Phase III Clinical Trials update First patient enrolment at University of Cincinnati
05 August 2019
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.
|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
|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 (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.