MRI scans generally aren't much use when assessing lung function, but Polarean has developed a way in which a small amount of inert gas can change that.
By inhaling and holding a small amount of the 129Xe 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.
Enrolment for the trials has now passed 80% (39 of 48 patients) in the lung transplant pathway and 50% (16 of 32) in the lung resection pathway.
Third site added
To improve the rate of enrolment for the lung resection pathway in order to align the pathway completion dates, and because neither site should enrol more than 65% of patients in a pathway, Polarean plans to add a third trial site at the University of Cincinnati, which is already one of its key clinical collaborators.
It is expected that UC will start enrolling patients next month (June), and bosses are confident it will not affect the regulatory submission timetable, with commercial launch still being targeted for the second half of 2020.
“We are satisfied with the progress of our clinical trials to date,” said chief executive Richard Hullihen.
“We are pleased to be adding an additional trial site at UC to improve the enrolment process for the lung resection pathway, thereby extending our collaboration with UC.”