Polarean Imaging PLC Phase III Clinical Trials update (8158H)
05 Agosto 2019 - 1:00AM
UK Regulatory
TIDMPOLX
RNS Number : 8158H
Polarean Imaging PLC
05 August 2019
Polarean Imaging Plc
("Polarean" or the "Company")
Phase III Clinical Trials update
First patient enrolment at University of Cincinnati
Polarean Imaging plc (AIM: POLX), the medical-imaging technology
company, with a proprietary drug-device combination product for the
magnetic resonance imaging (MRI) market, announces that the first
patient has been enrolled in its third trial site at the University
of Cincinnati ("UC").
As announced on 11 June 2019, the Company added a third trial
site, in addition to Duke University and the University of
Virginia, to improve enrolment rates for its Phase III Clinical
Trials (the "Clinical Trials"). The Clinical Trials 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 98% in the lung
transplant pathway and 75% in the lung lobe resection pathway, with
a total of 80 patients targeted for enrolment. The Company remains
on target to complete enrolment for the Clinical Trials before the
end of Q3 2019.
Richard Hullihen, CEO of Polarean, said: "The first patient
enrolment at our additional trial site at UC provides reinforcement
that we will deliver on our commitment to a timely completion of
enrolment for the Clinical Trials. We remain focused on the
completion of our New Drug Application and submission to the US
Food and Drug Administration following readout of the Clinical
Trials. We are funded to complete this and undertake post
submission launch preparation and planning. I look forward to
providing our shareholders with further updates regarding the
Clinical Trials as they near 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
About Polarean (www.polarean.com)
The Company and its wholly owned subsidiary, Polarean, Inc.
(together the "Group") are revenue generating, medical drug-device
combination companies operating in the high resolution functional
magnetic resonance imaging market.
The Group develops equipment that enables existing MRI systems
to achieve an improved level of pulmonary function imaging and
specialises in the use of hyperpolarised Xenon gas ((129) Xe) as an
imaging agent to visualise ventilation and gas exchange regionally
in the smallest airways of the lungs, the tissue barrier between
the lung and the bloodstream and in the pulmonary vasculature.
Xenon gas exhibits solubility and signal properties that enable it
to be imaged within other tissues and organs.
The Group operates in an area of significant unmet medical need
and the Group's technology provides a novel diagnostic approach,
offering a non-invasive and radiation-free functional imaging
platform which is more accurate than current methods. The annual
burden of pulmonary disease in the US is estimated to be over
US$150 billion.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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