Nexalin announced a case study showing its 15 mA neurostimulation device achieved complete abstinence from gambling and alcohol in a patient with co‑diagnosed gambling disorder and alcohol use disorder. The study was published in The American Journal on Addictions and was conducted at Shanghai Mental Health Center. The patient underwent 20 outpatient sessions over 10 days, each delivering 15 mA at 77.5 Hz for 40 minutes. The patient achieved full abstinence from both gambling and alcohol, with marked improvements in cognitive control and no adverse effects observed during a three‑month follow‑up. The study is registered on ClinicalTrials.gov (NCT06195995).
The publication expands Nexalin’s evidence base for its Gen‑2 SYNC platform into dual‑diagnosis addiction, a key milestone that supports the company’s strategy to pursue broader regulatory submissions and market adoption. The company has already secured regulatory approvals for the device in China, Brazil, Oman, and Israel, and a U.S. FDA Q‑submission for Alzheimer’s disease and dementia treatment was accepted in November 2025. The case study demonstrates the clinical efficacy of the company’s Deep Intracranial Frequency Stimulation (DIFS™) technology, reinforcing its claim that a non‑pharmacological, drug‑free approach can modulate brain networks involved in complex neuropsychiatric conditions.
CEO Mark White said the study “reinforces what we believe to be the growing scientific validation of Nexalin’s 15 mA device as a non‑pharmacological approach for addressing addiction and other complex neuropsychiatric conditions.” The result is a significant step toward the company’s long‑term goal of expanding the therapeutic indications for its platform, but it also highlights the need for continued clinical development and regulatory engagement.
Despite the positive clinical outcome, Nexalin’s financial performance remains a concern. The company’s Q3 2025 earnings report, released on November 14 2025, showed a significant year‑over‑year decline in revenue and an increase in net loss, reflecting the high cost of clinical development and the need for additional capital. Nexalin has raised capital through a $5 million underwritten public offering in May 2025, which dilutes existing shareholders and underscores the company’s ongoing funding needs.
Analysts have noted the study as a positive development for Nexalin’s technology pipeline, but they caution that the company’s financial challenges and the need for further regulatory approvals could temper enthusiasm. The market reaction has been mixed, with some investors focusing on the potential upside of the device’s expanded indications while others remain wary of the company’s current valuation and capital structure.
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