Non-regulatory
Sedana Medical AB (publ) announces that the US Patent and Trademark Office (USPTO) has granted Sedana Medical a patent for the medical device Sedaconda ACD-S (US Patent No. 11,707,593 B2). The patent will run until 2037.
Non-regulatory
Sedana Medical AB’s (publ) CEO Johannes Doll and CFO Johan Spetz have each acquired 100,000 shares in the company from the founders Ola Magnusson and Sten Gibeck. The transactions were done on 25 September 2023 at a price of SEK 18 per share, corresp…
Regulatory
Strong sales momentum and a clear target to achieve EBITDA break-even in our Ex-US business during 2024
Regulatory
Sedana Medical AB (publ) today informs that the US Food and Drug Administration (FDA) has requested the company to include long-term outcomes data in the Clinical Study Report (CSR) of the INSPIRE-ICU trials before the New Drug Application (NDA) can…
Non-regulatory
Sedana Medical AB (publ) plans to present its interim report for the second quarter of 2023 on Friday July 21 at 13:30 CET.
Non-regulatory
Sedana Medical AB (publ) announces the publication of a post-hoc analysis of the company's pivotal Sedaconda study (SED001) in the Journal of Critical Care. The post-hoc analysis that focused on long-term outcomes demonstrated 3.5 more ICU-free days…
Regulatory
Sedana Medical AB (publ) today announces that the primary endpoint of its Phase 3 IsoCOMFORT study was met in the full analysis set, but was not met in the per-protocol analysis. The completion of the trial extends the company’s data exclusivity of t…
Regulatory
Sedana Medical AB’s annual general meeting was held on Tuesday, May 16, 2023. The main resolutions passed were the following.
Non-regulatory
Sedana Medical AB (publ) plans to present its interim report for the first quarter of 2023 on Thursday April 27 at 13:30 CET.
Regulatory
Sedana Medical AB (publ) publishes its Annual Report for 2022. The Annual Report describes important events and financial information for 2022, as well as the progress the company has made on its strategic priorities during the year.
Regulatory
Fast track designation in the US and our strongest quarter in 2022
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.
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.
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…
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…
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…
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…
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…