Key Takeaways INSP reported positive Inspire V data with enhanced safety and better patient adherence.INSP's trials showed 20% shorter surgical times and superior AHI improvement versus Inspire IV.INSP's U.S. release confirmed efficient implantation, stable therapy use and no serious adverse events. Inspire Medical Systems (INSP) recently unveiled promising clinical data from its Inspire V system at the ISSS and AAO-HNS meetings, showcasing strong safety, enhanced respiratory sensing and improved patient ad ...

Core Insights - Nexalin Technology, Inc. has appointed Dr. Robert Rothstein to its Scientific Advisory Board, enhancing its focus on addressing the global mental healthcare crisis, particularly in Alzheimer's disease and Traumatic Brain Injury (TBI) [1][3] Company Developments - Dr. Rothstein brings over 40 years of experience in emergency medicine and mental health, having held senior roles at institutions like the University of Chicago and Johns Hopkins Medicine, which positions him well to support Nexalin's neuropsychiatric therapeutic initiatives [2][4] - The expansion of the Scientific Advisory Board follows a reconstitution in May 2025, aligning with Nexalin's intensified focus on Alzheimer's disease and TBI, with plans to initiate Alzheimer's-specific trials in Q4 2025 [3][5] Strategic Focus - Nexalin's DIFS™ technology is believed to stimulate deep brain regions linked to memory and executive function, with ongoing research suggesting its potential benefits for TBI recovery, especially in military populations [3][5] - The company aims to leverage robust imaging biomarkers and MEG-guided protocols to support its clinical trials, ensuring rigorous oversight from the Scientific Advisory Board [5] Industry Context - The company is positioned at the intersection of bioelectronic medicine and unmet neuropsychiatric needs, with Dr. Rothstein expressing enthusiasm for the non-invasive nature of Nexalin's technology in treating Alzheimer's and TBI [4]

Core Insights - Nexalin Technology, Inc. has published positive clinical data demonstrating that its Gen-2 Nexalin DIFS™ technology significantly improves cognitive performance and brain connectivity in patients with mild Alzheimer's disease, marking a significant milestone for the company's technology platform [1][2] Clinical Study Findings - The study is the first to provide fMRI confirmation that a 40-Hz, 15 mA electrical waveform can enhance hippocampal-cortical connectivity in Alzheimer's patients, correlating with measurable cognitive improvements [2] - Patients using Nexalin's Gen-2 SYNC 40-Hz DIFS device showed statistically significant improvements in Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) scores compared to the sham group, with P-values of .001 and .03 respectively [5] - Enhanced functional connectivity was observed between the hippocampus and key cortical regions, critical for memory and executive function, as confirmed by resting-state fMRI [5] - Increased connectivity between the hippocampus and middle cingulate gyrus was significantly correlated with improvements on the Boston Naming Test, indicating a link between brain network modulation and cognitive outcomes [5] Safety and Regulatory Status - The Nexalin Gen-2 SYNC 15 mA DIFS device has been approved in China for treating depression and insomnia, and in Brazil and Oman for anxiety, depression, and insomnia [3][6] - No adverse events were reported during the treatment period, reinforcing the safety and tolerability of Nexalin's DIFS technology [5] Market Potential - The global Alzheimer's disease market is projected to exceed $20 billion annually, highlighting the potential for Nexalin's non-invasive neurostimulation technology as a safe and effective alternative to pharmacologic treatments [2]

Accessibility StatementSkip Navigation "We welcome Trinity Capital as a financing partner and appreciate their confidence in providing us this important financial flexibility as we continue our commercial expansion of our newly launch, next-generation Therapy Disc, and build upon our recent publication of what we believe is the largest long-term real-world data set for a permanent PNS device that demonstrated reliable long-term pain relief to a broad spectrum of patients," said Tom West, President and CEO ...

Core Insights - Nexalin Technology, Inc. is hosting a webinar on September 9, 2025, to discuss its innovative approach to mental healthcare using its proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology [1][2] - The company is positioned in a $537 billion mental health market, with international regulatory approvals and U.S. expansion plans underway [2] - Nexalin's technology includes real-time AI-driven patient monitoring and aims to provide scalable, at-home treatment options through its Gen-3 HALO™ Clarity headset and Virtual Clinic model [2] Company Overview - Nexalin Technology, Inc. designs and develops non-invasive neurostimulation products aimed at addressing the global mental health epidemic [4] - The company's devices are believed to penetrate deep brain structures associated with mental health disorders, potentially enhancing patient response without adverse side effects [4] - The Nexalin Gen-2 15 milliamp neurostimulation device has received regulatory approval in China, Brazil, and Oman [4]

Core Insights - Nexalin Technology, Inc. has appointed Justin Van Fleet as Chief Financial Officer effective August 1, 2025, bringing over 20 years of experience in public accounting and assurance services [1][2] - Mr. Van Fleet has a strong track record in financial systems development, regulatory compliance, and strategic financial management, particularly in guiding companies through complex financial transactions [2][3] - The company is at a pivotal moment with its innovative neurostimulation technology aimed at treating serious mental health conditions, and Mr. Van Fleet's expertise will be crucial for scaling operations and advancing the technology [4] Company Overview - Nexalin Technology designs and develops non-invasive neurostimulation products to address the global mental health epidemic, utilizing bioelectronic medical technology [6] - The company's Generation 2 and Generation 3 devices are currently under FDA review and are designed to provide deep-brain stimulation without drugs or invasive procedures, targeting conditions such as anxiety and depression [4][6] - Nexalin's Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman, indicating its potential for international market expansion [6]

Core Insights - Nexalin Technology, Inc. is hosting a webinar on June 3, 2025, to discuss its innovative approach to mental healthcare using its proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology [1][2] - The company is positioned in a $537 billion mental health market, with international regulatory approvals and U.S. expansion plans underway [2] - Nexalin's technology includes real-time AI-driven patient monitoring and aims to provide scalable, at-home treatment options [2] Company Overview - Nexalin designs and develops non-invasive neurostimulation products aimed at addressing the global mental health epidemic [4] - The company's devices are believed to penetrate deep brain structures associated with mental health disorders, enhancing patient response without adverse side effects [4] - The Nexalin Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman [4]

Core Viewpoint - Nexalin Technology, Inc. has successfully closed a public offering of 3,850,000 shares at a price of $1.30 per share, raising approximately $5.0 million in gross proceeds before expenses [1]. Company Overview - Nexalin Technology, Inc. specializes in developing innovative neurostimulation products aimed at addressing the global mental health crisis. The company's products are designed to be non-invasive and are believed to provide relief for mental health issues [5]. - The company utilizes bioelectronic medical technology to treat mental health disorders, with a focus on penetrating deep brain structures associated with these conditions. Nexalin's next-generation devices are expected to enhance patient response without adverse side effects [5]. - The Nexalin Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman [5]. Offering Details - The public offering was conducted under an effective shelf registration statement filed with the U.S. Securities and Exchange Commission (SEC) on April 23, 2025, and declared effective on April 29, 2025 [3]. - Maxim Group LLC served as the sole book-running manager for the offering [2].

Company Overview - Nexalin Technology, Inc. is a leader in Deep Intracranial Frequency Stimulation (DIFS™) technology aimed at addressing mental health issues through innovative neurostimulation products [5] - The company's products are designed to be non-invasive and are believed to provide relief for individuals suffering from mental health disorders [5] Public Offering Details - Nexalin announced a public offering of 3,850,000 shares of common stock priced at $1.30 per share, with expected gross proceeds of approximately $5.0 million [1] - The offering is set to close on or about May 6, 2025, subject to customary closing conditions [1] - An additional 577,500 shares may be purchased by underwriters within a 45-day option period at the public offering price [1] Use of Proceeds - The net proceeds from the offering will be utilized for working capital and general corporate purposes, including sales and marketing, product development, and capital expenditures [2] Regulatory Compliance - A shelf registration statement for the shares was filed with the SEC on April 23, 2025, and was declared effective on April 29, 2025 [3] - The offering is being conducted through a written prospectus and prospectus supplement available on the SEC's website [3]

Core Viewpoint - Nexalin Technology, Inc. is initiating formal regulatory engagement with the FDA for its Gen-2 SYNC system, aimed at treating Alzheimer's disease, dementia, and mild cognitive impairment (MCI) [1][2]. Regulatory Engagement - The company plans to submit a Q-Submission ("Q-Sub") to the FDA to facilitate structured dialogue regarding clinical trial design [1][2]. - This decision follows recent publications, encouraging internal data, and preliminary feedback from the FDA, marking a critical step in advancing Gen-2 SYNC as a non-invasive therapeutic option [2]. Product Development - The Gen-2 SYNC system features technical enhancements over prior generations, including a redesigned enclosure and a proprietary 15 milliamp advanced waveform [3]. - The company is rebranding the device to clearly differentiate it from earlier versions, marketing it as "Gen-2 SYNC" [3]. Company Focus - Nexalin is committed to progressing regulatory engagement and advancing its neuromodulation platform as a promising therapeutic alternative for cognitive and neuropsychiatric disorders [3]. - The company designs and develops innovative neurostimulation products aimed at addressing the global mental health epidemic, utilizing bioelectronic medical technology [5].