Dublin-listed medical devices firm Mainstay Medical has applied for a CE mark for its ReActiv8 product, an implantable neurostimulation system to treat chronic low back pain.
The company said the move represents a further key step towards the commercialisation of the product in Europe.
Mainstay estimates that there are over two million people in the US and EU who could be candidates for treatment with ReActiv8.
Trial results show that after 90 days of treatment with ReActiv8, 63% of people showed a "clinically important" improvement in their low back pain.
57% showed a clinically important improvement in their disability while 67% showed a clinically important improvement in their quality of life.
"With FDA approval to start the ReActiv8-B clinical trial to gather data for an application for US approval, we are moving towards our goal of commercialisation of ReActiv8 in major world markets," commented Peter Crosby, Mainstay's chief executive.
"We believe ReActiv8 has the potential to change the lives of millions of people who have no effective treatment for their chronic low back pain and we are now a step closer to selling ReActiv8 in Europe," he added.
