Phase III Clinical Trials - Update
11 June 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 a further update regarding the Company's Phase III Clinical Trials (the "Clinical Trials"), following the Company's announcement of 13 May 2019.
The Clinical Trials continue to progress 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 85.4% in the lung transplant pathway and 62.5% the lung resection pathway.
To improve the rate of enrolment for the lung resection pathway, the Company will now add a third trial site at the University of Cincinnati ("UC"), which is already one of the Company's key clinical collaborators. It is expected that the first patient will be enrolled at UC shortly.
With the addition of the UC trial site, completion of enrolment for the Clinical Trials will now extend into Q32019.
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 pleased to confirm that Polarean will be activating the additional trial site at UC this month, to help ensure a timely completion of the enrolment process for the lung resection pathway.
Enrolment for the lung transplant pathway is now nearing completion and I look forward to providing shareholders with further updates regarding our Clinical Trials as soon as practicable."
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|
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|David Hignell / Lindsay Mair / Jamie Spotswood (Corporate Finance)
Vadim Alexandre / Rob Rees (Corporate Broking)
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