Sedana Medical Concludes US Patient Enrollment for INSPiRE-ICU 1 Trial

Sedana Medical, a pioneering company in the field of medical technology and pharmaceuticals specializing in inhaled sedation, has achieved a significant milestone with the completion of patient recruitment for its INSPiRE-ICU 1 phase III clinical trial in the United States. This trial, along with its counterpart INSPiRE-ICU 2, focuses on evaluating the effectiveness and safety of isoflurane sedation administered through the company's innovative Sedaconda ACD device. The trials aim to compare the time spent at an adequate level of sedation with that of intravenous sedation using propofol, while also examining secondary outcomes such as opioid consumption, awakening time, cognitive recovery, and spontaneous breathing.

The recruitment of 235 patients for INSPiRE-ICU 1 and the near-completion of INSPiRE-ICU 2, with only 23 patients left to enroll, signals a major step forward for Sedana Medical. The trials, which began in April 2022, are being conducted across 31 esteemed clinics in the United States and are designed similarly to the successful Sedaconda study (SED001) that took place in Europe from 2017 to 2019, leading to market approval in 2021.

Peter Sackey, the Chief Medical Officer of Sedana Medical, expressed excitement about the trials' progress and the potential of inhaled sedation in the U.S. healthcare system. He detailed the next steps, which include a 30-day follow-up, final monitoring, data cleaning, and analysis by the company's statistician team. Additionally, the long-term patient outcomes will be centrally collected by a specialized team at Vanderbilt Medical Center.

Christopher Hughes, a Professor of Anesthesiology at Vanderbilt University Medical Center and the Senior Lead Investigator for the INSPiRE-ICU 1 study, highlighted the rewarding nature of the trials and the collective effort of clinical researchers in critical care across the U.S. He echoed the anticipation of healthcare professionals to see inhaled sedation become available in the U.S.

Johannes Doll, President and CEO of Sedana Medical, extended his gratitude to all involved in the trials, emphasizing the importance of the collaboration with intensive care teams from prominent U.S. hospitals. He underscored the value of their advice and support in making inhaled sedation benefits accessible to patients in the United States.

Sedana Medical, established in 2005 and listed on Nasdaq Stockholm, is headquartered in Stockholm, Sweden. The company has a direct sales presence in several European countries and partners with external distributors in other regions, including Asia, Australia, Canada, and South and Central America. The company's mission is to enhance patient care during and after sedation through its medical device and pharmaceutical offerings.