Nexalin Technology, Inc.
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 and insomnia, without the need for drugs or psychotherapy. Our original Gen-1 devices are cranial electrotherapy stimulation (CES) devices that emit waveform at 4 milliamps during treatment and are presently classified by the U.S. Food and Drug Administration (“FDA”) as a Class II device.
Medical professionals in the United States have utilized the Gen-1 device to administer 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, as a result 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 device and require a new PMA (premarket approval) application to demonstrate safety and effectiveness.
While we continue providing services to medical professionals to support patients’ use of the Gen-1 devices which were in operation prior to December 2019, we are not making new sales or new marketing efforts of Gen-1 devices in the United States. We continue to derive revenue from devices which we sold or leased prior to the FDA’s December 2019 reclassification announcements. This revenue consists of monthly licensing fees and payments for the sale of electrodes. We have suspended marketing efforts for new sales of devices related to the Gen-1 device for treatment of anxiety or insomnia in the United States until a new 510(k) application, if we determined to make such filing with the FDA, is approved. Our regulatory team has also informed the FDA of the suspension of the marketing and sale of the Gen-1 products to new providers. We are analyzing whether to proceed with an amended application with the FDA for Gen-1 devices for the treatment of insomnia and anxiety.
We have designed and developed new advanced waveform technology to be emitted at 15 milliamps through our existing medical device improved with a modern enclosure — referred to as Generation 2 or Gen-2 — which can penetrate deeper into the brain and stimulate associated structures of mental illness, which we believe will generate enhanced patient response. The Nexalin regulatory team has made a strategic decision to develop strategies for a new PMA application in the United States for the treatment of depression with our new Gen-2 device. Gen-2 is presently being tested in clinical trials, for anxiety, insomnia and depression in the United States. It is our intention to design a new clinical trial strategy with our new Gen-2 devices at 15 milliamps for the treatment of major depressive disorder (MDD) in the United States. Preliminary data provided by the University of California San Diego supports the safety of utilizing our waveform technology at an increased power; however, the determination of safety and efficacy of medical devices in the United States is subject to clearance by the FDA.
In September 2018, we entered into an agreement with Wider Com Limited, a company formed under the laws of China (“Wider”), pursuant to which we and Wider agreed to form a joint venture entity to be domiciled in Hong Kong (the “Joint Venture”). The Joint Venture will be formed following the completion of certain funding, clinical study, and publication milestones, which Wider has agreed to undertake as part of the joint venture arrangements but not yet completed. Following its formation, the Joint Venture will design and implement a comprehensive business model and distribution plan for our devices in China, Hong Kong, Macau and Taiwan and elsewhere for greater distribution and additional treatment uses. We anticipate that the Joint Venture will be formed in the fourth quarter of 2022.
|Industry:||ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS|
|Address||1776 Yorktown, Suite 550 Houston, TX 77056|
|Phone Number||(713) 660-1100|
|View Prospectus:||Nexalin Technology, Inc.|
|Revenues||$0.14 mil (last 12 months)|
|Net Income||$-6.08 mil (last 12 months)|
|Price range||$6.00 - $7.00|
|Est. $ Volume||$9.0 mil|
|Manager / Joint Managers||Maxim Group|
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