polarean Regulatory News (POLX)

13 March 2023

Polarean Imaging Plc

("Polarean" or the "Company") 

 Silicon Valley Bank Relationship

Request for temporary suspension from trading on AIM

Company provides update on exposure to Silicon Valley Bank ("SVB") receivership in light of US Federal Reserve announcement

Polarean Imaging plc (AIM: POLX), the medical imaging technology company, announces that the Company has sufficient cash outside of SVB to meet its immediate liquidity needs.

Cash Balances

The Company had a total cash balance of $13.9M on 28 February 2023. $1.5M of this cash is held at Wells Fargo. $12.4M of this cash is held through Silicon Valley Bank, of which $9.8M is held in money market mutual fund accounts ("MMFA") operated by other financial institutions (Morgan Stanley, BlackRock and Western Asset). In addition, the Company has $1.0M in a SVB checking account and £1.3M ($1.6M) in a SVB sterling checking account. The United States Federal Deposit Insurance Corporation ("FDIC") guarantees $250,000 of deposits in the US.

Money Market Mutual Fund Accounts

Based on the Company's review of its banking agreements and information currently in the public domain, the Directors believe that the $9.8M MMFA shares are not considered deposits of SVB and, therefore, not a part of the SVB receivership estate. However, Polarean may not have immediate access to these funds until the FDIC establishes procedures for access.

Working Capital

The $1.5M held at Wells Fargo will fund the working capital needs of the Company through the end of April 2023. In addition, the FDIC has indicated they will provide companies with access to their $250,000 guaranteed amounts in the very near-term.

Next Steps

The US Federal Reserve has issued a press release stating that it has created an emergency lending facility guaranteeing depositors access to their funds: federalreserve.gov/newsevents/pressreleases/monetary20230312a.htm. The press release states that the funds will be made accessible from today.

The Company has requested that the listing of the Company's ordinary shares on AIM be temporarily suspended while it seeks further clarification.

The Company will update the market when appropriate.

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: 

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.

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