Polarean Imaging (AIM: POLX)  has submitted a New Drug Application ("NDA") and request for priority review to the US Food and Drug Administration ("FDA") for hyperpolarised 129Xenon gas used to evaluate pulmonary function and to visualise the lung using MRI. 
 
As explained in an FDA guidance document, a priority review pathway expedites the review of a product with the FDA reviewing a drug in just six months instead of the standard 10. 
 
The submission of the NDA follows the Company's successful completion of the two Phase III clinical trials which demonstrated an effective measurement of regional lung ventilation.  
 
The medical imaging technology firm unveiled to investors back in January that both clinical trials from its phase III study had successfully met their primary endpoint and that some of the data would be used in the Company’s NDA application submission to the FDA. 
 
In the clinical trials, Polarean’s used 129Xenon gas, an imaging agent to visualise ventilation, to measure regional pulmonary function in patients with a wide variety of underlying lung diseases who were being evaluated for possible lung resection or lung transplant surgery. 
 
Shares in Polarean Imaging have traded strongly over the past three months, rising from lows of 29pto open at 47p following the news. 

In a half-year report published last month, Richard Hullihen, CEO of Polarean Imaging described the positive readout as one of the group’s “most important milestones to date”. 
 
"The positive results of these Clinical Trials validate our belief that Polarean's technology allows clinicians to visualise aspects of the lung function, which have never before been visible by MRI, both safely and quantitatively.” said Hullihen at the time of the results. 
 
He added: “More than 30 million Americans suffer from a chronic lung disease and the financial burden of lung disease now exceeds US$150 billion annually.”  
 
Polarean believes its technology could offer clinicians a powerful tool to visualise lung function, overcoming limitations of existing methods of diagnosis and monitoring treatment. 
 
The group also recently outlined that the "129Xe MRI Clinical Trials Consortium" continues to discuss the application of its technology to the case of post infection COVID-19 patients in regard to assessing the long-term effects and case management of patients with the virus. 
 
It said investigator-initiated government research grants have been submitted to study the use of its technology to assess the long-term effects of COVID-19 post infection in patients. Some of these grants have been awarded and COVID-19-related clinical research has begun. 
 
Hullihen said today’s news represented “another key regulatory milestone” for Polarean. 
 
“We see a significant unmet need for non-invasive, quantitative and cost-effective image-based diagnostic technology without exposing patients to ionising radiation,” he told investors, adding, “we look forward to working with the FDA to address this unmet need." 
 
Polarean said it is looking towards a potential commercial launch before the end of 2021. 
 
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