First patient IN Phase III FDA clinical trial
23 August 2018
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.
|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|
|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 [email protected]|
|Paul McManus / Anna Dunphy
|Mob: +44 (0)7980 541 893 / +44 (0)7879 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 (129Xe) 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.