Polarean Imaging PLC - Completion of patient enrolment & PDMR appointment
("Polarean" or the "Company")
Completion of patient enrolment for Clinical Trials and PDMR Appointment
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.
Consistent with Polarean's target of achieving commercial sales upon receiving FDA approval, the Company also announces that Mr.
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
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.
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Tel: +44 (0)20 3470 0470
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Tel: +44 (0)20 7933 8780 or [email protected]
Mob: +44 (0)7980 541 893 / +44 (0)7879 741 001
About Polarean (www.polarean.com)
The Company and its wholly owned subsidiary,
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
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.
This information is provided by RNS, the news service of the
Quick facts: Polarean Imaging PLC
Market Cap: £32.5 m
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