Nexalin Technology, Inc. announced on May 1, 2025, its plan to submit a Q-Submission (“Q-Sub”) to the U.S. Food and Drug Administration (FDA) related to its Gen-2 SYNC system. This regulatory milestone aims to facilitate structured dialogue with the FDA regarding clinical trial design for the treatment of Alzheimer’s disease, dementia, and mild cognitive impairment (MCI).
The decision to proceed with the Q-Sub follows recent publications, a review of new encouraging internal data, and preliminary feedback received from the FDA. Nexalin believes this regulatory engagement is a critical step toward advancing Gen-2 SYNC as a potential non-invasive therapeutic option for patients with debilitating cognitive conditions.
The Gen-2 SYNC system incorporates technical enhancements, including a redesigned enclosure and Nexalin’s proprietary 15 milliamp advanced waveform. The company has initiated a rebranding initiative for the device, which will be marketed as “Gen-2 SYNC,” as it focuses on progressing regulatory engagement and advancing its neuromodulation platform.
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