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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 and insomnia in the United States until the Nexalin regulatory team makes a decision on a new 510(k) application at 4 milliamps based on FDA comments expected to be received in December 2022. Our regulatory team continues to inform 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 pilot 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 “potential 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 by the third quarter of 2023. In March 2022, we entered into a second supplement to the Joint Venture agreement with Wider, whereby the parties confirmed that the potential Joint Venture had not yet been established and is subject to further review and analysis of regulatory issues in China and the United States, trade and political issues between the two countries and potential changes in the use and market for the Company’s products and technology. Pursuant to the second supplement, the parties agreed to use their commercial efforts to complete documentation by September 30, 2022. In light of general economic conditions in China and the United States, the continued impact of regulatory issues within China and the United States and trade and political issues between the two counties, the parties determined to further extend the time frame to complete establishment of the joint venture to September 30, 2023 and entered into a supplement 3 to the potential Joint Venture Agreement to memorialize such extension. The parties intend to continue to work together to complete the establishment prior to such extended time. Further, the parties agreed that all references within the Joint Venture agreements to funding and formation were amended from December 21, 2018 to be September 30, 2023. During the first half of 2022, we sold Gen-2 devices in China through Wider which agreed to act as a distributor on a limited basis pursuant to a separate written agreement entered into in May 2019, pending formation of the potential Joint Venture. As a result, we recognized revenue of approximately $624,000 during the first half of 2022. In conjunction with such revenue, during the first half of 2022, we incurred costs of approximately $143,000 for cost of goods sold, delivery and labeling costs. In 2021, we incurred expenses relating to certain development costs associated with these devices sold during the first half of 2022 which were recorded during 2021. The Company expects that the $143,000 of costs attributed to the $624,000 sale in the first half of 2022 may not be indicative of our cost of sales in future periods and that beginning in the second half of 2022 gross margins may decrease due to an increase in the costs of components, manufacturing, delivery, sales and marketing. In addition, we derived approximately $9,700 revenue as a royalty fee from the China based manufacturer of electrodes for electrodes ordered by Wider in connection with the distribution of our devices in China. The manufacturer is to pay us a 20% royalty based upon its electrode sales price to Wider in connection with Wider’s device distribution activities. In September of 2021, the China National Medical Products Administration (NMPA), the equivalent of the United States FDA, approved the Gen-2 device for marketing and sale in China for the treatment of insomnia and depression. These treatment indications and clearances from the NMPA have allowed us to market and sell the Gen-2 device in China for the treatment of insomnia and depression. We are currently designing clinical trials for the use of Gen-2 for the treatment of substance use disorders, opiate addictions, chronic pain, Alzheimer’s disease, and dementia. In part due to increasing incidence attributed to the devastating impacts of the COVID-19 pandemic, mental health and cognitive disorders are widespread across the globe and cause substantial health, social and economic losses, and hardships accordingly. Our focus is on the continued development of our innovative bioelectronic medical technologies and rapid regulatory approval to help reverse these losses and hardships by safely and effectively treating various mental health disorders. All our products are non-invasive, undetectable and, critically, can provide relief to those afflicted with mental health issues without adverse side effects. We have a proprietary design of varying voltages, currents, electromagnetic fields, and various frequencies — referred to collectively as waveform — particularly our proprietary, patented symmetrical alternating current waveform. Our devices generate a high frequency, charge balanced electrical current waveform that is applied to an array of electrodes on the head. The features of this waveform make the application of the stimulation undetectable to the human body allowing this proprietary technique to enable the use of a higher current than all other devices in the market. Currently, the waveform that comprises the basis of Gen-2 and new Gen-3 headset devices has been tested in a research setting to develop safety data to be provided for review by the FDA for safety and efficacy evaluation for marketing and sales in the United States. Determinations of the safety and efficacy of our devices in the United States are solely within the authority of the FDA. We recognize that an additional barrier to treatment in today’s mental health treatment landscape — beyond the concerns about safety, efficacy and discomfort that have been associated with conventional mental health treatments such as drugs, psychotherapy, and other forms of electrical stimulation — is stigma. We have received industry reports and feedback that many patients that struggle with mood disorders have the stigma of embarrassment associated with psychotherapy (e.g., counselling with a therapist). Additional stigmas and other issues are associated with the side effects of medication prescribed by psychiatrists. When we researched the current pharmaceuticals model, public information highlighted the many side effects associated with these medications. Frequently, patients would stop taking the medication because of the uncomfortable side effects. Additional public information mentions dependency and withdrawal issues associated with medication for psychiatric disorders. To address the embarrassment stigma, we are developing a new headset design to emit our waveform technology which will offer medical professionals the opportunity to prescribe the headset device for use in a patient’s home — referred to as Generation 3 or Gen-3 — to increase access and compliance to mental health treatment. We believe that in order to preserve product safety and integrity for home use, the headset device will require physician oversight including prescriptions for use, monthly authorization for continued patient use and monthly physician monitoring through our digital management platform which is currently in development. We were originally formed as a Nevada corporation on October 19, 2010 as Nexalin Technology, Inc. On December 1, 2021, we completed the corporate reorganization pursuant to which Nexalin Nevada merged with and into a newly incorporated Delaware company of the same name, Nexalin and, as a result, Nexalin succeeded Nexalin Nevada and our existing shareholders exchanged each of their shares in Nexalin Nevada for one twentieth (1/20th) of a common share of the newly formed Delaware corporation. Nexalin had nominal assets and liabilities and did not conduct any operations prior to the reorganization other than its incorporation. Our principal executive offices are located at 1776 Yorktown, Suite 550, Houston, Texas.
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