Polarean Imaging PLC (LON:POLX) said it's on track to complete recruitment to its phase III clinical trial by the end of the current quarter following the enrolment of the first patient to its third site.
The University of Cincinnati was added to the roster alongside Duke University and the University of Virginia in the US.
The company’s drug-device combination uses hyperpolarised 129-Xenon gas to make magnetic resonance imaging (MRI) more effective in assessing lung function.
The study is designed to show Polarean’s technology is at least as good as the existing methods of evaluating pulmonary ventilation.
Progress being made
Enrolment for clinical assessment has now passed 98% in lung transplant patients and 75% in the lung lobe resection.
"The first patient enrolment at our additional trial site at the University of Cincinnati provides reinforcement that we will deliver on our commitment to a timely completion of enrolment for the clinical trials,” said chief executive Richard Hullihen.
“We remain focused on the completion of our new drug application and submission to the US Food and Drug Administration following readout of the clinical trials.
“We are funded to complete this and undertake post submission launch preparation and planning. I look forward to providing our shareholders with further updates regarding the clinical trials as they near completion."
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 is looking to sell the gas, the instrument which polarises the gas, and an associated quality assurance device.