Sedana Medical receives approval in Germany
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received market approval for inhaled sedation in Germany.
Sedana Medical presenting at ISICEM
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company will host a symposium at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels on August 31-September 3, 2021, where the full details…
Sedana Medical's Sedaconda study published in the Lancet
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the results of the company's pivotal study Sedaconda (SED001) have been published in the highly ranked scientific journal, the Lancet Respiratory Medicine.
Sedana Medical receives approval in France
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received market approval for inhaled sedation in France.
Invitation for presentation of Sedana Medical’s interim report for the second quarter 2021
Non-regulatory
Sedana Medical AB will present its interim report for the second quarter 2021 in an audiocast on August 19 at 13.30 CEST.
Sedana Medical receives approval for European dossier
Regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received a positive outcome for its European registration application for the drug Sedaconda (isoflurane) for inhaled sedation. Sedaconda is indicated for sedation o…
Sedana Medical announces positive FDA interaction
Regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has completed a successful End of phase II meeting with the US Food and Drug Administration (FDA). The FDA accepted Sedana Medical's proposals for phase III program, inc…
Sedana Medical receives QMS MDR approval
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received an approval for its quality system (QMS) according to the EU Medical Device Regulation (MDR) 2017/745. The approval means that Sedana Medical's Class I medi…
Sedana Medical's Sedaconda study awarded at DGIIN & ÖGIAIN
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company's pivotal phase III study Sedaconda (SED001) has been named one of the three best posters at the 52[nd] intensive care conference DGIIN & ÖGIAIN 16–18 June 2021.
Record date for division of shares (split) in Sedana Medical determined to May 27, 2021
Regulatory
At the annual general meeting of Sedana Medical AB (publ) (SEDANA: FN Stockholm) held May 10, 2021, it was resolved, in accordance with the board of directors' proposal, on a division of shares (split), whereby each current share is divided into four…
Sedana Medical appoints Johannes Doll as new CEO
Regulatory
Sedana Medical’s (publ) (SEDANA: FN Stockholm) Board of Directors has appointed Johannes Doll as the company’s new CEO. Johannes Doll will take office no later than November 1, 2021, succeeding Christer Ahlberg, who, as announced previously, will lea…
Bulletin from the annual general meeting in Sedana Medical AB
Regulatory
Today, May 10, 2021, the annual general meeting of Sedana Medical AB (publ) (SEDANA: FN Stockholm) was held. In order to counteract the spreading of the corona virus, the general meeting was held only through advance voting (so-called postal voting)…
Sedana Medical AB (publ), First Quarter Report 2021
Regulatory
A quarter of launch preparations and continued increase in sales, lifted by the pandemic
Sedana Medical publishes its Annual Report 2020
Regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that its Annual Report for 2020 has been published.
Notice of Annual General Meeting in Sedana Medical AB (publ)
Regulatory
The shareholders in Sedana Medical AB (publ), reg. no. 556670-2519, are hereby given notice to attend the annual general meeting to be held on Monday 10 May 2021. In order counteract the spreading of the corona virus, the board of directors of the co…
The nomination committee’s proposal in respect of election of board members at the annual general meeting of Sedana Medical
Regulatory
The nomination committee of Sedana Medical AB (publ) (SEDANA: FN Stockholm) has presented its proposal in respect of election of board members at the annual general meeting to be held May 10, 2021. The nomination committee proposes re-election of all…
Sedana Medical AB (publ), Fourth Quarter and Year-end Report
Regulatory
Registration application submitted in the EU – strong sales increase as a result of COVID-19
Sedana Medical's CEO Christer Ahlberg is leaving the company
Regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that Christer Ahlberg has informed the board of directors of Sedana Medical that he is resigning as CEO to become CEO of Cinclus Pharma AB. Christer Ahlberg will remain as CEO until the…
First patient included in pediatric study IsoCOMFORT
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the first patient has been included in the company's pediatric study IsoCOMFORT (SED002) which is conducted to investigate if inhaled sedation of Sedaconda (isoflurane) via AnaConDa…