Nexalin Technology Announces Issuance of U.S. Patent Covering HALO™ Clarity Device Featuring DIFS™ Technology
Rhea-AI Summary
Nexalin Technology (NASDAQ: NXL) has secured U.S. Design Patent No. D1,092,758 for its HALO™ Clarity neuromodulation device, providing 15 years of design protection. The device utilizes the company's proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology to deliver non-invasive, drug-free treatment for mental health and neurological conditions.
The HALO™ Clarity system enables at-home, professionally supervised treatment with remote monitoring capabilities. The company is conducting multiple clinical studies across various indications including anxiety, insomnia, PTSD, and mild traumatic brain injury. The FDA has already provided consensus on pivotal trial designs for anxiety and insomnia indications.
The DIFS™ platform has demonstrated safety and efficacy signals in over two dozen trials worldwide. Nexalin has completed usability, safety, and design verification testing and is scaling manufacturing for broader clinical deployment.
Positive
- Secured 15-year design patent protection for HALO™ Clarity device
- FDA consensus achieved on pivotal trial designs for anxiety and insomnia indications
- Platform demonstrated safety and efficacy in over two dozen trials
- At-home treatment capability could reduce healthcare costs and improve patient compliance
- Successfully completed usability, safety, and design verification testing
Negative
- Product still requires regulatory clearance before commercialization
- Clinical trials are still ongoing with no definitive completion timeline
News Market Reaction – NXL
On the day this news was published, NXL declined 6.05%, reflecting a notable negative market reaction. Argus tracked a peak move of +6.4% during that session. Argus tracked a trough of -18.2% from its starting point during tracking. Our momentum scanner triggered 10 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $1M from the company's valuation, bringing the market cap to $18M at that time.
Data tracked by StockTitan Argus on the day of publication.
HOUSTON, TX, Sept. 25, 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 the United States Patent and Trademark Office (USPTO) has issued U.S. Design Patent No. D1,092,758, entitled Transcranial Electro-Stimulation Device, providing 15 years of design protection for the Company’s next-generation HALO™ Clarity neuromodulation device.
HALO™ Clarity is designed to deliver non-invasive neuromodulation by stimulating deep brain structures associated with mental health and neurological conditions, such as Alzheimer’s, without reliance on pharmaceuticals or surgery. The newly issued patent strengthens Nexalin’s expanding intellectual property estate, supporting the Company’s DIFS™ platform and ongoing clinical and regulatory initiatives.
“This patent represents another important milestone in our mission to transform mental health and neurological care,” said Mark White, Chief Executive Officer of Nexalin. “HALO™ Clarity is engineered for comfort, usability, and performance to deliver our proprietary DIFS™ technology — a non-invasive, drug-free approach we believe can meaningfully impact conditions such as depression, anxiety, insomnia, trauma-related disorders, and neurodegenerative diseases including Alzheimer’s and dementia. Importantly, the system is designed for supervised use from the patient’s home, giving physicians the ability to monitor and guide treatment remotely while offering patients a safe and convenient alternative to in-clinic visits. We believe this unique capability has the potential to expand access, improve compliance, and lower the cost of care for patients worldwide.”
The at-home, professionally supervised treatment model enabled by HALO™ Clarity provides a number of advantages:
- Enhanced convenience and accessibility. Patients may receive therapy in the comfort of their own home, reducing the need for frequent office visits or travel.
- Remote clinician oversight and monitoring. Physicians can review treatment data in real time and adjust protocols as needed through secure telemedicine integration.
- Improved compliance and continuity. The reduction of logistical burdens helps patients adhere to prescribed treatment regimens more consistently.
- Potential for lower overall cost of care. With fewer in-clinic resources required, HALO™ Clarity may reduce the total cost of care while alleviating burdens on healthcare infrastructure.
- Scalable clinical trial design and data capture. The ability to collect data remotely can streamline clinical trials, shortening timelines and reducing costs.
The Company is advancing multiple clinical studies of HALO™ Clarity across indications including anxiety, insomnia, post-traumatic stress disorder, and mild traumatic brain injury. Feedback from the U.S. Food and Drug Administration has already established consensus on the design of pivotal trials for anxiety and insomnia, paving the way for future regulatory submissions. Independent trials at leading academic institutions such as the University of California, San Diego are also underway, evaluating the device in PTSD and related conditions. Nexalin’s DIFS™ platform has been studied in more than two dozen completed or ongoing trials worldwide, demonstrating consistent signals of safety and efficacy.
With this new patent, Nexalin has further strengthened its intellectual property portfolio, adding to previously issued utility patents that protect the home-use aspect of the HALO™ Clarity system. Having successfully completed usability, safety, and design verification testing, the Company is scaling manufacturing in preparation for broader clinical deployment.
As Nexalin continues to pursue regulatory clearance and eventual commercialization, the Company remains committed to making safe, effective, and drug-free treatment options available to patients struggling with mental health and neurological conditions. The HALO™ Clarity system reflects Nexalin’s vision of combining innovative science with real-world practicality — offering patients relief under the supervision of their clinicians, from the comfort and convenience of home.
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 believed to be 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, 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. 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
What is the new patent Nexalin Technology (NXL) received for its HALO™ Clarity device?
How does Nexalin's HALO™ Clarity device treat mental health conditions?
What conditions is Nexalin's HALO™ Clarity device being studied for?
What are the advantages of Nexalin's HALO™ Clarity home treatment system?
What is the current development status of Nexalin's HALO™ Clarity device?
