Nexalin Technology, Inc.NXL
What Nexalin Technology, Inc. does.
Nexalin is headquartered, and maintains its base of management and operations, in Houston, Texas. We design and develop innovative neurostimulation products to uniquely and effectively help combat the ongoing global mental health epidemic. We developed an easy-to-administer medical device — referred to as “Generation 1” or “Gen-1” — that utilizes bioelectronic medical technology to treat anxiety, insomnia and depression without the need for drugs or psychotherapy. Our original Gen-1 devices are cranial electrotherapy stimulation (CES) devices that emit a waveform at 4 milliamps during treatment and are presently classified by the U.S. Food and Drug Administration (the “FDA”) as a Class II device.
Medical professionals in the United States have utilized the Gen-1 device to administer treatment to patients in clinical settings. While the Gen-1 device had been cleared by the FDA to treat depression, anxiety, and insomnia, three prevalent and serious diseases, because of the FDA’s December 2019 reclassification of CES devices, the Gen-1 device was reclassified as a Class II device for the treatment of anxiety and insomnia. We are required to file a new application under Section 510(k) of the Federal Food, Drug and Cosmetic Act (“510(k) Application”) to be approved by the FDA for the sales and marketing of our devices for the treatment of anxiety and insomnia. In the FDA’s December 2019 reclassification ruling, the treatment of depression with our device will require a Class III certification and require a new PMA (premarket approval) and/or a new De Novo application to demonstrate safety and effectiveness.
Revenue and profit, by fiscal year.
| Fiscal year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Revenue | — | $144,065 | $1.3M | $110,748 | $168,721 | $301,647 |
| Net income | — | -$6.1M | -$1.7M | -$4.6M | -$7.6M | -$8.2M |
More on NXL.
- Nexalin Technology, Inc. summary
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- Nexalin Technology, Inc. earnings
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- Nexalin Technology, Inc. valuation
- Nexalin Technology, Inc. ownership and insiders
- Nexalin Technology, Inc. peers
Figures from Nexalin Technology, Inc.'s filings with the U.S. SEC, standardised automatically; prices are end-of-day closes. Not financial advice.