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 secure reimbursement are likely to be needed and indications such as depression could be developed. Nexstim has cash to last until Q316. The CEO left on 20 April; the chairman is acting as CEO.
