Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) has received approval from US regulators to expand the use of its lung imaging agent, XENOVIEW, to include children as young as six, opening access to an estimated one million additional patients.
The decision by the Food and Drug Administration lowers the minimum approved age from 12 to six years, allowing clinicians to use XENOVIEW with magnetic resonance imaging (MRI) to assess how well air moves through the lungs in younger patients.
As part of the approval, Polarean will introduce new dose delivery bags designed for smaller lungs, along with updates to its equipment that measures gas polarisation levels.
These modifications are aimed at ensuring safe and accurate use in paediatric care.
The move broadens the market for XENOVIEW, a product used in functional MRI scans to evaluate lung ventilation without exposing patients to ionising radiation.
Polarean said the approval reflects its continued efforts to increase access to advanced lung imaging across a wider group of patients.
CEO Christopher von Jako added: "This expanded indication further enhances our technology's clinical utility, offering clinicians an advanced tool to assess the lungs in children with chronic respiratory conditions, and strengthens its return on investment for hospitals.
"We look forward to launching a controlled US market release of the paediatric dose delivery bags later this year, starting with Cincinnati Children's."