Nexalin Technology completes FDA Q-sub meeting for Gen-2 SYNC neurostimulation

Nexalin Technology (NXL) announced the successful completion of a substantive Q-Submission, Q-Sub, meeting with the U.S. Food and Drug Administration, FDA, regarding its Gen-2 SYNC neurostimulation console for the treatment of Alzheimer’s disease. The meeting focused on Nexalin’s proposed clinical development plan and overall regulatory strategy for the Gen-2 SYNC console in Alzheimer’s disease. As part of the interaction, the Company and the FDA discussed the potential use of the De Novo classification pathway for this indication, reflecting the novel mechanism of action of Nexalin’s deep, frequency-specific neurostimulation technology. The discussion provided a clear understanding of Nexalin’s existing clinical data for the treatment of Alzheimer’s disease. Additional discussions included Nexalin’s plans for new U.S.-based Pilot Studies, followed by a large pivotal study designed to demonstrate the safety and efficacy of the Gen-2 SYNC console in patients with mild to moderate Alzheimer’s disease.