Corporate News

EXPLAIN study will evaluate the underlying causes of persistent breathlessness in patients with long COVID using hyperpolarised xenon MRI

Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with an investigational drug‑device combination product using hyperpolarised ¹²⁹xenon gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, and Oxford University Hospitals NHS Foundation Trust (“OUH”) announce that they have entered into a research collaboration to study the long-term effects of COVID-19 in patients who are still experiencing difficulty breathing months after the virus infection is gone, as part of the upcoming EXPLAIN study.

Under the terms of the collaboration, Polarean will provide its investigational xenon polariser system to OUH for their research. In turn, OUH will work with Polarean to optimise the imaging workflow and analyse the datasets coming from the newly enrolling EXPLAIN study. Through novel analyses of gas-exchange images, Polarean and OUH hope to better characterise long COVID and improve patient care.

¹²⁹Xenon MRI imaging technology uses a novel approach that can detect functional changes of the lung that impact its ability to properly handle the exchange of gases during inhalation and exhalation. The upcoming research builds upon the pioneering work conducted at OUH showing that hyperpolarised xenon MRI can detect underlying damage that is not detectable by traditional lung imaging, such as CT scans.

Prof Fergus Gleeson, Professor of Radiology at the University of Oxford and Consultant Radiologist at OUH, said: "We are pleased to be working with Polarean, now having access to their most advanced hyperpolarised xenon equipment. With this new system, we will be able to image increased numbers of patients more efficiently to see if we can uncover the underlying causes driving long COVID as part of our EXPLAIN study.”

Richard Hullihen, CEO of Polarean, said: "Oxford University is a leading pioneer in the use of ¹²⁹Xe MRI to unravel the underlying pathophysiology that drives persistent breathlessness in patients with long COVID. We are delighted to collaborate with them on new image analyses as part of the upcoming EXPLAIN trial that might shed additional light on the mysterious illness that has been affecting a growing number of patients over the past few years and affecting their quality of life.”

Enquiries:

About long COVID

Long COVID is an umbrella term used to describe ongoing symptoms following COVID-19 infection after four weeks. Symptoms are wide-ranging but breathlessness is one of the most common and can persist for months after the initial infection. Investigations including Computed Tomography (CT) and physiological measurements (lung function tests) can often be unremarkable. The mechanisms driving breathlessness remain unclear, and this may be hindering the development of effective treatments. Therefore, new diagnostic modalities are crucial to advance the care of these patients.

About hyperpolarised Xe MRI

A polarisation device transforms the inert noble gas, ¹²⁹xenon, into a hyperpolarised state using circularly polarised laser light. The hyperpolarised gas is inhaled by a patient to fill the space normally occupied by air in a single 10-second breath hold. The hyperpolarised gas then enhances the MRI signal, making regional lung function, including gas exchange, from the lungs to the blood visible in an MRI scan. The use of xenon MRI is non-invasive, and does not impart any radiation to the patient.

About the EXPLAIN Clinical Study

The EXPLAIN study, which involves teams in Oxford, Sheffield, Cardiff and Manchester, is using hyperpolarised xenon MRI scans to investigate possible lung damage in long COVID patients who have not been hospitalised with COVID-19 but who continue to experience breathlessness. 

It is envisaged that 400 participants will be recruited. These include:

• Patients diagnosed with long COVID, who have all been seen in dedicated long COVID clinics and who have normal CT scans
• Participants who have been in hospital with COVID-19 and discharged more than three months previously, who have normal or nearly normal CT scans and who are not experiencing long COVID

An age- and gender-matched control group who do not have long COVID symptoms and who have not been hospitalised with COVID-19

The findings of an initial pilot study involving 36 people has identified abnormalities in the lungs of long COVID patients who had been experiencing breathlessness.

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. On 30 March 2022, the Company filed the resubmission of its NDA with the US FDA and has received a PDUFA date of Sept 30, 2022.

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.