Polarean Imaging PLC (LON:POLX) aims to advance the world’s understanding of Coronavirus (COVID-19) through its technology, the medical imaging technology company said in its 2020 results statement.
The company, which has developed a breakthrough drug-device combination that uses hyper-polarised xenon gas in magnetic resonance imaging (MRI) lung imaging, said its technology will provide the types of quantitative information necessary for fully understanding COVID-19’s mechanisms and post-infection consequences.
“Current events have made clear that medicine is still not fully equipped to analyse and understand the many ways that pulmonary function can be affected by disease. The company looks forward to working with its growing installed base of luminary researchers to help understand the diagnosis, methods of action and therapies for all pulmonary disease,” said Polarean's chairman, Jonathan Allis.
READ Polarean Imaging hails latest milestone as US regulator confirms acceptance of its new drug application
In his review of 2020, the chairman said the highlight of the year was acceptance by the US Food and Drug Administration (FDA) of its new drug application (NDA) in December.
The primary focus for the current year will be the planning and preparation for commercial launch and then initiating the launch post-approval.
Richard Hullihen, the chief executive officer of Polarean, said it had been a strong year for Polarean, in which it achieved some significant milestones, "beginning with the positive readout of our Phase III clinical trials in early 2020".
"This was followed quickly by a successful placing and subscription in April 2020, and a further oversubscribed fundraise in March 2021 which was needed to fund sales and marketing expenses to build the commercial team and infrastructure, to support ongoing clinical trial, regulatory and medical affairs costs, to support the continued investment in research and development and to provide additional working capital and for general corporate purposes,” Hullihen said.
"We have made significant board changes to reflect our progress and we're very excited to have a target PDUFA date from the FDA,” he added.
Revenues of US$1.06mln for 2020 were down on 2019’s US$2.30mln and were a tad below plan but so were expenses.
The loss before tax widened a little to US$6.53mln from US$6.10mln the year before.
The group maintained its pricing and margins throughout the year on equipment, albeit the timing of grant receipts slightly diluted overall margins, the company said.
Polarean is not counting its chickens but is working on the basis that it will receive regulatory approval for its new drug application in the second half of 2021; in the meantime, it continues to collaborate with researchers in the US and abroad, looking to expand its installed base of research systems.
“The exciting new developments in COVID-19, cardiology and pulmonary vascular disease are deepening, and our knowledge base about these conditions is expanding,” the company said.