{"id":3189,"date":"2014-03-21T07:00:00","date_gmt":"2014-03-21T07:00:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/fdas-expertpanelen-rostade-enhalligt-for-att-xps-med-steen-solution-uppfyller-kraven-for-hde\/"},"modified":"2014-03-21T07:00:00","modified_gmt":"2014-03-21T07:00:00","slug":"fdas-expertpanelen-rostade-enhalligt-for-att-xps-med-steen-solution-uppfyller-kraven-for-hde","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/fdas-expertpanelen-rostade-enhalligt-for-att-xps-med-steen-solution-uppfyller-kraven-for-hde\/","title":{"rendered":"FDA:s Expertpanelen r\u00f6stade enh\u00e4lligt f\u00f6r att XPS\u2122 med STEEN Solution\u2122 uppfyller kraven f\u00f6r HDE"},"content":{"rendered":"
Den av FDA inkallade expertpanelen r\u00f6stade enh\u00e4lligt, med r\u00f6stsiffrorna 10-0, f\u00f6r att XPS\u2122 System med STEEN Solution\u2122 uppfyller kraven f\u00f6r HDE-godk\u00e4nnande (Humanitarian Device Exemption). XVIVO Perfusion kommer n\u00e4rmast att inleda en dialog med FDA f\u00f6r att diskutera de sista stegen i ans\u00f6kningsprocessen samt post-marketing studie.<\/strong><\/div>\n

Ig\u00e5r, torsdagen den 20 mars 2014, h\u00f6lls ett expertpanelm\u00f6te i Maryland, USA d\u00e4r expertpanelen tog st\u00e4llning till XVIVO Perfusions HDE ans\u00f6kan av XPS\u2122 System med STEEN Solution\u2122. Expertpanelen tog fr\u00e4mst st\u00e4llning till de kliniska data som ackumulerats i NOVEL-studien. NOVEL-studien styrs av ett protokoll d\u00e4r XPS\u2122 och STEEN Solution\u2122 ing\u00e5r. Efter \u00e5tta timmars m\u00f6te r\u00f6stade expertpanelen enh\u00e4lligt f\u00f6r att XPS\u2122 System med STEEN Solution\u2122 uppfyller kraven f\u00f6r HDE godk\u00e4nnande.<\/span><\/p>\n

Expertpanelen kallades in av FDA och dess roll \u00e4r att ge r\u00e5d och rekommendation till FDA g\u00e4llande regulatoriska fr\u00e5gor. Beslut i fr\u00e5gan om marknadsgodk\u00e4nnande tas av FDA. Vid HDE-godk\u00e4nnande kan XVIVO Perfusion marknadsf\u00f6ra och s\u00e4lja STEEN Solution\u2122, XPS\u2122 och tillh\u00f6rande eng\u00e5ngsartiklar i USA. NOVEL-studien med STEEN Solution\u2122 och XPS\u2122 kommer forts\u00e4tta att rekrytera patienter och resultatet fr\u00e5n studien kommer ligga till grund f\u00f6r en PMA (Pre-Market Approval) ans\u00f6kan.<\/span><\/p>\n

"Det \u00e4r mycket gl\u00e4djande att expertpanelen r\u00f6stade enh\u00e4lligt f\u00f6r att STEEN Solution\u2122 och XPS\u2122 uppfyller kraven f\u00f6r ett HDE-godk\u00e4nnande. Vi kommer nu omg\u00e5ende inleda samtal med FDA f\u00f6r att diskutera de sista stegen i ans\u00f6kningsprocessen." s\u00e4ger Dr Magnus Nilsson, VD p\u00e5 XVIVO Perfusion.<\/span><\/p>\n

G\u00f6teborg 21 mars 2014
XVIVO Perfusion AB (publ)
Magnus Nilsson
Verkst\u00e4llande direkt\u00f6r<\/span><\/p>\n

\n

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

Christoffer Rosenblad, CFO, tel: 031-788 21 59, e-post: christoffer.rosenblad@xvivoperfusion.com<\/a>
F\u00f6r ytterligare information om XVIVO Perfusions verksamhet h\u00e4nvisas till bolagets hemsida, www.xvivoperfusion.com<\/a><\/span><\/p>\n

XVIVO Perfusion\u00a0\u00e4r skyldigt att offentligg\u00f6ra informationen i detta pressmeddelande enligt lagen om v\u00e4rdepappersmarknaden och\/eller lagen om handel med finansiella instrument. Informationen l\u00e4mnades f\u00f6r publicering den\u00a021 mars 2014 kl. 08:00.<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Den av FDA inkallade expertpanelen r\u00f6stade enh\u00e4lligt, med r\u00f6stsiffrorna 10-0, f\u00f6r att XPS\u2122 System med STEEN Solution\u2122 uppfyller kraven f\u00f6r…<\/p>\n","protected":false},"template":"","class_list":["post-3189","mfn_news","type-mfn_news","status-publish","hentry","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-vpml","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-ci-other"],"acf":[],"yoast_head":"\nFDA:s Expertpanelen r\u00f6stade enh\u00e4lligt f\u00f6r att XPS\u2122 med STEEN Solution\u2122 uppfyller kraven f\u00f6r HDE - 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\/fdas-expertpanelen-rostade-enhalligt-for-att-xps-med-steen-solution-uppfyller-kraven-for-hde\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA:s Expertpanelen r\u00f6stade enh\u00e4lligt f\u00f6r att XPS\u2122 med STEEN Solution\u2122 uppfyller kraven f\u00f6r HDE - 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