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 last summer in two sites: Duke University and the University of Virginia and at the University of Cincinnati in June.
The trial was a 'head-to-head' non-inferiority trial testing 129Xe MRI against 133-Xenon (133Xe) scintigraphy with 80 patients, 48 of which were in a lung transplant pathway while the remaining 32 are for lung resection, a process where part of the lung tissue is removed.
Both phase III trials met their primary endpoint, which means they succeeded in showing that Polarean’s technology was at least equivalent to an approved comparator called 133 Xenon Scintigraphy.
The data revealed that the company’s approach provided an effective measure of regional lung ventilation.
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 third quarter.
If approved by the FDA, the commercial launch is expected thereafter.
In December, the US regulator accepted its new drug application, which is traditionally reviewed 10 months after submission.
What the boss says: Richard Hullihen, chief executive
"FDA acceptance for the filing of Polarean's NDA represents another important step forward for the Company's platform. If approved, Polarean's drug-device technology could provide a new diagnostic option for patients with pulmonary disease.”
- Latest research unit installed at University of Iowa Hospitals and Clinics
- FDA decision
- Commercial launch
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.