Nexalin Technology announced that the U.S. Food and Drug Administration has formally accepted its Q‑Submission for the Gen‑2 SYNC system, a non‑invasive neurostimulation device that delivers a proprietary 15‑milliamp waveform. The acceptance initiates a structured dialogue with the FDA to discuss trial design, endpoints, and the regulatory pathway for treating Alzheimer’s disease, dementia, and mild‑to‑moderate cognitive impairment, and is a prerequisite for filing an Investigational Device Exemption (IDE).
The Gen‑2 SYNC platform builds on Nexalin’s Deep Intracranial Frequency Stimulation (DIFS™) technology, which has already received regulatory approvals in China, Brazil, Oman, and Israel. The device’s non‑invasive approach distinguishes it from implanted neurostimulators and positions it as a cost‑effective alternative in a high‑growth therapeutic area. The FDA’s acceptance signals that the agency has reviewed Nexalin’s preliminary data and clinical strategy and found them sufficient for a formal discussion, reducing regulatory uncertainty and potentially shortening the time to market.
Nexalin’s financial performance in the first half of 2025 underscores the company’s ongoing investment in clinical development. In Q1 2025, the company reported a net loss of $1.99 million, a 91% increase from the prior year, and an earnings per share of –$0.15, missing analyst expectations of –$0.10. Revenue for the quarter was $41,015, exceeding the $35,000 estimate. In Q2 2025, the company posted an EPS of –$0.10, beating the –$0.14 consensus, and revenue of $70,000, above the $40,000 forecast. The widening losses are largely attributable to higher operating expenses, including professional fees and stock‑based compensation, as Nexalin accelerates its clinical program and expands its global footprint.
The FDA acceptance is a significant milestone for Nexalin’s commercial strategy. It opens the door to U.S. clinical trials, which are essential for demonstrating efficacy and safety in the largest Alzheimer’s market. The company’s CEO, Mark White, described the acceptance as an “important step” toward redefining treatment for cognitive disorders associated with Alzheimer’s, emphasizing the supportive internal data and published results that underpin the device’s potential. Nexalin’s next step is a regulatory meeting later this year to finalize trial design and discuss the IDE filing, a move that could accelerate the company’s entry into the U.S. market and broaden its global reach.
No immediate market reaction or analyst commentary was identified in the fact‑check report. The event is primarily a regulatory development that will influence Nexalin’s future earnings trajectory once clinical data are available and regulatory approval is achieved.
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