Medical imaging technology developer Polarean Imaging (LON: POLX) has gained New Chemical Entity designation from the US FDA for its drug product XENOVIEW. There is a designated five-year market exclusivity period. The share price rose 13.8% to 46.1p.
XENOVIEW is a hyperpolarised contrast agent prepared from the Xenon Xe 129 gas blend that is used in magnetic resonance imaging. It can be used for evaluation of lung ventilation for patients aged 12 and older. It does not expose the patients to ionising radiation. This diagnostic technology could be relevant to more than 30 million Americans suffering from chronic lung disease.
A new clinical study is planned to expand the range of clinical applications for the technology. The trial is being designed.
Polarean Imaging is estimated to have generated revenues of £1.5m in 2022 and they are expected to jump to $9.8m this year. The XENOVIEW product could be eligible for reimbursement of $250/scan.
Losses are set to continue to be significant and the cash pile will be reduced. Net debt could fall below $3m by the end of 2023. That suggests that a fundraising will be required in the next 12 months. If the latest news and other positive announcements push up the share price, then a fundraising will be less dilutive.