Polarean Imaging PLC on Tuesday said it has submitted a new phase 3 clinical trial protocol to the US Food & Drug Administration, to support an expanded remit for Xenoview.
The medical imaging technology developer said the proposed expansions would include quantitative gas-exchange imaging in addition to the currently approved ventilation imaging indication.
Xenoview is the firm’s FDA-approved contrast agent for magnetic resonance imaging, or MRI, of the lungs.
Polarean has formally requested written feedback from the FDA under a Type C meeting to guide development and alignment on the phase 3 study design, the company said.
It expects the FDA review of the proposed clinical trial to be completed in the fourth quarter.
Polarean Chief Executive Officer 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.’
Polarean shares rose 6.1% to 0.97 pence each on Tuesday afternoon in London.
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