Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) has submitted a new phase III clinical trial protocol to the US Food and Drug Administration to support an expanded use of its lung imaging agent, XENOVIEW.
The AIM-listed medical imaging company’s contrast agent, already approved for ventilation imaging of the lungs, could gain a broader indication that includes quantitative gas-exchange imaging.
This technique measures how well the lungs transfer gas from the air into the bloodstream, a key marker of pulmonary function.
Polarean has asked the FDA for formal feedback on the trial design through a Type C meeting, with the agency’s review expected to conclude by the end of 2025.
The proposed study will compare the safety and diagnostic performance of XENOVIEW against the current standard lung function test.
The ability to visualise and quantify gas-exchange abnormalities could fill a significant gap in diagnosing and managing a range of chronic lung diseases, including chronic obstructive pulmonary disease, interstitial lung disease and pulmonary vascular conditions.
CEO Christopher von Jako said: "Submission of this new protocol and our Type C meeting request marks a critical milestone in Polarean's clinical development programme and mission to transform pulmonary imaging.
"Embarking on a multi-centre trial to add gas-exchange to the existing ventilation indication is key to our growth strategy.
"If successful, this expanded utility of XENOVIEW will have the potential to provide a comprehensive, multi-compartment assessment of deep lung function, information that is not currently available with conventional imaging or pulmonary function tests, all in a single breath hold."