Sedana lämnar in ansökan i USA – ”Avgörande milstolpe”

Sedana Medical har nu lämnat in en FDA-ansökan om marknadsgodkännande av sin kombinationsprodukt för inhalationssedering. ”Ansökan är resultatet av flera års hängivet arbete”, säger bolagets vd Johannes Doll.

By Anders Göransson

June 17, 2026 11:41 AM

Sedana Medical siktar på en amerikansk kombinationsregistrering av den medicintekniska produkten Sedaconda ACD och isofluran för sedering av mekaniskt ventilerade intensivvårdspatienter.

Ansökan baseras på Sedanas kliniska program för inhalationssedering, inklusive de två pivotala studierna INSPIRE ICU-1 och INSPIRE ICU-2, som båda uppnådde sitt primära effektmått. Ett betydelsefullt sekundärt effektmått, opioidanvändning, var också statistiskt signifikant till fördel för isofluran, enligt bolaget.

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