Polarean Imaging - Completion of patient enrolment for Clinical Trials and PDMR Appointment
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:
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Polarean Imaging plc |
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Richard Hullihen, Chief Executive Officer |
Via Walbrook PR |
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Richard Morgan, Chairman |
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SP Angel Corporate Finance LLP |
Tel: +44 (0)20 3470 0470 |
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David Hignell, Soltan Tagiev (Corporate Finance) Vadim Alexandre / Rob Rees (Corporate Broking) |
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Walbrook PR |
Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com |
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Paul McManus / Anna Dunphy |
Mob: +44 (0)7980 541 893 / +44 (0)7879 741 001 |
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