Ankündigung • 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. Ankündigung • Sep 16
Polarean Imaging plc to Report First Half, 2025 Results on Sep 25, 2025 Polarean Imaging plc announced that they will report first half, 2025 results on Sep 25, 2025 Ankündigung • Aug 13
Polarean Imaging plc Announces Submission of New Phase III Study Protocol to FDA for Expanded Indication of XENOVIEW Polarean Imaging plc announced the submission of a new Phase III clinical trial protocol to the U.S. Food and Drug Administration (FDA) to support an expanded indication for XENOVIEW (xenon Xe 129 hyperpolarised). XENOVIEW is the Company's FDA-approved contrast agent for MRI of the lungs. The proposed expansion would include quantitative gas-exchange imaging in addition to the currently approved ventilation imaging indication. As part of the submission, Polarean has formally requested written feedback from the FDA under a Type C meeting to guide development and alignment on the Phase III study design. The FDA review of the proposed clinical trial should be completed by fourth quarter 2025. The new protocol aims to evaluate the safety and diagnostic performance of XENOVIEW in assessing how effectively the lungs can transfer gas from the air into the bloodstream (pulmonary function), as compared to the standard of care test which is currently used. There is a substantial need to quantify and visualise gas-exchange abnormalities across a range of chronic obstructive, interstitial and pulmonary-vascular diseases. If approved, the expanded indication would significantly broaden the clinical utility of XENOVIEW by enabling clinicians to obtain a more comprehensive picture of lung function through non-invasive imaging. Ankündigung • Jun 02
Polarean Imaging plc Expands XENOVIEW Indication to Include Children from Six Years of Age Polarean Imaging plc announced that the US Food and Drug Administration has approved the Company's Supplemental New Drug Application to expand the indication of XENOVIEW. This approval immediately lowers the minimum patient age from 12 to six years old, significantly broadening access to this technology and expanding Polarean's total addressable market. The approval means that XENOVIEW can now be used with MRI for evaluation of lung ventilation in adults and paediatric patients aged six years and older, representing an increase in the number of eligible patients by approximately one million. The FDA supplement approval also includes the introduction of new XENOVIEW Dose Delivery Bag sizes tailored for smaller lungs of younger patients and corresponding updates to the HPX Polarisation Measurement Station to measure various bag sizes. This approval reinforces Polarean's dedication to advancing functional lung imaging and increasing access to its technology, enabling enhanced care for a broader patient population. Ankündigung • May 08
Polarean Imaging plc, Annual General Meeting, Jun 09, 2025 Polarean Imaging plc, Annual General Meeting, Jun 09, 2025. Location: the companys offices, 2500 meridian parkway, durham, nc 27713, United States Ankündigung • Apr 25
Polarean Imaging plc to Report Fiscal Year 2024 Results on May 08, 2025 Polarean Imaging plc announced that they will report fiscal year 2024 results at 8:00 AM, GMT Standard Time on May 08, 2025 Ankündigung • Nov 21
Polarean Imaging plc Receives 510(K) Clearance from the U.S. Food and Drug Administration for the Specialised MRI Chest Coil Polarean Imaging plc announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company's specialised MRI Chest Coil to now include GE HealthCare 3 Tesla (3T) MRI scanners for the visualisation of Xenon-129 nuclei. With this new introduction, the Company now supports Xenon MRI scanning of both clinical and research patients on all three major MRI scanner vendors: GE HealthCare, Philips, and Siemens Healthineers. Polarean's GE HealthCare compatible XENOVIEW® 3T Chest Coil is a flexible, single-channel, transmit-receive radiofrequency 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. The XENOVIEW 3T Chest Coil is indicated 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. The addition of the new Chest Coil seamlessly supports institutions with GE HealthCare compatible MRI systems looking to adopt Xenon MRI, with safety and effectiveness confirmed through testing and FDA clearance. Ankündigung • Aug 28
Polarean Imaging plc Appoints Chase Hall, M.D., as Chief Medical Advisor Polarean Imaging plc announced 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. He also serves as Associate Director at the University of Kansas Interstitial Lung Disease and Rare Lung Disease Clinic. Dr. Hall's research focus has been on establishing imaging biomarkers in respiratory disease, utilising Xenon MRI. In his lab, he is currently working to utilise Xenon MRI as a sensitive measure of treatment response in a number of respiratory diseases, as well as rapid image acquisition protocols and fully automated image analysis programmes. In addition, Dr. Hall is a member of the Xenon MRI Clinical Trials Consortium, a growing collaboration of 13 clinical research sites; its activities include the harmonisation and standardisation of Xenon imaging protocols for multi-center clinical trials, training of new sites establishing Xenon MRI programmes, and growing awareness and expertise in the field. In his role as Chief Medical Advisor, Dr. Hall will assist in guiding Polarean's clinical development strategy and medical education initiatives with fellow clinicians and professional societies. He will leverage his experience while maintaining his clinical pulmonology practice, providing valuable insights to help Polarean address unmet medical needs in pulmonary care. Dr. Hall received his medical degree from the University of Kansas School of Medicine and completed his residency in Internal Medicine and fellowship training in Pulmonary and Critical Care at Washington University School of Medicine in St. Louis. He serves as a peer-reviewer for many prestigious journals, such as Academic Radiology and The American Journal of Respiratory and Critical Care Medicine. Ankündigung • Aug 21
Polarean Imaging plc to Report First Half, 2024 Results on Sep 04, 2024 Polarean Imaging plc announced that they will report first half, 2024 results on Sep 04, 2024 Ankündigung • Aug 16
Bastiaan Driehuys Steps Down from His Position on the Board of Polarean Imaging plc Polarean Imaging plc announced the appointment of Bastiaan Driehuys Ph.D., previously a Board member and Chief Scientific Officer of Polarean, as a consultant to the Company with immediate effect. As announced in the Company's preliminary results on 28 June 2024, Bastiaan stepped down from his position on the Board effective 24 July 2024 but will retain his position as Chief Scientific Officer of the Company, which he will serve on a consultancy basis. Bastiaan Driehuys invented hyperpolarised gas MRI while completing his Doctorate in Atomic Physics at Princeton University, and co-founded Polarean Imaging in 2011. He and his team developed the underlying technology of 129Xe hyperpolarisation, as well as novel MR image acquisition, reconstruction and analysis strategies and how to apply them to problems in pulmonary medicine.Under the terms of the consultancy contract, Polarean will pay Dr. Driehuys an annual fee of USD 36,500. Ankündigung • Aug 01
Polarean Imaging plc Submits New Drug Application Supplement to the US Food and Drug Administration Polarean Imaging plc announced that it has submitted a New Drug Application supplement to the US Food and Drug Administration, to allow the administration of XENOVIEW to paediatric patients aged six years and older. This supplement includes updatesto the HPX Polarisation Measurement Station and new XENOVIEW Dose Delivery Bag sizes. Currently XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarised contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and paediatric patients aged 12 years and older. Ankündigung • Jun 30
Polarean Imaging plc, Annual General Meeting, Jul 24, 2024 Polarean Imaging plc, Annual General Meeting, Jul 24, 2024. Location: 2500 meridian parkway, suite 175, nc 27713, durham United States Ankündigung • Aug 16
Polarean Imaging plc to Report First Half, 2023 Results on Sep 07, 2023 Polarean Imaging plc announced that they will report first half, 2023 results on Sep 07, 2023 Ankündigung • Aug 04
Polarean Receives Clearance for New MRI Chest Coil Polarean 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 Polarean XENOVIEW(TM) 3.0T Chest Coil is a flexible, single channel, transmit-receive RF coil tuned to image 129Xe nuclei while a patient is positioned inside a multinuclei-capable MRI scanner. The XENOVIEW Chest Coil is indicated to be used in conjunction with compatible 3.0T MRI scanners and approved hyperpolarized 129Xe for oral inhalation for the evaluation of lung ventilation in adults and pediatric patients, aged 12 years and older. The addition of the new Philips configuration does not affect the intended use of the device; the safety and effectiveness has been confirmed with testing. Ankündigung • May 27
Polarean Imaging plc, Annual General Meeting, Jun 28, 2023 Polarean Imaging plc, Annual General Meeting, Jun 28, 2023, at 09:00 US Eastern Standard Time. Location: 2500 Meridian Parkway, Suite 175, Durham Durham North Carolina United States Ankündigung • May 12
Polarean Imaging plc Announces First Clinical Scan Using XENOVIEW Conducted At Cincinnati Children’s Hospital Medical Center Polarean Imaging plc announced 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. XENOVIEW is the only hyperpolarised contrast agent approved by the U.S. Food and Drug Administration for use with magnetic resonance imaging (MRI) for the evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. The first patient to receive a clinical scan using XENOVIEW is a 19-year-old male with cystic fibrosis. Cincinnati Children’s has several other patients it believes are medically indicated for the lung imaging XENOVIEW provides and anticipates performing scans to monitor patients on a more regular basis. XENOVIEW expands the opportunity to visualise lung ventilation without exposing patients to ionising radiation and its associated risks. The dose of XENOVIEW, created through the Polarean HPX Hyperpolarisation System, is administered in a single 10 to 15 second breath hold MRI procedure. More than 37 million Americans suffer from chronic lung disease, and there is a significant unmet need for non-invasive diagnostic technology. XENOVIEW can provide pulmonologists, surgeons, and other respiratory specialists with regional maps of ventilation in their patients’ lungs to assist them in managing their disease. Ankündigung • Feb 02
Polarean Imaging plc Announces FDA Grants New Chemical Entity Designation for XENOVIEW Polarean Imaging plc announced that the U.S. Food and Drug Administration ("FDA") has granted New Chemical Entity ("NCE") designation for its drug product, XENOVIEW. XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarised contrast agent indicated for use with magnetic resonance imaging ("MRI") for evaluation of lung ventilation in adults and paediatric patients aged 12 years and older. XENOVIEW has not been evaluated for use with lung perfusion imaging. It has designated a five year market exclusivity period. XENOVIEW expands the opportunity for pulmonary medicine to utilise the first and only inhaled MRI hyperpolarised contrast agent for novel visualisation of lung ventilation without the risk of exposing patients to ionising radiation. The dose of XENOVIEW, created through the Polarean HPX hyperpolarisation system, is administered in a single 10-15 second breath-hold MRI procedure. More than 30 million Americans suffer from a chronic lung disease and there is a significant unmet need for non-invasive diagnostic technology. XENOVIEW can provide pulmonologists, surgeons, and other respiratory specialists with regional maps of ventilation in their patients' lungs to assist them in managing their disease. 