GCIPolarean Imaging submits FDA application to lower age limit for XENOVIEW to 6 years
() , a commercial-stage MRI technology company, said it has submitted a New Drug Application (NDA) supplement to the US Food and Drug Administration, to allow the administration of XENOVIEW to paediatric patients aged 6 years and older. The NDA supplement includes updates to the HPX Polarisation Measurement Station and new XENOVIEW Dose Delivery Bag sizes.
XENOVIEW, based on a Xenon Xe 129 gas blend, is a hyperpolarised contrast agent indicated for use with MRI for evaluation of lung ventilation, currently in adults and paediatric patients aged 12 years and older.
Christopher von Jako, PhD, CEO of Polarean, commenting: "I am pleased to have submitted our NDA supplement to the FDA to expand the minimum age of XENOVIEW to paediatric patients six years and older. If granted, this will allow our technology to help even more children with chronic lung conditions and their clinicians, allowing for better management of their disease. I look forward to further updating the market in due course."
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Polarean reports further progress in expanding the commercial footprint of XENOVIEW, its disruptive Xenon MRI technology. The platform promises to revolutionise medical imaging with the ability to illuminate hidden diseases non-invasively. This can enable early intervention and significantly improve patient outcomes.
If 's application to the FDA is successful, XENOVIEW would become available to patients aged 6 and older, down from the current age limit of 12, significantly expanding the product's utility in paediatric care. The FDA has already granted XENOVIEW a New Chemical Entity designation, providing a 5-year market exclusivity period, and issued 510(k) clearance for a specialised MRI chest coil compatible with Philips 3.0T MRI scanners.
Last year's approval of a new C-code from US Medicare, corresponding to a payment range of US$1,201 to US$1,300, was another major milestone. The new code, along with additional existing codes for XENOVIEW, enables hospitals to request a total reimbursement of approx. $2,500, which is a significant incentive.
also recently secured a key US patent for Xenon MRI imaging, expanding the utility of its technology in the diagnosis and monitoring of diseases of the pulmonary vasculature. To fully avail of the new patent, is working to secure a gas exchange indication for XENOVIEW from the FDA, with an associated clinical trial expected soon.
's recent US$10m fundraise extended its cash runway into Q1 2026. Management expects US$2.5m of revenues in FY24 while active discussions are ongoing with more medical institutions as XENOVIEW sales continue to gain momentum.
Current customers include the world-renowned Cincinnati Children's Hospital Medical Center, the University of Virginia Health System, University of Missouri Health Care, University of Alabama at Birmingham Hospital, and most recently the University of Kansas Medical Center.
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