Core Insights - Nexalin Technology, Inc. has successfully completed a Q-Submission meeting with the FDA regarding its Gen-2 SYNC neurostimulation console for Alzheimer's disease, indicating a clear regulatory pathway for the device [1][2][5] Group 1: FDA Interaction and Regulatory Pathway - The meeting focused on Nexalin's clinical development plan and regulatory strategy, discussing the potential use of the De Novo classification pathway due to the novel mechanism of action of the technology [2][3] - Feedback from the FDA provided clarity on primary and secondary endpoints for measuring clinically meaningful outcomes in Alzheimer's disease, which will support Nexalin's upcoming clinical protocol and Investigational Device Exemption (IDE) submission [4][7] Group 2: Clinical Study Plans - Nexalin plans to conduct new U.S.-based Pilot Studies followed by a large pivotal study to demonstrate the safety and efficacy of the Gen-2 SYNC console in patients with mild to moderate Alzheimer's disease [3][5] - The design of both pilot and pivotal trials has been discussed, with alignment on key components such as patient population, dosing paradigm, and statistical analysis plan [3][4] Group 3: Technology and Efficacy - The Gen-2 SYNC console utilizes a proprietary 15-milliamp DIFS waveform, employing a 100 kHz carrier frequency modulated at gamma frequencies (40 Hz and 77.5 Hz) to non-invasively stimulate brain structures associated with cognition and mood [5] - Independent peer-reviewed studies have shown that Nexalin's DIFS technology can significantly improve cognitive performance and enhance functional brain connectivity in Alzheimer's patients, supporting the company's development strategy [6]

Core Insights - Nexalin Technology, Inc. is participating in the 2025 Maxim Growth Summit on October 22nd, showcasing its leadership in Deep Intracranial Frequency Stimulation (DIFS™) technology [1][2] Company Overview - Nexalin develops innovative neurostimulation products aimed at addressing the global mental health epidemic, focusing on non-invasive and undetectable treatments [3] - The company's neurostimulation devices are designed to penetrate deep brain structures associated with mental health disorders, potentially enhancing patient response without adverse side effects [3] - The Nexalin Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman, indicating its international market potential [3]

Core Viewpoint - Nexalin Technology, Inc. has successfully enrolled the first patients in a clinical trial for its Deep Intracranial Frequency Stimulation (DIFS™) technology, aiming to treat mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) [1][2][3] Company Overview - Nexalin Technology focuses on developing innovative neurostimulation products to address the global mental health crisis, utilizing non-invasive bioelectronic medical technology [5] - The company's DIFS™ technology is designed to penetrate deep brain structures associated with mental health disorders, potentially offering enhanced patient responses without adverse side effects [5] Clinical Trial Details - The clinical trial is being conducted in collaboration with the University of California, San Diego (UCSD) and the VA San Diego Healthcare System, marking a significant step in evaluating the efficacy of Nexalin's HALO™ Clarity devices [2][3] - The trial aims to gather comprehensive data on the impact of DIFS™ technology on mental health conditions, particularly for underserved populations such as veterans [3][4] Technology and Devices - The HALO™ Clarity device is currently under evaluation and is not yet approved for marketing in the U.S., with its safety and efficacy still being assessed by the FDA [6] - Nexalin's HALO™ Clarity devices provide non-invasive, at-home neurostimulation therapy, integrated with AI for remote monitoring of patient adherence and treatment progress [4]