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 xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces the Company has received an additional research unit order for a Xenon Polariser system from McMaster University in Ontario, Canada. The newest unit (version 9820) will supplement the University's existing hyperpolarisation 129Xe MRI research programme which is currently using a prior Polarean model (version 9800).

The system will be installed in St. Joseph's Healthcare Hamilton ("SJHH"). SJHH is a member of the St. Joseph's Health System ("St. Joseph's"), and is affiliated with McMaster University. St. Joseph's is also home to the Firestone Institute for Respiratory Health, which is an internationally regarded hospital-based centre-of-excellence for adult pulmonary research and patient care.

Richard Hullihen, CEO of Polarean, said: "We are excited that this distinguished Canadian academic and research health centre is extending its utilisation of our 129Xe MRI technology. This new addition to the University's hyperpolarised 129Xe MRI research programme will help to support its increasing volume of clinical studies, from both academia and drug industry collaborators. We are pleased to support these researchers' use of our platform as they continue their efforts to advance pulmonary patient care."

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