Nexalin Technology Announces Positive Results of Clinical Study Validating its Gen-2 tACS Device for Reducing Pain Among Veterans with Mild Traumatic Brain Injury at University of California, San Diego
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Insights
The recent findings from Nexalin Technology's clinical study present a significant development in the treatment of Mild Traumatic Brain Injury (mTBI) and its associated symptoms, including post-concussive symptoms (PCS) and post-traumatic stress disorder (PTSD). The study's use of the Gen-2 tACS device, which is designed to stimulate the brain without medication, aligns with the increasing demand for non-pharmacological treatment options.
The positive outcome of the study, indicating a reduction in pain and symptomatology without adverse events, suggests the potential for Nexalin's technology to address a critical gap in mTBI treatment. This is particularly relevant given the projected growth of the Traumatic Brain Injuries Assessment Market, which is expected to more than double by 2032. The absence of side effects is a noteworthy advantage over traditional pharmacological treatments, which often carry the risk of dependency or other negative side effects.
Furthermore, the study's rigorous design—a randomized, double-blind, placebo-controlled clinical trial—strengthens the credibility of the results. The use of magnetoencephalography (MEG) to demonstrate changes in brain activity provides objective evidence supporting the therapeutic claims. The observed changes in delta and gamma wave activity could signify a normalization of brain function, which is a promising indicator of the device's efficacy.
The Traumatic Brain Injuries Assessment Market's expected growth suggests a significant commercial opportunity for Nexalin's Gen-2 tACS device, particularly if it gains traction as a non-invasive alternative to current treatments. The study's results could contribute to increased interest from investors, as they represent progress in a field with high unmet medical needs. The positive data could also lead to partnerships or acquisition interest from larger pharmaceutical or medical device companies looking to expand their portfolio in neurostimulation technologies.
However, the path from clinical study to market success includes regulatory hurdles and market adoption challenges. The company's ability to navigate FDA approvals and secure insurance coverage for the device will be key determinants of its commercial potential. Additionally, the endorsement by healthcare professionals, influenced by further clinical data and real-world efficacy, will play a important role in the device's market penetration.
Investors will be monitoring the upcoming presentation at BARDA's event for potential impacts on the company's stock valuation. The focus will be on the company's strategy to leverage its clinical data to secure government contracts, which could provide a stable revenue stream and validation of the technology's utility in a military and civilian context.
The collaboration with the United States Department of Veterans Affairs (VA) adds a layer of significance to the study, as the VA's endorsement could influence broader adoption within military healthcare systems. The focus on veteran patients with combat-related mTBI highlights the device's potential impact on a population that is particularly affected by these injuries and often faces challenges with current treatment options.
The policy implications of this study are substantial, as successful integration of Nexalin's device into VA treatment protocols could lead to improved quality of life for veterans and potentially lower healthcare costs associated with long-term medication management. It also aligns with the VA's ongoing efforts to incorporate innovative treatments that address both physical and psychological aspects of service-related injuries.
Given the VA's role in setting treatment standards for veterans, the study's findings could catalyze policy changes that prioritize non-pharmacological interventions for mTBI. Moreover, the cost-effectiveness of such treatments will be a critical consideration for policymakers, particularly in the context of optimizing the allocation of VA resources.
Collaborative Study involving the VA and UCSD achieved statistically significant decrease in PCS and PTSD symptoms versus control group
The data supports the Company’s strategy to offer military and civilian physicians a new tool to effectively treat mTBI without the use of medication, and without side effects or adverse events
HOUSTON, TEXAS, March 28, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) today announced the positive results of a clinical study evaluating Nexalin’s Gen-2 tACS device for reducing pain in veteran patients with Mild Traumatic Brain Injury (mTBI). The study was conducted at The University of California, San Diego, and is further detailed in an abstract co-authored by the United States Department of Veterans Affairs (VA) San Diego Healthcare System, and the Radiology, Psychiatry and Neurosciences Departments of UC San Deigo.
mTBI is a leading cause of sustained physical, cognitive, emotional, and behavioral deficits in veterans and the general public. However, the underlying pathophysiology is not completely understood, and there are few effective treatments for post-concussive symptoms (PCS). In addition, PCS and post-traumatic stress disorder (PTSD) symptoms overlap considerably. According to Global Market Insights, the Traumatic Brain Injuries Assessment Market size was valued at approximately
The study was conducted as a randomized, double-blind, placebo-controlled clinical trial over an eight-week period, with two groups being examined: an active tACS group and a sham tACS group. As part of the clinical study, 24 veteran patients with mTBI received twelve sessions of active or sham tACS over a period of four consecutive weeks, followed by a four-week follow-up period.
The abstract summarizing the findings of the study was submitted for a presentation at the Biomedical Advanced Research and Development Authority (BARDA) “State of the Technology Meeting: Neurotrauma Diagnosis, Monitoring, and Assessment” on March 12, 2024. BARDA is a U.S. government agency under the Department of Health and Human Services focusing on the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
A repeated analysis of variance (ANOVA) measurement tested the treatment effect in resting-state magnetoencephalography (MEG) data. Post-concussive symptoms (PCS) were assessed using the Rivermead Post-Concussion Symptoms Questionnaire (RPQ), Neurobehavioral Symptom Inventory (NSI), and McGill Pain Questionnaire (MPQ). When measured by the MPQ pain scale, the Nexalin treatment group showed a significant reduction in pain when compared to the sham group, as measured by MPQ. Additionally, the active treatment group showed reduced RPQ and NSI symptoms (measured by total score) relative to the sham group. Additionally, no adverse events were observed during treatment in the two groups.
As part of the study, MEG was used to visually assess neuronal changes in veterans with combat-related mTBI after they received treatment with Nexalin’s non-invasive, frequency based deep brain stimulation. Before and after MEG imaging demonstrated significant changes (i.e., p<0.01) in deep brain structures related to abnormal hyperactive waveforms in the brain, including both delta and gamma waves at the center of increased abnormal activity in the brain.
Compared with the sham group, veterans in the active treatment group showed significant reductions in delta-band activity and abnormal gamma-band activity. These reductions in abnormal activity may indicate that a healing of the neurons is occurring and may be returning certain abnormal areas of brain function to normal, which then suggests an improvement in GABA-ergic inhibitory functions.
Mark White, CEO of Nexalin Technology, stated, "We are encouraged by the results of the clinical study, reinforcing the significant reduction in pain and other persistent symptoms of mild traumatic brain injury among veteran patients. We look forward to further discussing the data at BARDA’s prestigious upcoming event. Importantly, this latest study builds on prior data in combat-related mTBI disclosed at the 2023 Military Health System Research Symposium (MHSRS) and validates the growing body of clinical evidence supporting Nexalin's new advanced 15 milliamp waveform. We believe the data we have reported provides evidence of the potential clinical efficacy of our neurostimulation device on improving mental healthcare outcomes among patients affected with mTBI, without any significant adverse effects. This is especially noteworthy given the growing number of patients seeking non-pharmacological treatment options. Additionally, it is further gratifying to learn from the results of our MEG studies that Nexalin therapy truly is a non-invasive deep brain stimulating tool, which can result in lasting therapeutic neuroplastic changes in brain disorders. We look forward to advancing the technology within the military and government agencies to bring hope to countless numbers of military and civilian patients impacted by these often-debilitating conditions in the United States and around the world.”
About Nexalin Technology, Inc.
Nexalin designs and develops innovative neurostimulation products to uniquely and effectively help combat the ongoing global mental health epidemic. All Nexalin’s products are non-invasive and undetectable to the human body and provide relief to those afflicted with mental health issues without adverse side effects. Nexalin utilizes bioelectronic medical technology to treat mental health issues without the need for drugs or psychotherapy. Nexalin believes its 15 milliamp medical device can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper penetrating waveform will generate enhanced patient response without any adverse side effects. The Nexalin tACS device was recently approved in China by the National Medical Products Administration (NMPA) for the treatment of insomnia and depression. The tACS device currently is distributed in the Asia Pacific region through a joint venture with Wider Come Limited, and further clinical research is ongoing. Additional information about the Company is available at: https://nexalin.com/.
FORWARD-LOOKING STATEMENTS
This press release contains statements that constitute "forward-looking statements," including with respect to the Company’s initial public offering. 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 most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and in subsequent filings made by Nexalin with the SEC, which are available on the SEC's website, www.sec.gov. 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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FAQ
What positive results were announced by Nexalin Technology, Inc. regarding its Gen-2 tACS device?
What was the focus of the collaborative study involving the VA and UCSD?
What type of clinical trial was conducted to evaluate Nexalin's Gen-2 tACS device?
What were the key findings of the clinical study regarding the reduction of pain in veteran patients with mTBI?
What did the MEG imaging demonstrate in veterans with combat-related mTBI after treatment with Nexalin's device?
