Mainstay Medical hits milestone in key US clinical trial
Group completes back pain neurostimulator implants in all 204 patients enrolled in test for device
The ReActiv8 unit is designed to treat disabling pain in patients with chronic lower back pain through the use of an implant that stimulates nerves to strengthen muscles in the lower back
The Reactiv8 unit is designed to treat disabling pain in patients with chronic lower back pain through the use of an implant that stimulates nerves to strengthen muscles in the lower back.
Mainstay, which is listed in Dublin and Paris, informed the stock exchange on Monday that it had completed all the implants in its US IDE study within its planned timetable. It expects to announce results from the trial towards the end of the year.
The study is designed to gather data to support its planned pre-market approval application to the FDA, the US regulator, a key step towards getting access to the US market.
Chief executive Jason Hannon said: “Completing all implants in the ReActiv8-B study is a significant step for Mainstay and represents continued momentum in our efforts to bring ReActiv8 to patients in the US.
“We remain on track to have full study data towards the end of 2018.”
An interim analysis last December of the first 58 patients to complete the trial showed there are no safety concerns with the device.
Apart from the US, regulators in Australia are awaiting data from this trial before deciding whether to approve the device for use in the Australian market.
Mainstay estimates the market for disabling chronic lower back pain in patients not suitable for surgery is worth up to $30 billion.
The group moved to Dublin in 2012 from the US following a $20 million funding round that was led by Dublin-based life sciences venture capital group, Fountain Healthcare Partners.