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Mainstay Will Supplement Australian ReActiv8 Application With ReActiv8 B Data

 
• By Reed Miller

Australia's Therapeutic Goods Administration asked for additional clinical data on Mainstay Medical's ReActiv8 neurostimulation device for chronic low-back pain, so the company will provide clinical data from the ongoing ReActiv8 B trial.

ReActiv8
Mainstay Medical's ReActiv8 neurostimulator for chronic low-back pain • Source: Mainstay Medical

Data from the US ReActiv8 B trial of Mainstay Medical International PLC's ReActiv8 neurostimulator to treat low-back pain will supplement the company's regulatory application in Australia.

The Irish company announced on April 5 that Australia's Therapeutic Goods Administration has requested additional clinical data supporting the regulatory application for ReActiv8, which the company filed in January.

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