Proactive Investors - Run By Investors For Investors
Why invest in POLX?
Polarean Imaging PLC: DEEP DIVE
OVERVIEW

Polarean Imaging on schedule for US launch of lung function scanner

Company has developed a drug-device combination, which uses hyperpolarised 129-Xenon gas MRI.
lung
OVERVIEW: POLX The Big Picture
IPF lung disease is often diagnosed too late for effective treatment
  • Polarean Imaging has started to enrol last patients for clinical testing of its drug-device combination for MRI lung scans.

  • A third trial site has been opened in Cincinnati

  • So far, 85.4% of lung transplant patients have been enrolled and 62.5% of the lung resection cohort, with completion of enrolment expected in the third quarter of 2019

  • On schedule to meet its timetable for the regulatory submission of a new drug application (NDA) with the US Food and Drug Administration (FDA).

What it does:

MRI scans generally aren’t very useful in assessing lung function, but Polarean Imaging PLC (LON:POLX) is trying to change that.

The company has developed a drug-device combination which uses hyperpolarised 129-Xenon gas MRI. By inhaling and holding a small amount of the gas for just a few seconds, the patient is able to create a much stronger MRI signal, providing doctors with multiple images of lung structure and function.

Polarean, which is looking to sell the gas, the instrument which polarises the gas, and an associated quality assurance device, kicked off a trial of the technology last summer in two sites: Duke University and the University of Virginia and at the University of Cincinnati in June.

The trial is a 'head-to-head' non-inferiority trial testing 129Xe MRI against 133-Xenon (133Xe) scintigraphy.

In the trial, the firm will be evaluating two patient populations - candidate patients for lung lobe resection, and lung transplant procedures - numbering 80 patients in total.

If approved by the FDA, the commercial launch is expected during the second half of 2020.

What the boss says - Richard Hullihen, chief executive:

“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."

Inflexion points:

  • Completion of enrolment of patients
  • Trial data and FDA decision
  • Commercial launch in 2020
  • Revenues in half year to June 2018 were US$1mln with a loss of US$2.8mln
  • Raised US$4mln in December.
  • At 16p, Polarean is valued at £16mln

Blue sky:

Pulmonary medicine and lung functions have been left behind in the diagnostic revolution that has seen MRI and CT scanning become the norm in oncology, for example.

COPD, IPF, emphysema, cystic fibrosis can all take years before the real cause of the problem is apparent and by that stage it is often too late.

“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,” broker Northland said last year.

View full POLX profile View Profile

Polarean Imaging PLC Timeline

Related Articles

An armour plate based on XTclave technology
April 28 2019
The upper limit of the defence supplier’s guidance this half-year is $21.6 million.
immotion vr racing game
February 06 2019
The out-of-home VR hardware and content maker turned over more than £1mln in the second half of 2018 with ‘only’ 150 or so headsets in operation, but it wants that figure to climb to over 1,000 by the end of this year
ROBO Global US CEO Travis Briggs
August 14 2018
Investors can buy directly into the popular ROBO ETF based on the benchmark index comprised of 87 top robotics, automation and AI companies.

© Proactive Investors 2019

Proactive Investors Limited, trading as “Proactiveinvestors United Kingdom”, is Authorised and regulated by the Financial Conduct Authority.
Registered in England with Company Registration number 05639690. Group VAT registration number 872070825 FCA Registration number 559082. You can contact us here.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use