DIFS Technology: A Potential Game-Changer for Mental Health Treatments

Setting New Benchmarks: 65% Response Rate Shown in Completed Depression Trials

Alzheimer’s Research Shows Promising Results with Increased Brain Activity

Virtual Clinic Poised to Revolutionize Mental Health Care with AI Integration

Pursuing CE Mark to Expand into European Markets in 2025

Strategic Focus on PTSD, TBI, and Addiction Research for Veterans

Global Growth with Approvals in China, Brazil, and Oman

Neuromodulation Market Positioned to Reach $11 Billion by 2028

HOUSTON, TX, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) the leader in Deep Intracranial Frequency Stimulation (DIFS) of the brain, is pleased to release a detailed letter from CEO Mark White, providing an update on the Company’s technology advancements, clinical achievements, and strategic focus for 2025.

Dear Shareholders,

I want to take this opportunity to thank you for your continued trust and support in Nexalin Technology. Our progress over the past year reflects our commitment to addressing the global mental health crisis through innovative, noninvasive neurostimulation solutions. Recently, Dr. David Owens, our Chief Medical Officer, and I conducted a comprehensive review of our clinical programs and strategic initiatives for 2025. This evaluation, as summarized below, highlights extraordinary successes which have positioned Nexalin as a leader in advanced mental health treatment technologies.

Groundbreaking Technology Developments

In 2019, regulatory updates from the FDA prompted our engineering team to revisit the foundational technology behind our Gen-1 devices. Through rigorous research, we developed a new proprietary frequency-based waveform designed to interact with the brain’s natural energy patterns. This waveform, 5 to 10 times more powerful than existing neurostimulation devices, enables targeted stimulation of deep brain structures—regions critical to addressing mental health conditions.

By 2022, this innovation had been awarded a U.S. patent, solidifying its place as a groundbreaking technology. Termed “Deep Intracranial Frequency Stimulation” (DIFS), we believe this approach provides an unparalleled standard of care for conditions such as depression, insomnia, Alzheimer’s, post-traumatic stress disorder (PTSD), and more. Importantly, the treatment utilizing the Company’s advanced waveform technology is designed to be undetectable to the human body, ensuring patient comfort without side effects.

Clinical Achievements

Over the past 24 months, Nexalin has either initiated, completed, or is actively conducting 29 Institutional Review Board (IRB)-approved clinical trials. These studies have consistently demonstrated the potential of our 15 mA waveform to safely and effectively treat a range of mental health disorders. Highlights include:

  • Major Depressive Disorder:
    • Nexalin’s technology achieved a remarkable 65% response rate in our treatment group over a four-week period, outperforming traditional antidepressants, which typically average a 50% response rate.
    • In combination with antidepressant medication, the response rate increased to 66% , compared to 33% for sham stimulation groups receiving medication alone.
  • Alzheimer’s Research:
    • Functional MRI studies show increased blood flow and neuronal activity in the hippocampus and temporal lobes, areas critical for memory and cognition.
    • These findings suggest the potential for combining DIFS with current drug therapies, providing a new pathway for treating mild cognitive impairment and Alzheimer’s disease.
  • Veterans’ Studies:
    • Collaborations with UC San Diego and the San Diego VA focus on using Nexalin’s Gen-3 Halo headset for veterans with traumatic brain injury (TBI) and PTSD. These efforts resulted in the establishment of Nexalin America, a subsidiary dedicated to working with the Department of Defense and Veterans Administration.
  • Published Research:
    • Fourteen peer-reviewed studies published in major international journals support the efficacy and safety of our technology, strengthening our competitive position in the neuromodulation market.

Innovative Virtual Clinic

In December 2024, Nexalin launched Phase 1 of its virtual clinic, leveraging cutting-edge artificial intelligence (AI) to revolutionize patient care and clinical trial processes. The virtual clinic integrates:

  • Electronic Data Capture: This platform enables real-time data acquisition and analysis, ensuring seamless compliance with study protocols.
  • Patient Monitoring System: This interactive smartphone application allows clinicians to monitor adherence to treatment protocols and adjust care as needed.
  • Telemedicine Capabilities: Patients can communicate directly with clinicians, receiving personalized care in the comfort of their homes.

Our Gen-3 Halo headset, which administers Nexalin’s advanced 15 mA waveform, is central to this initiative. The virtual clinic represents a transformative step toward making mental health treatment more accessible, efficient, and patient-centric.

Strategic Focus for 2025

As we look to the future, Nexalin’s strategic priorities are built on a foundation of clinical success:

  1. Primary Mood Disorders: Expanding research and trials targeting insomnia, depression, and migraines.
  2. Military and Government Relations: Strengthening partnerships to address TBI and PTSD within military and veteran populations.
  3. Alzheimer’s and Addiction: Accelerating research in these areas, leveraging pilot studies and publications that demonstrate DIFS’ potential.
  4. European Market Expansion: In 2025, we are actively pursuing CE Mark approval for our Gen-3 Halo device to enable entry into the European market. This critical step will align with our global strategy of making Nexalin technology available to more patients worldwide.

Clinical Evaluation Techniques

To ensure rigorous validation of our technology, Nexalin employs advanced methodologies, including:

  • Patient-Reported Outcomes: Pre- and post-treatment assessments of symptom severity and quality of life.
  • Neuroimaging Tools:
    • Electroencephalography (EEG) to measure brain activity.
    • Functional MRI (fMRI) to track blood flow changes.
    • Magnetoencephalography (MEG) for detecting brain activity.
    • PET scans using radioactive tracers to visualize function.

These tools provide critical insights into DIFS’ effectiveness and ensure its differentiation from consumer-grade stimulators.

Positioning for Global Growth

In addition to our U.S.-based achievements, Nexalin has received regulatory approvals in China, Brazil, and Oman, paving the way for global adoption of DIFS technology. The CE Mark approval we are pursuing in Europe represents a pivotal milestone in our international expansion strategy. With the neuromodulation market projected to reach $11 billion by 2028, Nexalin is poised to capture significant market share.

Closing Remarks

The global mental health crisis touches all of us—our families, friends, and communities. Nexalin’s innovative approach to neurostimulation, utilizing Deep Intracranial Frequency Stimulation, offers a new standard of care, providing effective treatment without the risks of pharmaceuticals or invasive procedures. I am proud of the extraordinary work our team has accomplished and confident in our ability to drive meaningful change in mental health care.

On behalf of everyone at Nexalin, thank you for your unwavering support. We look forward to keeping you informed as we continue this transformative journey.

Warm regards,

Mark White, CEO

About Nexalin Technology, Inc.

Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. All of Nexalin’s products are non-invasive and undetectable to the human body and are 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 neurostimulation device has been approved in China, Brazil, and Oman. 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, 2023, 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: [email protected]