Polarean Imaging (POLX) , the medical imaging technology company developing a magnetic resonance imaging (MRI) drug-device combination revealed that its phase 3 clinical trials both met their primary endpoint on Wednesday.

The two clinical trials were multi-center, randomised, open-label studies that compared MRI with 129Xenon gas, polarised in Polarean's system, to 133Xenon scintigraphy, the FDA-approved reference standard.

The trials measured regional pulmonary function in patients being evaluated for possible lung resection surgery and possible lung transplant surgery. Both trials met their primary endpoint, the company said.

Some of the data from the trials will be used in Polarean’s New Drug Application submission to the FDA, scheduled for Q3 2020.

Shares in Polarean were trading 6.35% higher at 35p on Wednesday

"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 Richard Hullihen, Chief Executive Officer of Polarean.

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.” 

The technology could offer clinicians a powerful tool to visualise lung function, overcoming limitations of existing methods of diagnosis and monitoring treatment, Polarean said.

The drug, 129Xenon, when polarised in Polarean's proprietary system, permits functional, regional and quantitative imaging of the lungs using MRI, without exposing patients to ionizing radiation, which Richard Hullihen described as a significant unmet need.

"The use of conventional, anatomical MRI has, historically, not played a role in addressing the substantial unmet need in working up difficult-to-diagnose pulmonary diseases.” said Y. Michael Shim, MD, Director of Pulmonary Rehabilitation and Director of the Pulmonary Function Testing Lab at the University of Virginia, and an investigator on the trials.

He added: “The innovative approach we have taken with the use of hyperpolarized 129Xenon gas opens up a whole new window into how physicians diagnose, stage and monitor responses to treatment in a broad range of lung diseases with this high resolution, non-ionizing MRI method.” 

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