Nexalin Technology Enrolls First Patients and Advances Toward Treatment in UCSD Clinical Trial
HOUSTON, TX, April 02, 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 it has successfully enrolled the first patients in its clinical trial at the University of California, San Diego (UCSD), in collaboration with the VA San Diego Healthcare System (San Diego VA). The company began treatment of the first patients this week with the Nexalin HALO™.
This significant milestone marks the transition from patient recruitment to active participation in the study, which aims to evaluate Nexalin's proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology, delivered through its HALO™ Clarity devices, as a potential treatment for mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) in military personnel and the civilian population. The collaboration with UCSD and the San Diego VA underscores Nexalin's commitment to advancing breakthrough treatment options for patients who are underserved by current therapies.
Mark White, CEO of Nexalin Technology, commented, "We are thrilled to announce that the first patients have now been successfully enrolled and treatment has begun in this important clinical trial at UCSD with the new Nexalin HALO™ headset. This marks a pivotal step forward as we move toward initiating treatments to civilians and veterans struggling with TBI and PTSD. We believe this study will provide critical insights into the efficacy and safety of our innovative DIFS™ technology, helping us further validate its potential as a transformative, drug-free approach to treating mental health disorders."
The study is designed to gather comprehensive data on the impact of Nexalin's DIFS™ technology in treating mental health conditions, particularly for veterans and other patient populations who often face limited treatment options. The results from this clinical trial will contribute to Nexalin's broader regulatory and commercialization strategy as the Company works toward gaining further approvals and expanding the reach of its technology.
"We are pleased to work alongside esteemed researchers at UCSD in collaboration with the San Diego VA as we advance this study," White continued. "Our goal is to offer new hope to individuals struggling with PTSD, depression, and anxiety, and we look forward to analyzing the findings as the trial progresses."
The trial follows the recent successful shipment and integration of Nexalin's HALO™ Clarity devices at UCSD, where they are being used to provide non-invasive, at-home neurostimulation therapy with AI-integrated remote monitoring. Nexalin's Electronic Data Capture (EDC) platform and Patient Monitoring System (PMS) enable real-time tracking of patient adherence and treatment progress. As the study progresses, additional HALO™ Clarity devices will be deployed to ensure optimal patient coverage and data collection.
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/.
About HALO™ Clarity
The HALO™ Clarity device currently is under evaluation, and to date, is not approved for marketing and commercial sale in the U.S. The safety and efficacy of the HALO™ Clarity device have not been fully evaluated by the FDA. For more information about the HALO Clarity device, visit www.nexalin-usa.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, 2024, 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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