NeuroOne Medical Technologies Corporation reported exceptional financial results for its fourth quarter and fiscal year ended September 30, 2025, with product revenue growth of 907% to $2.7 million in the quarter and 163% to $9.1 million for the full year. The medical technology company, which focuses on improving surgical care for neurological disorders, achieved these results while decreasing operating expenses and significantly improving gross margins.
The revenue growth was primarily fueled by sales of the OneRF® Ablation System, which saw expanded commercialization through an exclusive distribution agreement with Zimmer Biomet. This partnership included a $3 million upfront payment in November 2024 and provides exclusive rights for the system's use in the brain in the United States and certain international markets. The company's product gross margin increased significantly to 56.5% for fiscal year 2025, compared to 31.3% for fiscal year 2024, while operating expenses decreased 4.6% to $12.4 million.
A key operational milestone was the FDA 510(k) clearance received in August 2025 for the OneRF® Trigeminal Nerve Ablation System, designed for creating radiofrequency lesions to treat pain. The system has already been used successfully to treat two patients with facial pain suffering from trigeminal neuralgia at University Hospitals in Cleveland, Ohio, with both patients reporting pain relief without complications. This development represents a significant advancement in pain management technology and demonstrates the system's potential clinical impact.
CEO Dave Rosa stated that the fourth quarter capped the most successful year in the company's history, noting that the financial condition has improved significantly and continues to advance toward anticipated profitability. The company's strengthened balance sheet, with cash and cash equivalents increasing to $6.6 million as of September 30, 2025 from $1.5 million a year earlier, positions it to be funded through fiscal year 2026. This financial stability enables continued expansion of the technology platform into three key areas: brain-related disorders, pain management, and drug delivery.
Beyond the trigeminal nerve system, NeuroOne is advancing multiple development programs with significant market potential. The company recorded its first device sale for pre-clinical testing to a large bio-pharmaceutical company as part of its sEEG-based drug delivery program, which focuses on treatments for glioblastomas, gene, and cell-based therapies. The spinal cord stimulation percutaneous paddle lead program has completed successful acute studies demonstrating full functionality, while a new basi-vertebral nerve ablation program was initiated in 2025 to treat lower back pain.
The company's operational improvements included initiating the process to gain ISO 13485 certification for international commercial expansion and bolstering its intellectual property portfolio with recent decisions from both the U.S. Patent & Trademark Office and European Patent Office. These developments strengthen NeuroOne's competitive position in the medical technology sector and provide protection for its innovative approaches to neurological treatment.
For business and technology leaders, NeuroOne's performance demonstrates how focused innovation in medical technology can drive exponential growth while addressing significant healthcare challenges. The company's ability to achieve substantial revenue growth while decreasing expenses and advancing multiple product lines suggests a scalable business model in the high-growth medical technology sector. The successful treatment outcomes with the trigeminal nerve ablation system indicate potential for broader adoption in pain management, a market with substantial unmet needs and growing demand for minimally invasive solutions.
The company's progress toward profitability, combined with its expanded partnership with Zimmer Biomet and growing intellectual property portfolio, positions it as a notable player in the convergence of medical technology and neurological treatment innovation. As NeuroOne continues to develop its technology platform across brain disorders, pain management, and drug delivery applications, it represents a case study in how specialized medical technology companies can achieve rapid growth through strategic partnerships, regulatory milestones, and clinical validation.
