Last checked at 7 Nov 2019 07:00
7 November 2019
Polarean Imaging Plc
("Polarean" or the "Company")
Completion of patient enrolment for Clinical Trials and PDMR Appointment
Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with a proprietary magnetic resonance imaging (MRI) drug-device combination, announces that the enrolment for its Phase III non-inferiority clinical trials (the "Clinical Trials") is now complete for both the lung transplant pathway and the lung resection pathway. The Clinical Trials enrolled a total of 80 patients of which 48 were in the lung transplant and 32 were in lung resection, respectively.
The aim of the Clinical Trials is to demonstrate non-inferiority of the Company's drug-device combination, which uses hyperpolarised 129-Xenon gas MRI, against an approved comparator for the diagnostic evaluation of pulmonary ventilation.
The readout process will now move to image and statistical analysis. This process is currently expected to take approximately 10 weeks and will conclude with the readout of the Clinical Trials.
On the current advice of Polarean's regulatory consultants, the completion of readout will form the basis for a Pre-New Drug Application ("NDA") Meeting with the FDA. Following the Pre-NDA Meeting and incorporation of its conclusions into the NDA submission, the process will conclude with the Company's NDA submission, currently estimated by the end of Q2 2020.
PDMR Appointment
Consistent with Polarean's target of achieving commercial sales upon receiving FDA approval, the Company also announces that Mr. Alex Dusek has joined as Vice-President of Commercialisation (non-Board role) with immediate effect. Prior to joining Polarean, Mr. Dusek has led multiple biopharmaceutical product launches in pulmonary disease, oncology cell therapy and HIV therapeutics, including at Bayer and United Therapeutics. Mr. Dusek earned a B.A. in Linguistics from the College of William and Mary, pre-medical programme at Columbia University, and received his M.B.A. from the University of North Carolina, Kenan-Flagler Business School.
Richard Hullihen, CEO of Polarean, said: "The Company is pleased to have successfully completed enrolment for its Clinical Trials and looks forward to the next stage of statistical analysis ahead of readout and the proposed submission of the NDA. We are also pleased to welcome Alex Dusek to our team, as he brings a wealth of direct pharmaceutical industry launch preparation and commercialisation experience to Polarean, as we ramp up our commercialisation planning."
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, Soltan Tagiev (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 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 and less harmful to the patient than current methods. The annual burden of pulmonary disease in the US is estimated to be over US$150 billion.
The Group also develops and manufactures high performance MRI radiofrequency (RF) coils which are a required component for imaging 129Xe in the MRI system. The development of these coils by the Group facilitates the adoption of the Xenon technology by providing application-specific RF coils which optimise the imaging of 129Xe in MRI equipment for use as a medical diagnostic as well as a method of monitoring the efficacy of therapeutic intervention.