NeuroOne Reports Record Financial Growth and FDA Clearance for Pain Management System

NeuroOne Medical Technologies Corporation reported substantial financial growth for its fourth quarter and fiscal year 2025, driven primarily by sales of its OneRF Ablation System. The company's product revenue surged 907% to $2.7 million in the fourth quarter compared to the same period last year, while full-year product revenue increased 163% to $9.1 million. This growth occurred alongside significant operational milestones, including FDA clearance for a new medical device and successful patient treatments.

The financial results demonstrate improving operational efficiency, with product gross margin increasing to 56.5% for the fiscal year compared to 31.3% in the prior year. Operating expenses decreased 4.6% to $12.4 million, marking the second consecutive year of declining expenses. Net loss improved significantly by 71% to $3.6 million for the full fiscal year. The company strengthened its balance sheet with cash and cash equivalents of $6.6 million as of September 30, 2025, and reported being funded through fiscal 2026.

Operationally, NeuroOne received FDA 510(k) clearance in August 2025 for its OneRF Trigeminal Nerve Ablation System, designed for creating radiofrequency lesions to treat pain. The company successfully treated two patients suffering from trigeminal neuralgia at University Hospitals in Cleveland, with both patients reporting pain relief without complications. This development represents an expansion of the company's technology platform into pain management applications.

The company's core OneRF Ablation System continues to show positive clinical outcomes without recorded adverse events. A notable case involved a professional pianist from Chicago who returned to his career after receiving an ablation with the system. The proprietary temperature probe has provided temperature control during procedures, increasing patient safety. All ablations have reportedly been performed at the patient's bedside, saving time and operating room costs.

NeuroOne expanded its strategic partnership with Zimmer Biomet in October 2024, granting exclusive commercialization rights for the OneRF Ablation System for brain applications in the United States and certain international markets. The company received a $3 million upfront payment as part of this expanded agreement. This partnership supports the company's commercial expansion efforts alongside its pursuit of ISO 13485 certification for international markets.

The company is advancing multiple development programs beyond its current commercial products. Its sEEG-based drug delivery program recorded its first device sale for pre-clinical testing to a large bio-pharmaceutical company, with a focus on applications for glioblastomas, gene, and cell-based therapies. The spinal cord stimulation percutaneous paddle lead program has completed successful acute studies demonstrating full system functionality, with chronic studies underway to assess biocompatibility and histology.

Additionally, NeuroOne initiated a basi-vertebral nerve ablation program in 2025 to treat lower back pain, creating an advisory board of leading pain specialists. The company plans to leverage its existing OneRF generator, temperature probe, and ablation electrode technology for this application. Bench top and animal studies are planned to confirm the system will meet clinical performance requirements.

CEO Dave Rosa stated that the fourth quarter capped the most successful year in the company's history, noting improved financial condition and progress toward anticipated profitability. The company believes its strengthened balance sheet positions it to expand its technology platform into three focus areas: brain-related disorders, pain management, and drug delivery. Management will host a conference call to discuss these results, accessible via webcast at https://viavid.webcasts.com/starthere.jsp?ei=1698764&tp_key=5a8e1c9d0a.