Polarean Imaging to submit NDA early in October
"The installation of new polarisers has continued and users of our systems are publishing research at an increased rate"
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 Imaging completes the 23rd installation of its breakthrough lung monitoring technology
The company has developed a drug-device combination which uses hyperpolarised 129-Xenon gas MRI
Polarean Imaging technological advances to be showcased at two industry conferences
Over 40 abstracts underlining the potential of hyperpolarized Xenon 129 have been accepted for the virtual events
Polarean Imaging hails year of accomplishment, targets FDA submission in third quarter
The medical imaging firm said it is focused on preparing its new drug application submission to the US regulator and is “hopeful” of receiving regulatory approval in the second half of 2021
Polarean Imaging bags £8.4m fundraising; welcomes new strategic investor
One of the new investors that joined in the placing is Bracco Imaging, part of Italy’s multinational Bracco Group and a world leader in diagnostic imaging
Polarean Imaging names Dr Jonathan Allis as non-executive chairman with immediate effect
Dr Allis is currently the founder and chief executive officer of Blue Earth Diagnostics, which was recently acquired by Bracco Imaging for US$450mln
Polarean Imaging scores phase III success
The company said it expects to submit a new drug application (NDA) for its drug/device in the third-quarter after what’s called a pre-NDA meeting with the US Food & Drug Administration
Polarean Imaging installs polariser at the University of Iowa Hospitals and Clinics
The University of Iowa Hospitals and Clinics is Iowa's only comprehensive academic medical centre;
Polarean Imaging delivers latest research unit
The order for the 9820 Xenon Polariser system was from the University of British Columbia
Polarean completes patient enrolment for Phase III clinical trial of MRI lung scan technology
The company is aiming to show in the trials that its drug-device combination, which uses a type of Xenon gas in MRI machines, is as good as current methods for diagnosing breathing problems
Hardware & electrical equipment
Amphion no longer holds any shares in Polarean Imaging
Amphion had pledged the shares as security against a loan and had no say in the decision to sell the shares
Hardware & electrical equipment
Polarean Imaging jumps as Amphion agrees loan extension
Amphion's institutional lender has agreed to allow the loan maturity date of the loan to be pushed back by a year to next September
Polarean Imaging expects top-line clinical trial data by year-end
"We have now entered a crucial period for the company as the clinical trials near completion"
Polarean installs second Xenon Polariser at SickKids hospital in Toronto
The new unit will expand the research at the hospital and bring Polarean’s total number of the installed and on-order polarisers to 24
Polarean Imaging on track to complete trial recruitment by the end of the current quarter after enrolment begins at third US site
MRI scans generally aren't much use when assessing lung function, but Polarean has developed a way in which a small amount of inert gas can change that
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Polarean Imaging raises £2.1mln in share placing
“We are now entering a crucial period in Polarean's development and I look forward to providing our shareholders with further updates as appropriate," said chief executive Richard Hullihen.
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