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Nexalin Advances Pivotal Insomnia Trial for HALO Clarity
Nexalin Technology has initiated a pivotal clinical trial for its HALO Clarity device to treat insomnia, collaborating with Lindus Health for trial execution. The 160-patient, triple-blinded study aims for enrollment in Q2 2026 to support a De Novo submission to the FDA, potentially establishing a new product category for its neurostimulator and enhancing Nexalin’s position in the sleep tech and mental health markets. The company sees significant potential in the underserved insomnia market for its non-pharmacologic solution.