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Pin to quick pickspolarean Regulatory News (POLX)

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Company update

6 Nov 2018 07:00

RNS Number : 4102G
Polarean Imaging PLC
06 November 2018
 

Polarean Imaging Plc 

("Polarean" or the "Company")

 

Company Update

 

Polarean Imaging plc (AIM: POLX), the medicalimaging technology company, with a proprietary drugdevice combination product for the magnetic resonance imaging (MRI) market, provides shareholders with the following update on Company progress:

 

New System Installation

Further to the announcement made on 3 October 2018, the Company announces the installation and commissioning of the latest model of Polarean's Xenon polariser to The Department of Radiology at University of Missouri Health Care ("MUHC"). The University of Missouri, Columbia is the flagship university in the University of Missouri system. The Department of Radiology at MUHC has a successful imaging research programme that will be further enhanced with the addition of hyperpolarised gas MRI. Faculty members Robby Thomen PhD, Lucia Flors, MD, PhD and Talissa Altes MD bring expertise from previous work at successful hyperpolarised gas imaging sites (Dr. Flors and Dr. Altes from University of Virginia and Dr. Thomen from Cincinnati Children's Hospital) and plan to establish a new hyperpolarised gas laboratory at MUHC focused on basic research and clinical translation.

 

Robby Thomen, Assistant Professor in Radiology and BioEngineering at MUHC, said: "We believe that hyperpolarised gas MRI opens a door to numerous applications in medicine and we're excited to bring the technology to the Midwest. The high polarisation and throughput afforded by Polarean's device along with its ease of use is necessary to bring the technology into the clinic and see real patient benefit. We are excited to work closely with Polarean to this end."

 

Richard Hullihen, CEO of Polarean, said: "We are excited to welcome the University, Drs. Altes, Thomen, and Flores and their staff to the community of researchers using our technology to develop these patient-benefitting clinical applications of the future. These include The University of Oxford, University of Wisconsin, Fraunhofer Institute, Robarts Institute, University of North Carolina, and others."

 

New Order

The Company also announces receipt of a new order to provide an upgrade to the polariser already operating at SickKids Hospital in Toronto (www.sickkids.ca), one of its earliest customers. This upgrade will more than double the system polarisation levels and will be a benefit to the research programme there in providing better image quality and results. This acquisition was enabled by a grant from the Canada Foundation for Innovation (for more information see: www.innovation.ca/about).

 

Richard Hullihen, CEO of Polarean, commented: "This is the most recent example of upgrading earlier polarisers to later levels of performance and supporting the work of our collaborative researchers worldwide. The staff at SickKids have co-ordinated one of the most prolific research programmes in hyperpolarised noble gas imaging from the start. We are grateful to the CFI for supporting this vital work and enabling us to upgrade the installed system there, which is a testament to the development potential of the original design."

 

Clinical Trial Update

The Company can also update shareholders that its Phase III Non-Inferiority Clinical Trial is up and running at both of its sites, Duke University and University of Virginia. Candidate patient flows are showing to be as planned for transplant and resection, screening methods are functioning as designed, enrolment is happening in both clinical indication pathways and data collection is in process. Per the design of the trial, data analysis will begin after a sufficient percentage of patients in both pathways have been accumulated.

 

Richard Hullihen, CEO of Polarean, said: "We are grateful to the staff and our trial institutions Duke and University of Virginia for their support and performance in conducting the trial, we are pleased with the performance of our CROs in executing and managing the trial, and look forward to the on-schedule completion of trial enrolment during the second quarter of 2019."

 

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

 

Enquiries:

 

Polarean Imaging plc

www.polarean.com / www.polarean-ir.com

Richard Hullihen, Chief Executive Officer

Via Walbrook PR

Richard Morgan, Chairman

 

 

 

Northland Capital Partners Limited

Tel: +44 (0)20 3861 6625

David Hignell / Gerry Beaney / Jamie Spotswood (Corporate Finance)

Vadim Alexandre/ Rob Rees (Corporate Broking)

 

 

 

MC Services (European IR)

Tel: +49 (0)89 210 2280

Raimund Gabriel

 

 

 

The Life Sciences Division (Financial Adviser)

 

Navid Malik, Director

Mob: 07957 224 730

Alia Minhas, Chief Executive Officer

Mob: 07590 696 057

 

 

Walbrook PR

Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com

Paul McManus / Anna Dunphy

Helen Cresswell

Mob: +44 (0)7980 541 893 / +44 (0)7879 741 001

+44 (0)7841 917 679

    

 

 

About Polarean (www.polarean.com)

 

The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are revenue generating, medical drug-device combination companies operating in the high resolution functional magnetic resonance imaging market.

The Group develops equipment that enables existing MRI systems to achieve an improved level of pulmonary function imaging and specialises in the use of hyperpolarised Xenon gas (129Xe) as an imaging agent to visualise ventilation and gas exchange regionally in the smallest airways of the lungs, the tissue barrier between the lung and the bloodstream and in the pulmonary vasculature. Xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs.

 

The Group operates in an area of significant unmet medical need and the Group's technology provides a novel diagnostic approach, offering a non-invasive and radiation-free functional imaging platform which is more accurate than current methods. The annual burden of pulmonary disease in the US is estimated to be over US$150 billion.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
 
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UPDVELFBVFFLFBL
Date   Source Headline
16th Apr 20247:00 amRNSU.S. Patent granted for Xenon MRI
14th Mar 20247:00 amRNSExercise of Warrants, Issue of Equity and TVR
12th Mar 20243:59 pmRNSHolding(s) in Company
29th Feb 20247:00 amRNS2024 Polarean Strategy Update
26th Jan 20247:00 amRNSBlock Listing Six Monthly Return
15th Jan 20247:00 amRNSComment re: share purchase
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27th Sep 20231:59 pmRNSDirectorate Change
8th Sep 20237:00 amRNSPartnership with VIDA
7th Sep 20234:54 pmRNSHalf-year Report
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5th Sep 202311:51 amRNSReimbursement code price range for XENOVIEW
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27th Jul 20237:00 amRNSBlock Listing Six Monthly Return
30th Jun 20237:00 amRNSExercise of Warrants
28th Jun 20233:00 pmRNSResult of AGM
21st Jun 20237:00 amRNSAppointment of Dr. Christopher von Jako as new CEO
2nd Jun 20233:00 pmRNSCollaboration with Philips at ISMRM 2023
2nd Jun 20237:00 amRNSExtension of Warrants
26th May 20237:00 amRNSFinal Results
11th May 20232:42 pmRNSFirst clinical scan using XENOVIEW in Cincinnati
3rd May 20235:00 pmRNSFeatured at 2023 ATS Respiratory Innovation Summit
26th Apr 20237:00 amRNSFirst order for XENOVIEW gas blend received
17th Apr 20237:00 amRNSAppointment of Dan Brague as consultant
14th Mar 20237:30 amRNSRestoration - Polarean Imaging PLC
14th Mar 20237:00 amRNSRequest for temporary suspension to be lifted
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13th Mar 20237:00 amRNSSilicon Valley Bank Relationship
20th Feb 20234:35 pmRNSPrice Monitoring Extension
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1st Feb 20234:25 pmRNSFDA grants New Chemical Entity designation
27th Jan 20237:00 amRNSBlock listing six monthly return
28th Dec 20229:05 amRNSSecond Price Monitoring Extn

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