Polarean Imaging PLC FIRST PATIENT IN PHASE III FDA CLINICAL TRIAL (6223Y)
23 August 2018 - 4:00PM
UK Regulatory
TIDMPOLX
RNS Number : 6223Y
Polarean Imaging PLC
23 August 2018
Polarean Imaging Plc
("Polarean" or the "Company")
First patient IN Phase III FDA clinical trial
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 Phase III FDA clinical trial which
aims to demonstrate non-inferiority of the Company's drug-device
combination, using hyperpolarised 129-Xenon (129Xe) gas MRI,
against an approved comparator.
Polarean is now in the process of its Phase III Clinical
Trial.
The trial is a 'head-to-head' non-inferiority trial testing
129Xe MRI against 133-Xenon (133Xe) scintigraphy. In the trial the
Company will be evaluating two patient populations - candidate
patients for lung lobe resection, and lung transplant procedures -
80 patients in total. The Phase III trial is taking place at two US
sites: Duke University and the University of Virginia.
The Phase III trial follows on from the completion of a Pilot
Study in which 10 patients with COPD were assessed using both
Polarean's technology and 133Xe scintigraphy. In this study the
design and analysis methods of the Phase III trial were
successfully demonstrated.
Richard Hullihen, CEO of Polarean, commented: "The entire
Company is thrilled to have initiated our Phase III Trial, after
all the hard work of preparation. We would like to thank our
shareholders for their support, without which this would not have
been possible. We also thank our clinical and research
collaborators as their skill and expertise has been invaluable in
enabling us to reach this important milestone. I look forward to
providing our shareholders with further updates as the trial
progresses."
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
Northland Capital Partners Limited Tel: +44 (0)20 3861
6625
David Hignell / Gerry Beaney / Jamie Spotswood
(Corporate Finance)
Vadim Alexandre / Rob Rees (Corporate Broking)
MC Services (European IR) Tel: +49 (0)89 210
2280
Raimund Gabriel
The Life Sciences Division (Financial Adviser)
Navid Malik, Director Mob: 07957 224 730
Alia Minhas, CEO Mob: 07590 696 057
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
Helen Cresswell 741 001
Mob: +44 (0)7841 917 679
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 medical
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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