polarean Regulatory News (POLX)

13 November 2018

Polarean Imaging Plc 

("Polarean" or the "Company")

Licencing Agreement with Duke University

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:

Patent Licence / New Market Opportunity in Pulmonary Vascular Disease

The Company announces that it has entered into a licencing agreement with Duke University for patents related to an entirely new use for hyperpolarised gas imaging in the field of pulmonary vascular disease ('PVD'). This opens the potential for Polarean to address an additional unmet medical need in diagnosis and monitoring of cardiopulmonary conditions.

Pulmonary vascular disease (PVD) is a group of disorders that cause high blood pressure in the lungs (pulmonary hypertension). Prevalence is significant in the western world, and hundreds of thousands of patients suffer from the disease in the US alone (source: American Thoracic Society link). Specifically, pulmonary arterial hypertension ('PAH') is difficult to diagnose and requires invasive and expensive heart catheterisation to diagnose. New drugs are available to address PAH, but these drugs are driving up the average annual cost of caring for some of these patients to over US $100,000. As such, frequent monitoring of the effectiveness of these new therapies is essential.

Duke University has recently patented a method of using hyperpolarised gas MRI in a novel, non-invasive manner to quantify pulmonary vascular pressure, potentially eliminating the need for the costly and invasive catheterisation required to confirm PVD and monitor its progression. 

The licencing agreement with Duke University grants Polarean exclusive rights to the technology, and the Company will work with Duke to drive this new technology towards clinical use and regulatory approval. This license further strengthens the previous licensing of Duke's 3D gas exchange imaging technology to provide a complete diagnostic suite that addresses a critical unmet need in the care of patients with PVD.

Richard Hullihen, CEO of Polarean, said: "We are delighted to expand our collaboration with Duke University and are especially excited to be co-developing this novel use for hyperpolarised MRI. With this extension of hyperpolarised xenon technology, we are expanding the usefulness of our core technology to fully address diseases of the airways, lung parenchyma, and now the pulmonary vasculature."

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.

The Group is currently undertaking Phase III Non-Inferiority Clinical Trials for 129Xe at Duke University and University of Virginia.