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Mainstay Medical clinical trial expands to Belgium

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Mainstay Medical International announced it has received authorization from the Belgian Federal Agency for Medicines and Health Products to expand its clinical trial of ReActiv8, a neurostimulation device for the treatment of chronic low back pain.

“We continue to make progress, in line with our plan, on the path to regulatory approval and commercialization of ReActiv8,” Peter Crosby, Mainstay’s CEO, said in a company press release. “We are pleased to now add Belgium to our clinical trial, which follows the commencement of our trial in Australia in March. When available, ReActiv8 has the potential to change the lives of the millions of people who suffer from chronic low back pain.”

The new sites in Belgium are beginning to enroll subjects in the trial, according to the press release.

The ReActiv8 trial — aimed at determining the efficacy of the product in patients with chronic low back pain who do not have many other treatment options — began in Australia and several sites have been enrolling subjects since March.

Reference: www.mainstay-medical.com