Polarean Imaging plc announces that the enrolment for its Phase III non-inferiority clinical trials (the "Clinical Trials") is now complete for both the lung transplant pathway and the lung resection pathway. The Clinical Trials enrolled a total of 80 patients of which 48 were in the lung transplant and 32 were in lung resection, respectively. The aim of the Clinical Trials is to demonstrate non-inferiority of the Company's drug-device combination, which uses hyperpolarised 129-Xenon gas MRI, against an approved comparator for the diagnostic evaluation of pulmonary ventilation. The readout process will now move to image and statistical analysis. This process is currently expected to take approximately 10 weeks and will conclude with the readout of the Clinical Trials. On the current advice of Polarean's regulatory consultants, the completion of readout will form the basis for a Pre-New Drug Application ("NDA") Meeting with the FDA. Following the Pre-NDA Meeting and incorporation of its conclusions into the NDA submission, the process will conclude with the Company's NDA submission, currently estimated by the end of Second Quarter 2020.

The Company also announced that Mr. Alex Dusek has joined as Vice-President of Commercialisation (non-Board role) with immediate effect. Prior to joining Polarean, Mr. Dusek has led multiple biopharmaceutical product launches in pulmonary disease, oncology cell therapy and HIV therapeutics, including at Bayer and United Therapeutics.