Both trials met their primary endpoint, showing pre-defined equivalence of hyperpolarized 129Xenon Gas MRI to an approved comparator, 133Xenon Scintigraphy Company plans for NDA submission to FDA in Q3 2020. Polarean's technology could offer clinicians a powerful tool to visualize lung function, overcoming limitations of existing methods of diagnosis and monitoring treatment
Durham, N.C. - January 29, 2020 - Polarean Imaging plc (AIM: POLX), a clinical stage medical imaging technology company developing a proprietary magnetic resonance imaging (MRI) drug-device combination, today announced positive top-line results from two pivotal Phase III clinical trials of the Company's drug-device combination, which uses hyperpolarized 129Xenon gas MRI to visualize and quantify regional lung function.
The drug, 129Xenon, when polarized in Polarean's proprietary system, permits functional, regional and quantitative imaging of the lungs using MRI, without the use of ionizing radiation. 129Xenon is administered as an inhaled gas that is given to patients in a 10-second breath-hold procedure. For patients who participated in the clinical trials, the ventilation in zones of interest was quantified and compared to images, similarly quantified, derived from a different imaging modality.
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