Sedana Medical AB’s Year-end report 2022
Regulatory
Fast track designation in the US and our strongest quarter in 2022
Sedana Medical receives market approval in Italy
Non-regulatory
Sedana Medical AB (publ) has received market approval for Sedaconda[®] (isoflurane) for inhaled sedation in intensive care in Italy, bringing the number of European countries where the company’s therapy is approved to 17.
Invitation to presentation of Sedana Medical’s fourth quarter and Year-End Report 2022
Non-regulatory
Sedana Medical AB (publ) plans to present its fourth quarter and Year-End Report for 2022 in an audiocast on February 16 at 13.30 CET.
First day of trading in Sedana Medical’s shares on Nasdaq Stockholm
Regulatory
Sedana Medical AB (publ) (the "Company" or "Sedana Medical") announced on 19 January 2023 that Nasdaq Stockholm's listing committee had resolved to approve the Company's application for admission to trading of the Company's shares on Nasdaq Stockholm…
Sedana Medical publishes prospectus and certain new financial information in connection with the listing change to Nasdaq Stockholm
Regulatory
Sedana Medical AB (publ) (the "Company" or "Sedana Medical") announced on 19 January 2023 that Nasdaq Stockholm's listing committee had approved the Company's application for admission to trading of the Company's shares on Nasdaq Stockholm. The Compa…
Sedana Medical has been approved for trading on Nasdaq Stockholm
Regulatory
Nasdaq Stockholm's Listing Committee has today informed that Sedana Medical AB's (publ) (the "Company" or "Sedana Medical") application for admission to trading of the Company's shares on Nasdaq Stockholm has been approved. The approval is subject to…
Sedana Medical completes patient recruitment for pediatric IsoCOMFORT study
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) announces that the last patient has been recruited for its pediatric phase III clinical study in Europe (IsoCOMFORT). Assuming positive study results, the company expects approval of the pediatric indic…
Sedana Medical receives FDA Fast Track Designation in the United States
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the evaluation of isoflurane via the Sedaconda ACD-S device for sedation of mechanically ven…
Correction: Sedana Medical receives positive opinion from EMA’s Pediatric Committee on reduced pediatric study design
Regulatory
Correction refers to change of category of press release from non-regulatory to regulatory. All other information is unchanged relative to previous version.
Sedana Medical’s Sedaconda (isoflurane) now approved in all 15 European countries included in the first submission
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that, following the national approval in Poland, the company has now received national market approvals in all 15 countries included in the Decentralised Procedure (DCP) approval receive…
Sedana Medical AB Interim report January-September 2022
Regulatory
Sales growth in our direct markets despite temporary market headwinds
Sedana Medical’s Nomination Committee established
Regulatory
According to the principles for the appointment of the Nomination Committee in Sedana Medical AB (publ), the Nomination Committee for the annual general meeting 2023 shall be composed of members appointed by the three largest shareholders as of Septe…
Sedana Medical presents at ESICM
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company will hold a scientific symposium during ESICM Lives 2022, the annual congress of the European Society of Intensive Care Medicine. Additional data on inhaled sedation wil…
Invitation to presentation of Sedana Medical’s interim report for the third quarter 2022
Non-regulatory
Sedana Medical AB (publ) plans to present its interim report for the third quarter 2022 in an audiocast on October 25 at 13.30 CET.
Sedana Medical’s products receive MDR certification
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company has received Medical Device Regulation (MDR) certification, which secures EU market access for Sedaconda® ACD under the new MDR regulation, well ahead of the deadline in…
Sedana Medical AB Interim report January-June 2022
Regulatory
Committed to change the standard of care, with commercial progress and a strong balance sheet.
Invitation to presentation of Sedana Medical’s interim report for the second quarter 2022
Non-regulatory
Sedana Medical AB (publ) plans to present its interim report for the second quarter 2022 in an audiocast on July 21 at 13.30 CET.
Bulletin from the annual general meeting in Sedana Medical AB (publ)
Regulatory
Today, 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) in accordance…
Sedana Medical AB Interim report January-March 2022
Regulatory
First patient enrolled in US clinical program