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 an investigational drug‑device combination product using hyperpolarised 129Xenon gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces it has received an additional research unit order for a Xenon Polariser 9820. The system will be installed in the Center for Pulmonary Imaging Research at the Cincinnati Children's Medical Center ("CCHMC"). The Company holds a Small Business Innovation Research grant with the Cincinnati Children's Center, awarded by the National Heart, Lung and Blood Institute (NHLBI) in April 2017.

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 collaborators. A key focus of the collaboration is to lead the field of paediatric pulmonary imaging through advanced imaging techniques and multi-nuclear capabilities, including hyperpolarised 129Xenon gas.

Jason Woods, Director at the Center for Pulmonary Imaging Research commented: "We're excited to expand our capabilities with an additional hyperpolariser, which will facilitate and accelerate clinical trials in the CCHMCand within the Xe MRI Clinical Trials Consortium. This model also allows future potential increases in demand."

Richard Hullihen, CEO of Polarean Imaging said: "We are pleased to announce the ordering of the latest model of our xenon polariser from the CCHMC. We are delighted to be able to support their exceptional programme for advancing non-invasive hyperpolarised noble gas MR imaging in paediatric research. The CCHMC have made significant progress in their breakthrough efforts in early detection, therapy development, evaluation and management and we believe our partnership can help them improve the outcomes for the most vulnerable of patients."

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, 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 6 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 economic burden of pulmonary disease in the US is estimated to be over US $150 billion. Cincinnati Children's Medical Center