Corporate News

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: 

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 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, XENOVIEW^TM (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.

XENOVIEW^TM is a trademark of Polarean, Inc.                                                                  

PLC-RNS-2304

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: 

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 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, XENOVIEW^TM (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.

XENOVIEW^TM is a trademark of Polarean, Inc.                                                                  

PLC-RNS-2304

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: 

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 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, XENOVIEW^TM (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.

XENOVIEW^TM is a trademark of Polarean, Inc.                                                                  

PLC-RNS-2304

2020

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: 

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 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, XENOVIEW^TM (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.

XENOVIEW^TM is a trademark of Polarean, Inc.                                                                  

PLC-RNS-2304

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: 

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 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, XENOVIEW^TM (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.

XENOVIEW^TM is a trademark of Polarean, Inc.                                                                  

PLC-RNS-2304

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: 

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 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, XENOVIEW^TM (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.

XENOVIEW^TM is a trademark of Polarean, Inc.                                                                  

PLC-RNS-2304