Irish listed medical device company Mainstay Medical says it has incurred “significant operating losses” and may not be able to sustain profitability, the company has said in its annual accounts.
Despite securing €30m in funding from a share placement in June of last year, Mainstay said costs associated with developing its treatment for lower back pain had risen to $16.8m (€15.5m) last year.
The company’s “ReActive8” device uses a stimulation system that targets nerves in the lower back. Mainstay is currently involved in clinical trial of the treatment and said it has been “pleased” at their progress.
The company said it expects its expenses to rise in the year ahead as it ramps up its efforts to commercialise ReAcive8.
Mainstay said it will need additional funding if it is to meet its capital and expenditure needs in the year ahead.
The company said its future financial performance was “substantially dependent on the commercial success of ReActiv8”.
However, Mainstay ceo Peter Crosby remains upbeat the company can deliver results:
“We are pleased to have moved forward to the commercial phase of Mainstay’s development. Our ReActiv8-B Clinical Trial is on track and is a key step towards commercialization in the US, our most significant target market,” Mr Crosby said.
“Early in 2017, we began commercialization in Europe, with the first sale and implantation of ReActiv8 in Germany, and look forward to gaining experience from our focused activities in this first market ahead of potential expansion to other territories,” he added.