Polarean Imaging PLC (LON:POLX) said it has submitted a New Drug Application (NDA) and a priority review request to the US Food and Drug Administration (FDA) for hyperpolarised Xenon gas used to evaluate pulmonary function and to visualise the lung using magnetic resonance imaging (MRI).
The medical imaging technology company said the submission of the NDA follows the successful completion of two Phase III clinical trials which demonstrated effective measurement of regional lung ventilation.
WATCH: Polarean Imaging PLC to submit New Drug Application of its lung imaging system to the FDA in October
In the tests, the AIM-listed firm used a Xenon gas MRI to measure regional pulmonary function in patients with a variety of underlying lung diseases who were being evaluated for possible lung resection or lung transplant surgery.
Both clinical trials met their primary endpoints, showing pre-defined equivalence of hyperpolarised Xenon Gas MRI to an approved comparator, Xenon Scintigraphy, and displayed a benign safety profile.
Xenon, when polarised 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 ionising radiation, the company said.
The polarised Xenon is administered as an inhaled gas that is given to patients in a 10 second breath-hold MRI procedure.
“The NDA submission of Xenon gas MRI as a drug-device combination represents another key regulatory milestone for our company,” Polerean chief executive Richard Hullihen said in a statement.
“More than 30mln Americans suffer from a chronic lung disease and we see a significant unmet need for non-invasive, quantitative and cost-effective image-based diagnostic technology without exposing patients to ionising radiation. We look forward to working with the FDA to address this unmet need.”