polarean Regulatory News (POLX)

Polarean Imaging Plc

("Polarean" or the "Company") 

Collaboration with Philips to be featured at ISMRM 2023

Philips' MR 7700 MRI scanner to be combined with XENOVIEW™, showcasing the capability to enhance pulmonary imaging by providing regional maps of ventilation in patients' lungs

Polarean Imaging plc (AIM:POLX), the medical imaging company, announces that it has entered into a collaboration with Philips, a global leader in health technology, to advance the field of hyperpolarised Xenon MRI. Philips will showcase its 3T MR 7700 system ("MR 7700"), featuring fully integrated multi-nuclei imaging, including Polarean's XENOVIEW (xenon Xe 129 hyperpolarised) technology at the 2023 International Society for Magnetic Resonance in Medicine Annual Meeting & Exhibition ("ISMRM"), held from 3-8 June, in Toronto, Canada.

This non-exclusive collaboration facilitates the sharing of technical data and marketing materials to jointly advance the field of Xenon MRI into the clinical realm. The collaboration delivers an advanced solution for the evaluation of lung ventilation in patients 12 years of age and older based on Xenon gas MR imaging, providing clinicians with enhanced productivity and image quality improvements. XENOVIEW has not been evaluated for use with lung perfusion imaging.

Combining XENOVIEW with Philips MR 7700 multi-nuclei MRI scanner may allow clinicians to view a patient's lungs in greater detail, while also enabling them to accurately measure lung ventilation. For patients with pulmonary disease, it has the potential to make the difference between early diagnosis and intervention in serious obstructive lung diseases. The first XENOVIEW clinical scan in North America recently took place at Cincinnati Children's Hospital Medical Center on a Philips MRI system using the 510(k) cleared multi-nuclei imaging scanning module.

Polarean team members, including Richard Hullihen, CEO and Alex Dusek, CCO will be onsite at ISMRM 2023 (booth #G23) to provide information on the technology and also for networking.

Richard Hullihen, CEO of Polarean, said: "Having attained FDA approval for the first and only hyperpolarized MR contrast agent with the launch of XENOVIEW at the beginning of 2023, we are excited to enter this agreement with Philips. Its strategic focus on patient and workflow centric multi nuclei imaging in its 3T system provides a uniquely capable platform for clinicians to extend their assessment of lung ventilation. By deploying this novel technology to visualize otherwise unobtainable clinical information using MRI technology, MR imaging can now be expanded into pulmonary medicine, providing a quantitative tool to help clinicians and the patients they treat."

Ruud Zwerink, General Manager of Magnetic Resonance and Digital X-Ray at Philips, said "With the MR 7700, we have seamlessly integrated multi-nuclei MR imaging into everyday workflows, making multi-nuclei studies of six different nuclei across all anatomies as simple as dragging and dropping the selected protocol onto an exam card. Our collaboration with Polarean to bring hyperpolarized Xenon imaging into the equation is a major breakthrough in our efforts to improve the diagnosis and management of respiratory disease."

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About Polarean (www.polarean.com)

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, XENOVIEW™ (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 www.xenoview.net

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