FDA feedback provides clear framework for Nexalin’s planned U.S. Pilot Study and supports a potential De Novo pathway for the Gen-2 SYNC™ device in Alzheimer’s diseaseHOUSTON, TX, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced the successful completion of a substantive Q-Submission (“Q-Sub”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding it ...

Core Insights - Nexalin Technology, Inc. is participating in the 2025 Maxim Growth Summit on October 22nd, showcasing its leadership in Deep Intracranial Frequency Stimulation (DIFS™) technology [1][2] Company Overview - Nexalin develops innovative neurostimulation products aimed at addressing the global mental health epidemic, focusing on non-invasive and undetectable treatments [3] - The company's neurostimulation devices are designed to penetrate deep brain structures associated with mental health disorders, potentially enhancing patient response without adverse side effects [3] - The Nexalin Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman, indicating its international market potential [3]

Core Viewpoint - Nexalin Technology, Inc. has successfully enrolled the first patients in a clinical trial for its Deep Intracranial Frequency Stimulation (DIFS™) technology, aiming to treat mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) [1][2][3] Company Overview - Nexalin Technology focuses on developing innovative neurostimulation products to address the global mental health crisis, utilizing non-invasive bioelectronic medical technology [5] - The company's DIFS™ technology is designed to penetrate deep brain structures associated with mental health disorders, potentially offering enhanced patient responses without adverse side effects [5] Clinical Trial Details - The clinical trial is being conducted in collaboration with the University of California, San Diego (UCSD) and the VA San Diego Healthcare System, marking a significant step in evaluating the efficacy of Nexalin's HALO™ Clarity devices [2][3] - The trial aims to gather comprehensive data on the impact of DIFS™ technology on mental health conditions, particularly for underserved populations such as veterans [3][4] Technology and Devices - The HALO™ Clarity device is currently under evaluation and is not yet approved for marketing in the U.S., with its safety and efficacy still being assessed by the FDA [6] - Nexalin's HALO™ Clarity devices provide non-invasive, at-home neurostimulation therapy, integrated with AI for remote monitoring of patient adherence and treatment progress [4]