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  • Johannes Doll

    President & CEO


    +46 (0)76 303 66 66
    http://www.sedanamedical.com
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    Sedana Medical AB (publ) has completed a directed new share issue of 2,896,000 shares, raising proceeds of SEK 375 million

    NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. PLEASE REFER TO IMPORTANT INFORMATION AT THE END OF THE PRESS RELEASE.The board of directors of Sedana Medical AB (publ) (”Sedana Medical” or the ”Company”) has, as announced in the Company’s press release earlier today, resolved to carry out a directed

    Sedana Medical AB (publ) prepares for listing on the Nasdaq Stockholm main market

    NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. PLEASE REFER TO IMPORTANT INFORMATION AT THE END OF THE PRESS RELEASE.The board of directors of Sedana Medical AB (publ) (“Sedana Medical” or the “Company”) has resolved to evaluate the possibilities of listing the Company’s shares on Nasdaq Stockholm’s

    Sedana Medical AB (publ) intends to undertake a directed new share issue

    NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. PLEASE REFER TO IMPORTANT INFORMATION AT THE END OF THE PRESS RELEASE.Sedana Medical AB (publ) (“Sedana Medical” or the “Company”) today announces its intention of a directed new share issue of approximately SEK 350 million to Swedish and international

    Sedana Medical's AnaConDa approved to be used in children

    Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company's medical device AnaConDa, for the administration of volatile anesthetics for sedation of mechanically ventilated intensive care patients, has received approval for use on children by the European notifying body BSI Group. The approval also means that AnaConDa can be used in patients with severely impaired lung capacity."This means that we have no restrictions on the use of AnaConDa and that we can reach the entire market for mechanically ventilated intensive care patients. Regardless of whether you are a child,

    Sedana Medical AB (publ), Interim report Q2, 2019

    Strategic partnership in Asia and continued strong growthFinancial summary, April - June ·  Net sales during the second quarter amounted to KSEK 17,359 (14,485) corresponding to an increase of 20% compared with the same period in 2018. ·  Earnings before interest, taxes, depreciation and amortisation (EBITDA) amounted to KSEK -2,330 (-1,006) KSEK. This corresponds to an EBITDA margin of -13% (-7%). ·  Earnings before interest and taxes (EBIT) amounted to KSEK -3,377 (-2,007), which corresponds to an EBIT margin of-19% (-14%). ·  Cash flow from operations before changes in

    Sedana Medical enters India – signs Indian distributor

    Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced a distribution agreement with the Indian distributor Hansraj Nayyar Medical. Sales will commence in the fall and a registration process will start in parallel. Hansraj Nayyar has committed to a first framework order of 25,000 euros. The Indian market potential for sedation in intensive care is estimated to be around two million ventilation days annually."Hansraj Nayyar is a pioneer in Indian intensive care and it is very gratifying that they will now launch our therapy." said Christer Ahlberg, CEO of Sedana Medical. Under

    The grant recipients of the Sedana Medical Research Foundation 2019 presented

    Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced the recipients of the Sedana Medical Research Foundation (SMRF) grant 2019. Three research projects will receive funding from SMRF 2019 covering the area of inhaled sedation in the intensive care field.One of Sedana Medical´s missions is to improve patient outcomes through medical innovation. SMRF has been established to stimulate and support international research in the field of sedation of mechanically ventilated Intensive Care Unit (ICU) patients and to create a unique opportunity for the scientific community to increase

    Sedana Medical enters China – signs with Chinese distributor

    Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced a 10-year exclusive distribution agreement with the Chinese distributor Kyuan Xinhai Medical, a subsidiary of partly state-owned Shanghai Pharma, the second largest life science company in China. Kyuan will immediately commence the fast-track registration of AnaConDa in China and estimates approval will be obtained in less than two years. The Chinese market potential for sedation in intensive care is estimated to be five to six million ventilation days annually.Kyuan is making a major investment in this cooperation which

    Bulletin from annual general meeting in Sedana Medical AB (publ)

    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 resolution proposal that was approved by the meeting is available on www.sedanamedical.com. A summary of the resolutions that were made at the meeting is presented below.Adoption of the income statement and balance sheet and the consolidated income statement and consolidated balance sheet, as well as resolution on disposal of profits and

    Progress in Japan

    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 300 million annually.At the Shiga University Hospital, Shiga University of Medical Science Hospital, SUMS, the first patient has now clinically been treated with AnaConDa. "The first patient in Japan is of course a milestone, but in addition, the AnaConDa treatment is currently being evaluated by the ethical committees of five university

    Sedana Medical AB (publ), Interim report Q1, 2019

    Clear regulatory pathway to approval in EU and USAFirst quarter, January - March 2019 ·  Net sales during the first quarter amounted to KSEK 17,814 (15,487) corresponding to an increase of 15% compared with the same period in 2018. ·  Earnings before interest, taxes, depreciation and amortisation (EBITDA) amounted to KSEK -2,641 (-788) KSEK. This corresponds to an EBITDA margin of -14,8% (-5,1%). ·  Earnings before interest and taxes (EBIT) amounted to KSEK -3,660 (-1,730), which corresponds to an EBIT margin of -20,5% (-11,2%) ·  Cash flow from operations before changes

    Sedana Medical publishes its Annual Report for 2018

    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.For additional information, please contact:Christer Ahlberg, CEO, Sedana Medical AB+46 70 675 33 30christer.ahlberg@sedanamedical.com (mailto:) Maria Engström, CFO, Sedana Medical AB+46 70 674 33 30maria.engstrom@sedanamedical.com  Sedana Medical is listed on Nasdaq First North in Stockholm. The company's Certified Adviser is Erik Penser Bank, +46 8 463 83 00, certifiedadviser@penser.se.  ___________

    Notice of Annual General Meeting in Sedana Medical AB (publ)

    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 Erik Penser Bank, Apelbergsgatan 27, Stockholm. Registration for the meeting commences at 3:30 p.m. (CEST).ParticipationA shareholder wishing to participate at the meeting must be entered as shareholder in the share register kept by Euroclear Sweden AB on the record date Wednesday 22 May 2019, and must notify the company of their attendance no

    The road to registration in the US clarified

    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 view of measures that have to be taken in order to reach marketing authorization approval of both IsoConDa and AnaConDa in the US. The meeting also confirmed Sedana Medical's estimate of the time and cost of a US approval that is expected to occur in 2024."The FDA has set clear requirements that are in line with the expectations we had, and they

    Sedana Medical Year-end Report, January – December 2018. - Strong growth and positive registration work development

    “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)Fourth quarter, October – December 2018 ·  Net sales during the fourth quarter amounted to 15 242 (10 796) KSEK corresponding to an increase of 41% compared with the same period in 2017. ·  Earnings before interest, taxes, depreciation and amortisation (EBITDA) amounted to -1 474 (-838) KSEK. This corresponds to an EBITDA margin of -9,7% (-7,8%). ·  Earnings before

    Positive interim analysis in pivotal IsoConDa phase III study

    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 in Europe. The interim analysis shows smaller variations in efficacy than anticipated and the study will therefore only need to cover a total of 300 patients instead of initially estimated 550 patients."This is very positive news. The interim analysis shows a low standard deviation in the primary variable, the proportion of time with adequate

    New release date for Sedana Medical’s year-end report 2018

    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.Sedana Medical invites all interested parties to a webcast conference call, with presentation of the year-end report at. 10.30 CET. Sedana Medical's CEO Christer Ahlberg and CMO Peter Sackey participate in the presentation held in English. Information on how to participate: The webcast including the presentation material, which can also be seen afterwards, is reached at: https://tv.streamfabriken.com/2019-03-12-sedana-medical-

    Sedana Medical establishes sedation research foundation

    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 patients.One of Sedana Medical´s missions is to improve patient outcomes through medical innovation. Sedana Medical Research Foundation is established to stimulate and support international research in the field of sedation of mechanically ventilated Intensive Care Unit (ICU) patients. “By supporting sedation research of critically ill ICU

    Sedana Medical receives go-ahead for pediatric study  - Milestone on the road to market exclusivity

    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).A complete Marketing Authorization Application (MAA) for drugs in EU must include a PDCO agreed and approved study plan for children, a so-called PIP (Pediatric Investigation Plan). "It is incredibly satisfying that PDCO has now approved our planned pediatric study, our PIP. An approved study plan on children is one of the prerequisites for a European market approval for our therapy, so this is

    Sedana Medical’s nomination committee appointed

    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 to form a Nomination Committee. These shareholders have been invited to appoint one representative each who, together with the Chairman of the Board, will comprise the Nomination Committee.Sedana Medical's Nomination Committee for the 2019 Annual General Meeting consists of: ·  Thomas Eklund, Chairman of the Board ·  Sten Gibeck, Board

    Sedana Medical AB (publ), Interim report Q3, 2018

    Strong development towards our strategic objectivesFinancial Summary July-September  · Net sales during the third quarter amounted to 12 682 (10 191) KSEK corresponding to an increase of 24% compared with the same period in 2017. · Earnings before interest, taxes, depreciation and amortisation (EBITDA) amounted to -964 (-980) KSEK. This corresponds to an EBITDA margin of -7,6% (-9,6%). · Earnings before interest and taxes (EBIT) amounted to -2 051 (-2 254) KSEK, which corresponds to an EBIT margin of -16,2% (-22,1%). · Cash flow from operations before changes in working

    Sedana Medical shows significant health-economic benefits with AnaConDa

    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 sedation via AnaConDa versus conventional intravenous sedation with propofol or midazolam.The analysis model has been developed to compare the costs and clinical outcome of sedated and ventilated intensive care patients. Clinical data is derived from a German retrospective study (Bellgardt et al., Eur J Anaesthesiology 2016, 33: 6-13), that

    Sedana Medical receives approval for AnaConDa in Japan

    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, sold and used in intensive care for the administration of volatile anaesthetics for mechanically ventilated patients. Sedana Medical and their Japanese distributor, who will promote the product, are now preparing for market launch in Japan during 2019.AnaConDa is Sedana Medical’s product for administration of volatile anaesthetics for

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