FDA Provides Feedback and Reaches Consensus on Nexalin’s Design for Planned Anxiety and Insomnia Clinical Studies of its Gen-3 HALO Clarity™ Headset Device
Clinical studies in anxiety and insomnia expected to commence in the third quarter of 2024
HOUSTON, TX, June 03, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) announces that the U.S. Food and Drug Administration (FDA) has provided feedback and reached consensus on the design for its planned clinical studies in anxiety and insomnia for its new Gen-3 HALO Clarity™ (“HALO”), a non-invasive, Deep Intracranial Frequency Stimulation (DIFS™) headset device designed to address the global mental health epidemic. After the studies are completed and evaluated, Nexalin plans to submit a De Novo request application for the HALO to the FDA. The De Novo request provides a marketing pathway to classify new novel medical devices.
The initial pilot and pivotal studies for anxiety and insomnia are expected to commence in the third quarter of 2024. Each of the pivotal studies will include 75 patients receiving active treatment and 75 patients receiving sham treatment and are intended to evaluate HALO’s ability to reduce symptoms of anxiety and insomnia, respectively. These two studies are intended to build on the positive results of prior published clinical studies evaluating Nexalin’s Gen-3 HALO utilizing the new advanced DIFS™ waveform.
Dr. David Owens, Chief Medical Officer of Nexalin, commented, "We are proud to have arrived at a consensus with the FDA for the clinical protocols to evaluate the safety and efficacy of HALO in both anxiety and insomnia. This marks a major milestone for Nexalin and a significant step forward in the regulatory pathway. These studies will build upon our extensive prior published clinical studies in the U.S. and Asia, which have repeatedly demonstrated the efficacy of our proprietary waveform.”
Mark White, CEO of Nexalin, added, “The approval of these protocols underscores the potential of HALO headset to revolutionize the standard of care in mental health treatment. We believe our technology represents a major breakthrough, as it offers an effective alternative to pharmacological treatments, which often have limited efficacy and may have severe side effects. Moreover, the HALO medical device will be prescribed and managed through Nexalin’s proprietary digital platform in a virtual clinic. Nexalin intends to manage the patient-physician relationship through a virtual clinic model, which we believe will lead to a shift in the standard of care for mental health, enabling patients to use our headset at home with remote monitoring by a physician."
“We have commenced a large production run of over 500 units, a key step that will support the FDA protocols for the planned studies. Overall, we believe the progress we have made is a major feat in a relatively short amount of time—from vision to design, pre-manufacturing to full manufacturing, and usability testing to protocol approval. We look forward to providing further updates on our clinical studies as developments unfold.”
Recent published clinical studies include:
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 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 was recently approved in Oman and China. Additional information about the Company is available at: .
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, . 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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