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 PRESS RELEASE

FDA expands XENOVIEW® indication to include children from six years of...

FDA expands XENOVIEW® indication to include children from six years of age Increases number of eligible patients by approximately one million DURHAM, NC and LONDON, June 02, 2025 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX) (“Polarean” or the “Company”), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, announces that the US Food and Drug Administration (“FDA”) has approved the Company’s Supplemental New Drug Application (“NDA”) to expand the indication of XENOVIEW®. This approval immediately lowers the minimum pa...

Colin Smith
  • Colin Smith

Polarean Imaging | FDA extends use of XENOVIEW® to 6-year-olds

The US Food and Drug Administration (FDA) has approved Polarean's proven Xenon MRI platform for use in paediatric patients as young as six years old from the previous limit of 12. This approval increases the number of eligible patients by c1 million, confirming a total addressable market (TAM) in the US of cUS$2bn for use of the technology in evaluating ventilation. The FDA decision has come a little ahead of previous guidance. Approval for use in gas exchange, which remains subject to a clinica...

 PRESS RELEASE

Xenon MRI Featured Prominently at ATS 2025 Across Broad Clinical Spect...

Xenon MRI Featured Prominently at ATS 2025 Across Broad Clinical Spectrum 30+ studies across diverse conditions illuminate the unique value of functional lung imaging with Xenon MRI DURHAM, NC and LONDON, May 15, 2025 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX) (“Polarean” or the “Company”), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, will be featured at the American Thoracic Society’s (ATS) 2025 Respiratory Innovation Summit (RIS), taking place May 16–17 at the Marriott Marquis in San Francisco, Californi...

Hybridan Team
  • Hybridan Team

Hybridan Small Cap Feast: 08/05/2025

Claire Louise Noyce Managing Partner, Chief Executive Birchin Court, 20 Birchin Lane, London EC3V 9DU Tel direct: +44 (0)203 764 2341 Mobile: +44 (0)7894 267 530 Call me on teams E-mail: Whilst it suits me to email now, I do not expect any response outside your own work times. Linkedin: /in/claire-louise-noyce-25b4588a Website: Follow us on X @hybridanllp Follow us on Linkedin Hybridan LLP would love your feedback. Post ...

Colin Smith
  • Colin Smith

Polarean Imaging | FY24 results – sales growth guidance reiterated

Polarean has more than tripled revenue YoY to US$3.1m for the year to December 2024 and raised the gross margin by 841 basis points, confirming that it is on a path to hyperbolic growth. Almost more importantly, the cost of a Phase III trial for the use of its XENOVIEW® technology in gas exchange has been halved to US$4.0m-US$4.5m. The cash runway has been extended to 2Q26 and the company reiterated revenue guidance for 2025 of US$5.0m-US$6.0m. Polarean has potential upside many times its curren...

Colin Smith
  • Colin Smith

Polarean Imaging | Investor update presentation confirms thesis

Polarean held a presentation for investors to recap the investment thesis for its unique technology for visualising lung function and provide real life examples of its Xenon MRI imaging in both research and clinical use. Dr Alan Huang, recently appointed VP Global Sales, provided a positive update on the sales pipeline and process. Polarean reaffirmed existing guidance. However, while there was no new news, the presentation certainly helped demonstrate the enthusiasm with which Polarean's techno...

Hybridan Team ... (+2)
  • Hybridan Team
  • Jon Levinson

Hybridan Small Cap Feast: 10/03/2025

Our daily digest of news from UK Small Caps @HybridanLLP 10th March 2025 * A corporate client of Hybridan LLP ** Potential means Intention to Float (ITF) has been announced, or it is a rumour ***Arranged by type of listing and date of announcement ****Alphabetically arranged Share prices and market capitalisations taken from the current price on the day of publication Dish of the day Admissions: None Delistings: None W...

Colin Smith
  • Colin Smith

Polarean Imaging | Xenon MRI pharma research collaboration

Polarean has announced that its Xenon MRI lung imaging has been selected by a leading global pharma company to be included in a clinical trial due to start in 4Q25. This collaboration opens up a new vertical for Polarean but more importantly provides third party validation of the unmatched lung imaging that Polarean's Xenon MRI system provides. Polarean recently announced a better than expected update for FY24 which, in our view, confirms that the company is on the cusp of hyperbolic growth with...

Hybridan Team ... (+2)
  • Hybridan Team
  • Jon Levinson

Hybridan Small Cap Feast: 27/02/2025

Our daily digest of news from UK Small Caps @HybridanLLP 27th February 2025 * A corporate client of Hybridan LLP ** Potential means Intention to Float (ITF) has been announced, or it is a rumour ***Arranged by type of listing and date of announcement ****Alphabetically arranged Share prices and market capitalisations taken from the current price on the day of publication Dish of the day Admissions: Delistings: What’s bak...

Colin Smith
  • Colin Smith

Polarean Imaging | FY24 update - Even better than expected

Polarean has published a trading update for the year to December which is even better than expected. Revenue for FY24 is anticipated to be US$3.0m-US$3.1m, above guidance of US$2.5m-US$3.0m, and more than treble revenue for FY23; our forecast was US$2.8m. Moreover, net cash at YEFY24 of US$12.1m was well above our forecast of US$10.8m and the company reiterated that it has a cash runway through 1Q26. A YoY jump in sales of over 50% in consumables demonstrates an increase in the number of Xenon M...

 PRESS RELEASE

Polarean and SimonMed Announce Collaboration to Advance Lung Imaging I...

Polarean and SimonMed Announce Collaboration to Advance Lung Imaging Innovation One of the largest US outpatient medical imaging providers to introduce Xenon MRI platform to its network DURHAM, NC and LONDON, Jan. 28, 2025 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX) (“Polarean” or the “Company”), a commercial-stage leader in advanced medical imaging focused on functional Magnetic Resonance Imaging ("MRI") of the lungs, announces a strategic collaboration with SimonMed Imaging, one of the largest outpatient medical imaging providers in the United States, to expand access to Pol...

Brian Moretta ... (+3)
  • Brian Moretta
  • Mark Thomas
  • Martin Hall

Hardman & Co Monthly: January 2025

Feature article: Hardman & Co Healthcare Index, 2024 – Tough year for Life Sciences By Dr Martin Hall The main function of the HHI is to monitor the performance, and to highlight the attractiveness, of life sciences investments over the long term, and to try to identify those stocks that have disruptive technologies that consistently allow them to outperform both the index and the markets. Many of the 53 constituents of the index are high-risk, with micro-capitalisations and a long way from pro...

Martin Hall
  • Martin Hall

Hardman & Co Healthcare Index: 2024 – Tough year for Life Sciences

The Hardman & Co Healthcare Index (HHI) has been running since 2009. Its main function is to highlight the attractions of life sciences investments over the long term. For the third year running, despite generally good returns in global markets, particularly in the US, performance in 2024 was poor, not helped by the capital-intensive nature of the sector. The HHI fell 17.7% to 398.9, underperforming all its benchmarks – FTSE 100 (+5.7%), FTSE All-Share (5.6%) and the FTSE AIM All-Share Index (-5...

Colin Smith
  • Colin Smith

Polarean Imaging Initiation - On the cusp of hyperbolic growth

Despite initial FDA approval and grant of the requisite reimbursement codes, investor confidence in Polarean is low, as reflected in the current share price. However, revenue growth is already accelerating and is set to go hyperbolic as Polarean's Xenon MRI platform meets a large unmet clinical need that cannot be satisfied by other methods. Crossing the bridge to profitability will require additional funding but there is a cash runway through 1Q26. Polarean has potential upside many times its c...

 PRESS RELEASE

FDA clears XENOVIEW® 3T Chest Coil in GE HealthCare MRI Systems

FDA clears XENOVIEW® 3T Chest Coil in GE HealthCare MRI Systems Expands accessibility for institutions utilizing GE HealthCare MRI systems DURHAM, NC and LONDON, Nov. 21, 2024 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX) (“Polarean” or the “Company”), a commercial-stage medical imaging technology leader in advanced Magnetic Resonance Imaging ("MRI") of the lungs, announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s specialized MRI Chest Coil to now include GE HealthCare 3 Tesla (3T) MRI scanners for the visualization ...

 PRESS RELEASE

Appointment of Alan Huang, PhD, as Vice President of Sales

Appointment of Alan Huang, PhD, as Vice President of Sales Experienced business leader with extensive commercial experience in Magnetic Resonance Imaging DURHAM, NC and LONDON, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX) (“Polarean” or the “Company”), a commercial-stage medical device leader in advanced Magnetic Resonance Imaging ("MRI") of the lungs, is pleased to announce the appointment of Alan Huang, PhD as Vice President of Sales. Dr. Huang brings extensive knowledge and 15 years of experience in the medical device industry, with specific expertise in M...

 PRESS RELEASE

Appointment of Chase Hall, M.D., as Chief Medical Advisor

Appointment of Chase Hall, M.D., as Chief Medical Advisor Adds significant pulmonary expertise to help drive engagement with the medical community DURHAM, NC and LONDON, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in advanced Magnetic Resonance Imaging ("MRI") of the lungs, announces that it has appointed Chase Hall, M.D., as Chief Medical Advisor. Dr. Hall is an Associate Professor, Pulmonary, Critical Care and Sleep Medicine, at the University of Kansas Medical Center in the Division of Pulmonary and Critical Care...

 PRESS RELEASE

Polarean Raises $12.6 Million in Oversubscribed Financing Round to Acc...

Polarean Raises $12.6 Million in Oversubscribed Financing Round to Accelerate XENOVIEW™ Commercialization and Strategic Growth Initiatives Financing led by existing and new investors DURHAM, NC and LONDON, June 20, 2024 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX) (“Polarean” or the “Company”), a commercial-stage medical device leader in advanced Magnetic Resonance Imaging (MRI) of the lungs, announces the closing of a $12.6 million oversubscribed financing via the Alternative Investment Market (AIM) of the London Stock Exchange. The fundraise was co-led by strategic investors ...

 PRESS RELEASE

Polarean’s Xenon MRI to be Featured at Upcoming ATS 2024 Conference

Polarean’s Xenon MRI to be Featured at Upcoming ATS 2024 Conference Featured Company at Respiratory Innovation Summit to Jump Start Robust Presence DURHAM, NC and LONDON, May 08, 2024 (GLOBE NEWSWIRE) -- Polarean (AIM: POLX),  a commercial-stage medical device leader in advanced magnetic resonance imaging (MRI) of the lungs, has been selected as one of the featured companies and a poster presenter at the American Thoracic Society’s (ATS) 2024 Respiratory Innovation Summit (RIS), a testament to the value of our XENOVIEW technology seen across lung clinicians and pulmonary drug developer...

 PRESS RELEASE

Polarean Partners with VIDA to Streamline Adoption of Advanced MRI of ...

Polarean Partners with VIDA to Streamline Adoption of Advanced MRI of the Lungs Two best-in-class lung imaging companies combine expertise for the deployment of a new xenon 129 MRI platform. Durham, NC and London, Sept. 08, 2023 (GLOBE NEWSWIRE) -- Polarean (AIM: POLX), a commercial-stage medical device leader in advanced magnetic resonance imaging (MRI) of the lungs, announced today it has partnered with VIDA Diagnostics (VIDA), a clinical imaging intelligence company providing medical imaging software solutions which manage the complexities of digital biomarkers.  The companies are pa...

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