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Nexalin’s Breakthrough DIFS™ Neurostimulation Device Demonstrates Reduction in Blood Pressure while Enhancing Mental Health According to New Landmark Study
HOUSTON, TX, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, announces the publication of a landmark study in the Journal of Affective Disorders demonstrating the potential efficacy of its proprietary DIFS technology. The research highlights the potential of DIFS to deliver meaningful reductions in systolic and diastolic blood pressure in patients with major depressive disorder (MDD), while offering a safe and non-invasive approach to addressing systemic health challenges.
Key findings include:
Clinically Significant Blood Pressure Reductions: Patients receiving Nexalin’s 15 mA DIFS therapy experienced a 2.04 mmHg reduction in systolic blood pressure and a 1.92 mmHg reduction in diastolic blood pressure compared to sham stimulation.
Strong Response Among Higher-Risk Patients: Participants with elevated baseline blood pressure demonstrated the greatest improvements.
Potential Safety and Tolerability: The treatment was well-tolerated, with no reported adverse effects or patient discomfort.
Mark White, Nexalin’s CEO stated, “Everyone at Nexalin, including our clinical and engineering teams, is excited about this landmark trial demonstrating a reduction in blood pressure in depressed patients. This study is a major first step in understanding the true power of our breakthrough DIFS waveform that stimulates the entire brain. We believe that the DIFS entire brain stimulation is important for general health as well as mental health. We continue to believe that this neurostimulation technique is a breakthrough in neurostimulation and represents the future of mental health treatment.”
This study builds on Nexalin’s robust clinical research program and highlights the versatility of its patented neurostimulation technology in targeting deep brain structures critical to emotional and physical health regulation.
The study analyzed data from a randomized controlled trial involving 68 first-episode, drug-naive patients with MDD. Over four weeks, participants underwent 20 sessions of either active DIFS or sham stimulation, targeting key brain regions associated with blood pressure regulation, including the brainstem, hypothalamus, and thalamus.
Significant reductions in blood pressure were observed as early as the fourth week of treatment, with greater reductions among participants who had higher baseline blood pressure. These results underscore the ability of Nexalin’s DIFS technology to modulate critical neurological pathways that influence systemic health.
Dr. David Owens, Chief Medical Officer of Nexalin, commented: "This study is a potential game-changer, demonstrating that our innovative DIFS technology not only addresses mental health disorders but also has far-reaching potential in systemic wellness, such as improving cardiovascular health. It validates our mission to create transformative solutions that are safe, effective, and non-invasive."
DIFS technology employs a proprietary frequency-based waveform to stimulate deep brain structures, a challenge for traditional treatments. Unlike pharmaceuticals or invasive procedures, Nexalin’s approach is designed to deliver powerful therapeutic effects without side effects. These findings complement prior research that highlighted DIFS’ potential to improve conditions such as depression, insomnia, PTSD, and Alzheimer’s disease.
Nexalin’s DIFS technology is supported by 29 completed or ongoing clinical trials, including studies evaluating its efficacy in Alzheimer’s disease and PTSD among veterans. With regulatory approvals in China, Brazil, and Oman, Nexalin is poised to expand its impact, targeting CE Mark certification for European markets in 2025.
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.
