Polarean Imaging (POLX) , a leader in advanced MRI lung imaging technology, announced the submission of a Phase 3 clinical trial protocol to the US FDA in support of an expanded indication for XENOVIEW, Polarean's proprietary Xenon MRI technology.
XENOVIEW leverages hyperpolarized Xenon Xe-129 to illuminate hidden lung diseases non-invasively. The proposed expansion would add quantitative gas-exchange imaging to the currently FDA-approved ventilation imaging method.
As part of the submission, Polarean has requested written feedback from the FDA under a "Type C" meeting to guide development and alignment on the Phase 3 study design. Polarean expects the FDA review of the proposed clinical trial to be completed by Q4 2025.
Christopher von Jako, CEO of Polarean, commenting: "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-center 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 with conventional imaging or pulmonary function tests, all in a single breath hold."
POLX shares gained 12% on the news.
View from Vox
Polarean announces the expansion of its Xenon MRI technology XENOVIEW to include a gas-exchange indication, significantly expanding the utility of the lung imaging technology. The XENOVIEW contrast agent (Xe-129) has already been approved by the US FDA for ventilation imaging. The proposed gas-exchange indication will be added through a proposed clinical trial, expected to be greenlit by the FDA by Q4 2024.
The gas-exchange indication will offer a fuller, more comprehensive imaging of deep lung function vs conventional methods, non-invasively through a single breath hold. The proposed Phase 3 study aims to evaluate the safety and diagnostic performance of XENOVIEW in assessing how effectively the lungs can transfer gas from the air into the bloodstream (pulmonary function), compared to the standard of care test currently used.
There is a substantial unmet medical need to quantify and visualise gas-exchange abnormalities across a range of chronic obstructive, interstitial and pulmonary-vascular diseases. Thus, if approved by the FDA, the gas-exchange indication would significantly broaden the utility and addressable market of XENOVIEW.
In FY24, POLX's revenue more than tripled to $3.1m across 22 active customers, beating guidance. Backed by a $12.6m fundraising round led by strategic partners, the company's current cash runway should extend at least until Q2 2026. If takeup continues its current trajectory, POLX should see revenues of US$5-6m by end of FY25, with profitability expected by FY27.
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