polarean Regulatory News (POLX)

Polarean Imaging plc

("Polarean" or the "Company")

Article on hyperpolarised xenon

Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational drug-device combination product for magnetic resonance imaging (MRI), notes the news release on 25 May by the Oxford Biomedical Research Centre concerning a study carried out in longer-term lung damage after COVID-19.

The study was published online in the Journal Radiology (https://pubs.rsna.org/doi/10.1148/radiol.2021210033). This preliminary research determined that hyperpolarised xenon MRI scans had found abnormalities in the lungs of some COVID-19 patients more than three months - and in some cases, nine months - after leaving hospital, when other clinical measurements were normal. Polarean had supplied Oxford University Hospitals Trust with an earlier research model that was used for the study and are working towards providing a new state-of-the-art polariser for further research.

Principal Investigator Prof Fergus Gleeson, Professor of Radiology at the University of Oxford and Consultant Radiologist at Oxford University Hospitals NHS Foundation Trust, said: "Many COVID-19 patients are still experiencing breathlessness several months after being discharged from hospital, despite their CT scans indicating that their lungs are functioning normally. Our follow-up scans using hyperpolarised xenon MRI have found that abnormalities not normally visible on regular scans are indeed present, and these abnormalities are preventing oxygen getting into the bloodstream as it should in all parts of the lungs."

The full news release can be viewed here: https://oxfordbrc.nihr.ac.uk/study-confirms-longer-term-lung-damage-after-covid-19/

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About Polarean (www.polarean.com)

The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are revenue-generating, investigational drug-device combination companies operating in the high-resolution medical imaging research space. 

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. 129Xe gas is currently being studied for visualisation of gas exchange regionally in the smallest airways of the lungs, across the alveolar tissue barrier, and into the pulmonary bloodstream.

In October 2020, the Group submitted a New Drug Application ("NDA") to the FDA for hyperpolarised 129Xe used to evaluate pulmonary function and to visualise the lung using MRI. In December 2020, the Group received confirmation of acceptance of its NDA by the FDA, with a target PDUFA action date of 5 October 2021.

The Group operates in an area of significant unmet medical need and the Group's technology provides a novel investigational diagnostic approach, offering a non-invasive and radiation-free functional imaging platform. The annual burden of pulmonary disease in the US is estimated to be over US$150 billion.