Polarean Imaging PLC Clinical trial update (7363Y)
13 Mayo 2019 - 1:00AM
UK Regulatory
TIDMPOLX
RNS Number : 7363Y
Polarean Imaging PLC
13 May 2019
13 May 2019
Polarean Imaging Plc
Phase III Clinical Trial Update
("Polarean" or the "Company")
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").
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.
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
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