Nexalin Technology, Inc. (NXL) announced progress in its U.S. regulatory pathway for Alzheimer's disease following a series of high-level meetings with the U.S. Food and Drug Administration (FDA) and international experts.
The company is developing its non-invasive Deep intracranial Frequency Stimulation (DIFS) technology as a drug-free approach to reduce Alzheimer's symptoms and cognitive decline. During a recent FDA Q-Submission meeting, regulators provided guidance on clinical trial design, including primary and secondary endpoints to measure treatment response in Alzheimer's patients. Nexalin plans to submit an amended application in the second quarter of 2026.
The strategy builds on extensive real-world neurostimulation data from both U.S. and China, where Nexalin collaborates with leading Alzheimer's specialists, including Professor Yi Tang, M.D., PhD, Vice Chairman of Xuanwu Hospital at Capital Medical University. The company emphasized that aligning global experience with FDA requirements is a critical step toward advancing its De Novo application and positioning DIFS as a novel therapy for age-related cognitive vulnerability.
"These meetings marked a critical step in aligning our global clinical experience with a disciplined U.S. regulatory and clinical strategy," said Mark White, President and CEO of Nexalin Technology. He noted that the upcoming FDA trial design will directly reflect insights from these discussions.
NXL has traded between $0.33 and $2.00 over the past year. The stock is currently trading at $0.47, up 11.66%.
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