Polarean Imaging Plc
("Polarean" or the "Company")
Submission of new Phase III study protocol to FDA for expanded indication of XENOVIEW
Gas exchange protocol submitted for final feedback is key to finalising the plan for this trial
Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs , announces 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 Q4 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.
Christopher von Jako, Ph.D., Chief Executive Officer of Polarean said: "Submission of this new protocol and our Type C meeting request marks a critical milestone in Polarean's clinical development programme and mission to transform pulmonary imaging.
"Embarking on a multi-center trial to add gas-exchange to the existing ventilation indication is key to our growth strategy. If successful, this expanded utility of XENOVIEW will have the potential to provide a comprehensive, multi-compartment assessment of deep lung function, information that is not currently with conventional imaging or pulmonary function tests, all in a single breath hold."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018.
For more information, visit www.xenoview.net.
Enquiries:
| Polarean Imaging plc |
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| Christopher von Jako, Ph.D., Chief Executive Officer Charles Osborne, Chief Financial Officer |
Via Walbrook PR
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| Stifel (NOMAD and Sole Corporate Broker) |
+44 (0)20 7710 7600 |
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| Nicholas Moore / Nick Harland / Ben Good |
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| Walbrook PR |
Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com |
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| Anna Dunphy / Paul McManus / Marcus Ulker |
Mob: +44 (0)7876 741 001 |
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About Polarean
Polarean is a revenue-generating medical imaging technology company revolutionising pulmonary medicine through direct visualisation 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 optimise 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 hyperpolarisation science and has successfully developed the first and only hyperpolarised Xenon MRI inhaled contrast agent, XENOVIEW™, which is now FDA-approved in the United States. Polarean is dedicated to researching, developing, and commercialising 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 hyperpolarisation 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 www.polarean.com .
XENOVIEW IMPORTANT SAFETY INFORMATION
Indication
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 pediatric patients aged 6 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.
Please see full prescribing information at www.XENOVIEW.net
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