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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) 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.
RedChip Companies announces the airing of interviews with LOBO EV Technologies (Nasdaq:LOBO) and Nexalin Technology on Bloomberg TV's RedChip Small Stocks, Big Money™ show on November 2, 2024, at 7 p.m. ET. Harry D. Schulman, Independent Director of LOBO EV, will discuss the company's growth and profitability plans for 2024. LOBO aims to become a leader in intelligent urban e-bikes, e-trikes, and off-highway four-wheeled electric vehicles market. The interviews will be broadcast to an estimated 73 million homes across the U.S. through Bloomberg TV.
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 (Nasdaq:NXL) and Calidi Biotherapeutics will be featured on Bloomberg TV's RedChip Small Stocks, Big Money show on October 26, 2024, at 7 p.m. ET. Nexalin's CEO Mark White will discuss their non-invasive neurostimulation technology for mental health treatment, including the Gen-3 HALO Clarity device, targeting a market projected to reach $537 billion by 2030. The technology addresses conditions like insomnia, PTSD, and traumatic brain injuries. Calidi's Chief Business Officer Stephen Thesing will present their oncolytic virotherapy developments for cancer treatment, featuring both systemic and localized approaches with engineered viruses protected by cell-based technologies.
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.
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