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.
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