Nexalin Technology Reports Significant Positive Results of Clinical Study Supporting the Therapeutic Benefits of its Gen-2, 15 Milliamp Neurostimulation Device on Treatment-Resistant Depression

Results published in General Psychiatry, a leading peer-reviewed journal

HOUSTON, TEXAS, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) today reported the results of a study in patients with treatment-resistant depression (TRD), concerning the potential therapeutic benefits of its second-generation (Gen-2), 15 milliamp (mA) neurostimulation device, 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 Xuanwu Hospital, Capital Medical University in Beijing, China. The results were also published in General Psychiatry, an open-source, peer-reviewed scientific journal. The published results of the study concluded that repeated treatment with Nexalin’s neurostimulation device suggests an acute effect in reducing depressive symptoms in patients with TRD. In addition, no adverse events were observed during treatment.

Major depressive disorder (MDD), also known as clinical depression, is a mental health condition that affects mood, behavior, appetite, and sleep. According to a 2022 National Survey on Drug Use and Health, an estimated 22.47 million adults, or 8.8% of all US adults in the United States, had at least one major depressive episode. According to Future Market Insights, the MDD treatment market is forecast to reach US$ 14.96 billion by 2032 from US$ 11.51 billion in 2022. It is estimated that one-third of patients with MDD will not respond to two or more antidepressant drugs with different mechanisms with these patients being referred to as having treatment-resistant depression (TRD). American military veterans are particularly at risk for TRD, with nearly one in seven suffering from MDD considered to have TRD. In part for this reason, the President’s 2023 Budget Request included $13.9 billion towards Veterans Mental Healthcare services, an increase of 14% above the 2022 Budget.

As part of the clinical study, 7 migraine patients were treated at the Xuanwu Hospital. Treatment was administered for 4 consecutive weeks via the forehead and both mastoid (twice per day, 5 days a week). Efficacy and adverse reactions were assessed at a 2-week screening/baseline period followed by a 4-week treatment phase. The study concluded that twice daily 15mA tACS, a unique form of non-invasive brain stimulation, offers an acute effective intervention for patients with TRD. The study showed that all patients with TRD had a significant reduction in depression symptoms after the 4-week treatment, and all of them achieved a clinical response (defined as HAMD-17/ MADRS scores that decreased by 50% or more from the baseline).