Mainstay Medical announces positive outcome of interim analysis
Dublin, Ireland: 11 December 2017 – Mainstay Medical International plc (Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, announces a positive outcome of the Interim Analysis in its US Pivotal ReActiv8-B Study, comprising a definitive size and an estimated completion date.
133 patients have been implanted in the pivotal cohort in the Study to date and clinical study sites have continued to implant patients pending the outcome of the Interim Analysis.
The Study is intended to gather data in support of an application for pre-market approval (PMA) from the US Food and Drug Administration (FDA), a key step towards commercialization of ReActiv8 in the US.
More info on Mainstay Medical’s website.