Nexalin’s Breakthrough DIFS™ Neurostimulation Device Demonstrates Reduction in Blood Pressure while Enhancing Mental Health According to New Landmark Study
February 03 2025 - 7:30AM
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.
Contact:Crescendo Communications, LLCTel: (212)
671-1020Email: NXL@crescendo-ir.com
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