Non-regulatory
Sedana Medical AB (publ) announces that the European Medicines Agency’s Paediatric Committee has issued a positive opinion regarding the compliance with the company’s Paediatric Investigation Plan. This confirms data exclusivity and market protection…
Non-regulatory
Sedana Medical AB (publ) today announces that the main results from the paediatric IsoCOMFORT study have been published in the Clinical Trials Registry EudraCT.
Regulatory
All-time-high Q3 sales and further steps towards ex-US profitability
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 2024 shall be composed of members appointed by the three largest shareholders as of Septe…
Non-regulatory
Sedana Medical AB (publ) today announces that the enrollment of the planned 700 patients in the SESAR trial has been completed. The trial Sevoflurane for Sedation in Acute Respiratory Distress Syndrome: A Multicenter Prospective Randomized Trial (SES…
Non-regulatory
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted Sedana Medical AB (publ) marketing authorization for the company’s pharmaceutical product Sedaconda[®] (isoflurane) in the United Kingdom.
Non-regulatory
Sedana Medical AB (publ) plans to present its interim report for the third quarter of 2023 on Thursday October 26 at 13:30 CET.
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