reports
- 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...
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 ...
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...
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...
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 ...
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...
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...
CMS grants reimbursement code for the Polarean XENOVIEW™ MRI Technolog...
CMS grants reimbursement code for the Polarean XENOVIEW™ MRI Technology The code is effective as of October 1, 2023 Durham, NC, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Polarean (AIM: POLX), a commercial-stage medical device leader in advanced MRI scanning of the lungs, announces that the Centers for Medicare & Medicaid Services (CMS) has established a new reimbursement code for the Polarean XENOVIEW™ (xenon Xe 129, hyperpolarized) technology, effective October 1, 2023. The code (C9791) enables healthcare providers a path to bill for “magnetic resonance imaging with inhaled hyp...
Polarean Receives Clearance for New MRI Chest Coil
Polarean Receives Clearance for New MRI Chest Coil Additional clearance for new MRI chest coil further supports the recently announced collaboration with Philips. Durham, NC, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Polarean (AIM: POLX) (“Polarean” or the “Company”), a commercial-stage medical device leader in advanced MRI scanning of the lungs, announces 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 Philips 3.0T MRI scanners for the visualization of the Xenon-129 (129Xe) nuclei. The Polare...
Appointment of Dr. Christopher von Jako as new CEO
Appointment of Dr. Christopher von Jako as new CEO Durham, N.C., June 21, 2023 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX), the medical imaging company, announces that the Company’s Board of Directors has appointed Christopher von Jako, Ph.D. (“Dr. von Jako”) as Chief Executive Officer and director of the Company, effective immediately. Dr. von Jako succeeds Richard Hullihen, who will be retiring and will be stepping down as a Director of the Company, effective immediately. Mr. Hullihen will assist the Company in a transitional position for the next six months. Since his app...
First clinical scan using XENOVIEW conducted at Cincinnati Children’s ...
First clinical scan using XENOVIEW conducted at Cincinnati Children’s Hospital Medical Center Scan marks a key milestone for imaging of lung ventilation Durham, N.C. , May 11, 2023 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM:POLX), the medical imaging company, announces that the first clinical scan utilising its XENOVIEW (xenon Xe 129 hyperpolarized) technology in the United States has taken place at Cincinnati Children’s Hospital Medical Center (“Cincinnati Children’s”). XENOVIEW is the only hyperpolarised contrast agent approved by the U.S. Food and Drug Administration for use with ...
FDA Approves Polarean’s XENOVIEW™ (xenon Xe 129 hyperpolarized) for us...
FDA Approves Polarean’s XENOVIEW™ (xenon Xe 129 hyperpolarized) for use with MRI for the Evaluation of Lung Ventilation XENOVIEW represents the first and only hyperpolarized MRI contrast agent ● FDA approved indication includes both adolescents and adults representing a significant market opportunity Durham, N.C., Dec. 28, 2022 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX), the medical imaging technology company, announces that the U.S. Food and Drug Administration (“FDA”) has granted approval for its drug device combination product, XENOVIEW. XENOVIEW, prepared from the Xenon X...
- Paul Hill
$6m contract win for breakthrough biothreat detector
Once the world is fully vaccinated, many investors incorrectly assume there will be no need for covid testing. Wrong. More contagious & deadlier variants are sure to appear, together with perhaps totally new infectious diseases that might even trigger another pandemic. Equally, the danger posed by deliberate (re rogue states, organised crime &/or terrorism) &/or even accidental (say a lab) biological release of harmful pathogens into the environmental isn’t going away anytime soon. The US gove...
- Paul Hill
Estimated H2’21 sales (£5.4m) jump 17% vs H1’21 (£4.6m)
After a quiet H1 due to the pandemic, Kromek is now enjoying a powerful rebound for its next generation, radiation detectors from existing & new medical (eg BMD, SPECT), nuclear (D3S) & security screening (Airport baggage/bottles) customers. Indeed today it reported that FY’21 results would be “in line with expectations”, with the Board equally being “excited” about the near-term prospects for its ground-breaking, biological threat detector. These mobile or static devices continuously test for...
- Paul Hill
Oversubscribed £13m fund raise to drive growth
Kromek yesterday confirmed that it had raised £13m gross at 15p/share from existing and new shareholders. The proceeds being earmarked to further develop the new groundbreaking biothreat/Covid airborne detector (see below), alongside optimising its CZT medical/nuclear imaging & D3S ‘dirty bomb’ commercialisation strategy. Whilst also bolstering the balance sheet. In particular, there are four key reasons why we’re excited about the Covid/Biothreat detectors: this is a large and untapped global...
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