HOUSTON, TX, Nov. 11, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) today released a letter to shareholders from its CEO Mark White:

Dear Shareholders,

I am pleased to provide an update on Nexalin Technologies’ recent milestones, which underscore our commitment to advancing our patented Deep Intracranial Frequency Stimulation (DIFS) technology for the treatment of neurological and mental health conditions. The past months have brought exciting developments, particularly in our Alzheimer’s research, showcasing Nexalin’s dedication to offering non-invasive treatments without the potential side effects of medication.

Alzheimer’s Research Breakthrough and Key Patent

Our Alzheimer’s research achieved an important breakthrough, with two significant studies published this October. On October 17, we announced the results of a new study using our DIFS technology, which demonstrated substantial improvements in memory and cognitive function for Alzheimer’s patients. This study confirms DIFS’s effectiveness in positively impacting cognitive outcomes, addressing Alzheimer’s disease through a non-invasive approach without the adverse effects associated with pharmaceuticals. The study’s findings support Nexalin’s goal of pioneering a potentially safer, alternative treatment for Alzheimer’s patients, thereby providing renewed hope for caregivers and families.

Furthermore, our October 28 press release highlighted a second publication in the Journal of Alzheimer’s Disease, reinforcing our prior study and validating DIFS as a promising therapy for cognitive decline. These results collectively position Nexalin as a leader in Alzheimer’s treatment innovation, bringing us closer to addressing the core challenges of neurodegenerative disease management.

In addition to these research milestones, we announced the issuance of a key patent on June 20 for using frequency-based deep brain stimulation to treat Alzheimer’s and dementia. This patent is an essential asset that strengthens our intellectual property and underscores our leadership in non-invasive neurostimulation. With this protection, Nexalin is well-positioned to expand its research and clinical applications, advancing our Alzheimer’s program with greater confidence.

Positive Clinical Data in Major Depressive Disorder

Nexalin’s DIFS technology has shown promising results beyond Alzheimer’s, notably in treating Major Depressive Disorder (MDD). As detailed in our June 26 press release, a study published in a leading scientific journal demonstrated that DIFS effectively reduces symptoms in MDD patients, potentially providing a new, non-invasive option for individuals seeking alternatives to antidepressant medications. With millions affected by depression globally, we believe Nexalin’s approach offers a safe and effective solution that could transform the mental health landscape.

Clinical Trial with UC San Diego and the San Diego VA

Expanding our clinical reach, we recently announced a collaboration with the University of California, San Diego (UCSD) and the San Diego VA to conduct a clinical trial using Nexalin’s Gen-3 Halo headset, designed to be used in a virtual clinic model and allowing patients to receive treatment from the convenience and privacy of their own home. As described in our October 22 press release, this trial will explore the effectiveness of DIFS for treating veterans with mild Traumatic Brain Injury (mTBI). This collaboration is a significant step toward validating our technology’s broader applications and addressing the unique challenges faced by veterans who suffer from these conditions.

Strategic Expansion of Regulatory Approvals

Aligned with our mission to make Nexalin’s innovative technology widely accessible, we are pursuing regulatory pathways to expand DIFS’s approved uses, including Alzheimer’s, MDD, PTSD, mTBI, and more. As we engage with regulatory agencies around the world, these approvals will be key to making safe and effective neurostimulation available for more patients globally.

As an example, we reached a major milestone in our international expansion with the approval of Nexalin’s Gen-2 15 mA neurostimulation device by the Brazilian Health Regulatory Agency (ANVISA) on June 13. This regulatory clearance follows similar approvals in China and Oman, and allows us to introduce our technology to the Brazilian market, marking Nexalin’s first approval in Latin America. Entering Brazil represents a critical step in our global growth strategy and aligns with our commitment to reaching patients in need of non-invasive alternatives for mental health and neurological treatments.

Looking Ahead

The recent Alzheimer’s studies, positive MDD data, UC San Diego and San Diego VA clinical trial, patent award, and regulatory clearance in Brazil are all significant milestones in Nexalin’s journey. Together, they reflect our commitment to providing safe, effective, and non-invasive solutions for those impacted by cognitive and mental health challenges.

I am deeply grateful to our shareholders, partners, and team for their unwavering support and confidence in Nexalin’s mission. We look forward to the journey ahead as we push the boundaries of DIFS technology, delivering life-changing solutions for Alzheimer’s, MDD, and beyond.

Warm regards,

Mark White

CEO, Nexalin Technologies

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 believed to be 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/.

Disclaimers

This study was conducted on a limited number of participants, and larger clinical trials are needed to confirm the efficacy and safety of DIFS for Alzheimer's disease. The information in this press release is for informational purposes only and does not constitute medical advice.

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.

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