{"id":5676,"date":"2024-10-18T13:03:58","date_gmt":"2024-10-18T11:03:58","guid":{"rendered":"https:\/\/sedanamedical.com\/var-forskning\/"},"modified":"2025-05-15T10:20:02","modified_gmt":"2025-05-15T08:20:02","slug":"var-forskning","status":"publish","type":"page","link":"https:\/\/sedanamedical.com\/sv\/var-forskning\/","title":{"rendered":"V\u00e5r forskning"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|desktop&#8221; admin_label=&#8221;Hero Section&#8221; module_class=&#8221;hero-section&#8221; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#002145&#8243; background_image=&#8221;<a href=\"https:\/\/sedanamedical.com\/wp-content\/uploads\/2024\/11\/Bedside_v3_Highres.jpg&#038;#8221\">https:\/\/sedanamedical.com\/wp-content\/uploads\/2024\/11\/Bedside_v3_Highres.jpg&#038;#8221<\/a>; background_blend=&#8221;soft-light&#8221; custom_padding=&#8221;120px|20px|120px|20px|false|true&#8221; 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_builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_heading title=&#8221;Forskning&#8221; admin_label=&#8221;Heading&#8221; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; title_font=&#8221;Sofia Pro Regular|600||on|||||&#8221; title_text_align=&#8221;center&#8221; title_font_size=&#8221;60px&#8221; title_line_height=&#8221;70px&#8221; custom_margin=&#8221;||10px||false|false&#8221; title_font_size_tablet=&#8221;40px&#8221; title_font_size_phone=&#8221;36px&#8221; title_font_size_last_edited=&#8221;on|desktop&#8221; title_line_height_tablet=&#8221;50px&#8221; title_line_height_phone=&#8221;46px&#8221; title_line_height_last_edited=&#8221;on|desktop&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_heading][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;Breadcrumb Section&#8221; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#1A3657&#8243; custom_padding=&#8221;15px|20px|15px|20px|false|false&#8221; da_disable_devices=&#8221;off|off|off&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; da_is_popup=&#8221;off&#8221; da_exit_intent=&#8221;off&#8221; da_has_close=&#8221;on&#8221; da_alt_close=&#8221;off&#8221; da_dark_close=&#8221;off&#8221; da_not_modal=&#8221;on&#8221; da_is_singular=&#8221;off&#8221; da_with_loader=&#8221;off&#8221; da_has_shadow=&#8221;on&#8221;][et_pb_row _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;100%&#8221; width_tablet=&#8221;100%&#8221; width_phone=&#8221;100%&#8221; width_last_edited=&#8221;on|desktop&#8221; max_width=&#8221;1296px&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text ul_type=&#8221;none&#8221; admin_label=&#8221;Breadcrumb Menu&#8221; module_class=&#8221;breadcrumb-menu&#8221; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Sofia Pro Light|||on|||||&#8221; text_text_color=&#8221;gcid-primary-color&#8221; text_letter_spacing=&#8221;0.07rem&#8221; link_font=&#8221;Sofia Pro Light|||on|||||&#8221; link_text_color=&#8221;#FFFFFF&#8221; link_letter_spacing=&#8221;0.07rem&#8221; ul_font=&#8221;Sofia Pro Light||||||||&#8221; ul_text_align=&#8221;left&#8221; global_colors_info=&#8221;{%22gcid-primary-color%22:%91%22text_text_color%22%93}&#8221; link_text_color__hover_enabled=&#8221;on|hover&#8221; link_text_color__hover=&#8221;#009ee6&#8243;]<\/p>\n<ul>\n<li><a href=\"\/\">Hem<\/a><\/li>\n<li class=\"active\">V\u00e5r forskning<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; da_disable_devices=&#8221;off|off|off&#8221; global_colors_info=&#8221;{}&#8221; da_is_popup=&#8221;off&#8221; da_exit_intent=&#8221;off&#8221; da_has_close=&#8221;on&#8221; da_alt_close=&#8221;off&#8221; da_dark_close=&#8221;off&#8221; da_not_modal=&#8221;on&#8221; da_is_singular=&#8221;off&#8221; da_with_loader=&#8221;off&#8221; da_has_shadow=&#8221;on&#8221;][et_pb_row _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||66px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_heading title=&#8221;Sedana Medical kliniska studier&#8221; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; title_font=&#8221;Sofia Pro Light|||on|||||&#8221; title_text_align=&#8221;center&#8221; title_text_color=&#8221;#009ee6&#8243; title_font_size_tablet=&#8221;&#8221; title_font_size_phone=&#8221;&#8221; title_font_size_last_edited=&#8221;on|tablet&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_heading][et_pb_text _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Sofia Pro Light||||||||&#8221; text_font_size=&#8221;21px&#8221; text_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;center&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span>Vi tror p\u00e5 att arbeta i partnerskap i v\u00e5ra forskningsprojekt, med m\u00e5let att forts\u00e4tta utvecklingen och de medicinska framstegen till f\u00f6rm\u00e5n f\u00f6r patienter inom intensivv\u00e5rden.<\/span><\/p>\n<p>[\/et_pb_text][et_pb_image src=&#8221;<a href=\"https:\/\/sedanamedical.com\/wp-content\/uploads\/2024\/10\/lungs-new-blue-6BC4E9.png&#038;#8221\">https:\/\/sedanamedical.com\/wp-content\/uploads\/2024\/10\/lungs-new-blue-6BC4E9.png&#038;#8221<\/a>; alt=&#8221;lungs-ny-bl\u00e5-6BC4E9&#8243; title_text=&#8221;lungs-ny-bl\u00e5-6BC4E9&#8243; align=&#8221;center&#8221; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#f8f8f8&#8243; max_width=&#8221;1296px&#8221; max_width_tablet=&#8221;1296px&#8221; max_width_phone=&#8221;1296px&#8221; max_width_last_edited=&#8221;on|tablet&#8221; custom_margin=&#8221;||80px||false|false&#8221; custom_margin_tablet=&#8221;||80px||false|false&#8221; custom_margin_phone=&#8221;||80px||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;||||false|false&#8221; box_shadow_style=&#8221;preset3&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_toggle title=&#8221;Program f\u00f6r tidig tillg\u00e5ng&#8221; open_toggle_text_color=&#8221;#009ee6&#8243; open_toggle_background_color=&#8221;#FFFFFF&#8221; closed_toggle_background_color=&#8221;#f8f8f8&#8243; icon_color=&#8221;#009ee6&#8243; toggle_icon=&#8221;&#x4c;||divi||400&#8243; use_icon_font_size=&#8221;on&#8221; icon_font_size=&#8221;25px&#8221; open_icon_color=&#8221;#009ee6&#8243; open_toggle_icon=&#8221;&#x4b;||divi||400&#8243; open_use_icon_font_size=&#8221;on&#8221; open_icon_font_size=&#8221;25px&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#666666&#8243; title_level=&#8221;h2&#8243; title_font=&#8221;Sofia Pro Light|500||on|||||&#8221; title_text_align=&#8221;left&#8221; title_font_size=&#8221;21px&#8221; closed_title_font=&#8221;Sofia Pro Light|||on|||||&#8221; closed_title_font_size=&#8221;18px&#8221; body_font=&#8221;Sofia Pro Light||||||||&#8221; body_text_align=&#8221;left&#8221; body_font_size=&#8221;18px&#8221; background_color=&#8221;#f8f8f8&#8243; background_enable_image=&#8221;off&#8221; background_size=&#8221;custom&#8221; background_image_width=&#8221;0%&#8221; background_image_height=&#8221;125%&#8221; background_position=&#8221;center_right&#8221; background_horizontal_offset=&#8221;7%&#8221; border_width_all=&#8221;0px&#8221; border_style_all=&#8221;double&#8221; border_width_bottom=&#8221;1px&#8221; border_color_bottom=&#8221;#D6D6D6&#8243; border_style_bottom=&#8221;solid&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Sedana Medical AB (publ) (&#8221;Sedana Medical&#8221;) \u00e4r ett banbrytande medicinteknik- och l\u00e4kemedelsbolag med fokus p\u00e5 inhalationssedering f\u00f6r mekaniskt ventilerade patienter inom intensivv\u00e5rden.<\/p>\n<h3>Syfte<\/h3>\n<p>Sedana Medical str\u00e4var efter att genom innovativ vetenskap f\u00f6rb\u00e4ttra patientens liv under och efter sedering. Patients\u00e4kerheten \u00e4r av yttersta vikt och m\u00e5let \u00e4r att tillhandah\u00e5lla behandlingar till patienter som kan ha nytta av dem utan att uts\u00e4tta dem f\u00f6r on\u00f6diga risker. <\/p>\n<p>Sedana Medical anser att pr\u00f6vningsl\u00e4kemedel (som \u00e4nnu inte godk\u00e4nts av relevanta h\u00e4lsov\u00e5rdsmyndigheter) b\u00f6r studeras p\u00e5 patienter som en del av kliniska pr\u00f6vningar som utformats f\u00f6r att generera data om s\u00e4kerhet och effekt. Dessa data kan anv\u00e4ndas f\u00f6r att st\u00f6dja regulatoriska ans\u00f6kningar, vilket i slut\u00e4ndan resulterar i nya, godk\u00e4nda l\u00e4kemedel. Sedana Medical uppmuntrar till en dialog mellan patienterna och deras l\u00e4kare f\u00f6r att hitta m\u00f6jligheter att delta i kliniska pr\u00f6vningar n\u00e4r s\u00e5 \u00e4r m\u00f6jligt.  <\/p>\n<p>I vissa fall \u00e4r patienter inte ber\u00e4ttigade att delta i p\u00e5g\u00e5ende kliniska pr\u00f6vningar, eller s\u00e5 kanske kliniska pr\u00f6vningar inte rekryteras i deras geografiska region. Dessutom kan det h\u00e4nda att pr\u00f6vningsl\u00e4kemedel inte finns tillg\u00e4ngliga mellan slutf\u00f6randet av de registreringsgrundande kliniska studierna och myndighetsgodk\u00e4nnande eller kommersiell tillg\u00e4nglighet. N\u00e4r patienter har utt\u00f6mt alla tillg\u00e4ngliga behandlingar kan Sedana Medical \u00f6verv\u00e4ga att tillhandah\u00e5lla ett pr\u00f6vningsl\u00e4kemedel utanf\u00f6r en klinisk pr\u00f6vning genom ett Early Access Program.  <\/p>\n<h3>Allm\u00e4n information om Early Access-program<\/h3>\n<p>Det finns en rad olika lokala best\u00e4mmelser och mekanismer f\u00f6r att tillhandah\u00e5lla pr\u00f6vningsprodukter f\u00f6re regulatoriskt godk\u00e4nnande eller kommersiell tillg\u00e5ng. Det finns olika lokala termer f\u00f6r dessa best\u00e4mmelser om tillg\u00e5ng f\u00f6re godk\u00e4nnande, inklusive &#8221;Compassionate Use Program&#8221;, &#8221;Expanded Access Program&#8221;, &#8221;Named Patient Program&#8221;, &#8221;Special Access Schemes\/Program&#8221;. I Sedana Medical avser &#8221;Early Access Programs&#8221; (EAP) mekanismer f\u00f6r att ge tillg\u00e5ng till en produkt utanf\u00f6r kliniska studier och f\u00f6re regulatoriskt godk\u00e4nnande och kommersiell tillg\u00e4nglighet. Ett Early Access Program (EAP) \u00e4r avsett att ge tillg\u00e5ng till och leverans av ett pr\u00f6vningsl\u00e4kemedel f\u00f6r humanit\u00e4rt bruk n\u00e4r det finns bevis f\u00f6r att en patient kan ha nytta av behandling f\u00f6re regulatoriskt godk\u00e4nnande och kommersiell tillg\u00e4nglighet av l\u00e4kemedlet.   <\/p>\n<p>Sedana Medicals kohortprogram kommer endast att \u00e4ga rum i l\u00e4nder d\u00e4r Sedana Medical avser att ans\u00f6ka om regulatoriskt godk\u00e4nnande. Relevant godk\u00e4nnande fr\u00e5n det lokala l\u00e4kemedelsverket eller annan beh\u00f6rig myndighet kommer att s\u00f6kas f\u00f6r b\u00e5da v\u00e4garna till tidig tillg\u00e5ng. <\/p>\n<p>&nbsp;<\/p>\n<h3>Allm\u00e4nna kriterier<\/h3>\n<p>Sedana Medical kommer att utv\u00e4rdera f\u00f6ljande kriterier innan ett program inr\u00e4ttas (d\u00e4r det \u00e4r till\u00e5tet enligt lokala best\u00e4mmelser) eller individuella patientf\u00f6rfr\u00e5gningar beaktas:<\/p>\n<ul>\n<li>Den specifika typ av program som f\u00f6resl\u00e5s \u00e4r till\u00e5ten enligt lokala landsspecifika regler och lagar.<\/li>\n<li>Pr\u00f6vningsl\u00e4kemedlet \u00e4r inte kommersiellt tillg\u00e4ngligt f\u00f6r den beg\u00e4rda indikationen i det ber\u00f6rda landet.<\/li>\n<li>Patienten \u00e4r inte ber\u00e4ttigad till, eller har inte tillg\u00e5ng till, en p\u00e5g\u00e5ende klinisk studie av pr\u00f6vningsl\u00e4kemedlet.<\/li>\n<li>Pr\u00f6vningsl\u00e4kemedlet \u00e4r avsett att genomg\u00e5 myndighetsgodk\u00e4nnande.<\/li>\n<li>Tidig tillg\u00e5ng kan inte beviljas om det fortfarande inte finns tillr\u00e4ckliga kliniska bevis f\u00f6r nytta med anv\u00e4ndningen av ett pr\u00f6vningsl\u00e4kemedel, eller om behandlingen skulle inneb\u00e4ra eller f\u00f6rv\u00e4ntas inneb\u00e4ra en oacceptabel eller \u00f6verdriven risk f\u00f6r patienten.<\/li>\n<li>Pr\u00f6vningsl\u00e4kemedlet kommer att anv\u00e4ndas som behandling f\u00f6r en allvarlig eller livshotande sjukdom enligt definitionen i lagar och f\u00f6rordningar i det ber\u00f6rda landet.<\/li>\n<li>Patienten i fr\u00e5ga kan inte behandlas p\u00e5 ett tillfredsst\u00e4llande s\u00e4tt med andra l\u00e4kemedel som \u00e4r godk\u00e4nda och kommersiellt tillg\u00e4ngliga f\u00f6r samma indikation.<\/li>\n<li>F\u00f6rfr\u00e5gningar om ett pr\u00f6vningsl\u00e4kemedel inom ramen f\u00f6r en EAP m\u00e5ste komma fr\u00e5n en kvalificerad l\u00e4kare som \u00e4r legitimerad i det land d\u00e4r pr\u00f6vningsl\u00e4kemedlet ska distribueras.<\/li>\n<li>Den behandlande l\u00e4karen m\u00e5ste vara kvalificerad att administrera pr\u00f6vningsl\u00e4kemedlet och f\u00f6lja alla relevanta s\u00e4kerhetskrav och rutiner.<\/li>\n<li>Den l\u00e4kare som behandlar den eller de patienter f\u00f6r vilka tillg\u00e5ng beg\u00e4rs samtycker till att f\u00f6lja alla till\u00e4mpliga lokala lagar och f\u00f6rordningar i samband med beg\u00e4ran, och alla krav i fr\u00e5ga om beh\u00f6righetskriterier, s\u00e4kerhetsrapportering eller annan dataf\u00f6rs\u00f6rjning som Sedana Medical f\u00f6reskriver.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>St\u00e4ngning av Early Access Program<\/h3>\n<p>Sedana Medical kan \u00f6verv\u00e4ga att avsluta ett program av olika sk\u00e4l som \u00e4r relaterade till pr\u00f6vningsl\u00e4kemedlet, inklusive men inte begr\u00e4nsat till:<\/p>\n<ul>\n<li>Kommersiell tillg\u00e4nglighet f\u00f6r ett visst behov eller tillst\u00e5nd<\/li>\n<\/ul>\n<ul>\n<li>Ett negativt regleringsbeslut<\/li>\n<li>Ny information blir tillg\u00e4nglig om s\u00e4kerheten som v\u00e4sentligt kan f\u00f6r\u00e4ndra dess nytto-\/riskprofil<\/li>\n<li>Begr\u00e4nsad tillg\u00e5ng eller andra tillverkningsproblem<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Process f\u00f6r beg\u00e4ran om tillg\u00e5ng<\/h3>\n<p>F\u00f6r n\u00e4rvarande har vi ett Expanded Access Program \u00f6ppet i USA.<\/p>\n<p>F\u00f6rfr\u00e5gningar om tidig tillg\u00e5ng ska l\u00e4mnas in av den behandlande legitimerade l\u00e4karen och ska inneh\u00e5lla tillr\u00e4ckligt med st\u00f6djande information f\u00f6r att Sedana Medical ska kunna utv\u00e4rdera f\u00f6rfr\u00e5gan om tidig tillg\u00e5ng. V\u00e4nligen inkludera kontaktinformation inklusive adress, telefonnummer och e-postadress. Observera att utbildning kr\u00e4vs och n\u00e4r vi utv\u00e4rderar en beg\u00e4ran \u00e4r det ocks\u00e5 beroende av v\u00e5ra utbildningsresurser.  <\/p>\n<p>Kontaktuppgifter:<\/p>\n<p>Sedana Medicals globala medicinska information:<span> <\/span><a href=\"mailto:medinfo@sedanamedical.com\">medinfo@sedanamedical.com.<\/a><\/p>\n<p>[\/et_pb_toggle][et_pb_toggle title=&#8221;INSPiRE-ICU 1 &amp; INSPiRE-ICU 2&#8243; open_toggle_text_color=&#8221;#009ee6&#8243; open_toggle_background_color=&#8221;#FFFFFF&#8221; closed_toggle_background_color=&#8221;#f8f8f8&#8243; icon_color=&#8221;#009ee6&#8243; toggle_icon=&#8221;&#x4c;||divi||400&#8243; use_icon_font_size=&#8221;on&#8221; icon_font_size=&#8221;25px&#8221; open_icon_color=&#8221;#009ee6&#8243; open_toggle_icon=&#8221;&#x4b;||divi||400&#8243; open_use_icon_font_size=&#8221;on&#8221; open_icon_font_size=&#8221;25px&#8221; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#666666&#8243; title_level=&#8221;h2&#8243; title_font=&#8221;Sofia Pro Light|500||on|||||&#8221; title_text_align=&#8221;left&#8221; title_font_size=&#8221;21px&#8221; closed_title_font=&#8221;Sofia Pro Light|||on|||||&#8221; closed_title_font_size=&#8221;18px&#8221; body_font=&#8221;Sofia Pro Light||||||||&#8221; body_text_align=&#8221;left&#8221; body_font_size=&#8221;18px&#8221; background_color=&#8221;#f8f8f8&#8243; background_enable_image=&#8221;off&#8221; background_size=&#8221;custom&#8221; background_image_width=&#8221;0%&#8221; background_image_height=&#8221;125%&#8221; background_position=&#8221;center_right&#8221; background_horizontal_offset=&#8221;7%&#8221; border_width_all=&#8221;0px&#8221; border_style_all=&#8221;double&#8221; border_width_bottom=&#8221;1px&#8221; border_color_bottom=&#8221;#D6D6D6&#8243; border_style_bottom=&#8221;solid&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>INSPiRE-ICU-studierna (Inhaled Sedation vs Propofol in Respiratory failure) (SED003 och SED004) \u00e4r tv\u00e5 identiska fas III-studier som syftar till att bekr\u00e4fta effekt och s\u00e4kerhet f\u00f6r inhalerad isofluran, tillf\u00f6rd via Sedaconda ACD, f\u00f6r sedering av vuxna mekaniskt ventilerade intensivv\u00e5rdspatienter, i j\u00e4mf\u00f6relse med intraven\u00f6s infusion av propofol.<\/p>\n<p>Resultaten av studierna kommer att ligga till grund f\u00f6r en ans\u00f6kan om godk\u00e4nnande av ett nytt l\u00e4kemedel (NDA) hos den amerikanska l\u00e4kemedelsmyndigheten FDA.<\/p>\n<p>Det prim\u00e4ra effektm\u00e5ttet \u00e4r andelen tid som tillbringas inom m\u00e5lintervallet f\u00f6r sederingsdjup i fr\u00e5nvaro av rescue-sedering, vilket bed\u00f6ms enligt Richmond Agitation Sedation Scale (RASS).<br \/>\nDessutom kommer studierna att unders\u00f6ka flera sekund\u00e4ra effektm\u00e5tt, bland annat anv\u00e4ndning av opioider, uppvaknandetid, kognitiv \u00e5terh\u00e4mtning efter avslutad sedering och spontan andningsanstr\u00e4ngning. <\/p>\n<p>Studierna kommer att omfatta totalt 470 vuxna patienter p\u00e5 25-30 kliniker i USA.<br \/>\nDen f\u00f6rsta patienten registrerades i april 2022. <\/p>\n<p>Ytterligare information om studierna finns p\u00e5 <a href=\"https:\/\/www.clinicaltrials.gov\/study\/NCT05312385\" target=\"_blank\" rel=\"noopener\">www.clinicaltrials.gov<\/a> (<span class=\"wixui-rich-text__text\"><a href=\"https:\/\/www.clinicaltrials.gov\/study\/NCT05312385\" target=\"_blank\" rel=\"noopener\">NCT05312385<\/a><\/span> f\u00f6r SED003 och <span class=\"wixui-rich-text__text\"><a href=\"https:\/\/www.clinicaltrials.gov\/study\/NCT05327296\" target=\"_blank\" rel=\"noopener\">NCT05327296<\/a><\/span> f\u00f6r SED004).<\/p>\n<p>[\/et_pb_toggle][et_pb_toggle title=&#8221;The IsoCOMFORT study&#8221; open_toggle_text_color=&#8221;#009ee6&#8243; open_toggle_background_color=&#8221;#FFFFFF&#8221; closed_toggle_background_color=&#8221;#f8f8f8&#8243; icon_color=&#8221;#009ee6&#8243; toggle_icon=&#8221;&#x4c;||divi||400&#8243; use_icon_font_size=&#8221;on&#8221; icon_font_size=&#8221;25px&#8221; open_icon_color=&#8221;#009ee6&#8243; open_toggle_icon=&#8221;&#x4b;||divi||400&#8243; open_use_icon_font_size=&#8221;on&#8221; open_icon_font_size=&#8221;25px&#8221; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#666666&#8243; title_level=&#8221;h2&#8243; title_font=&#8221;Sofia Pro Light|500||on|||||&#8221; title_text_align=&#8221;left&#8221; title_font_size=&#8221;21px&#8221; closed_title_font=&#8221;Sofia Pro Light|||on|||||&#8221; closed_title_font_size=&#8221;18px&#8221; body_font=&#8221;Sofia Pro Light||||||||&#8221; body_text_align=&#8221;left&#8221; body_font_size=&#8221;18px&#8221; background_color=&#8221;#f8f8f8&#8243; background_enable_image=&#8221;off&#8221; background_size=&#8221;custom&#8221; background_image_width=&#8221;0%&#8221; background_image_height=&#8221;125%&#8221; background_position=&#8221;center_right&#8221; background_horizontal_offset=&#8221;7%&#8221; border_width_all=&#8221;0px&#8221; border_style_all=&#8221;double&#8221; border_width_bottom=&#8221;1px&#8221; border_color_bottom=&#8221;#D6D6D6&#8243; border_style_bottom=&#8221;solid&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Under 2021 inledde Sedana Medical IsoCOMFORT-studien (SED002), en pediatrisk fas III-studie som syftar till att unders\u00f6ka om sedering med Sedaconda (isofluran), administrerad via Sedaconda ACD, \u00e4r s\u00e4ker och mer effektiv \u00e4n intraven\u00f6st administrerat midazolam hos mekaniskt ventilerade pediatriska patienter p\u00e5 intensivv\u00e5rdsavdelningar i \u00e5ldern 3-17 \u00e5r.<\/p>\n<p>F\u00f6r n\u00e4rvarande \u00e4r midazolam det enda sederingsalternativet f\u00f6r barn p\u00e5 intensivv\u00e5rdsavdelningen eftersom propofol \u00e4r kontraindicerat p\u00e5 grund av risken f\u00f6r allvarliga biverkningar.<br \/>\nPatienterna kommer att sederas under 12-48 timmar med endera sederingsmetoden, och det prim\u00e4ra effektm\u00e5ttet \u00e4r andelen tid som tillbringas med adekvat sederingsdjup. <\/p>\n<p>Studien kommer att omfatta 160 patienter fr\u00e5n intensivv\u00e5rdskliniker i Tyskland, Frankrike, Spanien, Sverige och Storbritannien.<br \/>\nResultaten av studien f\u00f6rv\u00e4ntas leda till en godk\u00e4nd pediatrisk indikation f\u00f6r inhalationssedering. <\/p>\n<p>Patientrekryteringen slutf\u00f6rdes under 2023.<\/p>\n<p>Ytterligare information om studien finns p\u00e5 <a href=\"https:\/\/www.clinicaltrials.gov\/study\/NCT04684238\" target=\"_blank\" rel=\"noopener\">www.clinicaltrials.gov<\/a> (NCT04684238).<\/p>\n<p>[\/et_pb_toggle][et_pb_toggle title=&#8221;The Sedaconda Study&#8221; open_toggle_text_color=&#8221;#009ee6&#8243; open_toggle_background_color=&#8221;#FFFFFF&#8221; closed_toggle_background_color=&#8221;#f8f8f8&#8243; icon_color=&#8221;#009ee6&#8243; toggle_icon=&#8221;&#x4c;||divi||400&#8243; use_icon_font_size=&#8221;on&#8221; icon_font_size=&#8221;25px&#8221; open_icon_color=&#8221;#009ee6&#8243; open_toggle_icon=&#8221;&#x4b;||divi||400&#8243; open_use_icon_font_size=&#8221;on&#8221; open_icon_font_size=&#8221;25px&#8221; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#666666&#8243; title_level=&#8221;h2&#8243; title_font=&#8221;Sofia Pro Light|500||on|||||&#8221; title_text_align=&#8221;left&#8221; title_font_size=&#8221;21px&#8221; closed_title_font=&#8221;Sofia Pro Light|||on|||||&#8221; closed_title_font_size=&#8221;18px&#8221; body_font=&#8221;Sofia Pro Light||||||||&#8221; body_text_align=&#8221;left&#8221; body_font_size=&#8221;18px&#8221; background_color=&#8221;#f8f8f8&#8243; background_enable_image=&#8221;off&#8221; background_size=&#8221;custom&#8221; background_image_width=&#8221;0%&#8221; background_image_height=&#8221;125%&#8221; background_position=&#8221;center_right&#8221; background_horizontal_offset=&#8221;7%&#8221; border_width_all=&#8221;0px&#8221; border_style_all=&#8221;double&#8221; border_width_bottom=&#8221;1px&#8221; border_color_bottom=&#8221;#D6D6D6&#8243; border_style_bottom=&#8221;solid&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Under 2020 slutf\u00f6rde Sedana Medical Sedaconda-studien (SED001), den hittills st\u00f6rsta randomiserade, kontrollerade, \u00f6ppna studien av inhalationssedering inom intensivv\u00e5rden.<\/p>\n<p>Fas III-studien syftade till att bekr\u00e4fta effekten av och s\u00e4kerheten hos sedering med Sedaconda (isofluran) som administreras via Sedaconda ACD till mekaniskt ventilerade intensivv\u00e5rdspatienter, och j\u00e4mf\u00f6rdes med standardsedering med intraven\u00f6st administrerat propofol.<br \/>\nTotalt 301 patienter fr\u00e5n 24 intensivv\u00e5rdskliniker i Tyskland och Slovenien randomiserades till endera sederingsmetoden. <\/p>\n<p>Studien n\u00e5dde framg\u00e5ngsrikt sitt prim\u00e4ra effektm\u00e5tt och visade att Sedaconda inte \u00e4r s\u00e4mre \u00e4n intraven\u00f6s propofol n\u00e4r det g\u00e4ller att uppr\u00e4tth\u00e5lla ett tillr\u00e4ckligt sederingsdjup.<br \/>\nDessutom visade resultaten att sedering med Sedaconda minskade behovet av opioider, underl\u00e4ttade spontanandning och m\u00f6jliggjorde ett snabbare och mer f\u00f6ruts\u00e4gbart uppvaknande.<br \/>\nN\u00e4r det g\u00e4ller s\u00e4kerhet tolererades Sedaconda v\u00e4l, med en s\u00e4kerhetsprofil som \u00f6verensst\u00e4mmer med tidigare resultat f\u00f6r isofluran.  <\/p>\n<p>Resultaten publicerades i tidskriften The Lancet Respiratory Medicine (Meiser et al., 2021) och l\u00e5g till grund f\u00f6r Sedana Medicals europeiska marknadsgodk\u00e4nnande f\u00f6r Sedaconda f\u00f6r inhalationssedering.<\/p>\n<p>[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Hem V\u00e5r forskning Vi tror p\u00e5 att arbeta i partnerskap i v\u00e5ra forskningsprojekt, med m\u00e5let att forts\u00e4tta utvecklingen och de medicinska framstegen till f\u00f6rm\u00e5n f\u00f6r patienter inom intensivv\u00e5rden.Sedana Medical AB (publ) (&#8221;Sedana Medical&#8221;) \u00e4r ett banbrytande medicinteknik- och l\u00e4kemedelsbolag med fokus p\u00e5 inhalationssedering f\u00f6r mekaniskt ventilerade patienter inom intensivv\u00e5rden. Syfte Sedana Medical str\u00e4var efter att [&hellip;]<\/p>\n","protected":false},"author":249802924,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"<div class=\"wp-block-group alignfull\" style=\"margin-top:0;margin-bottom:0;padding-top:calc( 0.5 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)));padding-right:var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal));padding-bottom:calc( 0.5 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)));padding-left:var(--wp--style--root--padding-left, var(--wp--custom--gap--horizontal))\">\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-columns alignwide\">\r\n<div class=\"wp-block-column\" style=\"flex-basis:50%\">\r\n<h2 class=\"wp-block-heading\">About<\/h2>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-column\" style=\"flex-basis:50%\">\r\n<p>Sedana Medical is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient\u2019s life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical product Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care.<\/p>\r\n\r\n\r\n\r\n<p>Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordic, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors.<\/p>\r\n\r\n\r\n\r\n<p>Sedana Medical was founded in 2005, is listed on Nasdaq Stockholm and is headquartered in Stockholm, Sweden.<\/p>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-group alignfull\" style=\"margin-top:0;margin-bottom:0;padding-top:calc( 0.5 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)));padding-right:var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal));padding-bottom:calc( 0.5 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)));padding-left:var(--wp--style--root--padding-left, var(--wp--custom--gap--horizontal))\">\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-columns alignwide\">\r\n<div class=\"wp-block-column\">\r\n<h3 class=\"wp-block-heading has-medium-font-size\">SEDANA MEDICAL IN NUMBERS<\/h3>\r\n\r\n\r\n\r\n<p>~100 No. of employees<\/p>\r\n\r\n\r\n\r\n<p>52\/48 % women\/men<\/p>\r\n\r\n\r\n\r\n<p>16 No. of nationalities employed<\/p>\r\n\r\n\r\n\r\n<p>159 Total sales 2021, MSEK<\/p>\r\n\r\n\r\n\r\n<p>>40 No. of countries where we have sales<\/p>\r\n\r\n\r\n\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image size-full\"><img src=\"https:\/\/dotcompatterns.files.wordpress.com\/2024\/01\/paint-tall.jpg\" alt=\"\" class=\"wp-image-13699\" style=\"aspect-ratio:3\/4;object-fit:cover\" \/><\/figure>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-column\">\r\n<figure class=\"wp-block-image size-full\"><img src=\"https:\/\/dotcompatterns.files.wordpress.com\/2024\/01\/paint-tall-alt.jpg\" alt=\"\" class=\"wp-image-13707\" style=\"aspect-ratio:3\/4;object-fit:cover\" \/><\/figure>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image size-full\"><img src=\"https:\/\/dotcompatterns.files.wordpress.com\/2024\/01\/paint-tall-alt.jpg\" alt=\"\" class=\"wp-image-13707\" style=\"aspect-ratio:4\/3;object-fit:cover\" \/><\/figure>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-group alignfull\" style=\"margin-top:0;margin-bottom:0;padding-top:calc( 0.5 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)));padding-right:var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal));padding-bottom:calc( 0.5 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)));padding-left:var(--wp--style--root--padding-left, var(--wp--custom--gap--horizontal))\">\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-columns alignwide\">\r\n<div class=\"wp-block-column is-vertically-aligned-center\">\r\n<h2 class=\"wp-block-heading has-text-align-center\">CERTIFICATES<\/h2>\r\n\r\n\r\n\r\n<p style=\"margin-right:var(--wp--preset--spacing--60);margin-left:var(--wp--preset--spacing--60)\">Sedana Medical\u2019s products are developed and manufactured in accordance with quality-controlled processes. The company has a quality management system that fulfils the requirements of ISO 13485 (design and manufacturing of medical devices) and holds MDSAP certificates for Canada and Japan.<\/p>\r\n\r\n\r\n\r\n<div class=\"wp-block-buttons\">\r\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-text-align-center wp-element-button\">Certificate MDR 736312<\/a><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-text-align-center wp-element-button\">Certificate Of Registration MD 667829<\/a><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\">Certificate CE 667826<\/a><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\">Certificate MDSAP 706954<\/a><\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div style=\"height:calc( 0.25 * var(--wp--style--root--padding-right, var(--wp--custom--gap--horizontal)))\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n<\/div>\r\n","_et_gb_content_width":"","footnotes":""},"dipi_cpt_category":[],"class_list":["post-5676","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>V\u00e5r forskning - Sedana Medical<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sedanamedical.com\/our-research\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"V\u00e5r forskning - Sedana Medical\" \/>\n<meta property=\"og:description\" content=\"Hem V\u00e5r forskning Vi tror p\u00e5 att arbeta i partnerskap i v\u00e5ra forskningsprojekt, med m\u00e5let att forts\u00e4tta utvecklingen och de medicinska framstegen till f\u00f6rm\u00e5n f\u00f6r patienter inom intensivv\u00e5rden.Sedana Medical AB (publ) (&quot;Sedana Medical&quot;) \u00e4r ett banbrytande medicinteknik- och l\u00e4kemedelsbolag med fokus p\u00e5 inhalationssedering f\u00f6r mekaniskt ventilerade patienter inom intensivv\u00e5rden. 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