POLAREAN IMAGING PLC

Report Publication Announcement • May 11, 2022

National Storage Mechanism | Additional information

RNS Number : 0128L

Polarean Imaging PLC

11 May 2022

Polarean Imaging plc

("Polarean" or the "Company")

Notice of Results

Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with an investigational drug‑device combination product using hyperpolarised 129Xenon gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, confirms that it will be announcing its full year results for the 12 months ended 31 December 2021, on Wednesday 18 May 2022.

Enquiries:

Polarean Imaging plc			www.polarean.com / www.polarean-ir.com
Richard Hullihen, Chief Executive Officer			Via Walbrook PR
Ken West, Chairman
Stifel Nicolaus Europe Limited (NOMAD and Sole Corporate Broker)				+44 (0)20 7710 7600
Nicholas Moore / Samira Essebiyea / William Palmer-Brown (Healthcare Investment Banking)
Nick Adams / Fred Walsh (Corporate Broking)
Walbrook PR	Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com
Paul McManus / Anna Dunphy		Mob: +44 (0)7980 541 893 / +44 (0)7879 741 001

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 membrane, 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. The Group received a complete response letter on 5 October 2021. On 30 March 2022, the Company filed the resubmission of its NDA with the US FDA and has received a PDUFA date of Sept 30, 2022.

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 economic burden of pulmonary disease in the US is estimated to be over US $150 billion.

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