NeuroOne Reports Record Growth with 907% Quarterly Revenue Surge Driven by Medical Device Expansion

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 compared to the same period last year. For the full fiscal year, product revenue grew 163% to $9.1 million, driven primarily by sales of the company's OneRF® Ablation System. The medical technology company also achieved significant improvements in gross margin, which increased to 56.5% for the fiscal year, while simultaneously reducing operating expenses by 4.6% to $12.4 million.

The company's operational achievements include receiving FDA 510(k) clearance for its OneRF® Trigeminal Nerve Ablation System in August 2025, with the first two patients successfully treated at University Hospitals in Cleveland, Ohio. Both patients suffering from trigeminal neuralgia reported pain relief without complications. NeuroOne expanded its exclusive distribution agreement with Zimmer Biomet, receiving a $3 million upfront payment in November 2024, which contributed to license revenue of $3.0 million for the fiscal year.

CEO Dave Rosa stated that the fourth quarter capped "the most successful year in our history," noting improved financial conditions that position the company toward anticipated profitability. NeuroOne'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. The company reported a significantly reduced net loss of $3.6 million for the fiscal year, a 71% improvement from the previous year's $12.3 million loss.

Beyond financial metrics, NeuroOne advanced multiple development programs with potential implications for neurological disorder treatment. The company's sEEG-based drug delivery program recorded its first device sale for pre-clinical testing to a large bio-pharmaceutical company, focusing on applications for glioblastomas, gene, and cell-based therapies. 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 to treat lower back pain.

The company's technology platform expansion into three focus areas—brain-related disorders, pain management, and drug delivery—represents a strategic approach to building long-term value. Clinical outcomes for existing products remain positive, with one reported case of a professional pianist from Chicago returning to his career after receiving an ablation with the system. NeuroOne has initiated the process to gain ISO 13485 certification for international commercial expansion and bolstered its intellectual property portfolio with recent decisions from both the U.S. Patent & Trademark Office and European Patent Office.

Management will host a conference call to discuss these results, accessible via webcast at https://www.example.com/4QWebcastLink. The company's progress in developing minimally invasive solutions for neurological disorders comes as healthcare systems seek technologies that can reduce hospitalizations, lower costs, and improve patient outcomes through combination diagnostic and therapeutic functions.