Nexalin Technology Announces UCSD IRB Approval for use of HALO™ Clarity in Clinical Trials for mTBI and PTSD Treatment

By: Nexalin Technology, Inc. via GlobeNewswire

February 18, 2025 at 08:30 AM EST

HOUSTON, TX, Feb. 18, 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 that it has received Institutional Review Board (IRB) approval from the University of California, San Diego (UCSD) for clinical testing of its HALO™ Clarity (HALO) headset in human subjects. This study is being conducted independently by UCSD. Nexalin is providing the HALO devices for research purposes but is not sponsoring, directing, or controlling the study or its outcomes. This approval follows a successful pilot testing protocol conducted with UCSD’s research team.

With this critical milestone achieved, UCSD has requested and will receive 50 HALO devices from Nexalin for this independent research project. Nexalin and its manufacturing partner have begun preparing the initial shipment of 50 HALO devices to UCSD. These devices will be deployed in upcoming clinical trials evaluating the efficacy of HALO in treating mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD), particularly in military personnel.

The HALO™ Clarity is powered by Nexalin’s proprietary Deep Intracranial Frequency Stimulation (DIFS) technology, delivering non-invasive, deep-brain stimulation without the use of drugs or invasive procedures. Key advantages include:

Non-Invasive Treatment – Provides a drug-free alternative for mental health care, reducing the risk of side effects associated with pharmacological treatments.
At-Home Use – Designed for patient comfort and convenience, allowing treatments to be administered in the privacy of one's home.
Remote Monitoring – Equipped with capabilities for physicians to monitor patient progress remotely, ensuring continuous care and support.

Nexalin has developed a virtual clinic model that leverages artificial intelligence (AI) and a proprietary Electronic Data Capture (EDC) platform to enhance patient care:

AI Integration – Utilizes AI to facilitate real-time data acquisition and analysis during clinical trials, improving efficiency and compliance.
Patient Monitoring System (PMS) – An interactive smartphone application allows clinicians to monitor adherence to treatment protocols and make necessary adjustments in real time.
Telemedicine Capabilities – Enables direct communication between patients and clinical teams, providing personalized care and support throughout the treatment process.

This virtual clinic model is designed to conduct the entire clinical trial process—and ultimately the treatment experience—remotely, ensuring accessibility while providing physicians with real-time digital data related to the patient’s treatment progress.

“The IRB approval from UCSD represents a significant step forward in validating the potential of our DIFS-powered HALO technology,” said Mark White, CEO of Nexalin Technology. “This approval underscores our commitment to delivering innovative, non-invasive solutions for mental health and neurological disorders. The independent study at UCSD will explore the potential of HALO in treating mTBI and PTSD. This trial at UCSD will provide essential data to further establish HALO as a revolutionary treatment option for military personnel and others suffering from mTBI and PTSD.”

David Owens, CMO of Nexalin Technology, added, “With the deployment of our first 50 HALO devices to UCSD, we are embarking on a critical phase in our mission to redefine neurostimulation therapy. The combination of DIFS technology with our virtual clinic model allows us to bring treatment into the homes of patients, ensuring accessibility, convenience, and enhanced patient outcomes. We look forward to the insights this independent research will provide regarding the HALO device's application The upcoming independent clinical trial at UCSD will provide further insights into the safety and effectiveness of HALO, building upon prior research that has demonstrated DIFS technology’s ability to modulate neural activity and support brain health without adverse side effects."

Nexalin remains committed to pioneering cutting-edge neuromodulation 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