Nexalin Technology Announces Initiation of Patient Recruitment for UCSD’s TBI & PTSD Clinical Study Following IRB Approval
Rhea-AI Summary
Nexalin Technology (NXL) has initiated patient recruitment for a clinical trial at the University of California, San Diego (UCSD) following IRB approval. The study will evaluate the company's HALO™ Clarity device for treating mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) in military and civilian populations.
The trial will test Nexalin's proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology, which provides non-invasive deep-brain stimulation without drugs or invasive procedures. The first batch of HALO devices has been delivered, randomized, and integrated with app-controlled remote monitoring. An additional 40-50 devices will be supplied as the study progresses.
Key features of the HALO™ Clarity device include:
- Non-invasive, drug-free therapy
- At-home usage capability
- AI-integrated remote monitoring through Electronic Data Capture platform
Positive
- IRB approval received for clinical trial initiation
- First shipment of HALO devices successfully delivered
- Remote monitoring system integration completed
- Expansion potential with 40-50 additional devices planned
Negative
- Product not yet FDA approved
- Clinical trial outcomes uncertain
- Timeline for study completion not specified
News Market Reaction
On the day this news was published, NXLIW gained 14.43%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
HALO™ Clarity Devices Successfully Shipped for First Phase of Clinical Trials
HOUSTON, TX, Feb. 28, 2025 (GLOBE NEWSWIRE) -- 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, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com
FAQ
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