Nexalin Technology advances FDA Alzheimer’s strategy

Nexalin Technology (NXL) announced the completion of a series of high-level meetings in the United States and China focused on advancing the Company’s global clinical strategy for the treatment of Alzheimer’s disease and dementia related cognitive decline. These meetings, including a productive Q-Submission interaction with the U.S. Food and Drug Administration, represent key milestones in the preparation of Nexalin’s De Novo application with the FDA for the treatment of Alzheimer’s disease. The FDA provided clinical guidance on the proposed Alzheimer’s symptom reduction FDA clinical trial and regulatory pathway. The Nexalin clinical and research teams are currently finalizing the clinical design that will provide primary and secondary endpoints to follow FDA guidance on clinical relevance and treatment response in the Alzheimer’s patient population. The Company plans to submit an amended FDA Q-Submission application based on these strategy meetings in Q2. The high-level meetings brought together Nexalin leadership, American-based academic research teams and members of the international Alzheimer’s clinical community. Insights gained from these discussions are directly informing Nexalin’s FDA strategy and shaping the final design of its upcoming FDA clinical trial focused on Alzheimer’s disease and 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, CEO. “The meeting insights and observations are directly informing our planned FDA application amendments and design of our FDA Alzheimer’s clinical trial. We believe this regulatory strategy will position Nexalin to become the leader in drug-free, non-invasive treatment focused on the core mechanisms of cognitive decline and the reduction of Alzheimer’s-related symptoms.”