polarean Regulatory News (POLX)

Polarean Imaging Plc 

("Polarean" or the "Company")

Company Update

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 the allowance of the latest patents on polarisation, the results of a 'pilot study' (the "Pilot Study") that was undertaken in preparation for its upcoming Phase III Clinical Trials and an update regarding the Company's Phase III Clinical Trials.

Highlights:

· Patent Allowance - The Company has received Notice of Allowance on the latest U.S. Patent Application No. 15/120,013 "Hyperpolarized Noble Gas Production Systems with Nanocluster Suppression, Detection, and/or Filtering and Related Methods and Devices" to which it has exclusive rights. This patent, together with the Company's know-how, has led to increasing levels of polarisation for its gas-hyperpolarisation platform for MRI. This is key to advancing image quality, exploring new applications and increasing the overall efficiency of the Company's polarisers.

· Completion of Pilot Study prior to Phase III Clinical Trials - In anticipation of its Phase III Trials comparing hyperpolarised 129-Xenon gas MRI ("129Xe MRI") to 133Xe scintigraphy (a widely-used imaging technique), Polarean commissioned a Pilot Study at one of its Trial sites. The Pilot Study was conducted to validate the study design and the proposed analysis methods of its Phase III Trials along with the proposed analytical methods that will be used in the Trials. The Pilot Study enrolled ten COPD patients across a range of disease severity. Each patient underwent scanning by both 129Xe MRI and 133Xe scintigraphy. COPD patients were selected for the Pilot Study due to their expected similarity to the patients that will participate in the Phase III Trials and the relative ease of their recruitment. All scanning protocols were identical to those that will be used in the Phase III Trials. The scans for each modality were quantified by a standard 6-zone analysis to calculate the percentage of lung function contributed by each of the 6 lung zones, as well as the total right lung function. This Pilot Study of ten patients, which is representative of population for the Phase III Trials, gives the Company confidence in its trial design, i.e. the chosen methodology is appropriate and should maximise the probability that both the primary and secondary endpoints of the Phase III Trials will accurately reflect the comparative values of 129Xe MRI versus 133Xe scintigraphy.

· Phase III Clinical Trials update - Polarean's Phase III Clinical Trials are now scheduled to start in mid-August 2018. They are 'head to head' non-inferiority trials versus 133Xe scintigraphy, with the aim to pursue a "structural claim" for the use of its product as a contrast agent. The Phase III Trials will evaluate two patient populations: candidate patients for (1) lung lobe resection and (2) lung transplant procedures, and will total 80 patients in aggregate. In those populations, lung function information will be obtained and non-inferiority against 133Xe scintigraphy will be compared.

Polarean currently expects data collection for the Phase III Trials to complete during Q3 of 2019 and if the Trials are successful the Company aims to submit its New Drug Application ("NDA") with the same claim as the approved comparator 133Xe drug, "for the evaluation of pulmonary function, for imaging the lungs" shortly thereafter.

Richard Hullihen, CEO of Polarean, commented:

"Polarean is a drug-device company and will undertake 'head to head' non-inferiority Clinical Trials. We took the opportunity to reduce the risk in our pivotal trials by commissioning the Pilot Study to directly test the workflow and analytical and measurement methodology of our Trials on ten patients which comprise 25% of each indication's trial population. We are pleased with the results of the Pilot Study and look forward to providing further updates regarding the Phase III Trials as appropriate."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

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