The pivotal study to support Nexalin's planned FDA submission builds on Nexalin's previously reported
and published clinical results in chronic insomnia, including a 120-participant randomized, double-blind,
placebo-controlled, multicenter study published in the Journal of Psychiatric Research. In that study,
Nexalin reported clinically meaningful and statistically significant improvements across key sleep
parameters compared to placebo, with no significant adverse effects reported. Nexalin's Gen-2 15 mA
device has also received regulatory approvals internationally for insomnia and related indications

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