Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with a proprietary drug-device combination product for the magnetic resonance imaging (MRI) market, announces that the first patient has been enrolled in its Phase III FDA clinical trial which aims to demonstrate non-inferiority of the Company’s drug-device combination, using hyperpolarised 129-Xenon (129Xe) gas MRI, against an approved comparator.
Polarean is now in the process of its Phase III Clinical Trial.
The trial is a ‘head-to-head’ non-inferiority trial testing 129Xe MRI against 133-Xenon (133Xe) scintigraphy. In the trial the Company will be evaluating two patient populations – candidate patients for lung lobe resection, and lung transplant procedures – 80 patients in total. The Phase III trial is taking place at two US sites: Duke University and the University of Virginia.
The Phase III trial follows on from the completion of a Pilot Study in which 10 patients with COPD were assessed using both Polarean’s technology and 133Xe scintigraphy. In this study the design and analysis methods of the Phase III trial were successfully demonstrated.
Richard Hullihen, CEO of Polarean, commented: “The entire Company is thrilled to have initiated our Phase III Trial, after all the hard work of preparation. We would like to thank our shareholders for their support, without which this would not have been possible. We also thank our clinical and research collaborators as their skill and expertise has been invaluable in enabling us to reach this important milestone. I look forward to providing our shareholders with further updates as the trial progresses.”
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