Nexalin Technology, Inc. designs and develops neurostimulation medical devices for the treatment of mental health conditions. The company focuses on creating non-invasive bioelectronic technologies that use proprietary waveforms to address anxiety, insomnia, depression, and related disorders without drugs or psychotherapy. Its primary products include the Gen-2 SYNC clinical device and the Gen-3 HALO patient headset, both utilizing a 15 milliamp waveform for deeper brain stimulation. Nexalin operates in the medical device industry, specifically within the neurostimulation and mental health technology sectors.

Nexalin generates revenue through multiple streams. The company earns income from the sale and lease of its neurostimulation devices, including the Gen-2 SYNC and Gen-3 HALO systems. Revenue also comes from recurring sales of single-use electrodes and patient cables compatible with its devices. Additionally, Nexalin derives income from monthly licensing fees associated with devices sold or leased prior to the FDA’s December 2019 reclassification of cranial electrotherapy stimulation devices. These fees support ongoing servicing, warranty coverage, and electrode replacements for existing Gen-1 devices in clinical use.

The company operates through the following segments: Neurostimulation Device Development and Virtual Clinic Platform.

• The Neurostimulation Device Development segment focuses on the research, design, testing, and regulatory approval of Nexalin’s medical devices. This includes the Gen-2 SYNC clinical device and Gen-3 HALO headset, both utilizing the proprietary 15 milliamp waveform. Activities involve preclinical testing, clinical trial preparation, FDA Q-submission processes, and intellectual property development to support future commercialization in the United States and international markets.

• The Virtual Clinic Platform segment encompasses the development and deployment of Nexalin’s digital health infrastructure. This includes a proprietary IT management platform, patient and provider mobile applications, cloud-based data systems, and telepsychiatry integration tools. The platform enables remote diagnosis, device prescription, home shipment, treatment monitoring via physician dashboards, and compliance tracking, supporting a decentralized mental health care model.

Nexalin positions itself as an innovator in the neurostimulation space, differentiating itself through its high-power, undetectable 15 milliamp waveform technology. Unlike conventional treatments such as pharmaceuticals, electroconvulsive therapy, or transcranial magnetic stimulation, Nexalin’s devices aim to deliver deeper brain stimulation without discomfort or systemic side effects. The company competes with other medical device firms in the mental health and neuromodulation markets but emphasizes its proprietary electrode array, RFID-protected single-use electrodes, and integrated virtual clinic model as key competitive advantages. Its focus on reducing stigma through private, home-based treatment monitored by licensed professionals further distinguishes its approach.

Nexalin serves licensed medical professionals, including psychiatrists, neurologists, and primary care physicians, who prescribe its devices for patient treatment. The company also supports end users, primarily patients suffering from anxiety, insomnia, depression, traumatic brain injury, and related conditions, who use the Gen-3 HALO headset in home settings under physician supervision. Additionally, Nexalin engages with U. S. federal agencies such as the Department of Defense and Veterans Affairs through its Military & Government Advisory Board, targeting potential deployment within military and government healthcare systems.