Indiana University Health in Indianapolis, USA has performed its first
transplantation using lungs from a DCD (Donation after Circulatory Death) donor
within the framework of the NOVEL-study. This has been made possible by using
STEEN Solution™ and the XPS™ to evaluate the lung function outside the body. The
FDA advisory committee meeting will be held on March 20, 2014.
The number of lungs from DCD donors used in lung transplantation is limited
today, but using the STEEN Solution™ method, these lungs can also be used for
transplantation to a greater extent than would otherwise be possible. It is
XVIVO Perfusion’s assessment that the number of lung transplants can be many
times greater in the future when the use of lungs from DCD donors is more
Dr Thomas Wozniak, Lung Transplant Surgical Director at IU Health stated
recently that "Despite the fact that most DCD lungs satisfy standard criteria
for transplantation, changes can occur during the DCD process that can render
some of these organs suboptimal. Prior to the availability of XVIVO, there was
no way to determine which of these lungs would fail other than implanting them
into recipients. For this reason, we have not previously utilized DCD lungs.
With XVIVO perfusion, we are now more able to predict which of these lungs will
be suitable for implantation into a recipient. To date, our program has
transplanted 2 patients utilizing XVIVO technology that otherwise would not have
been considered for DCD lungs."
The FDA process is proceeding according to plan and XVIVO Perfusion has
submitted material for the advisory committee meeting to be held on March 20,
2014. The expert panel consists of external experts and it primarily assesses
the results from the NOVEL study in the USA. The expert panel gives advice and
recommendation to the FDA regarding regulatory questions.
"It is good news that IU Health has performed its first transplantation of lungs
from a DCD donor using STEEN Solution™ and the XPS™. As the donor pool can
become many times greater if there is access to DCD donors’ lungs and the STEEN
Solution™ EVLP method enables more patients with severe lung disease improved
access to lung transplantation and therefore to enjoy a longer and better life."
says Dr Magnus Nilsson, CEO of XVIVO Perfusion.
March 14, 2014
XVIVO Perfusion AB (publ)
Magnus Nilsson, CEO
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 March
14, 2014 at 8:30 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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