Trial Results Fail To Support Mainstay Medical's Neuromodulation Device
Mainstay Medical says it will move forward with a US PMA application for its ReActiv8 neuromodulation therapy for chronic back pain even though the ReActiv8 clinical trial failed to reach its primary endpoint.
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The company has begun the US launch of the ReActiv8 implantable neurostimulator for treating low back pain in the US while expanding commercialization in Australia and Europe.
Mainstay Medical is making steps towards the US commercialization of its neurostimulation system ReActiv8. The company announced a positive outcome from interim analysis of its US ReActiv8 B clinical trial which aims to gather data in support of an application for pre-market approval from the US FDA.
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