{"id":2956,"date":"2018-06-25T08:00:00","date_gmt":"2018-06-25T08:00:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/perfadex-plus-approved-by-the-fda\/"},"modified":"2018-06-25T08:00:00","modified_gmt":"2018-06-25T08:00:00","slug":"perfadex-plus-approved-by-the-fda","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/perfadex-plus-approved-by-the-fda\/","title":{"rendered":"Perfadex Plus approved by the FDA"},"content":{"rendered":"
XVIVO Perfusion has received marketing approval (510k) in the United States from the FDA for the company's 'ready-to-use' product Perfadex Plus for cold preservation of lungs. It is already launched in European countries and will be launched in August on the important US market. About 40 percent of all lung transplants are performed in the United States.<\/strong><\/div>\n

As XVIVO Perfusion has reported earlier, the company has developed a new, ready-to-use version of its cold preservation product for lungs. Patent applications have been submitted for the new formulation called Perfadex Plus. It is currently being launched in European countries, will be launched in the US market during August, and is expected to be available on all major markets within 12 months. XVIVO Perfusion has upgraded the product through development of the formulation so that it can now be used without manual addition of buffer and electrolyte.<\/span><\/p>\n

Perfadex is the market gold standard and has been marketed by XVIVO Perfusion since 1999. It is used for cold preservation of lungs i.e. flushing away donor blood and preserving the donated lungs before transplantation. It is being used in an overwhelming majority of all lung transplantations performed in the world and is estimated to have a worldwide market share of around 90 percent.<\/span><\/p>\n

\u201cIt is positive that the company now offers clinics in the United States a new, safer and more easy-to-use product for cold preservation of lungs. The new version of XVIVO's 'Gold Standard' product, Perfadex Plus, will save time, reduce the risk of mistakes during preparation and thus facilitate the retrieval process for the transplant teams\u201d says XVIVO Perfusion CEO Magnus Nilsson.<\/span><\/p>\n

June 25, 2018
<\/span>Gothenburg
Magnus Nilsson, CEO
XVIVO Perfusion AB (publ)<\/p>\n

\n

For further information please contact:<\/span><\/p>\n

Christoffer Rosenblad, CFO, +46 735 192159, christoffer.rosenblad@xvivoperfusion.com
Magnus Nilsson, CEO, +46 31 788 2150, magnus.nilsson@xvivoperfusion.com<\/span>
For further information on XVIVO Perfusion\u2019s business, please refer to the company\u2019s website, www.xvivoperfusion.com<\/span><\/p>\n

The information was submitted for publication, through the agency of the contact person set out above, at 10:00 am CET on June 25, 2018.<\/span><\/p>\n

This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

XVIVO Perfusion has received marketing approval (510k) in the United States from the FDA for the company's 'ready-to-use' product Perfadex…<\/p>\n","protected":false},"template":"","class_list":["post-2956","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn-lang-en","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-ci-other"],"acf":[],"yoast_head":"\nPerfadex Plus approved by the FDA - 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\/perfadex-plus-approved-by-the-fda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Perfadex Plus approved by the FDA - XVIVO\" \/>\n<meta property=\"og:description\" content=\"XVIVO Perfusion has received marketing approval (510k) in the United States from the FDA for the company's 'ready-to-use' product Perfadex...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.xvivogroup.com\/us\/pressreleases\/perfadex-plus-approved-by-the-fda\/\" \/>\n<meta property=\"og:site_name\" content=\"United States\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.xvivogroup.com\\\/us\\\/pressreleases\\\/perfadex-plus-approved-by-the-fda\\\/\",\"url\":\"https:\\\/\\\/www.xvivogroup.com\\\/us\\\/pressreleases\\\/perfadex-plus-approved-by-the-fda\\\/\",\"name\":\"Perfadex Plus approved by the FDA - 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