Irish company Mainstay Medical has taken a major step towards its goal of tackling chronic lower back pain on a mass scale as its implantable treatment system receives CE approval.
It means the firm can begin the commercialisation of its ReActiv8 product across Europe.
Mainstay CEO Peter Crosby said:
"CE marking is a pivotal milestone for Mainstay.
"Our team has been working tirelessly towards making ReActiv8 commercially available to physicians and their patients.
"We believe ReActiv8 has the potential to change the lives of millions of people who currently have limited treatment options for their chronic low back pain".
Mainstay is now planning to focus on the German market, particularly large hospitals that boast a multi-disciplinary approach to treating the problem of back pain.
Plans are also afoot to launch a clinical trial in the US. An application for pre-market approval – required for commercialisation across the Atlantic - would follow, subject to funding.
Mainstay was established in the US back in 2008, before making the move to its current Swords home in County Dublin.
Mainstay explains its system thusly:
"ReActiv8 is a small implanted device which stimulates the nerves responsible for contracting the key muscles that stabilize the lower back.
"Similar to exercise programs used to restore muscle control, you deliver ReActiv8 sessions twice a day for about 30 minutes. During the sessions ReActiv8 will make the muscles in your lower back cycle between contraction and relaxation. You are always in control of the stimulation session via a handheld wireless remote control.
"Over time, the stimulated contractions may help your brain and body learn how to better control the muscles in between sessions. Restoration of muscle control and spine stabilisation allows your body to recover from chronic low back pain".
