Nexalin Technology Announces Initiation of Patient Recruitment for UCSD’s TBI & PTSD Clinical Study Following IRB Approval
February 28 2025 - 7:30AM
Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company”
or “Nexalin”) the leader in Deep Intracranial Frequency Stimulation
(DIFS™) of the brain, today announced that following Institutional
Review Board (IRB) approval, the University of California, San
Diego (UCSD) has received the first shipment of HALO™ Clarity
devices to commence its clinical trial evaluating the
treatment of mild traumatic brain injury (mTBI) and post-traumatic
stress disorder (PTSD) in military personnel and the civilian
population. Patient recruitment for the study is now set to begin
immediately.
This milestone follows the successful IRB approval, pilot
testing and evaluation of Nexalin’s Halo technology at UCSD. The
study will evaluate Nexalin’s proprietary Deep Intracranial
Frequency Stimulation (DIFS™) technology, which delivers
non-invasive deep-brain stimulation without the use of drugs or
invasive procedures.
The initial devices have been randomized and integrated with
Nexalin’s app-controlled remote monitoring system, ensuring
seamless oversight of treatment adherence and progress. An
additional 40-50 HALO devices will be delivered as the study
progresses.
Key Advantages of the HALO™ Clarity Device Include:
- Non-Invasive Therapy – A drug-free alternative for neurological
and mental health conditions, reducing side effects associated with
traditional treatments.
- At-Home Convenience – Designed for easy use in a home setting,
increasing patient compliance and accessibility.
- AI-Integrated Remote Monitoring – Enables real-time data
capture and physician oversight through Nexalin’s advanced
Electronic Data Capture (EDC) platform and Patient Monitoring
System (PMS).
Mark White, CEO of Nexalin Technology, stated, “The initiation
of patient recruitment marks a major milestone in the validation of
our HALO Clarity device for TBI and PTSD treatment. UCSD’s
independent study is a crucial step in demonstrating the
transformative potential of our Deep Intracranial Frequency
Stimulation (DIFS) technology for military personnel and others
affected by these conditions. With this deployment, we are moving
closer to making non-invasive deep brain stimulation an accessible,
real-world solution for those in need.”
David Owens, CMO of Nexalin Technology, added, “We are delighted
to see the first HALO devices in place for clinical use. The
combination of DIFS technology with our advanced virtual clinic
model enables real-time tracking of patient progress while
providing a seamless, patient-centered treatment experience. We
look forward to the data from this study as we continue to push the
boundaries of neurostimulation for neurological and mental health
care.”
Nexalin remains committed to pioneering cutting-edge
neurostimulation technologies to address unmet needs in mental
health and neurological care. The HALO device is currently under
evaluation and not yet approved by the FDA for these uses in the
United States. For more information about Nexalin Technology and
the HALO device, visit www.nexalin-usa.com.
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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