View ValuationPolarean Imaging 향후 성장Future 기준 점검 2/6Polarean Imaging은 연간 수입과 매출이 각각 46.4%와 69.3% 증가할 것으로 예상되고 EPS는 연간 44.8%만큼 증가할 것으로 예상됩니다.핵심 정보46.4%이익 성장률44.81%EPS 성장률Medical Equipment 이익 성장16.5%매출 성장률69.3%향후 자기자본이익률n/a애널리스트 커버리지Low마지막 업데이트17 Nov 2025최근 향후 성장 업데이트공고 • Sep 27+ 1 more updatePolarean Imaging plc Revises Earnings Guidance for 2025Polarean Imaging plc revised earnings guidance for 2025. For the year, the company lowered revenue guidance from a range of USD 5 million to USD 6 million to a range of USD 2.5 million to USD 3.5 million. The company expects similar sales level in 2025 as compared to 2024.모든 업데이트 보기Recent updates공고 • Dec 02Polarean Imaging plc Announces FDA-Cleared XENOVIEW 3T Chest Coil Passes Philips Compatible TestingPolarean 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.공고 • Sep 27+ 1 more updatePolarean Imaging plc Revises Earnings Guidance for 2025Polarean Imaging plc revised earnings guidance for 2025. For the year, the company lowered revenue guidance from a range of USD 5 million to USD 6 million to a range of USD 2.5 million to USD 3.5 million. The company expects similar sales level in 2025 as compared to 2024.공고 • Sep 16Polarean Imaging plc to Report First Half, 2025 Results on Sep 25, 2025Polarean Imaging plc announced that they will report first half, 2025 results on Sep 25, 2025공고 • Aug 13Polarean Imaging plc Announces Submission of New Phase III Study Protocol to FDA for Expanded Indication of XENOVIEWPolarean 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.공고 • Jun 02Polarean Imaging plc Expands XENOVIEW Indication to Include Children from Six Years of AgePolarean 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.공고 • May 08Polarean Imaging plc, Annual General Meeting, Jun 09, 2025Polarean Imaging plc, Annual General Meeting, Jun 09, 2025. Location: the companys offices, 2500 meridian parkway, durham, nc 27713, United States공고 • Apr 25Polarean Imaging plc to Report Fiscal Year 2024 Results on May 08, 2025Polarean Imaging plc announced that they will report fiscal year 2024 results at 8:00 AM, GMT Standard Time on May 08, 2025공고 • Nov 21Polarean Imaging plc Receives 510(K) Clearance from the U.S. Food and Drug Administration for the Specialised MRI Chest CoilPolarean 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.공고 • Aug 28Polarean Imaging plc Appoints Chase Hall, M.D., as Chief Medical AdvisorPolarean 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.공고 • Aug 21Polarean Imaging plc to Report First Half, 2024 Results on Sep 04, 2024Polarean Imaging plc announced that they will report first half, 2024 results on Sep 04, 2024공고 • Aug 16Bastiaan Driehuys Steps Down from His Position on the Board of Polarean Imaging plcPolarean 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.공고 • Aug 01Polarean Imaging plc Submits New Drug Application Supplement to the US Food and Drug AdministrationPolarean 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.공고 • Jun 30Polarean Imaging plc, Annual General Meeting, Jul 24, 2024Polarean Imaging plc, Annual General Meeting, Jul 24, 2024. Location: 2500 meridian parkway, suite 175, nc 27713, durham United States공고 • Aug 16Polarean Imaging plc to Report First Half, 2023 Results on Sep 07, 2023Polarean Imaging plc announced that they will report first half, 2023 results on Sep 07, 2023공고 • Aug 04Polarean Receives Clearance for New MRI Chest CoilPolarean 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.공고 • Jun 21+ 1 more updatePolarean Imaging plc Announces CEO ChangesPolarean Imaging plc announced that the Company's Board of Directors has appointed Christopher von Jako, Ph.D. as Chief Executive Officer, 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 appointment as CEO in 2017, Richard has overseen significant progress for Polarean. He led the Company through its successful IPO in 2018 and over $60 Million of capital raises culminating in Polarean receiving FDA approval forXENOVIEW™ (Xenon Xe129 hyperpolarized) for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older, and the initiation of the Company's commercial phase. With 30 years of global healthcare leadership experience, Dr. von Jako has led both private and publicly listed businesses, with a proven track record of commercialization while developing and executing sound business and operating strategies. He has experience across a multitude of healthcare sectors, including radiology, pulmonology, and various surgical interventions. In his most recent executive position, Dr. von Jako served as President and CEO of BrainsWay from 2020 to 2023. BrainsWay(NASDAQ & TASE: BWAY), is a global leader in advanced non-invasive neurostimulation treatments for mental health disorders. At BrainsWay, he launched five key differentiated products, obtained numerous reimbursement coverages, and executed an equity investment with a follow-on raise of over $45m, comprised of top-tier US MedTech investors. Prior to this, Dr. von Jako was CEO of Dynatronics (NASDAQ: DYNT), a medical device company providing restorative products to accelerate optimal health, from 2018 to 2019, where he developed a new growth strategy focused on driving sales, business development, and proactive investor relations. Before joining Dynatronics, Dr. von Jako served as President and CEO of NinePoint Medical Inc., a medical imaging company, where he successfully secured a significant strategic investment and long-term partnership with Merit Medical Systems Inc. He also served as President and CEO of NeuroTherm Inc., a pain management business until its acquisition by St. Jude Medical Corporation. Earlier in his career, Dr. von Jako worked in senior executive roles of progressive responsibility with other leading medical device companies such as Integra LifeSciences, Covidien, Medtronic, and Radionics. Dr. von Jako will continue to serve as an Independent Director on the Board of nView medical Inc., a privately held MedTech imaging company that generates real-time 3D images using advanced AI solutions for surgery. He earned a double B.S. degree from Bates College, an M.S. degree from the Massachusetts Institute of Technology, and a Ph.D. degree from the University of Pe´cs Medical School. Dr. von Jako does not currently hold an interest in the Company's share capital however, pursuant to his employment agreement, Dr. von Jako was granted 5,325,000 stock options to participate in the Polarean Imaging plc Share Option Plan (the "Share Options"). 25% of the Share Options will vest on 20 June 2024 with the remaining Share Options vesting in equal portions on the last day of each calendar month over the period of 36 months starting on July 31, 2024, subject to his continued employment with the Company and the exercise price shall be 29p per Share Option, being equal to the closing market price of an ordinary share of the Company as at the date of grant.공고 • May 27Polarean Imaging plc, Annual General Meeting, Jun 28, 2023Polarean 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 States공고 • May 12Polarean Imaging plc Announces First Clinical Scan Using XENOVIEW Conducted At Cincinnati Children’s Hospital Medical CenterPolarean 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.공고 • Feb 02Polarean Imaging plc Announces FDA Grants New Chemical Entity Designation for XENOVIEWPolarean 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.이익 및 매출 성장 예측OTCPK:PLLW.F - 애널리스트 향후 추정치 및 과거 재무 데이터 (USD Millions)날짜매출이익자유현금흐름영업현금흐름평균 애널리스트 수12/31/202717-5N/A-4112/31/20266-10N/A-9112/31/20253-10N/A-916/30/20253-10-8-8N/A3/31/20253-9-7-7N/A12/31/20243-9-6-6N/A9/30/20242-9-6-6N/A6/30/20242-9-6-6N/A3/31/20241-10-8-8N/A12/31/20231-12-11-10N/A9/30/20231-13-12-12N/A6/30/20230-14-13-13N/A3/31/20231-14-13-13N/A12/31/20221-14-12-12N/A9/30/20221-15-14-14N/A6/30/20221-16-16-15N/A3/31/20221-15-14-14N/A12/31/20211-14-13-12N/A9/30/20211-11-10-9N/A6/30/20211-8-6-6N/A3/31/20211-7-6-6N/A12/31/20201-7-6-6N/A9/30/20202-6-5-5N/A6/30/20202-6-5-4N/A3/31/20202-6-5-4N/A12/31/20192-6-5-5N/A9/30/20192-6-5-4N/A6/30/20192-6-4-4N/A3/31/20192-6N/A-4N/A12/31/20182-5N/A-5N/A9/30/20182-5N/A-5N/A6/30/20182-5N/A-5N/A3/31/20182-4N/A-4N/A12/31/20171-4N/A-3N/A12/31/20161-1N/A-1N/A12/31/20151-1N/A-1N/A12/31/201410N/A0N/A더 보기애널리스트 향후 성장 전망수입 대 저축률: PLLW.F 향후 3년 동안 수익성이 없을 것으로 예상됩니다.수익 vs 시장: PLLW.F 향후 3년 동안 수익성이 없을 것으로 예상됩니다.고성장 수익: PLLW.F 향후 3년 동안 수익성이 없을 것으로 예상됩니다.수익 대 시장: PLLW.F 의 수익(연간 69.3%)이 US 시장(연간 12.4%)보다 빠르게 성장할 것으로 예상됩니다.고성장 매출: PLLW.F 의 수익(연간 69.3%)은 연간 20%보다 빠르게 증가할 것으로 예상됩니다.주당순이익 성장 예측향후 자기자본이익률미래 ROE: PLLW.F의 자본 수익률이 3년 후 높을 것으로 예상되는지 판단하기에 데이터가 부족합니다.성장 기업 찾아보기7D1Y7D1Y7D1YHealthcare 산업의 고성장 기업.View Past Performance기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2025/12/24 09:35종가2025/12/22 00:00수익2025/06/30연간 수익2024/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델의 세부 정보는 당사의 GitHub 페이지에서 확인하실 수 있습니다. 또한 보고서 사용 방법에 대한 가이드와 YouTube 튜토리얼도 제공하고 있습니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스Polarean Imaging plc는 1명의 분석가가 다루고 있습니다. 이 중 1명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Colin SmithCapital Access Group
공고 • Sep 27+ 1 more updatePolarean Imaging plc Revises Earnings Guidance for 2025Polarean Imaging plc revised earnings guidance for 2025. For the year, the company lowered revenue guidance from a range of USD 5 million to USD 6 million to a range of USD 2.5 million to USD 3.5 million. The company expects similar sales level in 2025 as compared to 2024.
공고 • Dec 02Polarean Imaging plc Announces FDA-Cleared XENOVIEW 3T Chest Coil Passes Philips Compatible TestingPolarean 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.
공고 • Sep 27+ 1 more updatePolarean Imaging plc Revises Earnings Guidance for 2025Polarean Imaging plc revised earnings guidance for 2025. For the year, the company lowered revenue guidance from a range of USD 5 million to USD 6 million to a range of USD 2.5 million to USD 3.5 million. The company expects similar sales level in 2025 as compared to 2024.
공고 • Sep 16Polarean Imaging plc to Report First Half, 2025 Results on Sep 25, 2025Polarean Imaging plc announced that they will report first half, 2025 results on Sep 25, 2025
공고 • Aug 13Polarean Imaging plc Announces Submission of New Phase III Study Protocol to FDA for Expanded Indication of XENOVIEWPolarean 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.
공고 • Jun 02Polarean Imaging plc Expands XENOVIEW Indication to Include Children from Six Years of AgePolarean 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.
공고 • May 08Polarean Imaging plc, Annual General Meeting, Jun 09, 2025Polarean Imaging plc, Annual General Meeting, Jun 09, 2025. Location: the companys offices, 2500 meridian parkway, durham, nc 27713, United States
공고 • Apr 25Polarean Imaging plc to Report Fiscal Year 2024 Results on May 08, 2025Polarean Imaging plc announced that they will report fiscal year 2024 results at 8:00 AM, GMT Standard Time on May 08, 2025
공고 • Nov 21Polarean Imaging plc Receives 510(K) Clearance from the U.S. Food and Drug Administration for the Specialised MRI Chest CoilPolarean 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.
공고 • Aug 28Polarean Imaging plc Appoints Chase Hall, M.D., as Chief Medical AdvisorPolarean 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.
공고 • Aug 21Polarean Imaging plc to Report First Half, 2024 Results on Sep 04, 2024Polarean Imaging plc announced that they will report first half, 2024 results on Sep 04, 2024
공고 • Aug 16Bastiaan Driehuys Steps Down from His Position on the Board of Polarean Imaging plcPolarean 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.
공고 • Aug 01Polarean Imaging plc Submits New Drug Application Supplement to the US Food and Drug AdministrationPolarean 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.
공고 • Jun 30Polarean Imaging plc, Annual General Meeting, Jul 24, 2024Polarean Imaging plc, Annual General Meeting, Jul 24, 2024. Location: 2500 meridian parkway, suite 175, nc 27713, durham United States
공고 • Aug 16Polarean Imaging plc to Report First Half, 2023 Results on Sep 07, 2023Polarean Imaging plc announced that they will report first half, 2023 results on Sep 07, 2023
공고 • Aug 04Polarean Receives Clearance for New MRI Chest CoilPolarean 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.
공고 • Jun 21+ 1 more updatePolarean Imaging plc Announces CEO ChangesPolarean Imaging plc announced that the Company's Board of Directors has appointed Christopher von Jako, Ph.D. as Chief Executive Officer, 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 appointment as CEO in 2017, Richard has overseen significant progress for Polarean. He led the Company through its successful IPO in 2018 and over $60 Million of capital raises culminating in Polarean receiving FDA approval forXENOVIEW™ (Xenon Xe129 hyperpolarized) for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older, and the initiation of the Company's commercial phase. With 30 years of global healthcare leadership experience, Dr. von Jako has led both private and publicly listed businesses, with a proven track record of commercialization while developing and executing sound business and operating strategies. He has experience across a multitude of healthcare sectors, including radiology, pulmonology, and various surgical interventions. In his most recent executive position, Dr. von Jako served as President and CEO of BrainsWay from 2020 to 2023. BrainsWay(NASDAQ & TASE: BWAY), is a global leader in advanced non-invasive neurostimulation treatments for mental health disorders. At BrainsWay, he launched five key differentiated products, obtained numerous reimbursement coverages, and executed an equity investment with a follow-on raise of over $45m, comprised of top-tier US MedTech investors. Prior to this, Dr. von Jako was CEO of Dynatronics (NASDAQ: DYNT), a medical device company providing restorative products to accelerate optimal health, from 2018 to 2019, where he developed a new growth strategy focused on driving sales, business development, and proactive investor relations. Before joining Dynatronics, Dr. von Jako served as President and CEO of NinePoint Medical Inc., a medical imaging company, where he successfully secured a significant strategic investment and long-term partnership with Merit Medical Systems Inc. He also served as President and CEO of NeuroTherm Inc., a pain management business until its acquisition by St. Jude Medical Corporation. Earlier in his career, Dr. von Jako worked in senior executive roles of progressive responsibility with other leading medical device companies such as Integra LifeSciences, Covidien, Medtronic, and Radionics. Dr. von Jako will continue to serve as an Independent Director on the Board of nView medical Inc., a privately held MedTech imaging company that generates real-time 3D images using advanced AI solutions for surgery. He earned a double B.S. degree from Bates College, an M.S. degree from the Massachusetts Institute of Technology, and a Ph.D. degree from the University of Pe´cs Medical School. Dr. von Jako does not currently hold an interest in the Company's share capital however, pursuant to his employment agreement, Dr. von Jako was granted 5,325,000 stock options to participate in the Polarean Imaging plc Share Option Plan (the "Share Options"). 25% of the Share Options will vest on 20 June 2024 with the remaining Share Options vesting in equal portions on the last day of each calendar month over the period of 36 months starting on July 31, 2024, subject to his continued employment with the Company and the exercise price shall be 29p per Share Option, being equal to the closing market price of an ordinary share of the Company as at the date of grant.
공고 • May 27Polarean Imaging plc, Annual General Meeting, Jun 28, 2023Polarean 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
공고 • May 12Polarean Imaging plc Announces First Clinical Scan Using XENOVIEW Conducted At Cincinnati Children’s Hospital Medical CenterPolarean 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.
공고 • Feb 02Polarean Imaging plc Announces FDA Grants New Chemical Entity Designation for XENOVIEWPolarean 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.