Welcome to our dedicated page for Nexalin Tech news (Ticker: NXLIW), a resource for investors and traders seeking the latest updates and insights on Nexalin Tech stock.
Overview of Nexalin Technology Inc
Nexalin Technology Inc is an innovator in the field of neurostimulation, utilizing advanced bioelectronic medical technology to provide non-invasive, drug-free solutions for mental health challenges. Leveraging patented waveform technology for transcranial electrical stimulation (TES) and deep intracranial frequency stimulation (DIFS), the company offers a unique approach to managing conditions such as anxiety, depression, insomnia, post-traumatic stress disorder (PTSD), and traumatic brain injuries. Industry-specific techniques in neurostimulation, digital health solutions, and targeted neuromodulation underscore its expertise and commitment to improving neurochemistry through safe, non-pharmaceutical interventions.
Technological Innovations and Clinical Applications
Nexalin Technology has developed medical devices that employ a proprietary waveform to stimulate brain regions associated with mood regulation and stress response. The technology is designed to normalize neurochemical imbalances by delivering controlled electrical pulses, which have been shown in laboratory and clinical studies to enhance the production of beta-endorphins and modulate the hypothalamus and related neural circuits. Its approach provides an alternative to traditional pharmaceutical therapies in treating various mental health disorders, making the device especially relevant in the current global landscape of mental health care.
Product Portfolio and Operational Scope
The company's product lineup includes innovative neurostimulation devices such as its Generation 1 (Gen-1) cranial electrotherapy stimulation (CES) devices and the next evolution in its product suite that leverages deep intracranial frequency stimulation (DIFS) technology. With its non-invasive design, each device is engineered to deliver optimal energy levels through pre-set waveforms that have undergone extensive safety and FDA classification processes, ensuring the technology is both effective and safe for clinical trials and therapeutic use. The devices are designed for ease of use, fitting into both clinical research protocols and potential home-based treatment models supported by virtual clinics and app-controlled monitoring systems.
Regulatory and Clinical Credentials
Nexalin Technology’s devices have been subject to rigorous clinical trials and safety analyses that position them within a non-significant risk category by the U.S. Food and Drug Administration (FDA), further emphasizing the technological robustness and clinical potential of their applications. The company has received approvals for clinical testing in various international jurisdictions, which reinforces its credibility and commitment to scientific validation. These regulatory credentials enhance the company’s E-E-A-T signals, demonstrating deep expertise, experience in clinical research, and a trustworthy approach to advancing mental health treatment options.
Market Position and Competitive Landscape
Operating at the intersection of mental health innovation and digital therapeutics, Nexalin Technology is positioned within an industry experiencing rapid growth and transformation. Its unique value proposition lies in its drug-free, non-invasive approach, offering a complementary or alternative path to traditional mental health treatments. As awareness of mental health issues increases globally, the company’s focus on bioelectronic therapy provides a strategic advantage in both clinical and consumer health markets. This positioning is bolstered by its ability to engage in research partnerships and align with public health initiatives aimed at addressing widespread challenges such as the opioid crisis and chronic mental health conditions.
Expertise, Safety, and the Future of Neurostimulation
With a strong foundation in clinical research and intellectual property, Nexalin Technology demonstrates its expertise through the integration of advanced medical technologies into practical, patient-centric applications. Its approach to neurostimulation combines precise engineering with clinical insights to create devices that are not only effective but also safe and easy to administer. The company’s commitment to rigorous scientific evaluation and regulatory compliance underpins its reputation as an experienced and trustworthy entity in the field of neurohealth innovation. Even as the scope of mental health challenges evolves, Nexalin’s focus on non-invasive, technology-driven treatments offers an enduring solution for patients seeking effective alternatives to traditional therapies.
Nexalin Technology closed a public offering of 3,000,000 shares of common stock at $1.75 per share, raising approximately $5.25 million in gross proceeds before fees and expenses. The offering was facilitated by Maxim Group as the sole placement agent.
The shares were registered under a Form S-1 registration statement, which the SEC declared effective on June 27, 2024. A final prospectus was filed on June 28, 2024, and the offering concluded on July 1, 2024.
This announcement does not constitute an offer or solicitation to sell these securities in any jurisdiction where such would be unlawful.
Nexalin Technology announced the pricing of a $5.2 million public offering, involving 3,000,000 shares of common stock at $1.75 per share. The company expects to generate gross proceeds of approximately $5.25 million before fees and expenses. Maxim Group is the sole placement agent for this offering, which is scheduled to close on July 1, 2024, contingent on standard closing conditions. This offering was made under a registration statement declared effective by the SEC on June 27, 2024. The final prospectus will be filed with the SEC, and copies can be obtained from Maxim Group
Nexalin Technology (Nasdaq: NXL; NXLIW) announced positive outcomes from a clinical study on their Deep Intracranial Frequency Stimulation (DIFS®) technology combined with escitalopram (Lexapro) for treating major depressive disorder (MDD). The 4-week, double-blind, randomized trial included 66 participants. Results showed that 66.7% of patients receiving the combination therapy improved, compared to 33.3% in the control group. The study revealed significant reductions in Hamilton Depression Rating Scale (HAMD-17) scores and found no serious adverse events. These findings were published in the journal Brain Stimulation, affirming the efficacy and feasibility of combining tACS with antidepressants for MDD treatment.
Nexalin Technology announced that the USPTO has awarded it U.S. Patent No 12,011,591 for its non-invasive Deep Intracranial Frequency Stimulation (DIFS®) device, designed to treat Alzheimer's and dementia-related diseases. The patent covers the Gen-2 and Gen-3 devices that use a proprietary frequency-based waveform for pain-free, undetectable brain stimulation. The global dementia treatment market is projected to grow from over $18 billion to $28 billion by 2030. The device also holds potential for other mental health disorders, including depression, migraines, anxiety, insomnia, addiction, and PTSD. The new patent enhances Nexalin's intellectual property portfolio and reflects significant advancements over the Gen-1 system. CEO Mark White emphasized the importance of this milestone, highlighting the growing need for innovative treatments in the expanding dementia market.
Nexalin Technology announced the regulatory approval of its Gen-2, 15 mA neurostimulation device by the Brazilian Health Regulatory Agency (Anvisa) on June 13, 2024. This marks Nexalin's second regulatory approval outside China this year. Brazil, the ninth largest economy globally with over 215 million people, includes more than 35 million individuals suffering from mental health disorders. CEO Mark White highlighted the strategic importance of this approval, positioning it as a gateway to broader South American markets. Nexalin is in advanced talks with a key distributor in Brazil, promising more updates soon.
Nexalin Technology (Nasdaq: NXL; NXLIW) announced its participation in the Spring MicroCap Rodeo Conference on June 6, 2024, in New York City. CEO Mark White will present at 10:00 a.m. Eastern Time, with the presentation available via live webcast. Nexalin's management will also hold one-on-one meetings with approved investors throughout the event. Further details and registration for the conference can be found on the MicroCap Rodeo website.
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.
Nexalin Technology announced that its new division, Nexalin America, has joined the National Traumatic Brain Injury (TBI) Registry Coalition. This Coalition comprises private sector and non-profit organizations dedicated to advancing research, raising awareness, and supporting clinical trials for TBI, affecting millions annually. Members include the NFL Players Association, Spaulding Rehabilitation at Mass General, United States Brain Injury Alliance, Abbott, and American Academy of Neurology. Nexalin America will leverage its neurostimulation technology expertise to contribute to developing a national TBI registry. CEO Mark White highlighted this partnership as a significant step towards combating brain injuries through advanced technology and collaborative research.
Nexalin Technology, Inc. is hosting an exclusive live investor webinar on May 23, 2024, featuring CEO Mark White discussing the company's clinical data on its deep brain stimulation device and new clinic model. Investors can register for the event and submit questions online.
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