FDA expands XENOVIEW® indication to include children from six years of age

Core Insights - The FDA has approved Polarean Imaging's Supplemental New Drug Application to expand the indication of XENOVIEW, lowering the minimum patient age from 12 to 6 years, thus increasing the number of eligible patients by approximately one million [1][2][3] Company Overview - Polarean Imaging is a commercial-stage medical imaging technology company focused on functional MRI of the lungs, aiming to improve pulmonary medicine through advanced imaging solutions [4] - The company has developed the first and only hyperpolarized Xenon MRI inhaled contrast agent, XENOVIEW, which is now FDA-approved for use in the United States [4] - Polarean's technology addresses the unmet medical needs of over 500 million patients worldwide suffering from chronic respiratory diseases [4] Product Details - XENOVIEW is indicated for use with MRI to evaluate lung ventilation in adults and pediatric patients aged 6 years and older [6] - The FDA approval includes new XENOVIEW Dose Delivery Bag sizes tailored for younger patients, enhancing the technology's clinical utility [2][3] Clinical Impact - The expanded indication allows clinicians to better assess lung conditions in children with chronic respiratory issues, such as cystic fibrosis and asthma, thereby improving personalized care [3][2] - The company plans to launch a controlled market release of the pediatric Dose Delivery Bags later in the year, starting with Cincinnati Children's Hospital [3]