First patient in PrimECC study included


PrimECC® is a CE-marked and patent-protected product, developed to prime the
heart-lung machine before open heart surgery. A previous “proof of concept”
study performed using PrimECC® has shown interesting clinical results. The study
that has now been started is intended to expand the clinical documentation for
PrimECC® and will include a total of 80 patients.
Several hundred thousand heart operations are performed in the world each year
using a heart-lung machine and the ‘proof of concept’ study performed using
PrimECC® indicates  that the patient has an improved fluid balance after the
operation if the heart-lung machine is primed with PrimECC® rather than the
simpler solutions that are often used. In order to expand the documentation the
company will perform a randomized clinical study on 80 patients at Sahlgrenska
University Hospital in Gothenburg in 2016. XVIVO does not plan any extensive
launch of the product before this study is complete. XVIVO Perfusion has applied
for a patent for PrimECC® in important markets and has so far been granted a
patent in the USA and EU.

PrimECC® is a fluid developed in collaboration with Professor Stig Steen in Lund
to prime heart-lung machines before use. These machines are used to maintain
blood circulation and take over oxygenation of the blood during heart
operations. The fluid is used to compensate for the volume of blood that is
outside the patient and in the heart-lung machine during the operation. Today
simple saline solutions are used which are not optimized for this purpose. The
aim of PrimECC® is to minimize adverse effects that may arise during and after
use of a heart-lung machine.

“We are delighted that the clinical study using PrimECC has now started as the
product has interesting clinical and commercial potential,” says XVIVO
Perfusion’s CEO Magnus Nilsson.

June 15, 2016
Gothenburg
XVIVO Perfusion AB (publ)
For further information please contact:
Christoffer Rosenblad, CFO, +1 720 616 2101,
christoffer.rosenblad@xvivoperfusion.com
Magnus Nilsson, CEO, +46 31 788 2150, magnus.nilsson@xvivoperfusion.com
For further information on XVIVO Perfusion’s business, please refer to the
company’s website, www.xvivoperfusion.com

The information was submitted for publication on June15, 2016 at 8:30 a.m.

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

Attachments

06149487.pdf