Press releases

To stay up to date with our development, sign up for a subscription.

Subscribe

Sedana Medical appoints Johan Spetz as new CFO

Regulatory

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces the appointment of Johan Spetz as the company’s new Chief Financial Officer (CFO). Johan Spetz will take office no later than April 4, 2022, succeeding Susanne Andersson who will leave h…

Sedana Medical receives IND approval for US trials

Non-regulatory

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate phase III pivotal clinical trials with its Sedaconda pro…

Sedana Medical applies for market approval in Italy

Non-regulatory

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company has submitted an application for market approval for Sedaconda (isoflurane) for inhaled sedation in intensive care in Italy.

Sedana Medical submits IND for US clinical trials

Non-regulatory

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA), with the aim to commence its phase III pivotal clinical trials…

Sedana Medical’s Nomination committee appointed

Regulatory

Sedana Medical AB (publ) today publish that in accordance with the resolution of the Annual General Meeting on May 10, 2021, the Chairman of the Board has contacted the company’s three largest shareholders or group of shareholders in terms of votes t…

Sedana Medical presents at ESICM

Non-regulatory

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company will hold a scientific symposium at ESICM Lives 2021, the annual congress of the European Society of Intensive Care Medicine. Additional data on inhaled sedation will al…

Sedana Medical receives approval in Germany

Non-regulatory

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received market approval for inhaled sedation in Germany.

Sedana Medical presenting at ISICEM

Non-regulatory

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company will host a symposium at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels on August 31-September 3, 2021, where the full details…

Sedana Medical's Sedaconda study published in the Lancet

Non-regulatory

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the results of the company's pivotal study Sedaconda (SED001) have been published in the highly ranked scientific journal, the Lancet Respiratory Medicine.

Sedana Medical receives approval in France

Non-regulatory

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received market approval for inhaled sedation in France.

Sedana Medical receives approval for European dossier

Regulatory

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received a positive outcome for its European registration application for the drug Sedaconda (isoflurane) for inhaled sedation. Sedaconda is indicated for sedation o…

Sedana Medical announces positive FDA interaction

Regulatory

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has completed a successful End of phase II meeting with the US Food and Drug Administration (FDA). The FDA accepted Sedana Medical's proposals for phase III program, inc…

Sedana Medical receives QMS MDR approval

Non-regulatory

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received an approval for its quality system (QMS) according to the EU Medical Device Regulation (MDR) 2017/745. The approval means that Sedana Medical's Class I medi…

Sedana Medical's Sedaconda study awarded at DGIIN & ÖGIAIN

Non-regulatory

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company's pivotal phase III study Sedaconda (SED001) has been named one of the three best posters at the 52[nd] intensive care conference DGIIN & ÖGIAIN 16–18 June 2021.