Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) hailed the receipt its first de novo order for its XENOVIEW polariser from a top-tier academic medical centre in the US north-east.
The company, which added that its current cash runway is expected to last into the third quarter of 2024, said it is also optimistic about the “positive” meetings and active negotiations it is having with other top-tier academic medical centres.
Chief executive Christopher von Jako said the Polarean team will work closely with the new customer to establish the use of XENOVIEW for their patients living with lung disease.
“As previously stated, establishing orders for new imaging technologies often takes time, even when clinicians are highly motivated to adopt the technology,” he said in a regulatory news statement.
For existing customers the University of Cincinnati Children's Hospital Medical Center and the University of Missouri (MU) Health Care, the company said it was working to help ensure increased and consistent utilisation of their polariser systems in patients with chronic lung disease.
Both centres have undertaken multiple clinical scans, Polarean said, with MU Health Care recently publicising its first scan via a video, adding that both radiology departments working on integrating the technology into their workflows and clinical pathways before promoting wider availability.
“We continue to have positive meetings with other high priority centres as they work through their budget cycle and value analysis processes, as well our already converted centres and those we expect to convert in 2024, to encourage increased utilisation of the technology in clinic,” said von Jako.
He said “strong progress” has been made in all areas of the growth initiatives established at the interim results.
“While we are assessing various financing options, I am confident that we will be able to finance the company for the medium term," von Jako added.
A new reimbursement APC-code issued by the US Centers for Medicare & Medicaid Services in August adds to existing codes and enables hospitals to request a total reimbursement of approximately US$2,500.
Polarean added that it is beginning work at its clinical sites to further expand the reimbursement for private US health insurers to enable further utilisation, while also holding “productive” talks with the US Food and Drug Administratiion (FDA) about expanding the minimum current age of XENOVIEW MRI in children from 12 down to six years old.
A clinical trial is planned for late 2024, with approval possible by the beginning of 2027, it said.
Progress was also reported on the collaboration with Philips, with a training session given on the polariser technology in October for the Philips US MRI sales force, which will introduce XENOVIEW MRI to its customer base.
Separately, contracts have been signed to sponsor a new clinical trial in patients with chronic obstructive pulmonary disease (COPD) in collaboration with a leading nebuliser device manufacturer.