Phase III Clinical Trial Update
13 May 2019
Polarean Imaging plc (AIM: POLX), the clinical stage medical-imaging technology company, with a proprietary drug-device combination product for the visualisation of pulmonary function in the magnetic resonance imaging (MRI) market, announces an update regarding the Company's Phase III Clinical Trials (the "Clinical Trials").
The Clinical Trials are progressing at Duke University and at the University of Virginia and aim to demonstrate non-inferiority of the Company's drug-device combination, which uses hyperpolarised 129-Xenon gas MRI, against an approved comparator for the evaluation of pulmonary ventilation.
Enrolment for the Clinical Trials has now passed 80% (39 of 48 patients) in the lung transplant pathway and 50% (16 of 32 patients) in the lung resection pathway.
To improve the rate of enrolment for the lung resection pathway in order to align the pathway completion dates and because neither site should enroll more than 65% of patients in a pathway, the Company plans to add a third trial site. The additional trial site will be the University of Cincinnati ("UC"), which is already one of the Company's key clinical collaborators. It is expected that the trial site at UC will be activated in June 2019.
Polarean's Directors remain confident that the Company is on track to meet its current timetable for the regulatory submission of a New Drug Application with the US Food and Drug Administration (FDA). If approved by the FDA, commercial launch is expected to occur during H22020.
Richard Hullihen, CEO of Polarean, said: "We are satisfied with the progress of our Clinical Trials to date. We are pleased to be adding an additional trial site at UC to improve the enrolment process for the lung resection pathway, thereby extending our collaboration with UC.
I look forward to providing shareholders with further updates as the Clinical Trials progress towards completion"
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.
|Polarean Imaging plc||www.polarean.com/www.polarean-ir.com|
|Richard Hullihen, Chief Executive Officer||Via Walbrook PR|
|Richard Morgan, Chairman|
|SP Angel Corporate Finance LLP||Tel: +44 (0)20 3470 0470|
|David Hignell / Lindsay Mair / Jamie Spotswood (Corporate Finance)|
|Vadim Alexandre / Rob Rees (Corporate Broking)|
|Walbrook PR||Tel: +44 (0)20 7933 8780 or[email protected]|
|Paul McManus / Anna Dunphy||Mob: +44 (0)7980 541 893 / +44 (0)7879 741 001|