Polarean Imaging PLC (LON:POLX) confirmed that enrolment of the final few patients for clinical testing of its drug-device combination for MRI lung scans will soon begin at a third trial site.
The trials, where the company is looking to prove that holding a breath of inert, hyperpolarised 129-Xenon gas while undertaking an MRI can provide clearer images for doctors, have so far enrolled 85.4% of the required number of patients in the lung transplant pathway and 62.5% for the lung resection pathway. This is up from 80% and 50% in mid-May.
As indicated last month, a third trial site at the University of Cincinnati will now be added to improve the rate of enrolment for the lung resection pathway, with the first patient expected to be enrolled at UC shortly.
Polarean said the addition of the third trial site will push back completion of enrolment into the third quarter of the 2019 but directors remain confident that the company is on track to meet its current timetable for the regulatory submission of a new drug application (NDA) with the US Food and Drug Administration (FDA).
Chief executive Richard Hullihen said: "We are pleased to confirm that Polarean will be activating the additional trial site at UC this month, to help ensure a timely completion of the enrolment process for the lung resection pathway.
“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."
Polarean, which is looking to market a single product the combined the 129-Xenon gas, the instrument which polarises the gas, and an associated quality assurance device, started trials of the technology last summer in two sites, Duke University and the University of Virginia.
If approved by the FDA, commercial launch is expected to occur during the second half of 2020, as previously indicated.