Curated News
By: NewsRamp Editorial Staff
December 17, 2025
NeuroOne Reports 907% Q4 Revenue Growth, FDA Clearance for Pain Treatment
TLDR
- 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.
Impact - Why it Matters
This news represents a significant advancement in neurological treatment options that could impact millions suffering from chronic pain and neurological disorders. NeuroOne's FDA-cleared OneRF® Trigeminal Nerve Ablation System offers a minimally invasive alternative for conditions like trigeminal neuralgia, which causes excruciating facial pain often resistant to conventional treatments. The company's technology platform addresses critical gaps in neurological care by combining diagnostic and therapeutic functions, potentially reducing hospitalizations, surgical procedures, and healthcare costs while improving patient outcomes. For investors, the dramatic revenue growth and strengthened financial position signal a maturing medical technology company approaching profitability with multiple growth vectors in brain disorders, pain management, and drug delivery. The successful patient outcomes, including the professional pianist returning to work, demonstrate real-world impact beyond financial metrics. As neurological conditions affect approximately 1 in 6 people globally, advancements like NeuroOne's could significantly improve quality of life while potentially reducing the economic burden of chronic neurological care.
Summary
NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) has reported a transformative fiscal year 2025, marked by explosive revenue growth and significant medical technology advancements. The company's product revenue surged 163% to $9.1 million for the full year, with a remarkable 907% increase to $2.7 million in the fourth quarter alone, driven primarily by sales of their OneRF® Ablation System. CEO Dave Rosa described this as "the most successful year in our history," highlighting improved gross margins of 56.5% while simultaneously reducing operating expenses by 4.6% and strengthening their balance sheet with cash reserves of $6.6 million, positioning them for growth through fiscal 2026.
The company achieved critical regulatory and clinical milestones, including FDA 510(k) clearance for their OneRF® Trigeminal Nerve Ablation System and successful treatment of the first two facial pain patients at University Hospitals in Cleveland. Their strategic partnership with Zimmer Biomet expanded significantly, bringing an upfront payment of $3 million and exclusive commercialization rights for the OneRF® system in key markets. NeuroOne also advanced multiple development programs including spinal cord stimulation for lower back pain, basi-vertebral nerve ablation, and a promising sEEG-based drug delivery program that recorded its first device sale to a large pharmaceutical company for pre-clinical testing of treatments for brain tumors and gene therapies.
Beyond financial success, NeuroOne demonstrated tangible patient impact, including a professional pianist from Chicago who returned to his career after receiving an ablation with their system. The company's proprietary temperature probe technology has enhanced patient safety during procedures, and all ablations have reportedly been performed at patients' bedsides, reducing costs and operating room time. With strengthened intellectual property protection from recent patent office decisions and plans for ISO 13485 certification to support international expansion, NeuroOne is positioned to transform treatment across three key areas: brain disorders, pain management, and drug delivery, potentially improving quality of life for millions suffering from debilitating neurological conditions.
Source Statement
This curated news summary relied on content disributed by NewMediaWire. Read the original source here, NeuroOne Reports 907% Q4 Revenue Growth, FDA Clearance for Pain Treatment
