polarean Regulatory News (POLX)

Polarean Imaging Plc 

("Polarean" or the "Company")

New System Order

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 that it has received an additional research unit order for a 9820 Xenon Polariser system from the University of British Columbia ("UBC"). This is the second system installation at UBC, following the original order in November 2019 which was initially installed at BC Children's Hospital ("BC Children's") while construction was carried out on its intended original site at St. Paul's.

As with the original system, this new unit will continue to support UBC's pulmonary disease research programme using hyperpolarised gas imaging. BC Children's is a major paediatric research and teaching hospital, and is the most well-known facility in the province for dealing in juvenile health.

Richard Hullihen, CEO of Polarean, said: "We value our long-standing relationship with UBC, a globally recognised research group, and we are excited that they are adding an additional Polariser system to expand their research into the clinical applications of this emerging and much needed technology. We are also pleased to be able to continue to expand our paediatric research cluster, which also includes Cincinnati Children's Hospital Medical Center and Toronto SickKids Hospital."

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

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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.

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 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.