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 (Nasdaq: NXL) released a shareholder letter highlighting recent achievements in their Deep Intracranial Frequency Stimulation (DIFS) technology. The company reported two significant Alzheimer's research studies in October showing improvements in memory and cognitive function. They secured a key patent for frequency-based deep brain stimulation in treating Alzheimer's and dementia. Additionally, their DIFS technology demonstrated positive results in treating Major Depressive Disorder (MDD). The company announced a clinical trial collaboration with UC San Diego and San Diego VA to study their Gen-3 Halo headset for mild Traumatic Brain Injury treatment. Nexalin also received regulatory approval in Brazil for their Gen-2 15 mA neurostimulation device.
Nexalin Technology (Nasdaq: NXL) announces an upcoming investor webinar scheduled for November 5th, 2024, at 4:15 p.m. ET. CEO Mark White will present the company's progress on their non-invasive deep brain stimulation device and the new Gen-3 HALO™ Clarity & Virtual Clinic model. The presentation will highlight clinical data showing improvements in treating insomnia, PTSD, and traumatic brain injuries. The company operates in a market projected to reach $537 billion by 2030. The event includes a live Q&A session and is free to attend with registration.
Nexalin Technology (Nasdaq: NXL) has received notice from Nasdaq confirming its regained compliance with the minimum bid price requirement under Rule 5550(a)(2). The notification was received on October 31, 2024. CEO Mark White emphasized this achievement as a significant milestone in the company's mission to develop non-invasive neurostimulation treatments, highlighting its importance for shareholder value and investor visibility as the company progresses with clinical research and global regulatory approvals.
Nexalin Technology (NXL) published a landmark study in the Journal of Alzheimer's Disease demonstrating the effectiveness of their Deep Intracranial Frequency Stimulation (DIFS) technology. The study, involving 46 patients over three weeks, showed significant improvements in brain function and cognitive performance in Alzheimer's patients. Key findings include increased neuronal activity, enhanced brain connectivity, improved blood flow, and sustained cognitive benefits over a three-month follow-up period. The treatment proved safe and well-tolerated, with no serious side effects reported. The study validates DIFS as a potential non-pharmacological treatment option for Alzheimer's disease, which affects over 50 million people globally.
Nexalin Technology (NXL) has announced plans for a new clinical trial in collaboration with UC San Diego and San Diego VA. The study will evaluate the effectiveness of Nexalin's Gen-3 Halo headset in treating veterans with mild Traumatic Brain Injury (mTBI) using a virtual clinic model. This innovative approach allows patients to receive treatment at home, potentially expanding access to care.
The trial builds on positive results from a previous study using Nexalin's Gen-2 device, which showed significant improvements in MEG signals and pain reduction for mTBI patients. The Gen-3 Halo headset incorporates Nexalin's proprietary Deep Intracranial Frequency Stimulation (DIFS®) technology with an advanced 15 milliamp waveform.
The study will recruit two groups: one receiving treatment with the Nexalin Gen-3 Halo headset and another using a sham device for comparison. It aims to assess changes in brain activity and correlate them with improvements in post-concussion symptoms and neuropsychological test performance.
Nexalin Technology (Nasdaq: NXL) has announced promising results from a clinical trial of its Deep Intracranial Frequency Stimulation (DIFS) technology for mild Alzheimer's disease. The study, published in Alzheimer's Research & Therapy, showed significant improvements in memory and cognitive function among patients treated with DIFS.
Key findings include:
- Statistically significant improvement in memory (ADAS-Cog scores)
- Significant increases in MMSE (p = 0.041) and MoCA (p = 0.025) scores
- Enhanced neural activity and increased blood flow in the hippocampus
- Well-tolerated treatment with minor side effects
The study involved 46 patients, with 23 in the DIFS group. Functional MRI scans revealed increased blood flow to hippocampal regions, important for memory function. Nexalin is planning further clinical trials to explore different waveform frequencies and enhance clinical response.
Nexalin Technology (Nasdaq: NXL) has appointed Carolyn Shelton as Senior Vice President of Clinical, Quality & Regulatory Affairs. With over 30 years of experience in the medical device industry, Shelton will oversee clinical studies, quality systems, and regulatory submissions for Nexalin's Deep Intracranial Frequency Stimulation (DIFS) technology.
Shelton's extensive career includes leadership roles at Openwater Health, Advanced Sterilization Products, Medtronic, and Smith & Nephew. Her expertise in regulatory compliance, quality assurance, and clinical development will be important as Nexalin pursues global regulatory clearances and FDA Breakthrough Device designations.
CEO Mark White emphasized Shelton's strategic importance in guiding Nexalin through complex regulatory processes and international expansion. Shelton expressed enthusiasm for joining Nexalin, highlighting the potential of DIFS technology to provide drug-free alternatives for mental health treatment.
Nexalin Technology (Nasdaq: NXL) participated in a Congressional roundtable in North Carolina focused on virtual therapeutic options for opioid treatment. The event, hosted by the Breaking Barriers for Substance Use Recovery initiative, featured key healthcare and policy stakeholders. Congressman Dr. Greg Murphy, the only practicing physician in Congress, led discussions on deploying virtual-based opioid therapy models nationwide.
Nexalin's approach to virtual therapeutic solutions, pending FDA clearance, was highlighted as a promising tool against opioid addiction. The company's non-invasive neurostimulation technology aims to revolutionize addiction treatment, especially for veterans in rural communities. The roundtable emphasized establishing stronger practices within the VA and SAMHSA to encourage the adoption of virtual-based therapies, expanding the reach and impact of mental health care.
Nexalin Technology (Nasdaq: NXL) has been selected as a founding member of Breaking Barriers to Substance Use Recovery, a coalition focused on addressing opioid use disorder in the USA. The organization aims to identify and dismantle obstacles to effective treatment through advocacy, policy solutions, and public education campaigns.
CEO Mark White participated in the inaugural meeting in Washington D.C. in June 2024, joining other industry leaders. The coalition plans to deploy Nexalin's neurostimulation technologies to provide accessible and innovative treatment for those affected by the opioid epidemic.
A key focus of the organization is advocating for Virtual-Based Opioid Treatment (VBOT), which aims to overcome traditional barriers to treatment, especially for veterans and rural communities. The initiative seeks to create a model using innovative virtual technologies and services, coupled with AI and data-driven methodologies.
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.
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