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FAQ: NeuroOne's Fiscal 2025 Financial Results and OneRF® System Milestones
TL;DR
NeuroOne's FDA-cleared OneRF systems and expanded partnership with Zimmer Biomet provide a competitive edge in neurological treatment markets with 907% quarterly revenue growth.
The OneRF system uses radiofrequency ablation with temperature control to treat neurological pain, achieving FDA clearance and successful patient outcomes in clinical procedures.
NeuroOne's technologies improve quality of life for patients with neurological disorders, enabling pain relief and functional recovery as demonstrated by treated patients.
A professional pianist returned to his career after treatment with NeuroOne's ablation system, showcasing the technology's real-world impact on patients' lives.
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Product revenue grew 163% to $9.1 million for the full fiscal year and 907% to $2.7 million in Q4, while product gross margin increased significantly to 56.5% for the year and operating expenses decreased 4.6% to $12.4 million.
NeuroOne received FDA 510(k) clearance for its OneRF® Trigeminal Nerve Ablation System and successfully used it to treat two patients with facial pain suffering from trigeminal neuralgia at University Hospitals in Cleveland, Ohio.
The company improved its balance sheet through a capital raise in April and received a $3 million upfront payment in November 2024 from expanding its exclusive distribution agreement with Zimmer Biomet.
The company advanced development of its spinal cord stimulation electrode for lower back pain, initiated a new product development program for basi-vertebral nerve ablation, reported sales of pre-clinical drug delivery devices to a pharmaceutical company, and bolstered its intellectual property portfolio.
Dave Rosa, CEO of NeuroOne, stated that fiscal 2025 was the most successful year in the company's history, with sales surging and operational achievements including FDA clearance and successful patient treatments.
NeuroOne initiated the process to gain ISO 13485 certification to support international commercial expansion of its medical technologies.
The results cover the fourth quarter and fiscal year ended September 30, 2025, and were announced on December 17, 2025.
NeuroOne is a medical technology company dedicated to transforming the surgical diagnosis and treatment of neurological disorders.
The content mentions that management will host a conference call at 8:30 a.m. Eastern Time on December 17, 2025, but does not provide specific contact information for accessing it.
Curated from NewMediaWire
