Nexalin Technology’s Q-Submission for Gen-2 SYNC Accepted by U.S. FDA for the Treatment of Alzheimer’s Disease and Dementia

Core Insights - The FDA has accepted Nexalin Technology's Q-Submission for its Gen-2 Console system aimed at treating Alzheimer's disease and dementia, marking a significant step towards clinical studies in the U.S. [1][2][4] Regulatory Milestone - The acceptance of the Q-Submission allows for structured dialogue with the FDA regarding clinical trial design, study endpoints, and regulatory pathways for the Gen-2 SYNC system [2][6]. - This regulatory milestone is based on encouraging internal data and published studies that suggest the potential of Nexalin's neurostimulator to improve cognitive function and memory [3][4]. Product and Technology - Nexalin's Gen-2 SYNC platform utilizes a proprietary 15-milliamp waveform designed to stimulate brain structures related to cognition and mood without drugs or surgical procedures [3][10]. - The company is also evaluating strategic collaborations with research institutions to accelerate studies involving its Gen-2 SYNC and next-generation Gen-3 HALO platforms [7]. Clinical Evidence - Recent data and independent research indicate observed improvements in cognitive performance in pilot studies using Nexalin's technology, with no serious adverse events reported, highlighting a favorable safety profile [9][10]. - EEG and qEEG evidence suggests that the waveform induces modulation correlated with improved neural connectivity in dementia-related conditions [9].