Mainstay to sell 'breakthrough' pain implant in Europe in 2016
Irish medical firm Mainstay Medical expects its "breakthrough" treatment for chronic back pain to sell commercially in Europe next year after reporting promising results from a clinical trial yesterday.
Its ReActiv8 is an implantable device that looks to alleviate back pain. The system helps restore control to the muscles that stabilise the lumbar spine.
Operating expenses at the firm, which is at a pre-revenue stage, rose to $6.3m in the six months to the end of June compared to $4.8m for the corresponding period in 2014.
The firm said that this was mainly due to costs associated with hiring and increased activity in the ReActiv8-A clinical trial.
The trial was carried out with long-term sufferers of lower back pain, all of whom had tried physical therapy and 70pc of whom were using opioids for the pain.
Results for the trial, which are based on data from the first 47 back pain sufferers to be implanted with the device, showed that nearly two-thirds had shown clinically-important improvements in their pain and 67pc revealed a noticeable benefit in quality of life.
The company, which was founded in 2008 and four years later shifted its base from the US to Ireland, now plans to use the results of the trial to support its submission for CE mark approval. A CE mark is a declaration by a manufacturer that its product meets European standards. After it receives the mark, ReActiv8 can be sold throughout Europe.
Speaking to the Irish Independent, Mainstay Medical chief executive Peter Crosby expects that the product will be available in Europe in 2016.
"We are targeting CE mark approval by the end of the year, which we think is possible, and then we are targeting commercialisation in 2016," he said.
"Our first key market will be Germany, [if] we are successful there we will start rolling out in other countries."
Mr Crosby said that he expects that the device will sell for about €15,000.
Mainstay also has received approval from the United States Food and Drug Administration (FDA) to begin a clinical trial of ReActiv8 with the aim of selling the product in the US.
Mr Crosby was unsure when ReActiv8 would be available commercially in the US, saying: "The timing will depend on the recruitment rate of subjects in the US, once we have some experience on how quick we can recruit we'll know better."
Earlier this month Mainstay announced that it has secured $15m in debt financing to help with the commercialisation of ReActiv8.
So far an initial tranche of $4.5m has been called. Declan Morrissey, an analyst with Davy Stockbrokers, said that the company's journey toward commercialisation of ReActiv8 "is progressing as planned".
"A satisfactory clinical trial outcome should pave the way for CE mark approval and subsequent commercialisation in Europe," he said.
Shares in the company, which trades on the Irish Stock Exchange's Enterprise Securities Market, were down by just under 8pc in late afternoon trading to €16.70.