Sedana Medical AB's Interim report January-March 2024
Regulatory
Off to a strong start with record sales in Q1
Regulatory
Off to a strong start with record sales in Q1
Non-regulatory
Sedana Medical AB (publ) announces that all 235 randomized patients have been recruited for its INSPiRE-ICU 1 phase III clinical trial in the United States. Concurrently, the identical INSPiRE-ICU 2 trial is nearing completion, with 23 of 235 randomi…
Regulatory
The board of directors of Sedana Medical AB (publ) has resolved to convene an annual general meeting of shareholders to be held Wednesday, 22 May 2024. Further details on the proposals can be found in the notice convening the meeting, below. The not…
Regulatory
Sedana Medical AB (publ) publishes its Annual Report for 2023. The Annual Report describes important events and financial information for 2023, as well as the progress the company has made on its strategic priorities during the year.
Non-regulatory
Sedana Medical AB (publ) plans to present its interim report for the first quarter of 2024 on Thursday April 25 at 13:30 CET.
Regulatory
Full year sales at upper end of financial guidance and an exciting year ahead
Non-regulatory
Sedana Medical AB (publ) plans to present its fourth quarter and year-end report for 2023 on Thursday February 15 at 13:30 CET.
Non-regulatory
Sedana Medical AB (publ) announces that the company has submitted a Type II variation with the aim of including the paediatric population (3-17 years) into the existing Sedaconda[®] indication for inhaled sedation of mechanically ventilated patients…
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.