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Company initiates formal regulatory engagement on trial design for Alzheimer’s, dementia, and MCI indications
HOUSTON, TX, May 01, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”), today announced that it plans 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 is intended 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 Company’s 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 next phase of regulatory engagement marks a critical step toward advancing Gen-2 SYNC as a potential non-invasive therapeutic option for patients affected by debilitating cognitive conditions.
“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 for Alzheimer’s, dementia, and MCI,” said Mark White, CEO of Nexalin. “The upcoming Q-Submission represents an important opportunity to align with the FDA on clinical study design and regulatory strategy as we continue to be in a position to provide safe, effective, and non-invasive neuromodulation therapies to patients in need.”
The Gen-2 SYNC system reflects technical enhancements from prior-generation devices, including a newly redesigned enclosure and the integration of Nexalin’s proprietary 15 milliamp advanced waveform. To clearly differentiate the system from earlier versions, the Company has initiated a rebranding initiative, and the device will be marketed as “Gen-2 SYNC.”
Nexalin remains focused on progressing regulatory engagement and advancing its neuromodulation platform as a promising therapeutic alternative in the treatment of cognitive and neuropsychiatric disorders.
For more information about Nexalin Technology and its digital neurotherapeutic ecosystem, please visit www.nexalin.com.
About Nexalin Technology, Inc.
Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. All of Nexalin’s products are non-invasive and undetectable to the human body and are developed to provide relief to those afflicted with mental health issues. Nexalin utilizes bioelectronic medical technology to treat mental health issues. Nexalin believes its neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper-penetrating waveform in its next-generation devices will generate enhanced patient response without any adverse side effects. The Nexalin Gen-2 15 milliamp neurostimulation device has been approved in China, Brazil, and Oman. Additional information about the Company is available at: https://nexalin.com/.