NeuroOne reported strong financial results for the fourth quarter and fiscal year 2025, with significant revenue growth and gross margin improvement.
The revenue growth was driven by sales of the OneRF® Ablation System.
FDA clearance was received for the OneRF® Trigeminal Nerve Ablation System.
The company strengthened its balance sheet to fund growth through fiscal year 2026.
Product Revenue Growth
Product revenue increased by 163% to $9.1 million in fiscal year 2025, compared to $3.5 million in fiscal year 2024.
FDA Clearance
Received FDA clearance for the OneRF® Trigeminal Nerve Ablation System.
Exclusive Distribution Agreement
Expanded exclusive distribution agreement with Zimmer Biomet and received an upfront payment of $3 million.
Patent Portfolio
Bolstered patent portfolio with recent decisions from U.S. and European Patent Offices.
- The fourth quarter of fiscal 2025 marked the most successful year in NeuroOne's history.
- Sales surged to $2.7 million in the fiscal fourth quarter and reached a total of $9.1 million for fiscal year 2025.
- The gross margin improved to 56.5%, and operating expenses decreased significantly.
- The company made advancements in technology and received FDA clearance for new products.
NeuroOne's strong financial performance in fiscal year 2025, along with strategic developments and technological advancements, positions the company for future growth and value creation in the medical technology sector.