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December 28, 2022 - Polarean Imaging plc, the medical imaging technology company, announces that the U.S. Food and Drug Administration ("FDA") has granted approval for its drug device combination product, Xenoview. Xenoview, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging ("MRI") for the evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. Xenoview has not been evaluated for use with lung perfusion imaging.
Xenoview expands the opportunity for pulmonary medicine to utilize the first and only inhaled MRI hyperpolarized contrast agent for novel visualization of lung ventilation without exposing patients to any ionizing radiation and its associated risks. The dose of Xenoview, created through the Polarean HPX hyperpolarization system, is administered in a single 10-15 second breath hold MRI procedure.
More than 30 million Americans suffer from a chronic lung disease, and there is a significant unmet need for non-invasive diagnostic technology. Xenoview can provide pulmonologists, surgeons, and other respiratory specialists with regional maps of ventilation in their patients’ lungs to assist them in managing their disease.
Xenoview is not approved for use in pediatric patients less than 12 years of age.