What it does:
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 early November, the firm completed patient enrolment for Phase III of the trial with 80 patients, 48 of which are in a lung transplant pathway while the remaining 32 are for lung resection, a process where part of the lung tissue is removed.
The trials will progress through the image and statistical analysis stage, expected to take around 10 weeks, and will conclude with a readout of the trial.
The readout will then form the basis for a pre-new drug application (NDA) meeting with the US Food and Drug Administration (FDA), with a formal application to be lodged in the second quarter of next year.
If approved by the FDA, the commercial launch is expected during the second half of 2020.
What the boss says - Richard Hullihen, chief executive:
"The Company is pleased to have successfully completed enrolment for its Clinical Trials and looks forward to the next stage of statistical analysis ahead of readout and the proposed submission of the NDA.”
- Latest research unit installed at hospital in Vancouver, Canada
- 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 19.5p, Polarean is valued at £21.7mln
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.