Polarean Imaging PLC (LON:PLLX) said it expects to make the submission for approval of its Xenon Polariser lung imaging system to the US Food and Drug Administration early next month.
The company said that on 28 September the FDA had granted it a Small Business Waiver for the US$2.9m filing fee for its new drug application (NDA).
In a statement for the half-year to June, Richard Hullihen, chief executive, added: “During the period under review, Polarean achieved one of its most important milestones to date, the positive readout from our Phase III clinical trials.
“We subsequently undertook an GBP8.4mln fundraising and welcomed our new strategic investor Bracco to our share register, alongside several new institutional investors.
“The installation of new polarisers has continued and users of our systems are publishing research at an increased rate, expanding and deepening the knowledge base of the use of hyperpolarised 129Xe in pulmonary medicine.”
Losses in the half-year to June were US$3.2mln on revenues of US$0.3mln, with cash at the period end of US$9.2mln.