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Recruitment completed for Prim...

Recruitment completed for PrimECC study

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. Recruitment is now complete for a study including a total of 80 patients that aims to increase the clinical documentation for PrimECC®. Analysis of the results will now begin and it is estimated that the first publication from the study will be towards the end of 2017.

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. During the past year the company has carried out a randomized, blind clinical study on 80 patients at Sahlgrenska University Hospital in Gothenburg in order to increase the documentation. All patients have now been included and it is estimated that the first results will be published towards the end of 2017.

Professor Anders Jeppsson, who is in charge of the study, is pleased that the recruitment of patients has gone according to plan and looks forward with interest to analyzing the results.

XVIVO Perfusion is waiting for analysis of the results from the study at Sahlgrenska University Hospital and does not plan any extensive launch of the product before the results from the study have been published. XVIVO Perfusion has applied for a patent for PrimECC® in important markets and has so far been granted a patent in the USA, EU, China and Japan.

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 recruitment for the clinical study on PrimECC® is now complete, as the product has interesting clinical and commercial potential.  We look forward to the results from the study which it is estimated will come later this year,” says XVIVO Perfusion’s CEO Magnus Nilsson.

July 13, 2017
Magnus Nilsson, CEO
XVIVO Perfusion AB (publ)

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