NeuroOne Medical Technologies Corporation reported substantial financial growth for its 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. This performance represents the most successful period in the company's history, driven primarily by sales of its OneRF® Ablation System. The company also achieved improved profitability metrics, with product gross margin reaching 56.5% for the fiscal year while reducing operating expenses for the second consecutive year.
The financial results are significant because they demonstrate the growing adoption of NeuroOne's technology platform for treating neurological disorders. The company's strengthened balance sheet, with cash and cash equivalents increasing to $6.6 million from $1.5 million the previous year, provides funding through fiscal 2026 and positions the company for continued expansion. This financial stability is crucial for advancing medical technologies that could improve patient outcomes in areas where treatment options have been limited.
Operationally, NeuroOne received FDA 510(k) clearance for its OneRF® Trigeminal Nerve Ablation System in August 2025, marking an important regulatory milestone. 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. This development matters because trigeminal neuralgia causes severe facial pain that can be debilitating, and new treatment options could significantly improve quality of life for affected individuals.
The company's expansion of its exclusive distribution agreement with Zimmer Biomet, detailed at https://www.zimmerbiomet.com, represents another strategic advancement. This partnership includes exclusive commercialization rights for NeuroOne's OneRF® Ablation System for brain applications in the United States and certain international markets. Such collaborations can accelerate the availability of innovative medical technologies to patients who need them.
Beyond its current products, NeuroOne is developing several promising programs that could have broader implications for neurological care. The company's spinal cord stimulation program has demonstrated successful acute study results, while its basi-vertebral nerve ablation program aims to treat lower back pain. Additionally, NeuroOne's sEEG-based drug delivery program recorded its first device sale for pre-clinical testing to a large bio-pharmaceutical company, focusing on treatments for glioblastomas, gene therapies, and cell-based therapies.
The company's progress in multiple therapeutic areas suggests potential for addressing various neurological conditions that affect millions worldwide. As CEO Dave Rosa noted, the technology platform aims to improve quality of life for people with debilitating neurological disorders across three focus areas: brain-related disorders, pain management, and drug delivery. This comprehensive approach could lead to more integrated treatment solutions for complex neurological conditions.
NeuroOne's improved financial position, with net loss decreasing by 71% to $3.6 million for fiscal year 2025, indicates progress toward anticipated profitability. The company has no debt outstanding as of September 30, 2025, and working capital increased to $7.9 million from $2.4 million the previous year. This financial strength enables continued investment in research and development while expanding commercial operations.
The company's initiatives toward ISO 13485 certification for international commercial expansion and its bolstered patent portfolio with recent decisions from both the U.S. Patent & Trademark Office and European Patent Office further strengthen its position in the medical technology sector. These developments matter because they support the long-term viability of technologies that could transform surgical diagnosis and treatment approaches for neurological disorders.
