XVIVO expands the NOVEL study in the USA

The University of Washington, Seattle, one of the major American lung transplant clinics, has been included in the American NOVEL study. It is the third clinic to have bought an XPS for this purpose. There continues to be great interest in the STEEN Solution™ method and the XPS™ in the USA.

XVIVO Perfusion AB (publ) was given approval by the FDA in the previous quarter to increase the number of centers in the ongoing NOVEL study in the USA. The participation of the University of Washington in Seattle in the NOVEL study will lead to more patients with lung disease now being able to receive a transplant.

The NOVEL trial was designed to safely increase the percentage of usable lungs from the donor pool. It is being performed at 8 centers in the USA. In the study, clinical outcomes after transplantation of lungs that have undergone warm perfusion after having been initially discarded are compared with a control group consisting of lungs that were initially assessed to be usable. Up until now 54 patients in the NOVEL study have received transplants after warm perfusion using the STEEN Solution™ method. The results so far from the study indicate that lungs evaluated using STEEN Solution™ in an XPS™ do not differ in terms of safety and function from lungs transplanted directly. These results thus indicate that more donated lungs will be able to be used safely for transplantation, and this will benefit patients on the waiting list for new lungs. These results are consistent with those published from centers in Canada and Europe that have used STEEN Solution™ clinically using an equivalent technique.

"We can see that there is growing interest in and outside the USA for the company’s technology for warm perfusion using STEEN Solution™ and XPS™ as clinical experience becomes more widespread. It is exciting that leading clinics’ interest is so great that they are investing considerable sums of money in equipment in order to be able to join the NOVEL study. They are doing so to be able to give transplants to more patients with severe lung disease," says Dr Magnus Nilsson, CEO of XVIVO Perfusion.

November 6, 2013
Gothenburg
XVIVO Perfusion AB (publ)

For further information please contact:

Christoffer Rosenblad, CFO, +46 31 788 21 59, christoffer.rosenblad@xvivoperfusion.com
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 November 6, 2013 at 11:00 a.m.

This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.

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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.
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XVIVO Perfusion AB (publ), Box 53015, SE-400 14 Göteborg. Corporate identity number 556561-0424.
Tel: 46 31 788 21 50. Fax: 46 31 788 21 69.
E-mail: info@xvivoperfusion.com. Website: www.xvivoperfusion.com

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