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].
Nexalin Technology Initiates FDA Q-Submission Process for Gen-2 SYNC Following Encouraging Data and Preliminary FDA Feedback