Regulatory
Sedana Medical AB (publ) (the "Company") held its annual general meeting on 28 May 2019 in Stockholm. The meeting resolved in accordance with all of the board of directors' and nomination committee's resolution proposals. Complete information on each…
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the first patient in Japan has been treated with AnaConDa and that the registration work for IsoConDa in Japan has been initiated. The Japanese market potential is estimated at EUR…
Regulatory
Clear regulatory pathway to approval in EU and USA
Regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announce that its Annual Report for 2018 has been published and is available on www.sedanamedical.com under Investors.
Regulatory
Sedana Medical AB (publ) hereby convenes the Annual General Meeting 2018. The shareholders in Sedana Medical AB (publ), reg. no. 556670-2519, are hereby given notice to attend the annual general meeting on Tuesday 28 May 2019 at 4 p.m. (CEST) at Eri…
Regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the US Food and Drug Administration (FDA) during a pre-IND meeting is positive about the combination registration of IsoConDa and AnaConDa in the US. Sedana Medical now has a clear…
Regulatory
“The fourth quarter and 2018 have been eventful, but in many ways, it is only the start of our journey. I look forward with excitement to the future.” - Christer Ahlberg, President and CEO Sedana Medical (publ)
Regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced the results of the interim analysis for the company's pivotal phase III study aimed at getting the candidate drug IsoConDa (isoflurane) approved for inhalation sedation in intensive care…
Regulatory
Sedana Medical AB (publ) announce today that the year-end report for 2018 will be released Tuesday 12th of March 2019 at 07.00 CET instead of 21st of March.
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced the establishment of the Sedana Medical Research Foundation, creating a unique opportunity for the scientific community to increase knowledge of sedation therapies of critically ill pati…
Regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces the company has been approved for its planned pediatric study from the Pediatric Committee of EMA, European Medicines Agency, (PDCO).
Regulatory
In the previously announced press release the following text was included: This information is such that Sedana Medical AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure…
Regulatory
Sedana Medical AB (publ) today publish that in accordance with the resolution of the Annual General Meeting on May 22, 2018, the Chairman of the Board has contacted the company’s three largest shareholders or group of shareholders in terms of votes t…
Regulatory
Strong development towards our strategic objectives
Non-regulatory
Sedana Medical AB (publ) (Sedana Medical or the company) presents a health economic analysis at the European Conference for Health Economics and Outcomes Research 2018 (ISPOR) in Barcelona, showing clinical and economic benefits of inhaled isoflurane…
Regulatory
Sedana Medical AB (publ) (Sedana Medical or the company) announces today that the company has received market approval for AnaConDa from the Ministry of Health, Labour and Welfare (MHLW) in Japan. Through the approval, AnaConDa can now be marketed,…
Non-regulatory
Sedana Medical AB (publ) (Sedana Medical or Company) has established its own sales organization in Great Britain, in accordance with the previously announced plan. The Company is now delivering its first direct deliveries of AnaConDa for sedation of…
Regulatory
Sedana Medical AB (publ) (“Sedana Medical”) broadens the shareholder base through a secondary sale of existing shares by four insiders to Handelsbanken Fonder, Apus Capital, Norron Asset Management and Brohuvudet AB (the “Block Sale”). The Block Sale…
Regulatory
In the press release published 30 August 07:00 CET the following has been reported: · EBITDA amounted to 1 794 (1 081) KSEK and the EBITDA margin was -6,0% (5,6%). Correct reporting is: · EBITDA amounted to -1 794 (1 081) KSEK and the EB…
Regulatory
The registration process for the United States commenced and European study resumed at full speed