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FDA Approves XENOVIEW™ (Xe 129 hyperpolarized)

28 Dec 2022 07:00

RNS Number : 9761K
Polarean Imaging PLC
28 December 2022

28 December 2022

Polarean Imaging Plc

("Polarean" or the "Company") 


 FDA Approves Polarean's XENOVIEW™ (xenon Xe 129 hyperpolarized)  

for use with MRI for the evaluation of lung ventilation


XENOVIEW represents the first and only hyperpolarized MRI contrast agent

FDA approved indication includes both adolescents and adults representing a significant market opportunity


Polarean Imaging plc (AIM: POLX), the medical imaging technology company, announces that the U.S. Food and Drug Administration ("FDA") has granted approval for its drug device combination product, XENOVIEW. XENOVIEW, prepared from the Xenon 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. XENOVIEW has not been evaluated for use with lung perfusion imaging. 


XENOVIEW expands the opportunity for pulmonary medicine to utilize the first and only inhaled MRI hyperpolarized contrast agent for novel visualization of lung ventilation without exposing patients to any ionizing radiation and its associated risks. The dose of XENOVIEW, created through the Polarean HPX hyperpolarization 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.


Richard Hullihen, Chief Executive Officer of Polarean said: "FDA approval represents achievement of a major milestone for Polarean's technology. This was only possible in close collaboration with multiple research clinicians and scientists globally, who we thank for their tireless and enthusiastic work. Approval of XENOVIEW represents a major step forward in modern respiratory imaging and we are proud to have pioneered this exciting new technology for clinical use. The commercial team at Polarean is prepared to rapidly launch XENOVIEW for clinical application."


Dr. Jason Woods, Director of Research in Pulmonary Medicine at the Cincinnati Children's Medical Center added: "My colleagues and I in the Xenon MRI research community are thrilled that this technology is now available to reach both adolescent and adult patients. With the availability of XENOVIEW in the clinical setting, we will have the ability to evaluate regional lung ventilation, delivered with a benign safety profile, which has been a major unmet need for the patients that look to us to better understand their lung disease." 

Polarean also announces that, simultaneously with the approval of the XENOVIEW NDA, two 510(k) devices were cleared by the FDA that will further support a successful launch of the technology into the clinical marketplace:


XENOVIEW VDP is image processing software that analyzes a pulmonary hyperpolarized 129-Xe MR image and a proton chest MR image to provide visualization and evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. This image analysis platform quantifies normalized xenon intensity of a ventilated space using a pulmonary hyperpolarized 129-Xe ventilation MR image and accompanying proton chest MR image. The software will be used by clinicians to assist in the interpretation and numerical classification of hyperpolarized 129-Xe ventilation MR images.


The Polarean XENOVIEW 3.0T Chest Coil is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 129Xe frequency on a 3.0T MRI magnetic field of a compatible MRI scanner. The Polarean XENOVIEW 3.0T Chest Coil is indicated to be used in conjunction with compatible 3.0T MRI scanners and approved xenon Xe 129 hyperpolarized for oral inhalation for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 129Xe gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 129Xe in the lungs. 




Clinical Trial Results: FDA approval of XENOVIEW was based on clinical trial results from two prospective, multi-center, randomized, open-label, cross-over clinical trials that compared XENOVIEW MRI to xenon Xe 133 scintigraphy in adult patients with pulmonary disorders. The mean XENOVIEW dose used in these trials was 99 mL Dose Equivalent ("DE") of hyperpolarized xenon Xe 129 at the time of measurement within 5 minutes of administration. Both trials met their primary endpoints. 


Study 1 compared XENOVIEW and xenon Xe 133 imaging in patients being evaluated for possible lung resection surgery. Patients had a medical history of respiratory disorders such as pulmonary mass (44%) and COPD (35%). Additional concomitant respiratory disorders were reported, including; cough (15%), sleep apnea syndrome (12%), and asthma (12%). In the primary analysis of 31 patients, the mean within-patient difference in the predicted postoperative percentage of remaining lung ventilation between XENOVIEW and xenon Xe 133 imaging was within a pre-specified equivalence interval with an observed estimate of 1.4% (95% confidence interval: -0.8%, 3.6%).


Study 2 compared XENOVIEW and xenon Xe 133 imaging in patients being evaluated for possible lung transplant surgery. Patients had a medical history of respiratory disorders, including; interstitial lung disease (49%), idiopathic pulmonary fibrosis (29%), COPD (22%), and other pulmonary fibrotic disorders (14%). In the primary analysis of the 49 patients who completed both scans, the mean within-patient difference in the percentage of overall lung ventilation contributed by the right lung between XENOVIEW and xenon Xe 133 imaging was within a pre-specified equivalence interval with an observed estimate of 1.6% (95% confidence interval: -3.7%, 0.5%).



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


US Customer support

Polarean offers support for customers who need assistance with; placing an order, reimbursement support, service request, and general inquiries. You may reach the Customer Care Center at 1-844-XENOVIE(W) or (1-844-936-6843) or via e-mail at


This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. 




 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

 Anna Dunphy / Phillip Marriage

Mob: +44 (0)7876 741 001 / +44 (0) 7867 984 082 



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 function, 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. On December 23, 2022, the FDA granted approval for Polarean's first drug device combination product, XENOVIEWTM (xenon Xe 129 hyperpolarized). 129Xe MRI is also currently being studied for visualization 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.


XENOVIEWTM is a trademark of Polarean, Inc. POL-PR-2201


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Date   Source Headline
21st May 20244:51 pmRNSProposed Placing, Subscription and Open Offer
10th May 20247:00 amRNSNew Xenon MRI System order received
8th May 20247:00 amRNSXenon MRI to be featured at ATS 2024 conference
3rd May 20247:00 amRNSOrder received for upgraded hyperpolariser
16th Apr 20247:00 amRNSU.S. Patent granted for Xenon MRI
14th Mar 20247:00 amRNSExercise of Warrants, Issue of Equity and TVR
12th Mar 20243:59 pmRNSHolding(s) in Company
29th Feb 20247:00 amRNS2024 Polarean Strategy Update
26th Jan 20247:00 amRNSBlock Listing Six Monthly Return
15th Jan 20247:00 amRNSComment re: share purchase
12th Jan 20245:00 pmRNSHolding(s) in Company
12th Jan 20245:00 pmRNSHolding(s) in Company
7th Dec 20237:00 amRNSCompany Update
27th Nov 20237:00 amRNSHolding(s) in Company
27th Sep 20231:59 pmRNSDirectorate Change
8th Sep 20237:00 amRNSPartnership with VIDA
7th Sep 20234:54 pmRNSHalf-year Report
7th Sep 20237:00 amRNSHalf-year Report
5th Sep 202311:51 amRNSReimbursement code price range for XENOVIEW
29th Aug 20237:00 amRNSCMS grants reimbursement code for XENOVIEW
21st Aug 20235:29 pmRNSHolding(s) in Company
15th Aug 20237:00 amRNSNotice of Results
7th Aug 20237:00 amRNSExercise of Warrants
3rd Aug 20237:00 amRNSClearance received for new MRI chest coil
31st Jul 20237:00 amRNSClinical imaging with XENOVIEW in Missouri
27th Jul 20237:00 amRNSBlock Listing Six Monthly Return
30th Jun 20237:00 amRNSExercise of Warrants
28th Jun 20233:00 pmRNSResult of AGM
21st Jun 20237:00 amRNSAppointment of Dr. Christopher von Jako as new CEO
2nd Jun 20233:00 pmRNSCollaboration with Philips at ISMRM 2023
2nd Jun 20237:00 amRNSExtension of Warrants
26th May 20237:00 amRNSFinal Results
11th May 20232:42 pmRNSFirst clinical scan using XENOVIEW in Cincinnati
3rd May 20235:00 pmRNSFeatured at 2023 ATS Respiratory Innovation Summit
26th Apr 20237:00 amRNSFirst order for XENOVIEW gas blend received
17th Apr 20237:00 amRNSAppointment of Dan Brague as consultant
14th Mar 20237:30 amRNSRestoration - Polarean Imaging PLC
14th Mar 20237:00 amRNSRequest for temporary suspension to be lifted
13th Mar 20237:30 amRNSSuspension - Polarean Imaging PLC
13th Mar 20237:00 amRNSSilicon Valley Bank Relationship
20th Feb 20234:35 pmRNSPrice Monitoring Extension
15th Feb 20237:00 amRNSInvestor presentation
13th Feb 20232:05 pmRNSSecond Price Monitoring Extn
13th Feb 20232:00 pmRNSPrice Monitoring Extension
13th Feb 202311:05 amRNSSecond Price Monitoring Extn
13th Feb 202311:00 amRNSPrice Monitoring Extension
13th Feb 20239:05 amRNSSecond Price Monitoring Extn
13th Feb 20239:00 amRNSPrice Monitoring Extension
13th Feb 20237:00 amRNSCompany Update
1st Feb 20234:40 pmRNSSecond Price Monitoring Extn

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