polarean Regulatory News (POLX)

Polarean Imaging Plc

(“Polarean” or the “Company”) 

Featured company at 2023 ATS Respiratory Innovation Summit

Polarean also exhibiting at 2023 American Thoracic Society annual meeting, providing a great opportunity to showcase XENOVIEW technology to other pulmonary care innovators and providers

Polarean Imaging plc (AIM: POLX), the medical imaging technology company, has been selected as one of the featured companies as a poster presenter at the American Thoracic Society's ("ATS") 2023 Respiratory Innovation Summit ("RIS"), taking place 19-20 May in Washington D.C.

The Respiratory Innovation Summit unites innovators, investors, clinicians, and advocacy groups who work in the field of pulmonary medicine. The meeting historically attracts more than 275 global leaders representing all facets of the respiratory industry, including start-ups, venture capital, government, academia, and clinicians.

In addition to Polarean being selected as a featured company, Bastiaan Driehuys, PhD, Polarean's Chief Scientific Officer, will speak on lung imaging as a panel member in the "Biomarkers and Innovation" session taking place in the afternoon of 20 May at RIS.

Following the Respiratory Innovation Summit, Polarean will be exhibiting at the 2023 ATS International Conference, taking place 21-24 May. Polarean team members, including Bastiaan Driehuys, PhD (Chief Scientific Officer), and Alex Dusek (Chief Commercial Officer) will be onsite to provide information on the technology and also for networking. Polarean can be found at booth # 2137.

The ATS International Conference connects specialists in all aspects of respiratory health - from clinicians to researchers to educators, all of whom share a passion for improving patient care. The conference showcases the latest advances and discoveries in respiratory science, patient care, and global public health.

Richard Hullihen, CEO of Polarean, said: "The Respiratory Innovation Summit and the American Thoracic Society's annual conference provide a great venue to showcase XENOVIEW and the Xe MRI platform with individuals interested in the opportunities to collaborate. By creating greater awareness of our Xe MRI platform amongst clinicians, regulators, investors, and potential pharma industry partners, these events will be another step in advancing our commercialization strategy by growing awareness and interest in the different ways that our technology can move pulmonary care forward."

Additionally, at ATS numerous clinicians and scientists will be presenting on various research applications of Xe MRI. A listing of these presentations, their title, author, and session time is available below.

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 revolutionize 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, 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 Dec. 23, 2022, the FDA granted approval for Polarean's first drug device combination product, XENOVIEWTM (Xenon Xe129 hyperpolarized). Xe129 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.

About The American Thoracic Society (www.thoracic.org)

The American Thoracic Society (ATS) improves global health by advancing research, patient care, and public health in pulmonary disease, critical illness, and sleep disorders. Founded in 1905 to combat TB, the ATS has grown to tackle asthma, COPD, lung cancer, sepsis, acute respiratory distress, and sleep apnea, among other diseases.

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