TIDMPOLX

RNS Number : 7478B

Polarean Imaging PLC

11 June 2019

Polarean Imaging Plc

("Polarean" or the "Company")

Phase III Clinical Trials - Update

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.

Clinical Trials

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.

Enquiries:

 
 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 polarean@walbrookpr.com 
 Paul McManus / Anna Dunphy                                                   Mob: +44 (0)7980 541 893 / +44 
                                                                                             (0)7879 741 001

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(END) Dow Jones Newswires

June 11, 2019 02:01 ET (06:01 GMT)

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