polarean Regulatory News (POLX)

Polarean Imaging Plc

("Polarean" or the "Company")

Third tranche of $3m paediatric lung disease imaging study grant confirmed

Phase III trial with Cincinnati Children's Hospital, one of the top pediatric centres in the US

Trial could support the routine application of xenon imaging to Cystic Fibrosis treatment for children

Polarean Imaging plc (AIM:POLX), the clinical stage medical-imaging technology company, with a proprietary drug-device combination product for the magnetic resonance imaging (MRI) market, announces that it will receive a third tranche of US$1 million as part of its US$3 million Small Business Innovation Research ("SBIR") grant. The funds will be used to continue a Phase III trial evaluating the use of 129 Xe MRI scanning for children being treated for Cystic Fibrosis ("CF").

The successful conclusion of this trial, which is being performed at Cincinnati Children's Hospital, one of the US's leading children's hospitals, could provide data to support the routine use of Polarean's 129 Xe MRI imaging technology for more accurate monitoring of lung function during CF treatment. CF is a genetic disease which can lead to impaired lung function and death. In the US alone, there are currently over 30,000 people with CF (Cystic Fibrosis Foundation Patient Registry).

Collaboration with Cincinnati Children's Hospital Medical Center ("Cincinnati Children's")

The SBIR grant was awarded from the National Heart, Lung and Blood Institute ("NHLBI"), part of the US National Institutes of Health (NIH). The Grant was jointly awarded to the Company and Cincinnati Children's (www.cincinnatichildrens.org) and will continue to fund an ongoing Phase III trial. The trial aims to evaluate the use of 129 Xe MRI scanning for CF patients as a means to provide more information to clinicians on lung function than is currently achievable with standard clinical tests.

The Company and Cincinnati Children's have a long-standing relationship regarding the development of 129 Xe MRI imaging and its paediatric research applications, including the treatment of CF. Cincinnati Children's is ranked as the third best US hospital for Paediatric Pulmonology and Lung Surgery according to US News & World Report, the global authority in hospital rankings. Jason Woods PhD, Director of the Center for Pulmonary Imaging Research at Cincinnati Children's, is a leader in developing safer lung imaging methods for children.

Jason Woods PhD, Cincinnati Children's said: "Year three of this NIH proposal will allow us to fully validate the hypothesis that hyperpolarized Xe MRI is sensitive to mild lung-function declines associated with CF in children. We anticipate that this work programme will be a launching point for future studies that will use the technique as a primary or secondary endpoint to demonstrate efficacy of therapeutic agents in CF and other obstructive lung diseases."

Richard Hullihen, CEO of Polarean said: "We are pleased to have received this continued award for developing biomarkers for CF with Dr. Woods and his team at Cincinnati Children's, one of Polarean's long-standing collaborators. This includes deploying recent developments in our gas exchange and red blood cell imaging techniques using 129 Xe MRI. There are several new drug therapies under development by manufacturers and a key element in expediting the development and commercialisation process is having quantitative, reproducible, non-invasive imaging-based biomarkers. These biomarkers could reduce the cost of trials and maximise the outcome and proof of cost efficacy in this critical patient population. Achieving these milestones may facilitate expansion of the developed techniques to other members of the Xenon MRI Trials Consortium for multi-centre trials. We believe the applications being developed in CF could further expand the use of 129-Xe imaging as we continue to progress our own Phase III Clinical Trials, which are testing our drug-device combination for the evaluation of pulmonary ventilation."

Background to the SBIR grant

As described in the Company's Admission Document dated 23 March 2018, in April 2017, the NHLBI awarded Polarean a provisional three-year SBIR grant of US$3m for a project entitled 'A Phase III Trial to Validate HP 129Xe MRI as a Functional Pulmonary Biomarker in Pediatric Lung Disease', for which the research would be conducted with Cincinnati Children's. The grant was payable in three tranches of US$1 million each year so long as Polarean continued to meet the grant's terms and applicable US law and regulation. The Company has received confirmation that it will be receiving the third tranche of US$1million.

For more information on the Xenon MRI Trials Consortium see: https://cpir.cchmc.org/XeMRICTC

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

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