GCIPolarean Imaging notes Oxford research on hyperpolarised xenon MRI scans
(POLX ) has highlighted preliminary research from the Oxford Biomedical Research Centre concerning a study carried out in longer-term lung damage after COVID-19.
The study identified persistent damage to the lungs of COVID-19 patients at least three months after they were discharged from hospital, and for some patients even longer.
Findings from the study, which aimed to determine if hyperpolarized 129Xe MRI (XeMRI) imaging could identify the possible cause of breathlessness in patients three months after hospital discharge following COVID-19 infection, have been published in Journal Radiology.
Polarean utilises its hyperpolarised Xenon gas (129Xe) as an imaging agent in order 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.
Oxford’s preliminary research determined that hyperpolarised xenon MRI scans had found abnormalities in the lungs of some COVID-19 patients more than three months - and in some cases, nine months - after leaving hospital, when other clinical measurements were normal.
Polarean, which is a medical-imaging technology company, had supplied Oxford University Hospitals Trust with an earlier research model that was used for the study. The two are currently working towards providing a new state-of-the-art polariser for further research.
Principal Investigator, Fergus Gleeson, Professor of Radiology at Oxford University and Consultant Radiologist at Oxford University Hospitals NHS Foundation Trust, commented:
"Many COVID-19 patients are still experiencing breathlessness several months after being discharged from hospital, despite their CT scans indicating that their lungs are functioning normally. Our follow-up scans using hyperpolarised xenon MRI have found that abnormalities not normally visible on regular scans are indeed present, and these abnormalities are preventing oxygen getting into the bloodstream as it should in all parts of the lungs."
Professor Jim Wild, Head of Imaging and NIHR Research Professor of Magnetic Resonance at Sheffield University, said: “The findings of the study are very interesting. The 129Xe MRI is pinpointing the parts of the lung where the physiology of oxygen uptake is impaired due to long standing effects of COVID-19 on the lungs, even though they often look normal on CT scans.”
“It’s an important study that highlights how intelligent imaging can identify ‘hidden’ impacts for COVID patients, and which is now unlocking wider funding and partner support,” said Dr Claire Bloomfield, CEO of NCIMI or the National Consortium of Intelligent Medical Imaging, which is one of several organisations that has co-funded the XeMRI research in Oxford.
She added, “Our hope is that this work can be further expanded to support more patients living with lung damage post-COVID-19, which had previously gone undetected and support detection both with and without Xenon.”
View from Vox
After submitting a New Drug Application to the FDA for hyperpolarised 129Xe in October 2020, Polarean received confirmation of acceptance of its NDA by the FDA in December. The firm, which intends to use hyperpolarised 129X to evaluate pulmonary function and to visualise the lung using MRI, said it is now targeting PDUFA action date of 5 October 2021.
Polarean’s £25m fundraise in March is expected to provide it with funds ahead of its PDUFA date with the US FDA, the deadline by which the FDA must decide whether to officially authorise the group’s drug-device combination which uses hyperpolarised xenon-129 gas.
If approved by the US FDA, Polarean's drug-device technology could provide a new diagnostic option for patients with pulmonary disease. The annual burden of pulmonary disease, a type of lung disease, in the US alone is estimated to be over US$150 billion.
Shares in Polarean Imaging have risen by over 40% in value since the beginning of the year. The stock was trading 3.30% higher this morning at 94p following the announcement.
Reasons to POLX
The Group and its wholly owned subsidiary, Polarean, Inc. are revenue generating, medical drug-device combination companies operating in the high-resolution medical imaging market.
Polarean’s equipment enables existing MRI systems to achieve an improved level of pulmonary function imaging and specialises in the use of hyperpolarised Xenon gas (129Xe).
The Group utilises the hyperpolarised Xenon gas (129Xe) as an imaging agent in order 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.
Polarean operates in an area of significant unmet medical need and its technology aims to provide a diagnostic approach, offering a non-invasive and radiation-free functional imaging platform which is more accurate and less harmful to the patient than current methods.
The annual burden of pulmonary disease in the US is estimated to be over US$150 billion.
In December 2020, Polarean confirmed that the US FDA had accepted the Group’s new drug application (NDA) for its drug device combination product using hyperpolarised xenon-129 gas.The US regulator informed the Group that the NDA will follow a “standard time frame”.
This means that the target Prescription Drug User Fee Act or PDUFA date is now 5 October 2021 - this being the deadline by which the FDA must review all new drug applications.
Hullihen told investors, "FDA acceptance for the filing of Polarean's NDA represents another important step forward for the Company's platform. If approved, Polarean's drug-device technology could provide a new diagnostic option for patients with pulmonary disease.”
Polarean told investors that following the achievement of this latest milestone, that it plans to make ‘full use of this time with regards to commercialisation and launch preparation.’
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