Polarean Imaging plc has submitted a New Drug Application and request for priority review to the US FDA for its hyperpolarized 129Xenon gas used to evaluate pulmonary function and to visualize the lung using MRI.
The submission of the NDA follows the Company’s successful completion of two Phase III clinical trials, which demonstrated effective measurement of regional lung ventilation. In the studies, Polarean’s 129Xenon gas MRI was used 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.
As detailed in the company’s announcement of January 2020, both trials met their primary endpoints, showing pre-defined equivalence of hyperpolarized 129Xenon Gas MRI to an approved comparator, 133Xenon Scintigraphy, and displayed a benign safety profile.
129Xenon, when polarized in Polarean’s proprietary drug-device system, permits functional, regional and quantitative imaging of the lungs using MRI, without the risk of exposing patients to ionizing radiation. The polarized 129Xenon is administered as an inhaled gas that is given to patients in a 10 second breath-hold MRI procedure.
“More than 30 million Americans suffer from a chronic lung disease and we see a significant unmet need for noninvasive, quantitative and cost-effective image-based diagnostic technology without exposing patients to ionizing radiation,” said Richard Hullihen, CEO of Polarean. “We look forward to working with the FDA to address this unmet need.”