Determine the ability of 129Xe MRI/MRS biomarker signatures to non-invasively monitor pulmonary vascular reverse remodeling induced by sotatercept in pulmonary arterial hypertension (PAH).

Start Date01 Dec 2024

Sponsor / Collaborator

Duke University

[+1]

NCT06104228 / RecruitingPhase 2IIT

129 Xenon MRI As a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)

The overall study objectives outlined in this study are to derive 129Xe MRI pulmonary vascular biomarker signatures that differentiate common subtypes of PAH and to determine the ability of 129Xe MRI to longitudinally monitor disease progression and response to therapy in PAH, with the aid of additional assessments, such as labs, echocardiography, and six-minute walk distance (6MWD).

Start Date12 Aug 2024

Sponsor / Collaborator

Duke University

[+1]

NCT06122922 / WithdrawnPhase 2IIT

Xenon MRI in Stable Patients With Pulmonary Hypertension

The objective of this project is to determine how pulmonary vascular remodeling in Pulmonary Arterial Hypertension (PAH) at cellular and pathological level is associated with gas exchange physiology changes and hemodynamics (monitored with 129Xe MRI/MRS) and how these signals change with disease progression or treatment.

Start Date15 Mar 2024

Sponsor / Collaborator

Duke University

[+1]

100 Clinical Results associated with XENON XE 129 hyperpolarized

100 Translational Medicine associated with XENON XE 129 hyperpolarized

100 Patents (Medical) associated with XENON XE 129 hyperpolarized

Literatures (Medical) associated with XENON XE 129 hyperpolarized

01 Sep 2022·CHEST

Asthma Control, Airway Mucus, and 129Xe MRI Ventilation After a Single Benralizumab Dose

Article

Author: Svenningsen, Sarah ; Nair, Parameswaran ; Jeimy, Samira ; Parraga, Grace ; McIntosh, Marrissa J ; Licskai, Christopher ; Yamashita, Cory ; Eddy, Rachel L ; Mackenzie, Constance A ; Kooner, Harkiran K

BACKGROUNDPatients with eosinophilic asthma often report poor symptomatic control and quality of life. Anti-IL-5 therapy, including anti-IL-5Rα (benralizumab), rapidly depletes eosinophils in the blood and airways and also reduces asthma exacerbations and improves quality of life scores. In patients with severe asthma, eosinophilic inflammation-driven airway mucus occlusions have been measured using thoracic x-ray CT imaging. Pulmonary ¹²⁹Xe MRI ventilation defect percentage (VDP) also sensitively measures asthma airway dysfunction caused by airway hyperresponsiveness, remodeling, and luminal mucus occlusions. Using ¹²⁹Xe MRI and CT imaging together, it is feasible to measure both airway luminal occlusions and airway ventilation in relationship to anti-IL-5 therapy to ascertain the direct impact of therapy-induced eosinophil depletion on airway function.RESEARCH QUESTIONDoes ¹²⁹Xe MRI detect airway functional responses to eosinophil depletion after a single benralizumab dose and do airway mucus occlusions mediate this response?STUDY DESIGN AND METHODSMRI, eosinophil count, spirometry, oscillometry, Asthma Control Questionnaire (ACQ), Asthma Quality of Life Questionnaire (AQLQ), and St. George's Respiratory Questionnaire were completed on day 0 and 28 days after a single 30-mg subcutaneous benralizumab dose. CT scan mucus plugs were scored on day 0, and MRI VDP was quantified on days 0 and 28.RESULTSTwenty-nine participants (27 with baseline CT imaging) completed day 0 and day 28 visits. On day 28 after a single benralizumab dose, significantly improved blood eosinophil counts, VDP, ACQ 6 scores, AQLQ scores (all P < .001), and peripheral airway resistance (P = .04) were found in all participants. On day 28, significantly improved VDP and ACQ 6 scores also were found in the subgroup of nine participants with five or more mucus plugs, but not in the subgroup (n = 18) with fewer than five mucus plugs. Based on univariate relationships for change in ACQ 6 score, multivariate models were generated and showed that day 0 VDP (P < .001) and day 0 CT scan mucus score (P < .001) were significant variables for change in ACQ 6 score on day 28 after benralizumab injection.INTERPRETATION¹²⁹Xe ventilation significantly improved in participants with uncontrolled asthma and in those with significant mucus plugging after a single dose of benralizumab.TRIAL REGISTRYClinicalTrials.gov; No.: NCT03733535; URL: www.CLINICALTRIALSgov.

01 Aug 2021·Radiology: Cardiothoracic Imaging

Imaging Dynamic Expiration: Feasibility of MRI Spirometry Using Hyperpolarized Xenon Gas

Article

Author: Chen, Mitchell ; Bewes, James ; McIntyre, Anthony ; Gleeson, Fergus ; Doganay, Ozkan

PURPOSETo examine the feasibility of imaging-based spirometry using high-temporal-resolution projection MRI and hyperpolarized xenon 129 (¹²⁹Xe) gas.MATERIALS AND METHODSIn this prospective exploratory study, five healthy participants (age range, 25-45 years; three men) underwent an MRI spirometry technique using inhaled hyperpolarized ¹²⁹Xe and rapid two-dimensional projection MRI. Participants inhaled ¹²⁹Xe, then performed a forced expiratory maneuver while in an MR imager. Images of the lungs during expiration were captured in time intervals as short as 250 msec. Volume-corrected images of the lungs at expiration commencement (0 second), 1 second after expiration, and 6 seconds after expiration were extracted to generate forced expiratory volume in 1 second (FEV₁), forced vital capacity (FVC), and FEV₁/FVC ratio pulmonary maps. For comparison, participants performed conventional spirometry in the sitting position using room air, in the supine position using room air, and in the supine position using a room air and ¹²⁹Xe mixture. Paired t tests with Bonferroni corrections for multiple comparisons were used for statistical analyses.RESULTSThe mean MRI-derived FEV₁/FVC value was lower in comparison with conventional spirometry (0.52 ± 0.03 vs 0.70 ± 0.05, P < .01), which may reflect selective ¹²⁹Xe retention. A secondary finding of this study was that 1 L of inhaled ¹²⁹Xe negatively impacted pulmonary function as measured by conventional spirometry (in supine position), which reduced measured FEV₁ (2.70 ± 0.90 vs 3.04 ± 0.85, P < .01) and FEV₁/FVC (0.70 ± 0.05 vs 0.79 ± 0.04, P < .01).CONCLUSIONA forced expiratory maneuver was successfully imaged with hyperpolarized ¹²⁹Xe and high-temporal-resolution MRI. Derivation of regional lung spirometric maps was feasible.Keywords: MR-Imaging, MR-Dynamic Contrast Enhanced, MR-Functional Imaging, Pulmonary, Thorax, Diaphragm, Lung, Pleura, Physics Supplemental material is available for this article. © RSNA, 2021.

01 Aug 2018·AnesthesiologyQ1 · MEDICINE

Nuclear Spin Attenuates the Anesthetic Potency of Xenon Isotopes in Mice

Q1 · MEDICINE

Article

Author: Zhang, Shihai ; Fu, Lisha ; Li, Na ; Tao, Huan ; Wang, Chenchen ; Liu, Hui ; Yang, Lei ; Lu, Dongshi ; Chummum, Yatisha ; Xu, Younian

AbstractWhat We Already Know about This TopicWhat This Article Tells Us That Is NewBackgroundXenon is an elemental anesthetic with nine stable isotopes. Nuclear spin is a quantum property which may differ among isotopes. Xenon 131 (131Xe) has nuclear spin of 3/2, xenon 129 (129Xe) a nuclear spin of 1/2, and the other seven isotopes have no nuclear spin. This study was aimed to explore the effect of nuclear spin on xenon anesthetic potency.MethodsEighty C57BL/6 male mice (7 weeks old) were randomly divided into four groups, xenon 132 (132Xe), xenon 134 (134Xe), 131Xe, and 129Xe groups. Due to xenon’s low potency, loss of righting reflex ED50 for mice to xenon was determined with 0.50% isoflurane. Loss of righting reflex ED50 of isoflurane was also measured, and the loss of righting reflex ED50 values of the four xenon isotopes were then calculated. The exact polarizabilities of the isotopes were calculated.ResultsCombined with 0.50% isoflurane, the loss of righting reflex ED50 values were 15 ± 4%, 16 ± 5%, 22 ± 5%, and 23 ± 7% for 132Xe, 134Xe, 131Xe, and 129Xe, respectively. For xenon alone, the loss of righting reflex ED50 values of 132Xe, 134Xe, 131Xe, and 129Xe were 70 ± 4%, 72 ± 5%, 99 ± 5%, and 105 ± 7%, respectively. Four isotopes had a same exact polarizability of 3.60 Å3.ConclusionsXenon isotopes with nuclear spin are less potent than those without, and polarizability cannot account for the difference. The lower anesthetic potency of 129Xe may be the result of it participating in conscious processing and therefore partially antagonizing its own anesthetic potency. Nuclear spin is a quantum property, and our results are consistent with theories that implicate quantum mechanisms in consciousness.

News (Medical) associated with XENON XE 129 hyperpolarized

08 May 2024

·www.biospace.com

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 developers. The summit is scheduled to take place on May 17th-18th in San Diego, CA, at the Manchester Grand Hyatt San Diego. The Respiratory Innovation Summit, a premier event in the field of pulmonary medicine, unites innovators, investors, clinicians, and advocacy groups. The meeting historically attracts more than 275 global leaders representing all facets of the respiratory industry, including start-ups, venture capital, government, academia, and clinicians. After the dynamic discussions of the Respiratory Innovation Summit, Polarean eagerly anticipates further collaboration within the pulmonary medicine community at the 2024 ATS International Conference, held from May 19th to 22nd. Visit booth #2813 to engage directly with our executive team, including Christopher von Jako, PhD, Chief Executive Officer; Alex Dusek, Chief Commercial Officer; and Kiarash Emami, PhD, VP of Technology & Applications. Discover firsthand how Polarean strives to revolutionize pulmonary medicine through direct visualization of lung ventilation as we share detailed insights, forge valuable connections, and collaborate to shape the future of lung imaging. This year, the breadth of Xenon MRI research and the number of displays outpaced all previous years, with 33 presentations from 10 different sites and multiple categories, including asthma, bronchopulmonary dysplasia, COPD, COVID-19, cystic fibrosis, hematopoietic stem cell transplant, lung cancer resection, radiation-induced lung injury, pulmonary arterial hypertension, and thoracic insufficiency syndrome. Christopher von Jako, PhD, CEO of Polarean, said: “The Respiratory Innovation Summit and the ATS annual conference serve as invaluable venues to spotlight our Xenon MRI platform, especially to those enthusiastic about fostering collaborative partnerships. These events provide an unparalleled opportunity to elevate awareness of our technology among clinicians, regulators, investors, and potential pharmaceutical industry partners. As we strive to advance our commercialization strategy, the increase in Xenon MRI posters and presentations marks significant strides in amplifying understanding and enthusiasm for Xenon MRI and the spectrum of therapeutic disciplines that could benefit from our technology.” See the listing below for details on the presentation title, abstract number, session time, and location. XENOVIEW IMPORTANT SAFETY INFORMATION Indication XENOVIEW™, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. CONTRAINDICATIONS None. Warnings and Precautions Risk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold. Risk of Transient Hypoxia: Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen desaturation and symptoms of hypoxemia and treat as clinically indicated. Adverse Reactions Adverse Reactions in Adult Patients: The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness. Adverse Reactions in Pediatric and Adolescent Patients: In published literature in pediatric patients aged 6 to 18, transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. In at least one published study of pediatric patients aged 6 to 18 years, transient decrease in SpO2% and transient increase in heart rate was reported following hyperpolarized xenon Xe 129 administration. XENOVIEW is not approved for use in pediatric patients less than 12 years of age. Please see full prescribing information at About Polarean ( ) Polarean is a revenue-generating medical imaging technology company revolutionizing pulmonary medicine through direct visualization of lung function by introducing the power and safety of MRI to the respiratory healthcare community. This community is in desperate need of modern solutions to accurately assess lung function. The Company strives to optimize lung health and prevent avoidable loss by illuminating hidden disease, addressing the global unmet medical needs of more than 500 million patients worldwide suffering from chronic respiratory disease. Polarean is a leader in the field of hyperpolarization science and has successfully developed the first and only hyperpolarized Xenon MRI inhaled contrast agent, XENOVIEW™, which is now FDA-approved in the United States. Polarean is dedicated to researching, developing, and commercializing innovative imaging solutions with its non-invasive and radiation-free pulmonary functional MRI platform. This comprehensive drug-device platform encompasses the proprietary Xenon gas blend, gas hyperpolarization system, as well as software and accessories, facilitating fully integrated modern respiratory imaging operations. Founded in 2012, with offices in Durham, NC, and London, United Kingdom, Polarean is committed to increasing global awareness of and broad access to its XENOVIEW MRI technology platform. For the latest news and information about Polarean, please visit . About The American Thoracic Society ( ) The American Thoracic Society (ATS) improves global health by advancing research, patient care, and public health in pulmonary disease, critical illness, and sleep disorders. Founded in 1905 to combat TB, the ATS has grown to tackle asthma, COPD, lung cancer, sepsis, acute respiratory distress, and sleep apnea, among other diseases. ATS Abstract Title Presentation Date Abstract Number Session and Location Hyperpolarized 129Xe MRI: What Additional Information Does It Provide? May 18, 2024 3:10 PM - 3:50 PM Session PG16 San Diego Convention Center, Room 6D (UpperLevel) Quantifying the Impact of Cannabis Smoking in Lungs of Young Adults Using CT and Xe MRI May 19, 2024 9:15 AM - 11:15 AM 1014 Session A29 San Diego Convention Center, Room 6E (UpperLevel) Six-month Longitudinal Changes in129-XE and HRCT Imaging Metrics Tend to Associate With On-study COPD Exacerbations May 19, 2024 9:15 AM - 11:15 AM 1017 Session A29 San Diego Convention Center, Room 6E (UpperLevel) Advanced 4D Hyperpolarized Gas Imaging of Ventilation and Dissolved Gas Biomarkers in COPD May 19, 2024 9:15 AM - 11:15 AM 1016 Session A29 San Diego Convention Center, Room 6E (UpperLevel) 3-month Change in Hyperpolarized Xe MRI Membrane Uptake Predicts 6-month Change in Lung Function in Patients With Idiopathic Pulmonary Fibrosis May 19, 2024 11:30 AM - 1:15 PM P862 Session A47 San Diego Convention Center, Area H (Hall H,Ground Level) Using Xenon MRI to Evaluate the Trajectories of Idiopathic Pulmonary Fibrosis May 19, 2024 2:15 PM - 4:15 PM 914 Session A104 San Diego Convention Center, Room 33A-C(Upper Level) Combining Hyperpolarized Xe MR Imagingand Spectroscopy to Estimate Pulmonary Vascular Resistance May 19, 2024 3:39 PM - 3:51 PM Session A97 San Diego Convention Center, Room 6D (UpperLevel) Magnetic Resonance Imaging Ventilation Phenotypes of Severe Asthma May 19, 2024 3:39 PM - 3:51 PM Session A99 Marriott Marquis San Diego Marina, PacificBallroom 24-26 (Ground Floor, North Tower) Success and Feasibility of MultipleBreath Washout: Prospective Multi-center Results From the Transpire Study May 20, 2024 9:15 AM - 11:15 AM 421 Session B25 San Diego Convention Center, Room 25A-C(Upper Level) Improved Quantification of Ventilation Heterogeneity in Hyperpolarized Xenon MRI Using Physics-rooted Bias-field Correction May 20, 2024 11:30 AM - 1:15 PM P170 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Addressing Healthy Aging Variations in Ventilation From Childhood to Older Age Using Xenon MRI May 20, 2024 11:30 AM - 1:15 PM P171 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Assessing Radiation-induced Lung Injury Using a Chemical Shift Imaging-based CSSR Technique May 20, 2024 11:30 AM - 1:15 PM P176 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Sex and Age-dependence of Xe MRI Cardiopulmonary Oscillations in Healthy Volunteers May 20, 2024 11:30 AM - 1:15 PM P188 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Estimating Physiological Values of Membrane and Red Blood Cell Conductance Using Xe Gas Exchange MRI May 20, 2024 11:30 AM - 1:15 PM P187 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Increased BMI Is Associated With Elevated Membrane Uptake on Xe Gas Exchange MRI in Healthy Subjects May 20, 2024 11:30 AM - 1:15 PM P178 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Establishing a Standardized Healthy Reference Distribution for Multi-site Xe Gas Exchange MRI Across Major Scanner Platforms May 20, 2024 11:30 AM - 1:15 PM P172 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Quantifying Spatial Distribution of Ventilation Defects in Lung Imaging With Hyperpolarized Xenon MRI May 20, 2024 11:30 AM - 1:15 PM P174 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Assessment of Gas Exchange WithHyperpolarized Xe MR Imaging in Mild Asthmatics When Administered a Vasodilator May 20, 2024 11:30 AM - 1:15 PM P190 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) 129Xe MRI With Optimized Bias Field Correction to Assess Ventilation Gradients in Individuals With Normal Lung Function May 20, 2024 11:30 AM - 1:15 PM P701 Session B80-2 Research and Clinical Applications of Hyperpolarized 129Xe MRI May 20, 2024 3:00 PM - 3:15 PM Session B91 San Diego Convention Center, Room 24A-C(Upper Level) Assessment of Obstructive and Restrictive Lung Disease Via MRI in Bronchopulmonary Dysplasia Patients May 21, 2024 9:15 AM - 11:15 AM 404 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) Changes in Individual Ventilation Defects in Cystic Fibrosis After Initiation of Modulator Therapy, in the Hypoint Trial May 21, 2024 9:15 AM - 11:15 AM 405 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) Xe MRI and Oscillometry Evidence ofImproved Small Airways Dysfunction After 6-weeks ICS/LABA/LAMA Therapy in Moderate Asthma May 21, 2024 9:15 AM - 11:15 AM 407 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) Comparison of CT-based Measurements of Ventilation and Perfusion to Ventilation and Gas Exchange Measurements From Hyperpolarized Xe MRI May 21, 2024 9:15 AM - 11:15 AM 410 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) CT Mucus Score Predicts Response to 6-weeks ICS/LABA/LAMA in Moderate Asthma May 21, 2024 9:15 AM - 11:15 AM 413 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) Xe MR Evidence of Abnormal Gas-exchange in Mild-moderate and Severe Asthma May 21, 2024 9:15 AM - 11:15 AM 418 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) Ventilation Defect Burden Quantified byTechnegas SPECT and Xe MRI Predicts Lung Cancer Resection Outcomes May 21, 2024 9:15 AM - 11:15 AM 420 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) Rapid and Persistent 6-week Responseto ICS/LABA/LAMA in Mild-moderate Asthma May 21, 2024 11:30 AM - 1:15 PM P690 Session C71 San Diego Convention Center, Area F (Hall A-B2,Ground Level) Evaluation of Xenon Gas Phase and Dissolved Phase Delays Using Dynamic 129Xe-hyperpolarized MRI in Pre-clinical Thoracic Insufficiency Syndrome Model May 21, 2024 11:30 AM - 1:15 PM P156 Session C73 San Diego Convention Center, Area F (Hall A-B2,Ground Level) Xe MRI Reveals Regional Gas-exchange Abnormalities in Cystic Fibrosis Lung Disease May 21, 2024 11:30 AM - 1:15 PM P174 Session C74 San Diego Convention Center, Area F (Hall A-B2,Ground Level) Quantitative Characterization of Regional Ventilation and Perfusion in Patients With Persistent COVID-19 Symptoms Using Hyperpolarized Xe MRI and Dual Energy CT May 21, 2024 11:30 AM - 1:15 PM P186 Session C75 San Diego Convention Center, Area F (Hall A-B2,Ground Level) The EXPLAIN (Hyperpolarised Xenon Magnetic Resonance Pulmonary Imaging in Patients With Long-COVID) Study: The Primary Outcome May 21, 2024 11:30 AM - 1:15 PM P195 Session C75 San Diego Convention Center, Area F (Hall A-B2,Ground Level) Same-day and Six-week Repeatability of Hyperpolarized Xe MRI Measures in Patients With Pulmonary Arterial Hypertension May 22, 2024 11:00 AM - 1:00 PM 306 Session D109 San Diego Convention Center, Room 28C-E(Upper Level) Contact Information: Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 cosborne@polarean.com Polarean Investors: Anna Dunphy / Phillip Marriage +44 (0)20 7933 8780 polarean@wallbrookpr.com Polarean Media Contact: Alexis Opp +1 (919) 206-7900 aopp@polarean.com General inquiries: info@polarean.com Follow Polarean on LinkedIn here Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 cosborne@polarean.com Polarean Investors: Anna Dunphy / Phillip Marriage +44 (0)20 7933 8780 polarean@wallbrookpr.com Polarean Media Contact: Alexis Opp +1 (919) 206-7900 aopp@polarean.com General inquiries: info@polarean.com

Radiation Therapy

03 Aug 2023

·www.biospace.com

Polarean Receives Clearance for New MRI Chest CoilAdditional 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 Polarean XENOVIEW™ 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. Christopher von Jako, CEO of Polarean, said: “Polarean continues to develop and launch new devices and accessories that empower sites to perform modern respiratory imaging, enabling as many clinicians as possible to use our technology for their patients. This FDA clearance also further supports our recently announced collaboration with Philips, by expanding our product line to be compatible with their advanced MRI systems.” About Polarean ( ) The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are revenue-generating, medical imaging technology companies operating in the high-resolution medical imaging space. Polarean aspires to revolutionize pulmonary medicine by bringing the power and safety of MRI to the respiratory healthcare community in need of new solutions to evaluate lung ventilation, diagnose disease, characterize disease progression, and monitor response to treatment. By researching, developing, and commercializing novel imaging solutions with a non-invasive and radiation-free functional imaging platform. Polarean’s vision is to help address the global unmet medical needs of more than 500 million patients worldwide suffering with chronic respiratory disease. Polarean is a leader in the field of hyperpolarization science and has successfully developed the first and only hyperpolarized MRI contrast agent to be approved in the United States. The company also commercializes systems (such as the HPX hyperpolarization system), accessories (such as Xe-specific chest coils and phantoms) and FDA-cleared post-processing software (to support ventilation defect analysis), to support fully integrated modern respiratory imaging operations. Contacts: Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 cosborne@polarean.com Investors: Anna Dunphy / Phillip Marriage +44 (0)20 7933 8780 polarean@wallbrookpr.com Media Contact: Director of Marketing & Logistics Michelle Caissie +1 (919) 206-7900, ext. 136 mcaissie@polarean.com POL-PR-2309 Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 cosborne@polarean.com Investors: Anna Dunphy / Phillip Marriage +44 (0)20 7933 8780 polarean@wallbrookpr.com Media Contact: Michelle Caissie Director of Marketing & Logistics +1 (919) 206-7900, ext. 136 mcaissie@polarean.com

11 May 2023

·www.biospace.com

First clinical scan using XENOVIEW conducted at Cincinnati Children’s Hospital Medical CenterScan 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 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. Richard Hullihen, CEO of Polarean, said: “The first clinical scan in the United States is a significant milestone for Polarean and the XENOVIEW technology. This scan ushers in a new era of lung imaging, opening the door tothe greater potential of MRI technology in pulmonary medicine. We are in discussions with numerous other medical centers about the adoption of this novel technology and expect this ability to view lung ventilation more fully will be available at additional hospitals in the coming months.” Dr. Jason Woods, Director of Research in Pulmonary Medicine at Cincinnati Children’s, added: “I am thrilled to be extending XENOVIEW from research to the clinical setting so that we can serve more patients in need at our hospital. Being able to use this technology for the evaluation of ventilation in the clinic, including on patients as young as 12 years old, increases the population of people that could benefit from this revolutionary imaging technology.” Inquiries: Polarean Imaging plc / Richard Hullihen, Chief Executive Officer Via Walbrook PR Kenneth West, Chairman Stifel Nicolaus Europe Limited (NOMAD and Sole Corporate Broker) +44 (0)20 7710 7600 Nicholas Moore / Samira Essebiyea / Kate Hanshaw (Healthcare Investment Banking) Nick Adams / Nick Harland (Corporate Broking) Walbrook PR Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com Anna Dunphy / Phillip Marriage Mob: +44 (0)7876 741 001 / +44 (0) 7867 984 082 RLF Communications (US media enquiries) mrash@rlfcommunications.com Michelle Rash 001 336-823-5501 About Polarean ( ) The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are revenue-generating, medical imaging technology companies operating in the high-resolution medical imaging space. Polarean aspires to revolutionise pulmonary medicine by bringing the power and safety of MRI to the respiratory healthcare community in need of new solutions to evaluate lung ventilation, diagnose disease, characterise disease progression, and monitor response to treatment. By researching, developing, and commercialising novel imaging solutions with a non-invasive and radiation-free functional imaging platform. Polarean’s vision is to help address the global unmet medical needs of more than 500 million patients worldwide suffering with chronic respiratory disease. Polarean is a leader in the field of hyperpolarisation science and has successfully developed the first and only hyperpolarised MRI contrast agent to be approved in the United States. On Dec. 23, 2022, the FDA granted approval for Polarean’s first drug device combination product, XENOVIEWTM (Xenon Xe129 hyperpolarised). Xe129 MRI is also currently being studied for visualisation and quantification of gas exchange regionally in the smallest airways of the lungs, across the alveolar tissue membrane, and into the pulmonary bloodstream for future clinical indications. XENOVIEW IMPORTANT SAFETY INFORMATION Warnings and Precautions Risk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold. Risk of Transient Hypoxia: Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen desaturation and symptoms of hypoxemia and treat as clinically indicated. Adverse Reactions Adverse Reactions in Adult Patients: The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness. Adverse Reactions in Pediatric and Adolescent Patients: In published literature in pediatric patients aged 6 to 18, transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. In at least one published study of pediatric patients aged 6 to 18 years, transient decrease in SpO2% and transient increase in heart rate was reported following hyperpolarized xenon Xe 129 administration. XENOVIEW is not approved for use in pediatric patients less than 12 years of age. Please see full prescribing information at Michelle Rash Vice President RLF Communications 336-823-5501 mrash@rlfcommunications.com

Radiation TherapyDrug Approval

100 Deals associated with XENON XE 129 hyperpolarized

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Contrast agents	US	Polarean, Inc.	23 Dec 2022
Lung Diseases	US	Polarean, Inc.	23 Dec 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary arterial hypertension associated with connective tissue disease	Phase 2	US	Duke University	12 Aug 2024
Pulmonary arterial hypertension associated with connective tissue disease	Phase 2	US	American Heart Association, Inc.	12 Aug 2024
Anemia	Phase 2	US	National Institutes of Health	12 Jan 2024
Chronic thromboembolic pulmonary hypertension	Phase 2	US	National Institutes of Health	12 Jan 2024
Dyspnea	Phase 2	US	National Institutes of Health	12 Jan 2024
Lung Diseases, Interstitial	Phase 2	US	National Institutes of Health	12 Jan 2024
Polycythemia	Phase 2	US	National Institutes of Health	12 Jan 2024
Pulmonary Embolism	Phase 2	US	National Institutes of Health	12 Jan 2024
Idiopathic Pulmonary Fibrosis	Phase 2	US	Duke University	19 Jul 2022
Progressive pulmonary fibrosis	Phase 2	US	Duke University	19 Jul 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03417687 (CTgov)	Phase 3	Lung Diseases	38	129Xe MRI	etijpyaztt(tiiaotspvq) = mfzkouemog kjtpelcvad (xxnzfmmlov, twlvfxqnrv - lepowuuefx)	-	28 Jun 2022
ASTRO	Not Applicable	-	-	Hyperpolarized 129 Xe (Gas exchange-optimized plans)	ukvrpwwhzc(ndkvwllrex) = czxlbjygmh dinlewmbzw (sgckxmnhzh, 45) View more	-	01 Nov 2020
				Hyperpolarized 129 Xe (Ventilation-optimized plans)	ukvrpwwhzc(ndkvwllrex) = ofkfzgsbyb dinlewmbzw (sgckxmnhzh, 31) View more
ERS2019	Not Applicable	Lung Diseases, Interstitial	33	Hyperpolarised 129-xenon	ekmhtysqjz(ipxghzbuuz) = rzldtyrfsv mciddwfrsr (dyhfxyijrb )	-	28 Sep 2019
				Hyperpolarised 129-xenon	ekmhtysqjz(ipxghzbuuz) = vtqdhmjjfa mciddwfrsr (dyhfxyijrb ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

XENON XE 129 hyperpolarized

Overview

Basic Info

Structure

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation