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Nexalin Technology, Inc. (NASDAQ: NXL) is a pioneering company in the field of neurostimulation, offering non-invasive and drug-free therapies for individuals suffering from anxiety, depression, and insomnia. The company has developed a patented device that uses transcranial electrical stimulation (tES), producing a unique waveform designed to stimulate brain activity and normalize neurochemical levels. This treatment aims to provide lasting relief from mental health conditions without the adverse side effects typically associated with drugs or psychotherapy.
One of the core products from Nexalin is the Gen-1 device, classified as a Class II medical device by the U.S. Food and Drug Administration (FDA). This cranial electrotherapy stimulation (CES) device emits a waveform at 4 milliamps during treatments and has been shown to increase beta-endorphins significantly during clinical trials.
Nexalin is also advancing the development of its Gen-2 and Gen-3 HALO™ Clarity devices, which aim to offer deeper brain penetration and enhanced patient response without side effects. The company's Gen-2 device was recently approved by the National Medical Products Administration (NMPA) in China for treating insomnia and depression and is distributed in the Asia Pacific region through a joint venture with Wider Come Limited.
Recent achievements include a collaborative study involving the U.S. Department of Veterans Affairs and UC San Diego, which demonstrated a significant decrease in post-concussion syndrome (PCS) and PTSD symptoms in veteran patients using the Gen-2 device. Moreover, the company continues to gather clinical data supporting its neurostimulation technology and is making progress in advancing its new Gen-3 HALO™ Clarity Virtual Clinic model.
Nexalin is committed to addressing the global mental health crisis through innovative solutions. The company's non-invasive devices are developed to be undetectable to the human body, ensuring a comfortable treatment experience. With ongoing research and development, Nexalin aims to extend the reach of its therapies to benefit more people worldwide.
Nexalin Technology (NXL) has received IRB approval from UCSD for clinical testing of its HALO™ Clarity headset. UCSD will conduct independent research using 50 HALO devices to evaluate its efficacy in treating mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD), particularly in military personnel.
The HALO device utilizes Nexalin's proprietary Deep Intracranial Frequency Stimulation (DIFS) technology, offering non-invasive, drug-free brain stimulation. The system includes a virtual clinic model featuring AI integration, patient monitoring, and telemedicine capabilities through a smartphone application.
Key features include at-home treatment administration, remote physician monitoring, and an AI-powered Electronic Data Capture platform. The device is currently under FDA evaluation and not yet approved for these uses in the United States.
Nexalin Technology (Nasdaq: NXL) has been appointed as Industry Co-Chair of the National Traumatic Brain Injury (TBI) Registry Coalition. The company, which specializes in Deep Intracranial Frequency Stimulation (DIFS™), will work with policymakers and stakeholders in Washington, D.C. to advance TBI advocacy and research.
The appointment aligns with Nexalin's ongoing initiatives, including a collaborative study with the University of California, San Diego (UCSD) and the San Diego Veterans Affairs (VA) focused on developing treatments for veterans with TBI. The company is also actively engaging with Congress members to strengthen relationships with federal agencies to improve TBI care and support. Federal spending on TBI is projected to increase significantly.
Nexalin Technology (Nasdaq: NXL) has published a landmark study in the Journal of Affective Disorders showcasing the effectiveness of its Deep Intracranial Frequency Stimulation (DIFS™) technology. The study demonstrated that patients receiving 15 mA DIFS therapy experienced significant blood pressure reductions: 2.04 mmHg in systolic and 1.92 mmHg in diastolic blood pressure compared to sham stimulation.
The randomized controlled trial involved 68 first-episode, drug-naive patients with major depressive disorder (MDD), who underwent 20 sessions over four weeks. The treatment showed particular efficacy in patients with elevated baseline blood pressure and was well-tolerated with no reported adverse effects.
The DIFS technology, supported by 29 clinical trials, targets deep brain structures including the brainstem, hypothalamus, and thalamus. Currently approved in China, Brazil, and Oman, Nexalin aims to obtain CE Mark certification for European markets in 2025.
Nexalin Technology (Nasdaq: NXL) has announced an exclusive live investor webinar scheduled for January 23, 2025, at 4:15 p.m. ET. The event, hosted by RedChip Companies, will feature CEO Mark White discussing the company's non-invasive frequency-based deep brain stimulation device and progress on their new Gen-3 HALO™ Clarity & Virtual Clinic model.
The company's solutions have demonstrated clinically meaningful improvements in treating insomnia, PTSD, and traumatic brain injuries. These conditions affect millions of people and currently have effective treatments. The market for these solutions is projected to reach $537 billion by 2030. The webinar will include a live Q&A session, and investors can pre-submit questions or ask them during the event.
Nexalin Technology (NXL) has released a shareholder letter highlighting achievements and 2025 outlook. The company's Deep Intracranial Frequency Stimulation (DIFS) technology has shown significant results in mental health treatment, achieving a 65% response rate in depression trials. Their Gen-3 Halo headset delivers a proprietary 15 mA waveform that's 5-10 times more powerful than existing devices.
Key developments include: launching a virtual clinic with AI integration, conducting 29 IRB-approved clinical trials, and receiving regulatory approvals in China, Brazil, and Oman. The company is pursuing CE Mark approval for European market entry in 2025. Research shows promising results in Alzheimer's treatment, with increased brain activity in memory-related areas. The company is also focusing on PTSD and TBI research through collaborations with UC San Diego and the VA.
With the neuromodulation market projected to reach $11 billion by 2028, Nexalin aims to expand its global presence while advancing research in mood disorders, Alzheimer's, and addiction treatment.
Nexalin Technology (NXL) has completed Phase 1 of its proprietary virtual clinic, incorporating AI components for Electronic Data Capture (EDC) and Patient Monitoring System (PMS). The virtual platform is designed to enable clinical trials and treatments to be conducted remotely from patients' homes while providing real-time data to physicians.
The system will support Nexalin's Generation 3 Halo Device, a non-invasive headset that delivers 15mAmp deep frequency stimulation to treat mental health conditions including depression, insomnia, Alzheimer's disease, and addiction. The Halo device requires FDA clearance and physician prescription.
The EDC platform enables real-time data collection during trials through a smartphone application, while the PMS allows clinical teams to monitor patient progress and make treatment adjustments. The virtual clinic includes telemedicine features for direct patient-physician communication.
Nexalin Technology (NXL) announces validation of its Deep Intracranial Frequency Stimulation (DIFS) technology in a new peer-reviewed editorial published in Psychotherapy and Psychosomatics. The company's 15mA DIFS technology demonstrates superior deep brain penetration compared to traditional neurostimulation methods, effectively reaching critical areas like the hippocampus, amygdala, and insula. The neuromodulation market is projected to reach $11.0 billion by 2028.
The publication validates DIFS's ability to non-invasively treat psychiatric conditions like major depressive disorder and chronic insomnia, offering a safer alternative to invasive procedures while providing tailored neuromodulation for different conditions.
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.
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