Nexalin Technology, Inc.

What they do

Nexalin designs and develops neurostimulation devices for mental health conditions, including anxiety, insomnia, and depression. Its only commercial product, the Gen-1 CES device, is no longer marketed in the U.S. following FDA reclassification; the company earns legacy licensing and electrode sales. The next-generation Gen-2 SYNC (clinical) and Gen-3 HALO (patient headset) devices are in FDA pre-submission review and clinical trials.

Revenue drivers

• Legacy Gen-1 device licensing fees — Monthly licensing fees from U.S. medical professionals for pre-2019 Gen-1 devices; no new U.S. sales are being made.
• Electrode and patient cable sales — Sales of consumables for Gen-1 devices; a steady but small revenue stream.
• International Gen-2 device sales — Revenue from sales of Gen-2 devices and supplies internationally; the company reported no international revenue in the first half of 2026.

Recent performance

For fiscal year 2025, revenue was $301,647, up 79% from $168,721 in 2024, but net loss widened to $8.2 million from $7.6 million. In the first half of 2026, quarterly revenue declined steadily: $18,149 (Q3 2025), $171,895 (Q4 2025), $14,950 (Q1 2026), and $12,161 (Q2 2026). As of June 30, 2026, cash and equivalents were $1.0 million, total assets $3.0 million, and shareholder equity $1.5 million. The company's accumulated deficit was approximately $92.9 million at year-end 2025.

Strategy

Management's stated priorities include obtaining FDA clearance for Gen-2 SYNC and Gen-3 HALO devices, conducting U.S. clinical trials, and pursuing CE marking. The company is building an integrated platform combining DIFS technology, the HALO Clarity home-use device, and the Nexalin NeuroCare digital health platform, which includes software acquired in the Q2 2026 PONM, Inc. acquisition. Revenue generation remains limited while the company advances regulatory and clinical milestones.

Risks

• Going concern risk — Recurring losses and negative cash flows raise substantial doubt about the ability to continue as a going concern; cash of $1.0M at June 30, 2026 may not be sufficient.
• Regulatory dependence — Future revenue depends on FDA clearance for Gen-2 SYNC and Gen-3 HALO; the path for depression treatment requires a PMA or De Novo application.
• Nasdaq listing compliance — The company received delisting notices in January and July 2026 and must regain compliance with minimum bid price requirements.
• Internal control weaknesses — Material weaknesses remain in segregation of duties and IT access controls, which could impair financial reporting and investor confidence.

Outlook

Management expects to continue incurring significant operating losses and expenses while advancing clinical and regulatory initiatives. The company plans to fund operations through its at-the-market offering and other financing activities, but there is no assurance that capital will be available. Revenue is expected to remain limited until FDA clearance is obtained for next-generation devices.