Mainstay Medical, the Dublin-based medical devices firm, said it has enrolled the first subject in its ReActiv8-B clinical trial.
The trial is intended to gather data in support of an application for pre-market approval from the US Food and Drug Administration (FDA) - a key step towards commercialisation of the drug in the US.
Mainstay's ReActiv8 product is seen as a potential breakthrough treatment for chronic back pain.
It is an implantable device, installed via a simple medical procedure, which can be activated twice daily to treat the condition. It is estimated that about 2 million people suffer from chronic back pain around the world.
The first subject was enrolled at the Genesis Research Services centre in Newcastle in Australia. If all eligibility criteria are met, the subject will be implanted with ReActiv8 within a few weeks, the company said.
"The enrolment of the first subject in the ReActiv8-B Clinical Trial is yet another significant step for Mainstay this year following the CE Marking for ReActiv8 in May, triggering the start of commercialisation activities in our first European market, Germany, and the raising of €30m new capital in June," commented Peter Crosby, Mainstay's chief executive.
