Futura Medical PLC (AIM:FUM) confirmed it remains on track for US marketing authorisation of its fast-acting erectile dysfunction gel, MED3000, in the first quarter of 2023.
Both the human factors trial and the FM71 confirmatory study are progressing to plan, the company said in an update alongside interim results.
It hopes the American regulator will sign off MED300 as a ‘denovo’ medical device that can be sold over the counter.
In the meantime, Futura hasn’t been slow in negotiating commercial contracts for its innovative gel.
It has inked deals covering China and south-east Asia, Mexico and Brazil and the Gulf Co-operation region, Jordan, Lebanon and Iraq.
The results for the six months revealed the company was sitting on £12.76mln at June 30.
This means its ‘cash runway’ extends beyond the initial MED3000 launches in 2022 and the expected US regulatory approval.
The company posted a loss of £1.6mln for the period, reflecting its investment in R&D.
"The company is well-positioned to deliver further positive news through the remainder of 2021 and in 2022 as we drive towards MED3000 2022 product launches, a global product franchise and our objective to deliver a long-term and sustainable revenue for shareholders," said chief executive James Barder.