The FDA Advisory Panel voted unanimously that XPS™ with STEEN Solution™ meets the requirements for HDE
ET | Source:Xvivo Perfusion AB
The Advisory Panel convened by the FDA voted unanimously, by 10 votes to 0, that
the XPS™ System with STEEN Solution™ meets the requirements for HDE
(Humanitarian Device Exemption) approval. XVIVO Perfusion will initiate a
dialogue with the FDA in the near future to discuss labelling and the post
An Advisory Panel meeting was held yesterday, Thursday, March 20, 2014, in
Maryland, USA, at which the Advisory Panel discussed XVIVO Perfusion’s HDE
application for the XPS™ System with STEEN Solution™. The Advisory Panel
primarily discussed the clinical data accumulated in the NOVEL study. The NOVEL
study is steered by a protocol including XPS™ and STEEN Solution™. After an
eight-hour meeting the Advisory Panel voted unanimously that the XPS™ System
with STEEN Solution™ meets the requirements for HDE approval.
The Advisory Panel was convened by the FDA and its role is to give advice and a
recommendation to the FDA with regard to regulatory questions. The decision on
market approval is taken by the FDA. If the HDE approval is granted, XVIVO
Perfusion can market STEEN Solution™, XPS™ and the accompanying single-use items
in the USA. The NOVEL study with STEEN Solution™ and XPS™ will continue to
recruit patients and the results from the study will form the basis of a PMA
(Pre-Market Approval) application.
"We are very pleased that the Advisory Panel voted unanimously that STEEN
Solution™ and XPS™ meet the requirements for HDE approval. We will now
immediately initiate a dialogue with the FDA to discuss the final steps in the
application process," says Dr Magnus Nilsson, CEO of XVIVO Perfusion.
March 21, 2014
XVIVO Perfusion AB (publ)
For further information please contact:
Christoffer Rosenblad, CFO, +46 31 788 21 59,
For further information on XVIVO Perfusion’s business, please refer to the
company’s website, www.xvivoperfusion.com
XVIVO Perfusion is required to publish the information in this press release in
accordance with the Swedish Securities Market Act and/or the Financial
Instruments Trading Act. The information was submitted for publication
on March21, 2014 at 8:00 a.m.
This is a translation of the Swedish version of the press release. When in
doubt, the Swedish wording prevails.
XVIVO Perfusion AB is a medical technology company which develops solutions and
systems for assessing and preserving organs outside the body and for selecting
usable organs and maintaining them in optimal condition pending transplantation.
The company is headquartered in Gothenburg, Sweden, and has one office in the
USA. The XVIVO share is listed on NASDAQ OMX First North and has the ticker
symbol XVIVO. More information can be found on the website
www.xvivoperfusion.com. The Certified Adviser is Redeye, www.redeye.se.
XVIVO Perfusion AB (publ), Box 53015, SE-400 14 Göteborg. Corporate identity
Tel: 46 31 788 21 50. Fax: 46 31 788 21 69.
E-mail: email@example.com. Website: www.xvivoperfusion.com
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