Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) said the focus for the current year is gaining commercial traction for XENOVIEW after securing US Food and Drug Administration (FDA) sign-off for the drug-device breakthrough.
XENOVIEW is a contrast agent that uses xenon gas, which allows doctors to evaluate lung ventilation as part of an MRI scan.
Polarean also received the green light for the supporting software and imaging technology.
This year has seen the first order for XENOVIEW followed by the first clinical scan in the US using the company’s approach.
“Having achieved FDA approval, our efforts are now focused on gaining commercial traction and engaging with potential corporate partners to further accelerate our commercial success,” said chairman Kenneth West in comments accompanying full-year results.
“Once we have achieved some of these near-term milestones, we will explore the options for additional financing to more aggressively pursue the development of the next indications and advance the continued development of our polarizer system and software.
“The company is exploring a broad range of options for future financing, including equity raises and corporate partnering.”
The financial results for the year ended 31 December 2022 showed Polarean posted an operating loss of US$13.67mln, which is to be expected from a company investing heavily in research and funding the regulatory approval process.
More importantly, it exited 2022 with US$16.4mln on the balance sheet.