polarean Regulatory News (POLX)

Polarean Imaging Plc 

("Polarean" or the "Company")

New System Installation

Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational proprietary drug-device combination product for the magnetic resonance imaging (MRI) market, announces that it has completed the installation of its 9820 Xenon Polariser system for the University of Texas MD Anderson Cancer Center ("MD Anderson Cancer Center").

MD Anderson Cancer Center is a world-renowned cancer research and teaching hospital. This new hyperpolarisation system will initiate their research programme using Xenon imaging in assessing lung function as consequence of chemotherapy, immunotherapy, antibiotics, radiation therapy, and their various combinations.

Richard Hullihen, CEO of Polarean, said: "We are excited to partner with MD Anderson Cancer Center researchers who have been instrumental in developing multiple medical imaging applications for patients with cancer. We welcome them to the group of our researchers pioneering the use of hyperpolarised 129 Xe in assessment of pulmonary function across multiple patient populations. This latest completion of installation expands the clinical and public health frontiers of hyperpolarised xenon imaging and will help continue the vital work in combatting lung disease."

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

Enquiries:

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 barrier, 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. 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 investigational diagnostic approach, offering a non-invasive and radiation-free functional imaging platform. The annual burden of pulmonary disease in the US is estimated to be over US$150 billion.