Sedana Medical AB (publ) announced The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for the company?s pharmaceutical product Sedaconda® (isoflurane) in the United Kingdom. This market approval will enable Sedana Medical to sell Sedaconda® (isoflurane) in the UK and to promote the clinical and health economic benefits of its therapy for inhaled sedation in intensive care. The medical device Sedaconda ACD has been sold in the UK for several years, and the company submitted the application for marketing authorization for Sedaconda® (isoflurane) in early 2021.

Already in 2022, the UK National Institute for Health and Care Excellence (NICE) recommended the Sedaconda ACD as a cost-saving option for delivering inhaled sedation in intensive care. According to NICE, cost modelling had shown cost savings compared with intravenous (IV) sedation of almost £4,000 per adult patient (30-day time horizon for adult patients needing mechanical ventilation for 24 hours or longer in intensive care). Sedana Medical has now received market authorization for Sedaconda® (isoflurane) in all 18 countries where an application for approval has been submitted.

In addition to the UK, the pharmaceutical is approved in Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden, and Switzerland.