Nexalin Technology, Inc.

Nexalin designs and develops neurostimulation products to address mental health conditions. The company is based in Houston, Texas. Nexalin developed a medical device, referred to as "Generation 1" or "Gen-1," which uses bioelectronic medical technology to treat anxiety, insomnia, and depression without drugs or psychotherapy. These original Gen-1 devices are cranial electrotherapy stimulation (CES) devices that emit a waveform at 4 milliamps during treatment. The U.S. Food and Drug Administration (FDA) currently classifies the Gen-1 device as a Class II device for treating anxiety and insomnia. Medical professionals in the United States have used the Gen-1 device to treat patients in clinical settings. Due to the FDA's December 2019 reclassification of CES devices, Nexalin is required to file a new 510(k) Application to gain FDA approval for sales and marketing of its devices for anxiety and insomnia treatment. For depression treatment, the device now requires Class III certification and a new PMA (premarket approval) and/or a new De Novo application to demonstrate safety and effectiveness. While Nexalin continues to support medical professionals and patients using Gen-1 devices that were operational before December 2019, it is not making new sales or marketing efforts for Gen-1 devices in the United States. The company continues to generate revenue from devices sold or leased prior to the FDA's December 2019 reclassification announcement, consisting of monthly licensing fees and payments for electrodes and patient cables.