NeuroOne Reports Record Financial Growth and FDA Clearance for Neurological Treatment System

NeuroOne Medical Technologies Corporation reported substantial financial growth for the fourth quarter and fiscal year 2025, with product revenue increasing 907% to $2.7 million in the quarter and 163% to $9.1 million for the full year. The company's product gross margin improved significantly to 56.5% for fiscal year 2025, while operating expenses decreased 4.6% to $12.4 million, marking the second consecutive year of expense reduction. This financial performance coincides with important regulatory and clinical milestones that position the company for continued expansion in neurological treatment technologies.

The company received U.S. Food and Drug Administration clearance to market the OneRF® Trigeminal Nerve Ablation System for creating radiofrequency lesions to treat pain or lesion nerve tissue for functional neurosurgical procedures. This clearance represents a significant advancement in treatment options for patients suffering from neurological disorders. The system was successfully used to treat two patients with facial pain from trigeminal neuralgia at University Hospitals in Cleveland, Ohio, with both patients reporting pain relief without complications. NeuroOne's technology platform aims to transform surgical diagnosis and treatment approaches for debilitating neurological conditions.

NeuroOne's financial improvements were bolstered by an expanded exclusive distribution agreement with Zimmer Biomet, which included a $3 million upfront payment in November 2024. The company's strengthened balance sheet, with cash and cash equivalents increasing to $6.6 million as of September 30, 2025, provides funding through fiscal year 2026. Management noted that the capital raise in April significantly improved the company's financial position as it advances toward anticipated profitability. The company's working capital increased to $7.9 million with no debt outstanding, creating a solid foundation for continued research and development initiatives.

Operational highlights include progress across multiple development programs. 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. The Spinal Cord Stimulation Percutaneous Paddle Lead Program completed successful acute studies demonstrating full system functionality, while a new Basi-Vertebral Nerve Ablation Program was initiated in 2025 to treat lower back pain. The company is pursuing strategic partnerships to minimize time and cost to commercialization across several programs while strengthening its intellectual property portfolio through recent decisions from both the U.S. Patent & Trademark Office and European Patent Office.

Clinical outcomes for the OneRF® Ablation System remain positive without any recorded adverse events, with reports including a professional pianist from Chicago returning to his career after receiving an ablation with the system. The proprietary temperature probe has provided temperature control during procedures, increasing patient safety during ablations. All ablations have reportedly been performed at patients' bedsides, saving time and operating room costs. The company has met with staff from participating hospitals to gather clinical outcomes and work toward initiating a post-market registry to further document treatment effectiveness and safety profiles.