Last checked at 14 Mar 2023 07:00
14 March 2023
Polarean Imaging Plc
("Polarean" or the "Company")
Request for temporary suspension from trading on AIM to be lifted
Following a press release by the US Federal Reserve and the US Federal Deposit Insurance Corporation ("FDIC") stating that the FDIC transferred all deposits and substantially all assets of the former Silicon Valley Bank to a newly created, full-service FDIC-operated 'bridge bank' in an action designed to protect all depositors of Silicon Valley Bank, the Company has verified its account balances and its ability to access its funds, and confirms it has full access to its previously outlined resources. Operating activities of the Company have proceeded unaffected throughout the course of this event.
As a result, the Company has requested that the temporary suspension of the Company's ordinary shares on AIM is now lifted.
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.
Enquiries:
Polarean Imaging plc | www.polarean.com / www.polarean-ir.com | ||||
Richard Hullihen, Chief Executive Officer | Via Walbrook PR | ||||
Kenneth West, Chairman | |||||
Stifel Nicolaus Europe Limited (NOMAD and Sole Corporate Broker) | +44 (0)20 7710 7600 | ||||
Nicholas Moore / Samira Essebiyea / Kate Hanshaw (Healthcare Investment Banking) | |||||
Nick Adams / Nick Harland (Corporate Broking) | |||||
Walbrook PR | Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com | ||||
Anna Dunphy / Phillip Marriage | Mob: +44 (0)7876 741 001 / +44 (0) 7867 984 082 | ||||
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 function, 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 December 23, 2022, the FDA granted approval for Polarean's first drug device combination product, XENOVIEWTM (xenon Xe 129 hyperpolarized). 129Xe 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 Xenoview
Indication
Xenoview, prepared from the xenon Xe 129 Gas Blend, is a hyperpolarised contrast agent for use with magnetic imaging (MRI) for evaluation of lung ventilation in adults and paediatric patients aged 12 years and older.
Limitations of Use
Xenoview has not been evaluated for use with lung perfusion imaging.
Important Safety Information
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 saturation 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 Patients: In published literature in paediatric patients aged 6 to 18 years, the following 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 were reported following hyperpolarised xenon Xe 129 administration. XENOVIEW is not approved for use in paediatric patients less than 12 years of age.
See full U.S. Prescribing Information at www.xenoview.net
XENOVIEW has received marketing approval in the United States and not in other countries.
XENOVIEWTM is a trademark of Polarean, Inc.
PLC-RNS-2304