The partly unblinded Phase III data, stopped after a futility analysis, show that two-thirds of treated patients showed meaningful clinical improvements, but also that the ‘active’ sham patients had similar responses. Nexstim will unblind the study, giving 138+ patients worth of data in Q2. The company aims to file an FDA de novo 510(k) application in Q316, which might give some US sales from mid-2017 if the FDA agrees. The system can already be sold in the EU. Extra trials to sec
25 Apr 2016
Sham surprise shows stroke success
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Sham surprise shows stroke success
The partly unblinded Phase III data, stopped after a futility analysis, show that two-thirds of treated patients showed meaningful clinical improvements, but also that the ‘active’ sham patients had similar responses. Nexstim will unblind the study, giving 138+ patients worth of data in Q2. The company aims to file an FDA de novo 510(k) application in Q316, which might give some US sales from mid-2017 if the FDA agrees. The system can already be sold in the EU. Extra trials to sec