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Nexalin Technology Awarded Key Patent Related to its Non-Invasive, Frequency-Based Deep-Brain Stimulation Device – the Transcranial Alternating Current Dynamic Frequency Stimulation (TACS) System

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Nexalin Technology, Inc. announced the award of a U.S. patent for its non-invasive, frequency-based deep brain stimulation device, extending IP protection through 2040. The Gen-3 system is a significant advancement to the predecessor Gen-1 system, providing painless brain neural stimulation for mental health conditions. Clinical studies have demonstrated therapeutic benefits in conditions such as treatment-resistant depression, migraines, anxiety, and insomnia, with potential applications in addiction, substance use disorder, Alzheimer’s, traumatic brain injury, and PTSD. The global mental health market was estimated at $383 billion in 2020 and is projected to reach $537 billion by 2030, indicating significant market potential for Nexalin's neurostimulation device.
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The awarding of U.S. Patent No. 11,872,397 to Nexalin Technology represents a pivotal moment for the company, reinforcing its intellectual property portfolio and potentially extending its competitive edge in the neurostimulation market. The Gen-3 system's advanced waveform technology, which is central to this patent, signifies a leap forward from its Gen-1 system, potentially offering a non-pharmaceutical alternative to mental health treatment. The emphasis on this technology's ability to treat a range of neurological conditions without invasive procedures aligns with current industry trends towards patient-friendly treatment options.

From a research perspective, the clinical evidence supporting the therapeutic benefits of the Nexalin device for conditions such as depression, migraines, anxiety and insomnia is noteworthy. The ongoing expansion into other mental health areas, including addiction and PTSD, could address significant unmet needs within the mental health care sector. Considering the projected growth of the global mental health market, Nexalin's strategic focus on regulatory approvals could facilitate entry into new markets and enhance its market share.

The mental health market's estimated value, projected to reach $537 billion by 2030, underscores the economic potential of Nexalin's Gen-3 system. The company's targeted approach to addressing widespread and diverse mental health conditions, coupled with the patented technology's unique waveform, positions Nexalin to capitalize on market demand for innovative and non-invasive treatment options. The patent protection through 2040 provides a substantial window for Nexalin to solidify its market presence before facing direct competition from similar technologies.

Investor interest in companies with strong IP portfolios and innovative healthcare solutions is typically high, suggesting potential positive implications for Nexalin's stock market performance. However, the actual impact will hinge on the successful commercial rollout of the Gen-3 system and the attainment of regulatory clearances, especially within the lucrative U.S. market.

The economic implications of Nexalin's patented neurostimulation device extend beyond the company's immediate financial prospects. By offering a drug-free alternative for treating mental health conditions, the Gen-3 system could contribute to reducing the overall cost burden of mental healthcare. This is particularly relevant given the increasing prevalence of mental health issues and the associated direct and indirect costs to healthcare systems worldwide.

Moreover, the potential to alleviate treatment-resistant conditions could lead to improved productivity and quality of life for patients, which has positive ripple effects on the economy. The focus on non-pharmacological treatments also aligns with broader health economic trends that prioritize sustainable and cost-effective healthcare solutions. As Nexalin advances its technology and seeks regulatory clearances, the economic impact of its Gen-3 system will become clearer, potentially influencing healthcare policy and reimbursement strategies in the mental health domain.

HOUSTON, TX, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) today announced that the United States Patent and Trademark Office (USPTO) has awarded U.S. Patent No. 11,872,397 relating to the Company’s non-invasive, frequency-based deep brain stimulation device.  The newly-issued patent, entitled “Transcranial Alternating Current Dynamic Frequency Stimulation (TACS) System,” covers the core technology utilized in the Company’s Gen-3 system, a proprietary and advanced waveform device that is designed to treat patients in a painless and undetectable manner.

The Gen-3 system reflects state-of-the-art development of Nexalin’s Deep Intracranial Frequency Stimulation (DIFS®) technology, and a significant advancement to the predecessor Gen-1 system.  The Company’s technology uses a digital breakthrough in electrical waveforms to provide deep and painless brain neural stimulation.  The Gen-3 system is applied through the placement of strategically-positioned electrodes on the patient’s cranium, and provides deep stimulation to regions of the brain associated with mental health conditions.

Mark White, CEO of Nexalin Technology, stated, “This patent award for our non-invasive, deep-frequency stimulation device marks a major milestone for the Company, as it extends our IP protection through 2040. Most notably, the unique nature of our device’s waveform can only be created with very specific electrical components, capacitors and designs. This patent covers these three key areas, and we believe it further protects the Company from others trying to circumvent our IP.  Importantly, this patent marks what we believe is a major advancement for the drug-free treatment of mental health conditions.  Recent published clinical evidence supports the clinical benefits of the Nexalin device for the treatment of a variety of neurological diseases associated with deep brain structures. At Nexalin, we are highly encouraged that our DIFS® technique will improve mental healthcare outcomes among patients.  Specifically, clinical studies have demonstrated therapeutic benefits in conditions ranging from treatment-resistant depression to migraines, anxiety, and insomnia. We are also targeting mental health conditions such as addiction, substance use disorder, Alzheimer’s, traumatic brain injury (TBI) and PTSD.  According to Allied Market Research, the global mental health market was an estimated $383 billion in 2020 and is projected to reach $537 billion by 2030.  We believe our neurostimulation device has the potential to transform the standard of care for the treatment of mental health disorders. We are laser-focused on advancing the commercial rollout, including expanding our regulatory approvals in overseas markets, as well as pursuing regulatory clearance in the U.S.”

About Nexalin Technology, Inc.

Nexalin designs and develops innovative neurostimulation products to uniquely and effectively help combat the ongoing global mental health epidemic. All of Nexalin’s products are non-invasive and undetectable to the human body and developed to provide relief to those afflicted with mental health issues. Nexalin utilizes bioelectronic medical technology to treat mental health issues. Nexalin believes its neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper penetrating waveform in its next-generation devices will generate enhanced patient response without any adverse side effects. The Nexalin Gen-2 15 milliamp (mA) neurostimulation device was recently approved in China by the National Medical Products Administration (NMPA) for the treatment of insomnia and depression. Additional information about the Company is available at: https://nexalin.com/.

FORWARD-LOOKING STATEMENTS

This press release contains statements that constitute "forward-looking statements," These statements relate to future events or Nexalin’s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that Nexalin or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward looking statements that involve risks and uncertainties which could cause actual events or Nexalin’s actual results to differ materially from those indicated by the forward-looking statements.  Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Report on Form 10-K for the year ended December 31, 2022 and other filings as filed with the Securities and Exchange Commission. Copies of such filings are available on the SEC's website, www.sec.gov. Such forward-looking statements are made as of the date hereof and may become outdated over time. Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Contact:
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com


FAQ

What is the U.S. patent number awarded to Nexalin Technology, Inc.?

The U.S. patent number awarded to Nexalin Technology, Inc. is 11,872,397.

What is the name of the proprietary and advanced waveform device developed by Nexalin Technology, Inc.?

The proprietary and advanced waveform device developed by Nexalin Technology, Inc. is the Gen-3 system.

What conditions have clinical studies demonstrated therapeutic benefits for using Nexalin Technology, Inc.'s device?

Clinical studies have demonstrated therapeutic benefits for conditions such as treatment-resistant depression, migraines, anxiety, and insomnia.

What is the projected value of the global mental health market by 2030?

The global mental health market is projected to reach $537 billion by 2030.

What is the potential application of Nexalin Technology, Inc.'s neurostimulation device?

The potential applications of Nexalin Technology, Inc.'s neurostimulation device include addiction, substance use disorder, Alzheimer’s, traumatic brain injury, and PTSD.

Nexalin Technology, Inc.

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nexalin technology is a non-invasive and drug-free therapy for those living with anxiety, depression and/or insomnia. nexalin’s patented waveform (1 u.s. patent #6904322b2) the nexalin device produces a patented waveform that provides transcranial electrical stimulation (tes). in clinical trials, this unique waveform resulted in the greatest increase in beta-endorphins. the nexalin device has undergone extensive safety analysis with the results clearly indicating that the device is safe for its intended use. additionally, the fda classification of the device for clinical trials places it into a non-significant risk (low risk device) category. natural frequency will promote balance in the brain by normalizing neurochemistry.this effectiveness of this unique therapy is long lasting and fda approved. laboratory and clinical evidence suggest that nexalin’s patented electrical stimulation affects the hypothalamus and related brain structures to adapt and change the levels of neurochemicals