NeuroOne Reports Record Fiscal 2025 Results with 907% Q4 Revenue Growth and FDA Clearance for New Pain Treatment System

NeuroOne Medical Technologies Corporation reported substantial financial growth for its fourth quarter and fiscal year ended September 30, 2025, with product revenue increasing 907% to $2.7 million in the fourth quarter and 163% to $9.1 million for the full fiscal year. The medical technology company, which focuses on transforming surgical diagnosis and treatment of neurological disorders, also achieved significant improvements in gross margin and operating efficiency while advancing multiple clinical programs.

The company's financial performance was driven primarily by sales of its OneRF® Ablation System, with product gross margin increasing to 56.5% for fiscal year 2025 compared to 31.3% in the previous year. Operating expenses decreased 4.6% to $12.4 million, marking the second consecutive year of expense reduction. Net loss improved significantly by 71% to $3.6 million for the full fiscal year, with the company reporting cash and cash equivalents of $6.6 million as of September 30, 2025, and no outstanding debt.

A key operational milestone was the U.S. Food and Drug Administration clearance received in August 2025 for the OneRF® Trigeminal Nerve Ablation System. The system is designed for creating radiofrequency lesions for pain treatment or lesioning nerve tissue for functional neurosurgical procedures. NeuroOne successfully treated two patients with facial pain suffering from trigeminal neuralgia at University Hospitals in Cleveland, Ohio, with both patients reporting pain relief without complications. The company is conducting a limited market release and discussing distribution with potential strategic partners.

The company expanded its exclusive distribution agreement with Zimmer Biomet, receiving an upfront payment of $3 million in November 2024. This partnership includes exclusive commercialization rights for NeuroOne's OneRF® Ablation System for use in the brain in the United States and certain international markets. Clinical outcomes for the system remain positive without any recorded adverse events, with procedures reportedly performed at patients' bedsides, saving time and operating room costs.

NeuroOne is advancing multiple development programs, including a spinal cord stimulation percutaneous paddle lead program that has demonstrated steerable capability in less than five minutes in cadaver studies. The company initiated a basi-vertebral nerve ablation program in 2025 to treat lower back pain and created an advisory board of leading pain specialists. Additionally, the sEEG-based drug delivery program recorded its first device sale for pre-clinical testing to a large bio-pharmaceutical company, with a 2026 goal of commercial-readiness for pre-clinical drug delivery devices.

CEO Dave Rosa stated that the company's financial condition has improved significantly and continues to advance toward anticipated profitability. NeuroOne believes it is well positioned to expand its technology platform into three focus areas: brain-related disorders, pain management, and drug delivery. The company has strengthened its intellectual property portfolio with recent decisions from both the U.S. Patent & Trademark Office and European Patent Office and is initiating the process to gain ISO 13485 certification for international commercial expansion.

The implications of NeuroOne's progress extend beyond financial metrics to potential improvements in patient care for neurological disorders and chronic pain conditions. The company's technology platform offers combination diagnostic and therapeutic functions that could reduce hospitalizations, surgical procedures, and costs while improving patient outcomes. With funding secured through fiscal year 2026 and multiple clinical programs advancing, NeuroOne appears positioned to expand treatment options in neurosurgery and pain management markets.