Nexalin Posts 77.8% Anxiety Response Rate in Brazilian 8-Week Trial
NXL•Nexalin’s 8-week Brazilian trial of its DIFS™ neurostimulation device achieved a 77.8% anxiety response rate by session 20 and reduced HAM-A scores by 18.3 points, with 66.7% depression remission and sustained PSQI sleep improvements at 8-week follow-up. No serious adverse events were reported, validating its tolerability profile.
1. Clinical Trial Results
The single-center, open-label trial in São Paulo evaluated 20 sessions of 15 mA, 77.5 Hz transcranial alternating current over four weeks followed by a four-week follow-up. It delivered rapid, large-magnitude improvements: a 77.8% anxiety response rate by session 20, an 18.3-point HAM-A reduction, 66.7% depression response and remission, and significant PSQI sleep score gains maintained at eight weeks.
2. Safety and Tolerability
No serious adverse events, seizures or manic/hypomanic switches occurred throughout the trial, underscoring the favorable tolerability of Nexalin’s non-invasive, frequency-based DIFS™ platform and reinforcing its differentiation from existing neurostimulation devices.
3. Brazilian Launch Strategy
The compelling pilot data strengthen Nexalin’s case for its upcoming product launch and sales campaign in Brazil. These results also bolster the Company’s broader clinical development and De Novo regulatory pathway as it targets deeper brain regions to address neuropsychiatric needs.
