- Nexalin Technology (NXL, Financial) has initiated the FDA Q-Submission process for its Gen-2 SYNC system.
- The submission aims to support clinical trial design discussions for treating Alzheimer’s, dementia, and mild cognitive impairment (MCI).
- Gen-2 SYNC features technical improvements and aims to offer a non-invasive treatment option.
Nexalin Technology, Inc. (NXL) has officially launched a Q-Submission process with the U.S. Food and Drug Administration (FDA) for its Gen-2 SYNC system. This move is a pivotal element in the company's journey to achieving regulatory approval for the innovative neuromodulation therapy system. The submission is designed to facilitate a structured dialogue with the FDA, focusing on the clinical trial design for treating Alzheimer’s disease, dementia, and mild cognitive impairment (MCI).
The decision to move forward with the Q-Sub comes on the heels of promising internal data and preliminary feedback from the FDA. Nexalin’s Gen-2 SYNC system incorporates significant technical upgrades, including a redesigned enclosure and the integration of the company's proprietary 15 milliamp advanced waveform. These enhancements are part of a broader rebranding initiative aimed at distinguishing the Gen-2 SYNC from earlier versions of the device.
Mark White, CEO of Nexalin, expressed optimism about the prospects for the Gen-2 SYNC system. "We are encouraged by our internal findings and preliminary interactions with the FDA, which support our view that there may be a viable path forward for our Gen-2 SYNC system as a potential treatment," he stated, underscoring the company's commitment to providing safe, effective, and non-invasive therapeutic options.
Nexalin remains focused on advancing its regulatory engagement to bring the Gen-2 SYNC to market as a promising treatment alternative for cognitive and neuropsychiatric disorders. Despite the progress, it is important to note that the Gen-2 SYNC system has not yet received FDA approval, and clinical trials are still awaiting design and execution.
