GCIPolarean Imaging secures FDA approval for key MRI technology on GE HealthCare systems
() , a commercial-stage MRI technology company, announced it has received a key 510(k) clearance from the US FDA. Polarean is best known for its proprietary Xenon MRI technology XENOVIEW, which uses hyperpolarised Xenon Xe-129 to illuminate hidden lung diseases non-invasively.
The 510(k) clearance from the FDA was for Polarean's specialised MRI chest coil, to now include GE HealthCare 3 Tesla (3T) MRI scanners for the visualisation of Xenon-129. With the approval, Polarean now supports Xenon MRI scanning of both clinical and research patients on all 3 major MRI scanner vendors: GE HealthCare, Philips, and Siemens Healthineers.
Technically, Polarean's 3T Chest Coil is a flexible, single-channel, transmit-receive RF coil, tuned to image Xenon-129 nuclei while a patient is positioned inside a GE HealthCare SIGNA Premier 3T or Discovery MR750 3T MRI scanner equipped with their multi-nuclear spectroscopy capability.
In simpler terms, the now GE-compatible product is meant to be used in conjunction with hyperpolarised Xenon-129 for oral inhalation for the evaluation of lung ventilation in adults and paediatric patients, aged 12 years and older.
Christopher von Jako, CEO of Polarean, commenting: "GE HealthCare is a global leader in MRI technology and we are delighted to now offer our XENOVIEW 3T Chest Coil for use on their cutting-edge 3T MRI systems. Expanding our FDA clearance to include GE HealthCare's platforms, following our previous clearance for Philips and Siemens systems, ensures that more institutions and clinicians across the US can access our innovative Xenon MRI technology. This expansion further enhances our ability to provide advanced imaging solutions to support patients and clinicians in the detection and ongoing monitoring of lung disease."
View from Vox
A major milestone for Polarean as the FDA clears its XENOVIEW 3T Chest Coil for use in GE HealthCare MRI systems in the US. The approval completes the product's compatibility portfolio as it was already cleared for use in Philips and Siemens scanners, the other 2 major MRI brands. The clearance will enable Polarean to market the coil to medical institutions using GE HealthCare systems, a significant portion of the market. Investors welcomed the news, sending shares 5% higher on the morning of the announcement.
The milestone means the XENOVIEW 3T Chest Coil now seamlessly supports potential customers with GE HealthCare-compatible MRI systems, looking to adopt Xenon MRI, with safety and effectiveness already confirmed through testing and the FDA clearance. Polarean's Xenon MRI 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.
Current customers of Polarean's Xenon MRI platform include the University of Kansas Medical Center, the world-renowned Cincinnati Children's Hospital Medical Center, the University of Virginia Health System, University of Missouri Health Care, and University of Alabama at Birmingham Hospital. The technology drove significantly higher sales for in 1H24 of US$1.1m, with strong revenue visibility and recently raised full-year sales guidance of US$2.5m-US$3.0m.
In 1H24, 's loss before tax narrowed to US$4.0m from US$7.4m a year ago, thanks to higher revenues and lower operating expenses. The company successfully raised US$12.6m in June 2024, and with the new FDA approval is now well-positioned to expand its sales efforts. With the proceeds from the fundraise, held a comfortable US$15.2m in net cash or cash eq on June 30, 2024.
In total, Polarean now has 21 sites that have either installed or ordered hyperpolariser systems. If takeup continues its current trajectory, by end of 2025 's total installed clinical base should be 12-14 systems with scans performing 5-6 scans/week and revenues of US$5-6m. Profitability would then be expected by 2027.
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