logo-loader
Polarean Imaging PLC

Phase III Clinical Trials - Update

/**/ link{ color: #0563C1 }visited{ color: #954F72 } .v{size:595.0pt 841.0pt;margin:72.0pt 72.0pt 28.4pt 72.0pt;}div.v{}p.a,li.a,div.a{margin:0cm;margin-bottom:.0001pt;font-size:12.0pt;font-family:"Calibri","sans-serif";}p.bf{margin:0cm;margin-bottom:.0001pt;font-size:12.0pt;font-family:"Calibri","sans-serif";font-weight: bold; text-align: center}span.bd{font-size:11.0pt}p.bg{margin:0cm;margin-bottom:.0001pt;font-size:12.0pt;font-family:"Calibri","sans-serif";text-align: center}p.bh{margin:0cm;margin-bottom:.0001pt;font-size:12.0pt;font-family:"Calibri","sans-serif";font-weight: bold}p.bi{margin:0cm;margin-bottom:.0001pt;font-size:12.0pt;font-family:"Calibri","sans-serif";text-align:justify;text-justify:inter-ideograph}p.bj{margin:0cm;margin-bottom:.0001pt;font-size:12.0pt;font-family:"Calibri","sans-serif";font-weight: bold; text-align: justify; text-justify: inter-ideograph}span.u{color:black;} p.bk{margin:0cm;margin-bottom:.0001pt;font-size:12.0pt;font-family:"Calibri","sans-serif";margin-right:.6pt;text-align:justify;text-justify: inter-ideograph}span.ax{font-size:11.0pt;letter-spacing: -.05pt}span.aw{font-size:11.0pt; letter-spacing:1.6pt}span.av{font-size:11.0pt; letter-spacing:-.05pt}span.au{font-size:11.0pt;letter-spacing:1.65pt}span.at{font-size:11.0pt;letter-spacing:-.1pt}span.as{font-size:11.0pt;letter-spacing:-.05pt}span.ar{font-size:11.0pt;letter-spacing:1.6pt}span.aq{font-size:11.0pt;letter-spacing:1.5pt}span.ap{font-size:11.0pt;letter-spacing:-.2pt} p.bl{margin:0cm;margin-bottom:.0001pt;font-size:12.0pt;font-family:"Calibri","sans-serif";font-div: italic; margin-right: .6pt; text-align: justify; text-justify: inter-ideograph}span.an{font-size:11.0pt;letter-spacing: -.2pt}p.bm{margin:0cm;margin-bottom:.0001pt;font-size:12.0pt;font-family:"Calibri","sans-serif";font-div: italic; text-align: justify; text-justify: inter-ideograph}span.ak{font-size:11.0pt;color:black}table.bn{width:459.9pt;margin-left:-5.4pt;border-collapse:collapse}td.aj{width:228.6pt;padding:0cm 5.4pt 0cm 5.4pt}td.ah{width:209.7pt;padding:0cm 5.4pt 0cm 5.4pt}p.bo{margin:0cm;margin-bottom:.0001pt;font-size:12.0pt;font-family:"Calibri","sans-serif";text-align: right}td.ag{width:315.0pt;padding:0cm 5.4pt 0cm 5.4pt}td.ae{width:123.3pt;padding:0cm 5.4pt 0cm 5.4pt} p.bp{margin:0cm;margin-bottom:.0001pt;font-size:12.0pt;font-family:"Calibri","sans-serif";font-div: italic; text-align: right}p.bq{margin:0cm;margin-bottom:.0001pt;font-size:12.0pt;font-family:"Calibri","sans-serif";font-weight: bold; text-align: right}td.ac{width:174.6pt;padding:0cm 5.4pt 0cm 5.4pt}td.aa{width:263.7pt;padding:0cm 5.4pt 0cm 5.4pt}span.ab{font-size: 11.0pt}td.z{width:201.6pt;padding:0cm 5.4pt 0cm 5.4pt}td.y{width:236.7pt;padding:0cm 5.4pt 0cm 5.4pt}td.x{border:none} /**/
RNS Number : 7478B
Polarean Imaging PLC
11 June 2019
 

 

Polarean Imaging Plc

("Polarean" or the "Company")

 

Phase III Clinical Trials - Update

 

Polarean Imaging plc (AIM: POLX), the clinical stage medical-imaging technology company, with a proprietary drug-device combination product for the visualisation of pulmonary function in the magnetic resonance imaging (MRI) market, announces a further update regarding the Company's Phase III Clinical Trials (the "Clinical Trials"), following the Company's announcement of 13 May 2019.

 

Clinical Trials

The Clinical Trials continue to progress at Duke University and at the University of Virginia and aim to demonstrate non-inferiority of the Company's drug-device combination, which uses hyperpolarised 129-Xenon gas MRI, against an approved comparator for the evaluation of pulmonary ventilation.

 

Enrolment for the Clinical Trials has now passed 85.4% in the lung transplant pathway and 62.5% the lung resection pathway.

 

To improve the rate of enrolment for the lung resection pathway, the Company will now add a third trial site at the University of Cincinnati ("UC"), which is already one of the Company's key clinical collaborators. It is expected that the first patient will be enrolled at UC shortly.

 

With the addition of the UC trial site, completion of enrolment for the Clinical Trials will now extend into Q32019.

 

Polarean's Directors remain confident that the Company is on track to meet its current timetable for the regulatory submission of a New Drug Application with the US Food and Drug Administration (FDA). If approved by the FDA, commercial launch is expected to occur during H22020.

 

Richard Hullihen, CEO of Polarean, said: "We are pleased to confirm that Polarean will be activating the additional trial site at UC this month, to help ensure a timely completion of the enrolment process for the lung resection pathway.  

 

Enrolment for the lung transplant pathway is now nearing completion and I look forward to providing shareholders with further updates regarding our Clinical Trials as soon as practicable."

 

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

 

 

 

SP Angel Corporate Finance LLP

Tel: +44 (0)20 3470 0470

David Hignell / Lindsay Mair / Jamie Spotswood (Corporate Finance)

Vadim Alexandre / Rob Rees (Corporate Broking)

 

 

 

Walbrook PR

Tel: +44 (0)20 7933 8780 or [email protected]

Paul McManus / Anna Dunphy

 

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

 

         

 


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 [email protected] or visit www.rns.com.
 
END
 
 
RESFBLLFKQFLBBE

Quick facts: Polarean Imaging PLC

Price: £0.24

Market: AIM
Market Cap: £27.64 m
Follow

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

FOR OUR FULL DISCLAIMER CLICK HERE

Watch

Full interview: Polarean Imaging begins enrolment for phase III clinical...

Polarean Imaging PLC's (LON:POLX) Richard Hullihen tells Proactive London's Andrew Scott they're on track to complete recruitment to their phase III clinical trial by the end of the current quarter following the enrolment of the first patient at the third site. The company’s drug-device...

2 weeks, 3 days ago

RNS

Phase III Clinical Trials update

2 weeks, 4 days ago

Total Voting Rights

3 weeks, 2 days ago

Holding(s) in Company

3 weeks, 3 days ago

Holding(s) in Company

3 weeks, 3 days ago

Holding(s) in Company

3 weeks, 4 days ago

Result of AGM

4 weeks, 1 day ago

Exercise of Warrants

4 weeks, 2 days ago