polarean Regulatory News (POLX)

Polarean Imaging Plc

("Polarean" or the "Company")

Partnership with VIDA to streamline adoption of advanced MRI of the lungs

Two best-in-class lung imaging companies combine expertise for the deployment of xenon 129 MRI platform

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in advanced magnetic resonance imaging ("MRI") of the lungs, announces that it has partnered with VIDA Diagnostics ("VIDA"), a clinical imaging intelligence company providing medical imaging software solutions which manage the complexities of digital biomarkers. The companies are partnering to further enable the Polarean xenon 129 MRI platform to accelerate clinical and research use.

VIDA has empowered more than 1,000 clinical and research sites globally with its imaging management platform, a cloud-native AI-enabled solution that drives standardisation and efficiencies in clinical trial imaging operations. The platform includes a unique orchestration engine used to integrate and optimise multimodality clinical algorithms and enable new high-quality imaging biomarkers to be more accessible to researchers, and clinical trials, as well as adopted into the clinical care workflows.

The collaboration between Polarean and VIDA is intended to support the integration of xenon 129 MRI workflow into the clinical continuum of care to establish a clinical trial network for pharma-sponsored drug and device development using standardised xenon 129 MR image acquisition and data-sharing methods, and to create automated image processing workflows and algorithms. These new products and services will be utilised to expand access to xenon 129 MRI as a lung imaging service and to investigate new indications and biomarkers in broader populations with unmet medical needs. Additionally, through this collaboration, each company will foster new research collaborations and amplify the opportunities it can bring to its lung imaging customers.

Christopher von Jako, Ph.D., CEO of Polarean, said: "Polarean continues to cultivate partnerships with entities that enhance our core capabilities. We are excited to form this partnership with VIDA, a world-renowned organisation in the field of lung imaging software platform solutions and biomarker development, to capitalise on their complementary expertise. Furthermore, this partnership perfectly aligns with our objective of extending the reach of XENOVIEW MRI, to provide tools to physicians that treat patients suffering from chronic lung disease."

Susan Wood, Ph.D., CEO of VIDA, said: "VIDA and Polarean are natural partners. Both companies share a goal of empowering providers with advanced medical imaging solutions to enhance clinical decisions and accelerate bringing new therapies to patients. We are excited at the prospect of expanding our imaging platform portfolio through our collaboration with Polarean, thereby introducing pioneering MRI-based lung imaging biomarkers."

Polarean recently launched the first and only inhaled MRI hyperpolarised contrast agent, XENOVIEWTM (xenon Xe 129, hyperpolarised), for novel visualisation of lung ventilation. Since the technology is based on MRI, it does not expose patients to any ionising radiation and its associated risks. The dose of XENOVIEW, created through the Polarean HPX hyperpolarisation system, is administered in a single 10-15 second breath-hold MRI procedure. XENOVIEW is indicated for use with MRI for evaluation of lung ventilation in adults and paediatric patients aged 12 years and older. XENOVIEW has not been evaluated for use with lung perfusion imaging.

Enquiries: 

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. The company also commercialises systems (such as the HPX hyperpolarisation 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.

About VIDA Diagnostics, Inc. 

VIDA is a clinical imaging intelligence company that is accelerating the development of life-saving therapies to patients through an AI-powered digital biomarker solution. With proprietary imaging biomarkers for precise quantitative endpoints and a trial imaging management solution, VIDA's solution is helping biopharma sponsors save millions in drug development costs. VIDA's software is FDA cleared, CE-marked, Health Canada licensed, TGA registered, and PMDA certified for clinical use in the U.S., European Economic Area, Canada, Australia, and Japan. Learn more at https://vidalung.ai. Follow @vidalung on Twitter and LinkedIn. 

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 Paediatric and Adolescent Patients: In published literature in paediatric 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 paediatric 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 paediatric patients less than 12 years of age.

Please see full prescribing information at www.xenoview.net

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