{"id":3008,"date":"2017-07-06T06:30:00","date_gmt":"2017-07-06T06:30:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/novel-studien-i-usa-med-steen-solution-och-xps-fardigrekryterad\/"},"modified":"2017-07-06T06:30:00","modified_gmt":"2017-07-06T06:30:00","slug":"novel-studien-i-usa-med-steen-solution-och-xps-fardigrekryterad","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/novel-studien-i-usa-med-steen-solution-och-xps-fardigrekryterad\/","title":{"rendered":"NOVEL-studien i USA med STEEN Solution\u2122 och XPS\u2122 f\u00e4rdigrekryterad"},"content":{"rendered":"
Inkluderingen av alla 220 (110 + 110) patienterna \u00e4r slutf\u00f6rd i NOVEL-studien som genomf\u00f6rs i USA med STEEN Solution\u2122 och XPS\u2122. Denna kliniska studie kommer att utg\u00f6ra underlag f\u00f6r bolagets PMA (Pre-Market Approval) ans\u00f6kan hos FDA. I USA g\u00f6rs cirka 40 procent av alla lungtransplantationer i v\u00e4rlden och STEEN Solution\u2122 och XPS\u2122 \u00e4r redan tidigare godk\u00e4nt f\u00f6r f\u00f6rs\u00e4ljning i USA under ett s\u00e5 kallat HDE-godk\u00e4nnande (Humanitarian Device Exemption).<\/strong><\/div>\n

I mars 2014 r\u00f6stade den av FDA inkallade expertpanelen enh\u00e4lligt, med r\u00f6stsiffrorna 10-0, f\u00f6r att XPS\u2122 System med STEEN Solution\u2122 uppfyller kraven f\u00f6r HDE-godk\u00e4nnande. I augusti 2014, erh\u00f6ll bolaget HDE-godk\u00e4nnande fr\u00e5n FDA f\u00f6r produkterna XPS\u2122 och STEEN Solution\u2122 f\u00f6r f\u00f6rs\u00e4ljning p\u00e5 den amerikanska marknaden. Ett HDE-godk\u00e4nnande medf\u00f6r vissa restriktioner, bland annat att det inte f\u00e5r g\u00f6ras fler \u00e4n 4\u00a0000 patientbehandlingar per \u00e5r under HDE-godk\u00e4nnandet och att separata etiska tillst\u00e5nd kr\u00e4vs f\u00f6r behandling. Den nu slutf\u00f6rda studien kommer att ligga till grund f\u00f6r bolagets PMA-ans\u00f6kan, vilket inneb\u00e4r att om den godk\u00e4nns s\u00e5 kommer inga s\u00e5dana restriktioner l\u00e4ngre att finnas.\u00a0<\/span><\/p>\n

Novel-studien forts\u00e4tter med uppf\u00f6ljning av patienterna i upp till ett \u00e5r. XVIVO Perfusion har en kontinuerlig dialog med FDA om utformningen och tidpunkt f\u00f6r inl\u00e4mning av PMA ans\u00f6kan och kommer att meddela n\u00e4r s\u00e5 sker. Samma 220 patienter som inkluderats i denna studie ing\u00e5r ocks\u00e5 i den av FDA beg\u00e4rda PAS (Post Approval Study vilket \u00e4r en uppf\u00f6ljningsstudie efter godk\u00e4nnande). PAS, som \u00e4r en obligatorisk s\u00e4kerhetsuppf\u00f6ljning som f\u00f6ljer p\u00e5 alla godk\u00e4nnanden, kommer att totalt inkludera 126+126 patienter, dvs ytterligare 16 patienter i varje grupp, vilka kommer att f\u00f6ljas upp i tre \u00e5r. <\/span><\/p>\n

XPS\u2122 \u00e4r idag marknadens enda CE-m\u00e4rkta och av FDA godk\u00e4nda (HDE-godk\u00e4nt) integrerade system som ger anv\u00e4ndaren flexibilitet att genomf\u00f6ra utv\u00e4rdering av lungor inf\u00f6r transplantation genom ett standardiserat och f\u00f6renklat f\u00f6rfarande. XPS\u2122 anv\u00e4nds med goda kliniska resultat p\u00e5 kliniker i hela v\u00e4rlden. Produkterna \u00e4r sedan tidigare CE-m\u00e4rkta och d\u00e4rmed godk\u00e4nda f\u00f6r f\u00f6rs\u00e4ljning p\u00e5 den europeiska marknaden, samt ocks\u00e5 godk\u00e4nda f\u00f6r f\u00f6rs\u00e4ljning i Kanada och Australien.<\/span><\/p>\n

\u00a0\u201cDet \u00e4r mycket gl\u00e4djande att PMA-studien med XPS\u2122 och STEEN Solution\u2122 i USA nu slutf\u00f6rts. Detta kommer inneb\u00e4ra att s\u00e5 snart \u00e4ven PAS studien \u00e4r f\u00e4rdigrekryterad kommer de restriktioner, till exempel i val av transplantationspatienter, som studien medf\u00f6rde f\u00f6r sjukhusen att f\u00f6rsvinna.\u00a0 Det kommer ocks\u00e5 g\u00f6ra att bolaget i USA kan fokusera mer p\u00e5 kundanpassning av tekniken, marknadsuppbyggnad och kundservice.\u201d, s\u00e4ger Magnus Nilsson, VD f\u00f6r XVIVO Perfusion.<\/span><\/p>\n

G\u00f6teborg den 6 juli 2017
Magnus Nilsson, VD
<\/span>XVIVO Perfusion AB (publ)<\/p>\n

\n

F\u00f6r ytterligare information, v\u00e4nligen kontakta: <\/span><\/p>\n

Christoffer Rosenblad, CFO, +1\u00a0720\u00a0616 2101, christoffer.rosenblad@xvivoperfusion.com
Magnus Nilsson, VD, +46 31-788 21 50, magnus.nilsson@xvivoperfusion.com<\/span><\/p>\n

F\u00f6r ytterligare information om XVIVO Perfusions verksamhet h\u00e4nvisas till bolagets hemsida, www.xvivoperfusion.com<\/span><\/p>\n

Denna information \u00e4r s\u00e5dan information som Xvivo Perfusion AB (publ) \u00e4r skyldigt att offentligg\u00f6ra enligt EU:s marknadsmissbruksf\u00f6rordning. Informationen l\u00e4mnades, genom ovanst\u00e5ende kontaktpersons f\u00f6rsorg, f\u00f6r offentligg\u00f6rande klockan 08:30 den 6 juli 2017.<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Inkluderingen av alla 220 (110 + 110) patienterna \u00e4r slutf\u00f6rd i NOVEL-studien som genomf\u00f6rs i USA med STEEN Solution\u2122 och…<\/p>\n","protected":false},"template":"","class_list":["post-3008","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci-other","mfn-news-tag-mfn","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn-lang-sv","mfn-news-tag-mfn-regulatory","mfn-news-tag-mfn-regulatory-mar","mfn-news-tag-mfn-ci"],"acf":[],"yoast_head":"\nNOVEL-studien i USA med STEEN Solution\u2122 och XPS\u2122 f\u00e4rdigrekryterad - XVIVO<\/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:\/\/www.xvivogroup.com\/us\/pressreleases\/novel-studien-i-usa-med-steen-solution-och-xps-fardigrekryterad\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NOVEL-studien i USA med STEEN Solution\u2122 och XPS\u2122 f\u00e4rdigrekryterad - 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