Polarean Imaging PLC's (AIM:POLX, OTC:PLLWF) shares surged 15% after the company submitted a phase III clinical trial protocol to the US Food and Drug Administration, aiming to broaden the use of its lung imaging agent, XENOVIEW.
Already approved for ventilation imaging, Polarean hopes to expand XENOVIEW’s indication to include quantitative gas-exchange imaging, a technique that measures how efficiently the lungs transfer gas from the air into the bloodstream, a vital sign of lung health.
The company has requested formal feedback from the FDA on the trial design, with the review expected to conclude by the end of 2025. The planned study will assess the safety and diagnostic accuracy of XENOVIEW compared to the current standard lung function tests.
This expanded capability could help diagnose and manage chronic lung diseases such as chronic obstructive pulmonary disease, interstitial lung disease, and pulmonary vascular conditions, filling a significant gap in pulmonary care.
Stifel, repeating its 'buy' recommendation, said: "This would substantially differentiate Xenoview from conventional imaging."
CEO Christopher von Jako described the submission as a “critical milestone” in Polarean’s mission to transform lung imaging, highlighting that the new trial could deliver a comprehensive assessment of deep lung function, all in a single breath hold.