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Polarean Imaging enrolls first patient in Phase III study at University of Cincinnati

By Iain Gilbert

Date: Monday 05 Aug 2019

Polarean Imaging enrolls first patient in Phase III study at University of Cincinnati

(Sharecast News) - Medical-imaging technology company Polarean has enrolled its first patient in the third trial of its proprietary drug-device combination product at the University of Cincinnati.
Polarean added a third trial site back in June, following trials at Duke University and the University of Virginia, in order to improve enrolment rates for its Phase III Clinical Trials.

The AIM-listed group said it was hoping its clinical trials would demonstrate non-inferiority of its drug-device combination, which uses hyperpolarised 129-Xenon gas MRI, against an approved comparator for the evaluation of pulmonary ventilation.

Polarean noted that enrolment for the clinical trials had now passed 98% in the lung transplant pathway and 75% in the lung lobe resection pathway, with a total of 80 patients targeted for enrolment.

Chief executive Richard Hullihen said: "The first patient enrolment at our additional trial site at UC provides reinforcement that we will deliver on our commitment to a timely completion of enrolment for the clinical trials.

"We remain focused on the completion of our New Drug Application and submission to the US Food and Drug Administration following readout of the clinical trials."

Hullihen added that the group was funded to complete trials and to also undertake post submission launch preparations and planning.

As of 0830 BST, Polarean shares had climbed 3.57% to 29p.

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