Polarean Imaging secures further 9820 Xenon Polariser system order
(POLX ) unveiled that it has received an additional research unit order for the group\s 9820 Xenon Polariser system from the University of British Columbia ("UBC").
This is the second system installation at UBC, following the University’s original order back in November 2019 which was initially installed at BC Children's Hospital, a Vancouver-based medical facility, while construction was carried out on its intended original site at St. Paul's.
BC Children's Hospital is a major paediatric research and teaching hospital, and is considered a well-known facility in the province for dealing in juvenile health.
As with the original system, the medical-imaging technology firm said the unit will continue to support UBC's pulmonary disease research programme using hyperpolarised gas imaging.
Compared to air that is typically within the lung, hyperpolarized xenon gas enhances the MRI signal by a factor of 100,000, making lung structure and regional ventilation more visible.
The process entails getting the patient to inhale a small quantity of the xenon gas and then undergoing an MRI scan which is typically completed within a 10-20 second breath hold.
Polarean said this ‘significantly higher functional resolution’ provided by this type of MRI ‘is so important to detecting early disease and subtle changes in the progression of disease.’
Commenting on today’s announcement, Rchard Hullihen, Chief Executive of Polarean, said: "We value our long-standing relationship with UBC, a globally recognised research group, and we are excited that they are adding an additional Polariser system to expand their research into the clinical applications of this emerging and much needed technology.
We are also pleased to be able to continue to expand our paediatric research cluster, which also includes Cincinnati Children's Hospital Medical Center and Toronto SickKids Hospital."
View from Vox
Today’s news follows the company’s placing in March 2021 which saw it raise £25m.
The fundraising will provide the company with funds ahead of its PDUFA date with the US FDA in October 2021, the deadline by which the FDA must decide whether to officially authorise the group’s drug-device combination which uses hyperpolarised xenon-129 gas.
The Company announced back in December 2020 that it had received confirmation of acceptance of its new drug application by the US FDA for the Group's drug-device combination using hyperpolarised xenon-129 gas to enhance MRI in pulmonary medicine.
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 increased by nearly 40% since the beginning of the year. The stock was trading 7.13% higher this morning at 98.56p 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.’
Follow News & Updates from here:
Disclaimer & Declaration of Interest
The information, investment views and recommendations in this article are provided for general information purposes only. Nothing in this article should be construed as a solicitation to buy or sell any financial product relating to any companies under discussion or to engage in or refrain from doing so or engaging in any other transaction. Any opinions or comments are made to the best of the knowledge and belief of the writer but no responsibility is accepted for actions based on such opinions or comments. Vox Markets may receive payment from companies mentioned for enhanced profiling or publication presence. The writer may or may not hold investments in the companies under discussion.