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Polarean Imaging shares soar on second de novo order for XENOVIEW

11:30, 10th May 2024
Victor Parker
Vox Newswire
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Polarean Imaging  (POLX) Follow | POLX, a UK-based medical imaging technology company, announced its second de novo order for a Xenon MRI System from the University of Alabama at Birmingham (UAB) Hospital. Polarean's novel Xenon MRI technology uses its proprietary contrast agent XENOVIEW. The agent is inhaled, then dissolves into lung tissue and enters the pulmonary microvasculature, allowing non-invasive MRI detection of microvascular blood flow impairment such as pre and post-capillary pulmonary hypertension.

The de novo designation indicates that UAB Hospital is acquiring the imaging technology for the first time, without a prior research programme utilising the Polarean Xenon MRI System. This marks a significant milestone for the company in the increasing adoption of its MRI solution. POLX shares soared 44% on the news.

Polarean said it expects to install the new system later this year, collaborating closely with the UAB Hospital team to develop a robust Xenon MRI programme. POLX's programme aims to advance clinical imaging, NIH-funded research, and pharmaceutical-sponsored trials. Polarean's other clinical sites include Cincinnati Children's Hospital Medical Center and University of Missouri Health Care.

Alex Dusek, Chief Commercial Officer of Polarean, commenting: "Feedback on the Polarean technology from physicians continues to be overwhelmingly positive, and we look forward to working closely with clinicians and scientists at UAB hospital to help establish the approved use of XENOVIEW™ for the visualisation of ventilation patients aged 12 and older. We are continuing to have productive meetings with our other high-priority centres, as they work through the necessary steps of the value assessment and procurement process. These centres are becoming increasingly aware of our technology's clinical, scientific, and economic value in lung ventilation, as well as research into gas exchange and cardiopulmonary for future applications, where we recently strengthened our patent portfolio."

 

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A major milestone for Polarean as it expands its clinical footprint with another top-tier medical institution, UAB Hospital. The site will be Polarean's first in the US southeast and second de novo overall, as sales momentum builds for XENOVIEW in both research and clinical settings. Only a week ago, POLX announced an order from the world-renowned Cincinnati Children's Hospital Medical Center for a new research polariser.

Sales momentum for POLX's Xenon MRI technology started slow as hospital acquisitions of capital equipment take some time. But as more hospitals have realised the benefits of POLX's technology in pulmonary care and advanced plans to adopt it, momentum has materially picked up. Today's announcement represents a value inflection point that markets have recognised, explaining the massive 44% jump in share price.

Polarean's pulmonary imaging 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. Last month, POLX 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. With the patent, Polarean's Xenon MRI platform can see expanded use in the US, following initial receipt of FDA approval in December 2022. To fully avail of the new patent, POLX is working to secure a gas exchange indication for XENOVIEW from the FDA, with an associated clinical trial expected soon.

Adding today's order to POLX's pipeline, the company expects FY24 revenues to hit US$2.5m, compared to under US$1m in FY23. While this is already strong visibility, it is likely that more orders will be placed in the coming months that can be fulfilled during the financial year. By end of FY24, POLX should have a total installed clinical base of 5-7 systems with sites performing 3-4 scans/week, enabling them to earn a positive ROI on the Polarean technology.

If takeup continues its current trajectory, by end of 2025 POLX's total installed clinical base should be 12-14 systems with scans performing 5-6 scans/week with revenues of US$5-6m. Profitability would then be expected by FY27, provided the FDA approves the gas exchange application for XENOVIEW, which is highly likely.

Based on existing deployments, industry interest, and today's announcement, there is good reason to believe in XENOVIEW's long-term success. 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 a major milestone. The new code, along with additional existing codes for XENOVIEW MRI, enables hospitals to request a total reimbursement of approx. $2,500, which is a significant incentive. POLX has confirmed that its initial clinical sites have attained reimbursement by both private insurers and Medicaid, and said it is working to broaden coverage.

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