Announcement • Dec 02
Polarean Imaging plc Announces FDA-Cleared XENOVIEW 3T Chest Coil Passes Philips Compatible Testing Polarean Imaging plc announced that its FDA-cleared XENOVIEW 3T Chest Coil has successfully completed compatibility testing conducted by Philips (Philips Medical Systems Nederland B.V.) and is now confirmed for use with Philips' latest 3T MRI platforms. Following extensive validation by Philips, the XENOVIEW 3T Chest Coil is now confirmed for integration with Philips MRI systems starting in early 2026, including 3.0T platforms such as the MR 7700 and Ingenia Elition X, along with their associated upgrade pathways. Building on Philips' introduction of Xenon MRI compatibility in 2022 with the MR 7700, the addition of the Polarean XENOVIEW 3 T Chest Coil expands access to advanced pulmonary imaging and supports a new era of functional lung assessment. This confirmation, building on the coil's FDA clearance in 2024, positions the technology for rapid clinical adoption and revenue generation. The XENOVIEW 3t Chest Coil enables healthcare providers to seamlessly adopt advanced functional lung ventilation imaging, supporting broader clinical adoption and advancing the Company's commitment to innovation in pulmonary imaging. This milestone marks a major advance in scaling Polarean's Xenon MRI technology across a major global installed base and enables clinical and research sites using Philips MRI systems to incorporate non-invasive, quantitative assessments of lung function as part of routine care and research. Following this, Polarean is well positioned to accelerate adoption, expand market penetration and enhance significant commercial and clinical value worldwide. The compatibility with Philips' MRI platforms greatly broadens the accessibility of Xenon MRI and will help more hospitals and imaging centres adopt this powerful technology. Equally significant, FDA-cleared coil's seamless integration with Philips systems positions to drive adoption by reducing workflow complexity for clinicians, accelerating market penetration and unlocking growth opportunities. The compatibility statement confirms that the FDA-cleared XENovIEW 3T Chest Coil can be used with Philips MR 7700, Ingenia Elition X., and compatible software upgrade configurations from 2026 onwards. This development significantly expands the potential reach of Polarean's technology and supports its goal of making functional lung MRI more widely available to clinicians and patients worldwide. New Risk • Oct 01
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of British stocks, typically moving 11% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$8.2m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Market cap is less than US$10m (UK£5.73m market cap, or US$7.72m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$947k net loss in 3 years). Revenue is less than US$5m (US$2.6m revenue). Reported Earnings • Sep 28
First half 2025 earnings released: US$0.004 loss per share (vs US$0.014 loss in 1H 2024) First half 2025 results: US$0.004 loss per share. Revenue: US$594.9k (down 47% from 1H 2024). Net loss: US$5.07m (loss widened 26% from 1H 2024). Revenue is forecast to grow 64% p.a. on average during the next 3 years, compared to a 5.7% growth forecast for the Medical Equipment industry in the United Kingdom.