Nexalin Technology, Inc. (NXL), a developer of non-invasive Deep Intracranial Frequency Stimulation (DIFS), announced positive results from an eight-week clinical trial evaluating its 15 mA, 77.5 Hz neurostimulation protocol in adults with generalized anxiety disorder and comorbid insomnia.
The study was conducted at the Institute of Psychiatry at the University of São Paulo, one of Brazil's major academic centers for mental health research.Participants received 20 treatment sessions over a four-week observation period. Each session lasted 40 minutes and used Nexalin's proprietary DIFS device.
The trial demonstrated rapid and durable improvements across multiple mental-health measures, including anxiety, depression, sleep quality, and overall quality of life. Benefits were observed early in treatment, continued through the end of the four-week course, and were maintained at the eight-week follow-up.
Mark White, CEO of Nexalin Technology, said the results represent a major milestone for the company and further validate its differentiated, non-invasive, frequency-based neurostimulation platform. He emphasized that the technology is not a "me-too" device, but a fundamentally new approach aimed at addressing unmet needs in neuropsychiatric care.
Key Findings From the Trial
•77.8% anxiety response rate at the end of treatment (Session 20)
•Rapid improvement: HAM-A anxiety scores dropped by 14.73 points by Session 5
•Durable benefit: HAM-A scores decreased by 18.30 points by Session 20 and remained improved at follow-up
•Depression improvement: HAMD scores fell by 9.90 points by Session 20, with 66.7% response and remission rates.
•Insomnia improvement: PSQI sleep scores improved significantly and remained better at follow-up
•Quality-of-life gains: Significant improvements across multiple domains
•Favorable safety: No serious adverse events, seizures, or manic/hypomanic switches were reported.
The company says the results strengthen its confidence in advancing commercialization plans in Brazil, where demand for non-pharmacological mental-health treatments continues to grow.
NXL has traded between $0.30 and $2.00 over the past year. The stock is currently trading at $0.49, up 10.18%.
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