polarean Regulatory News (POLX)

Polarean Imaging Plc

("Polarean" or the "Company")

System delivery

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, announces that following on from the RNS on 25 April 2022, it has completed the installation of the additional Xenon Polariser 9820 at the Center for Pulmonary Imaging Research at the Cincinnati Children's Hospital Medical Center ("CCHMC").

CCHMC is a non-profit academic medical center, which is distinguished and globally renowned for paediatric teaching and research, and is one of the Company's longest key clinical research collaborators. A key focus of the collaboration is to lead the field of paediatric pulmonary imaging through advanced imaging techniques and lung function imaging, including hyperpolarised 129Xenon gas.

Richard Hullihen, CEO of Polarean Imaging said: "CCHMC runs an exceptional programme for advancing non-invasive hyperpolarised noble gas MR imaging in paediatric research and we are thrilled that we can support them in their endeavours. The CCHMC have made significant progress in their research efforts in early detection, diagnostic development, evaluation and management of serious lung diseases and we believe our partnership can help them improve the outcomes for these most vulnerable of patients."

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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 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.