Upgrade to SI Premium - Free Trial

Nexalin advances Alzheimer's FDA strategy after meetings in US and China

April 15, 2026 10:00 AM

Nexalin Technology, Inc. (NASDAQ: NXL) completed meetings in the United States and China focused on advancing its clinical strategy for Alzheimer's disease treatment, according to a company statement.

The meetings included a Q-Submission interaction with the U.S. Food and Drug Administration, which provided clinical guidance on the company's proposed Alzheimer's symptom reduction trial and regulatory pathway. Nexalin plans to submit an amended FDA Q-Submission application in Q2 2026.

The company is developing its De Novo application with the FDA for Alzheimer's disease treatment using its Deep Intracranial Frequency Stimulation technology. The clinical and research teams are finalizing trial design to meet FDA guidance on clinical relevance and treatment response in Alzheimer's patients.

"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 Chief Executive Officer. "The meeting insights and observations are directly informing our planned FDA application amendments and design of our FDA Alzheimer's clinical trial."

In China, Nexalin continues collaboration with Professor Yi Tang, Vice Chairman of Xuanwu Hospital at Capital Medical University and leader at China's National Neuroscience and Research Center for Geriatric Diseases. The collaboration involves ongoing studies using Nexalin's medical device on Alzheimer's patients, representing clinical data from neurostimulation in aging and dementia-related populations.

Nexalin's technology targets disrupted brain networks associated with cognitive decline. The company's Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, Oman and Israel.

The Houston-based company designs non-invasive neurostimulation products for mental health treatment using bioelectronic medical technology.

Categories

Corporate News FDA

Next Articles