Nexalin Technology Completes FDA Q-Submission Meeting for Gen-2 SYNC™ Neurostimulation Console in Alzheimer’s Disease Program

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]