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
Nexalin Technology announced that the FDA has provided feedback and reached consensus on the design for clinical studies of its Gen-3 HALO Clarity™ headset. These studies, focusing on anxiety and insomnia, are set to commence in Q3 2024. Each study will involve 75 patients receiving active treatment and 75 receiving sham treatment. The HALO device uses Deep Intracranial Frequency Stimulation (DIFS™) to potentially offer an effective alternative to pharmacological treatments. Following the studies, Nexalin plans to submit a De Novo request to the FDA, seeking a new marketing pathway for the device.
The production of over 500 units of the HALO headset has started to support these studies. Nexalin aims to manage the patient-physician relationship through a virtual clinic model, allowing at-home use with remote monitoring by a physician. CEO Mark White sees this as a significant step towards revolutionizing mental health treatment standards.
- FDA consensus on clinical study design for Nexalin's Gen-3 HALO Clarity™.
- Clinical studies are set to begin in Q3 2024.
- Each study will involve 75 patients for active and sham treatments.
- HALO device uses Deep Intracranial Frequency Stimulation (DIFS™).
- Potentially effective alternative to pharmacological treatments.
- Initiation of production run of over 500 HALO units.
- Virtual clinic model for remote patient monitoring.
- De Novo request to FDA for new marketing pathway post-study.
- Clinical studies not commencing until Q3 2024, delaying potential market entry.
- Dependence on successful completion and positive outcomes of clinical studies.
- Potential financial burden due to ongoing production and study-related costs.
- Uncertainty in FDA approval following the De Novo request.
Insights
The FDA's feedback and consensus on the clinical study designs for Nexalin's new Gen-3 HALO Clarity™ headset device signifies a critical advancement for the company. The HALO device, which uses Deep Intracranial Frequency Stimulation (DIFS™), is targeting the significant market of anxiety and insomnia treatments. Clinical trials are important in assessing both safety and efficacy before any product can proceed to market. The FDA's agreement on the study protocols streamlines the regulatory pathway, increasing the likelihood of eventual marketing approval.
The planned studies will involve 150 patients in each trial, with a double-blind, placebo-controlled design. This rigorous methodology enhances the reliability of the results. Given the earlier positive outcomes from studies in the U.S. and Asia, there is reasonable optimism about these new trials.
Understanding the De Novo request is essential. It offers a pathway for novel medical devices to be classified without a direct predicate, potentially accelerating the introduction of innovative technologies. For retail investors, this development reduces some regulatory uncertainties, likely bolstering investor confidence. However, the full impact hinges on the outcomes of these pivotal studies and any adverse results could significantly affect Nexalin's prospects.
From a financial perspective, Nexalin’s progress with the FDA is promising. The commencement of large-scale production of 500 units indicates a strategic push towards readiness for clinical trials and eventual market entry. This operational milestone suggests prudent financial planning and resource allocation, important for investor trust.
The potential market for anxiety and insomnia treatments is substantial. Non-invasive, non-pharmacological solutions like the HALO Clarity™ device could capture significant market share, especially given the side-effect profiles and limitations of existing treatments. The company's move towards a virtual clinic model—enabling at-home use with remote monitoring—could further reduce costs and increase accessibility, positioning Nexalin competitively in the telehealth arena.
The broader market implications of Nexalin's advancements are significant. The mental health market is burgeoning, with increasing awareness and demand for effective treatments. Nexalin’s technology, if proven effective, could fill a critical gap in this landscape. The company's emphasis on a non-invasive, non-pharmacological approach aligns with current trends favoring alternative therapies over traditional pharmaceuticals, which often have adverse side effects.
The virtual clinic model is an innovative approach that could disrupt traditional mental health care delivery. By allowing patients to use the headset at home with remote physician monitoring, Nexalin leverages the growing trend towards telehealth and digital health solutions. This model could improve patient adherence and outcomes while reducing the burden on healthcare systems.
For investors, understanding these market dynamics is crucial. The combination of an innovative product, a robust regulatory pathway and a strategic market approach positions Nexalin to potentially revolutionize mental health treatment. However, investor caution is warranted until clinical trial outcomes are clear.
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:
- EFFICACY OF TACS FOR CHRONIC INSOMNIA – ELSEVIER (1)
- MEG SOURCE IMAGING REVEALS NEURONAL CHANGES IN COMBAT-RELATED MILD TRAUMATIC BRAIN INJURY AFTER TRANSCRANIAL ELECTRICAL STIMULATION USING NEXALIN
- CLINICAL STUDY OF TRANSCRANIAL AC STIMULATION IN THE TREATMENT OF MIGRAINE WITHOUT AURA
- EFFECT OF TRANSCRANIAL ALTERNATING CURRENT STIMULATION FOR THE TREATMENT OF CHRONIC INSOMNIA: A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED CLINICAL TRIAL
- EVIDENCE OF A LARGE CURRENT OF TRANSCRANIAL ALTERNATING CURRENT STIMULATION DIRECTLY TO DEEP BRAIN REGIONS
- TRANSCRANIAL ALTERNATING CURRENT STIMULATION FOR TREATING DEPRESSION: A RANDOMIZED CONTROLLED TRIAL
- ACUTE EFFECT OF TWICE-DAILY 15 MA TRANSCRANIAL ALTERNATING CURRENT STIMULATION ON TREATMENT-RESISTANT DEPRESSION: A CASE SERIES STUDY
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: 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:
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