment based on the totality of the future submission, including pooled analyses of both US trials and the European Sedaconda trial (SED001).