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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Attis surges after increasing production levels
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University of Kansas Medical Center orders another of Polarean’s 9820 Xenon Polariser systems
The hyperpolarised 129-Xenon gas helps to create a much stronger MRI signal, providing doctors with multiple images of lung structure and function
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FTSE 100 closes lower again as European shares slide as mood sours
Footsie closed on Thursday nearly 21 points lower at 7,509.
Polarean Imaging reports slightly higher revenues and lower costs
"We have begun early discussions with potential strategic partners in the pharmaceutical industry and in other geographic markets that could lead to important developments in new applications and uses for our technology"
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FTSE 100 closes lower on day but up slightly on week as trade tensions still weigh
The UK's index of leading company shares closed Friday down nearly 23 points at 7,345
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Polarean Imaging begins enrolling at third site for clinical trials of MRI lung scan
If approved by the FDA, commercial launch of the combined drug-device product is expected to occur during the second half of 2020, as previously indicated
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FTSE 100 closes higher despite continued trade fears
China has pledged to spend more on infrastructure to offset any downturn caused by Trump’s trade tariffs
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Polarean Imaging receives system order from Canadian children’s hospital
The order for the 9820 Xenon Polariser system will take the total number of Polarean's polarisers installed or on order to 24
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FTSE 100 closes near flat as US ADP jobs report shakes confidence
The UK blue-chip share index finished up around four points at 7,218
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Stilo putting on the agony after a profit warning
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Cellcast downcast as Kenya ups the ante in attack on the gambling industry
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Polarean Imaging to receive third tranche of research grant
The grant was awarded from the National Heart, Lung and Blood Institute to Polarean and Cincinnati Children's Hospital Center. The money will continue to fund an ongoing Phase III trial evaluating the use of 129 Xe MRI scanning on children
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Polarean adds third trial site to late-stage study of its lung MRI scan technology
MRI scans generally aren’t very useful in assessing lung function, but Polarean’s 129Xe gas is trying to change that
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Polarean Imaging appoints former CFO of cancer therapeutics firm as new finance boss
Charles (Chuck) Osborne, Jr joins the company from oncology group Innocrin Pharmaceuticals and would start the role with immediately
FTSE 100 closes higher after US inflation data
It comes after latest data showed that core inflation in the US was flat last month (March) while consumer spending rose
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Amphion Innovations provides “concentrated but well-managed portfolio” in high growth sectors
The company invests and helps build companies in the medical and technology sectors, with a target exit valuation of over US$100mln
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Stobart Group flying high after court room victory
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Polarean Imaging signs deal with University of British Colombia
CEO Richard Hullihen said: “UBC has a long history and pioneering reputation in the field of medical imaging research and I look forward to providing further updates regarding our collaboration with UBC as appropriate.”
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FTSE 100 joins global benchmarks to head higher on Friday on trade deal hopes
Britain's blue chip index closed up around 39, or 0.55% at 7,236 on the day
Hardware & electrical equipment
Amphion Innovations still looking at funding options; unsure why shares have surged of late
“The company remains cash constrained and as previously announced continues to consider both its short term and medium-term funding options and work with the company's debt providers”
City broker reckons Polarean shares are worth three times their current value
“The annual burden of pulmonary disease in the US is estimated to be over US$150bn and Polarean expects over US$500mln in system sales just to top-tier institutes,” read Northland’s note
Hardware & electrical equipment
Amphion Innovations agrees loan facility top up
Following drawdown of the new funds, the balance on the loan facility will be US$4.23mln
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Amphion Innovations lines up FireStar for 2019 IPO
Another of Amphion’s investee companies, Polarean Imaging, was floated on AIM earlier this year, and FireStar is the next one earmarked to go public
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Amphion Innovations announces first patient enrolment in Phase III FDA clinical trial
The trial is aiming to demonstrate the non-inferiority (i.e. the efficacy in treatment) of the group's drug-device combination
Amphion Innovations gets a boost from Polarean's progress
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Amphion Innovations chairman and non-executive director step down
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FTSE 100 closes higher ending an "ugly quarter"; GKN top riser after Melrose succeeds in bid
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