Polarean Imaging announces FDA expansion of XENOVIEW indication

Polarean Imaging (PLLWF) announces that the US Food and Drug Administration has approved the Company’s Supplemental New Drug Application to expand the indication of XENOVIEW. This approval immediately lowers the minimum patient age from 12 to six years old, significantly broadening access to this technology and expanding Polarean’s total addressable market. The approval means that XENOVIEW can now be used with MRI for evaluation of lung ventilation in adults and pediatric patients aged six years and older, representing an increase in the number of eligible patients by approximately one million. The FDA supplement approval also includes the introduction of new XENOVIEW Dose Delivery Bag sizes tailored for smaller lungs of younger patients and corresponding updates to the HPX Polarization Measurement Station to measure various bag sizes. This approval reinforces Polarean’s dedication to advancing functional lung imaging and increasing access to its technology, enabling enhanced care for a broader patient population.