Polarean Imaging continues preparations for launch pending FDA approval
“Although the delay in FDA approval is disappointing, we are using this time to continue to explore potential future applications for our technology”
Company
Polarean Imaging PLC
LON:POLX
Polarean Imaging PLC and its wholly owned subsidiary, Polarean Inc., 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.
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Polarean and Oxford University to collaborate on long Covid study
Polarean will provide its xenon polariser system for the EXPLAIN study being run by OUH
Polarean Imaging chairman retires; new independent director appointed
Jonathan Allis is retiring and will be replaced by existing independent director, Kenneth West
Polarean Imaging secures new system order
"We are pleased to announce the ordering of the latest model of our xenon polariser from the CCHMC [Cincinnati Children's Medical Center]," said Richard Hullihen, Polarean Imaging's CEO
Polarean Imaging says US regulator accepts updated submission
The Food & Drug Administration set a user fee goal date, effectively a deadline to assess the application, of September 30
Polarean Imaging appoints former GE Healthcare exec as independent director
Frank Schulkes’ last appointment was as CFO of ConvaTec Group, the FTSE 250 medical products and technologies group
Polarean Imaging upbeat as it resubmits new drug application to US FDA
"We look forward to completing the Food & Drug Administration review and approval processes necessary to bring our unique technology to market addressing the significant unmet need for our non-invasive, quantitative and cost-effective funct
Polarean Imaging says Canada's McMaster University orders additional kit
Polarean is the pioneer of using xenon-129 gas to enhance magnetic resonance imaging and has created a drug-device product based on its know-how
Polarean Imaging completes BC hospital installation
The hyperpolarisation system order was previously announced in May 2021
Polarean Imaging receives Complete Response Letter from US Food and Drug Administration
The list of issues provided by the regulator are “attainable” and “mostly technical or manufacturing-related in nature”, the company said
Polarean Imaging says its technology has been installed at the world-renowned MD Anderson Cancer Center
The firm's drug-device combination allows medics and researchers to use magnetic resonance imaging to assess lung function by deploying xenon gas
Polarean Imaging hails "year of accomplishment of critical goals"
"We have made significant board changes to reflect our progress and we're very excited to have a target PDUFA date from the FDA," said Richard Hullihen, Polarean's CEO
Polarean Imaging lands second order from the University of British Columbia
The BC Children's Hospital is a major paediatric research and teaching hospital and is the most well-known facility in the province for dealing with juvenile health
Polarean Imaging hits funding target in open offer
"The net proceeds of the fundraise will allow us to prepare for commercialisation and launch post-approval of our proprietary drug-device combination in the United States."
Polarean Imaging plans to raise at least £20mln to help fund breakthrough drug-device
The company said minimum of £17.5mln will come via a share placing
Polarean Imaging is fully funded to complete regulatory process
The company has developed a drug-device combination, which uses hyperpolarised 129-Xenon gas MRI
Polarean Imaging hails latest milestone as US regulator confirms acceptance of its new drug application
The company has developed a drug‑device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging in pulmonary medicine
Novel MRI scan type can find undetected lung damage in former COVID-19 patients, study shows
The use of xenon gas helped to identify lung damage that conventional scans wouldn't show
Polarean Imaging receives order from world-leading cancer research and teaching hospital
University of Texas MD Anderson Center has placed a research unit order for the 9820 Xenon Polariser
Polarean Imaging submits hyperpolarised Xenon gas MRI NDA to FDA for priority review
The gas is used to evaluate pulmonary function and to visualise the lung using magnetic resonance imaging (MRI)