{"id":3007,"date":"2017-07-06T06:30:00","date_gmt":"2017-07-06T06:30:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/recruitment-completed-for-novel-study-in-the-us-on-steen-solution-and-xps\/"},"modified":"2017-07-06T06:30:00","modified_gmt":"2017-07-06T06:30:00","slug":"recruitment-completed-for-novel-study-in-the-us-on-steen-solution-and-xps","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/recruitment-completed-for-novel-study-in-the-us-on-steen-solution-and-xps\/","title":{"rendered":"Recruitment completed for NOVEL study in the US on STEEN Solution\u2122 and XPS\u2122"},"content":{"rendered":"
Inclusion of all 220 (110 + 110) patients is now completed in the NOVEL study which is being carried out in the US on STEEN Solution\u2122 and XPS\u2122. This clinical study will form the basis of the company\u2019s PMA (Pre-market Approval) application to the FDA. Approximately 40 percent of all lung transplantations in the world are done in the US and STEEN Solution\u2122 and XPS\u2122 have already been approved for sales in the US under an HDE (Humanitarian Device Exemption) approval.<\/strong><\/div>\n

In March 2014 the Advisory Panel convened by the FDA voted unanimously, by 10 votes to 0, that the XPS\u2122 System with STEEN Solution\u2122 meets the requirements for HDE (Humanitarian Device Exemption) approval. In August 2014 the company received HDE approval from the FDA for the products XPS\u2122 and STEEN Solution\u2122 for sales on the American market. HDE approval entails certain restrictions, amongst other things that no more than 4,000 patients may be treated per year under HDE approval and that separate ethical approval may be required for treatment. The study that has now been completed will form the basis of the company\u2019s PMA application, which means that if it is approved, there will no longer be any such restrictions.\u00a0<\/span><\/p>\n

The NOVEL study is continuing with follow-up of the patients for up to one year. XVIVO Perfusion has an ongoing dialogue with the FDA about the design and the time for submission of the PMA application and will post information when this has been done. The PAS (Post Approval Study) required by the FDA, which is a compulsory safety follow-up after all approvals, will include a total of 126+126 patients that will be followed for 3 years. Sixteen more patients in each group are required to complete enrollment into the PAS. <\/span><\/p>\n

XPS\u2122 is the only CE-marked and FDA-approved (HDE approval) normothermic lung perfusion integrated system on the market today, that provides the clinician \u00a0the flexibility to evaluate lungs before transplantation by means of a standardized and simplified procedure. XPS\u2122 is used worldwide with good clinical results. The XPS\u2122 and STEEN Solution\u2122 have already been CE-marked and thus approved for sales on the European market, and are also approved for sales in Canada and Australia.<\/span><\/p>\n

\u00a0\u201cWe are delighted that the PMA study on XPS\u2122 and STEEN Solution\u2122 in the US has now been completed. This will mean that as soon as recruitment for the PAS study is complete, some of the restrictions that were part of the clinical trial will disappear and more patients will have an option to receive an EVLP lung. This will also mean that the company can focus more in the US on tailoring the technology for customers, building up the market and customer service,\u201d says Magnus Nilsson, CEO of XVIVO Perfusion.<\/span><\/p>\n

July 6, 2017
<\/span>Gothenburg
Magnus Nilsson, CEO
XVIVO Perfusion AB (publ)<\/p>\n

\n

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

Christoffer Rosenblad, CFO, +1 720 616 2101, 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

This information is information that Xvivo Perfusion AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 am CET on July 6, 2017.<\/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":"

Inclusion of all 220 (110 + 110) patients is now completed in the NOVEL study which is being carried out…<\/p>\n","protected":false},"template":"","class_list":["post-3007","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-regulatory","mfn-news-tag-mfn-regulatory-mar","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-ci-other"],"acf":[],"yoast_head":"\nRecruitment completed for NOVEL study in the US on STEEN Solution\u2122 and XPS\u2122 - 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\/recruitment-completed-for-novel-study-in-the-us-on-steen-solution-and-xps\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Recruitment completed for NOVEL study in the US on STEEN Solution\u2122 and XPS\u2122 - 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