polarean Regulatory News (POLX)

Polarean Imaging Plc 

("Polarean" or the "Company")

Company Update

Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with a proprietary drug‑device combination product for the magnetic resonance imaging (MRI) market, provides shareholders with the following update on Company progress:

New System Installation

Further to the announcement made on 3 October 2018, the Company announces the installation and commissioning of the latest model of Polarean's Xenon polariser to The Department of Radiology at University of Missouri Health Care ("MUHC"). The University of Missouri, Columbia is the flagship university in the University of Missouri system. The Department of Radiology at MUHC has a successful imaging research programme that will be further enhanced with the addition of hyperpolarised gas MRI. Faculty members Robby Thomen PhD, Lucia Flors, MD, PhD and Talissa Altes MD bring expertise from previous work at successful hyperpolarised gas imaging sites (Dr. Flors and Dr. Altes from University of Virginia and Dr. Thomen from Cincinnati Children's Hospital) and plan to establish a new hyperpolarised gas laboratory at MUHC focused on basic research and clinical translation.

Robby Thomen, Assistant Professor in Radiology and BioEngineering at MUHC, said: "We believe that hyperpolarised gas MRI opens a door to numerous applications in medicine and we're excited to bring the technology to the Midwest. The high polarisation and throughput afforded by Polarean's device along with its ease of use is necessary to bring the technology into the clinic and see real patient benefit. We are excited to work closely with Polarean to this end."

Richard Hullihen, CEO of Polarean, said: "We are excited to welcome the University, Drs. Altes, Thomen, and Flores and their staff to the community of researchers using our technology to develop these patient-benefitting clinical applications of the future. These include The University of Oxford, University of Wisconsin, Fraunhofer Institute, Robarts Institute, University of North Carolina, and others."

New Order

The Company also announces receipt of a new order to provide an upgrade to the polariser already operating at SickKids Hospital in Toronto (www.sickkids.ca), one of its earliest customers. This upgrade will more than double the system polarisation levels and will be a benefit to the research programme there in providing better image quality and results. This acquisition was enabled by a grant from the Canada Foundation for Innovation (for more information see: www.innovation.ca/about).

Richard Hullihen, CEO of Polarean, commented: "This is the most recent example of upgrading earlier polarisers to later levels of performance and supporting the work of our collaborative researchers worldwide. The staff at SickKids have co-ordinated one of the most prolific research programmes in hyperpolarised noble gas imaging from the start. We are grateful to the CFI for supporting this vital work and enabling us to upgrade the installed system there, which is a testament to the development potential of the original design."

Clinical Trial Update

The Company can also update shareholders that its Phase III Non-Inferiority Clinical Trial is up and running at both of its sites, Duke University and University of Virginia. Candidate patient flows are showing to be as planned for transplant and resection, screening methods are functioning as designed, enrolment is happening in both clinical indication pathways and data collection is in process. Per the design of the trial, data analysis will begin after a sufficient percentage of patients in both pathways have been accumulated.

Richard Hullihen, CEO of Polarean, said: "We are grateful to the staff and our trial institutions Duke and University of Virginia for their support and performance in conducting the trial, we are pleased with the performance of our CROs in executing and managing the trial, and look forward to the on-schedule completion of trial enrolment during the second quarter of 2019."

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, medical drug-device combination companies operating in the high resolution functional magnetic resonance imaging market.

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 and gas exchange regionally in the smallest airways of the lungs, the tissue barrier between the lung and the bloodstream and in the pulmonary vasculature. Xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs.

The Group operates in an area of significant unmet medical need and the Group's technology provides a novel diagnostic approach, offering a non-invasive and radiation-free functional imaging platform which is more accurate than current methods. The annual burden of pulmonary disease in the US is estimated to be over US$150 billion.