Recent Polarean News and Press Releases
Complete Response Letter Received from FDA
October 6, 2021
Requirement to address approvability issues identified by FDA ahead of NDA resubmission.
Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational drug-device combination product using hyperpolarized xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces that the Company has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) for the New Drug Application (“NDA”) for their drug-device combination product.Read the Full Press Release
Polarean Announces NDA Submission of 129Xenon Gas MRI
October 7, 2020
NDA submission for Polarean's hyperpolarized 129Xenon gas drug-device diagnostic for lung imaging.
Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with an investigational drug‑device combination product for magnetic resonance imaging (MRI), announces its submission of a New Drug Application (“NDA”) and request for priority review to the US Food and Drug Administration (“FDA”) for hyperpolarized 129Xenon gas used to evaluate pulmonary function and to visualize the lung using MRI.Read the Full Press Release
Positive Results Announced from Pivotal Phase III Clinical Trials
January 29, 2020
Both trials met their primary endpoint, showing pre-defined equivalence of hyperpolarized 129Xenon Gas MRI to an approved comparator, 133Xenon Scintigraphy.
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.Read the Full Study