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:
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."
- 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
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.