polarean Regulatory News (POLX)

Polarean Imaging plc

("Polarean" or the "Company")

Key Patent in China Secured

New patent covers the use of Xenon MRI to non-invasively visualise pulmonary gas exchange and vascular function

Polarean Imaging Plc (AIM: POLX), a commercial-stage medical device leader in advanced Magnetic Resonance Imaging ("MRI") of lung function, announces the issuance of Chinese patent ZL201980047729.5.

The new Chinese patent covers the use of Polarean's Xenon MRI platform to visualise global and regional pulmonary gas exchange and microvascular blood flow in real time, helping position the Company for a potential future entry into the Chinese market and underscoring the Company's commitment to tackling the global burden of lung disease.

China has one of the highest burdens of lung disease globally, driven by factors such as air pollution, smoking, and an aging population, accounting for nearly a quarter of all chronic obstructive pulmonary disease (COPD) cases and 40% of new lung cancer cases globally. Chronic conditions like interstitial lung disease (ILD) and pulmonary hypertension are major challenges, particularly when symptoms such as unexplained dyspnea (breathlessness) cannot be clearly diagnosed using conventional tools. By illuminating hidden aspects of lung function, Polarean's Xenon MRI platform offers clinicians valuable new insights into complex lung diseases.

Christopher von Jako, Ph.D., CEO of Polarean, commented: "This new patent represents another step forward in our mission to optimise lung health globally. China faces an immense burden of respiratory diseases, and the addition of this patent will enable us, when the time is right, to bring our innovative, non-invasive Xenon MRI platform to a country that urgently needs it. With our cutting-edge Xenon MRI platform, we aim to deliver novel diagnostic tools that can improve outcomes for millions of patients with lung disease."

Chase Hall, M.D., Chief Medical Advisor at Polarean, added: "China's burden of chronic lung disease is exacerbated by late diagnoses and inadequate screening. Our newly granted patent for gas exchange imaging will help expand the use of Xenon MRI in China to visualise lung function and vascular health - potentially enabling earlier detection, better monitoring of disease progression, and providing a new tool to help clinicians improve the long-term outlook for conditions like COPD, asthma, and ILD."

Enquiries:

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 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 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 hyperpolarised xenon Xe 129 administration. XENOVIEW is not approved for use in pediatric patients less than 12 years of age.