TIDMPOLX
RNS Number : 0194L
Polarean Imaging PLC
11 May 2022
Polarean Imaging Plc
("Polarean" or the "Company")
Research collaboration with Oxford University Hospitals for long
COVID
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 (129) xenon 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.
(129) Xenon 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 (129) Xe 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:
Polarean Imaging plc www.polarean.com / www.polarean-ir.com
Richard Hullihen, Chief Executive Via Walbrook PR
Officer
Ken West, Chairman
Stifel Nicolaus Europe Limited (NOMAD and
Sole Corporate Broker) +44 (0)20 7710 7600
Nicholas Moore / Samira Essebiyea / William Palmer-Brown
(Healthcare Investment Banking)
Nick Adams / Fred Walsh (Corporate
Broking)
Walbrook PR Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com
Paul McManus / Anna Dunphy Mob: +44 (0)7980 541 893 / +44 (0)7879
741 001
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, (129)
xenon, 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 ((129) Xe) as an
imaging agent to visualise ventilation. (129) Xe 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 (129) Xe 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.
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