Nexalin Technology, Inc. provided an update on the growing body of clinical data supporting the potential therapeutic benefits of its second-generation (Gen-2), 15 milliamp (mA) neurostimulation device, including the results of a study in patients with migraine headaches, which indicated a substantial and statistically significant benefit in patients. The clinical trial was funded by the Company's joint venture partner, Wider Come Limited ("Wider"), and its related companies, and was conducted at the Vertigo Center, Department of Neurology, Second Affiliated Hospital of Zhengzhou University. The results were also presented in Chin J Neuromed, a peer-reviewed scientific journal in China, which concluded that repeated treatment with Nexalin's neurostimulation device suggests a significant reduction in the frequency and degree of pain of migraine patients.

In addition, a strong safety profile was reported. As part of the clinical study, 40 migraine patients (without migraine aura) were treated at the Vertigo Center. Patients were randomly assigned 1:1 to experimental and sham groups.

Treatment was administered for four consecutive weeks with a 4 week follow-up period. Efficacy and adverse reactions were assessed before treatment, at the end of treatment, and at the end of follow-up, respectively. A statistically significant improvement was achieved across all key metrics, including Visual Analog Scale (VAS), Pittsburgh Sleep Quality Index (PSQI), Hamilton Anxiety Rating Scale (HAMA), Hamilton Depression Rating Scale (HAMD) and Migraine-Specific Quality of Life Questionnaire (MSQ) scores.

All of these measures are used as standard scales in clinical practice to assess the severity and impact of migraine and related symptoms, as well as the effectiveness of treatment. Additionally, no adverse events were observed during treatment in the two groups. Migraine trial results: The migraine study follows the Company's recent clinical study in depression, which demonstrated statistically significant improvements among patients.

Numerous studies have indicated an association between migraines and major depressive disorder (MDD), and depression is estimated to affect nearly 80% of all migraine sufferers. The previous 8-week randomized, double-blind, sham-controlled trial evaluating 100 patients with MDD, published in the international journal, Brain, indicated that patients receiving treatment with the Company's Gen-2, 15mA neurostimulation device had better remission and response rates than the sham group. Compared with sham treatment, almost all depressive symptoms among the active treatment showed significant improvement.

Moreover, there was no significant statistical difference in adverse events between the two groups. Depression trial results: According to the World Health Organization (WHO), the prevalence of mental health disorders and conditions is increasing worldwide and there has been a 13% increase in mental health conditions and other depressive disorders in the last decade alone. Notably, in 2020, among adolescents between ages 12 and 17, 17% had a major depressive episode (MDE), and 12% had MDE with severe impairment in 2020, according to the USA Department of Health and Human Services (HHS).