NeuroOne Q4 2025: FDA 510(k) clears OneRF trigeminal nerve ablation + basivertebral lower back pain program launched
Summary
NeuroOne reported Q4 2025 results with two key milestones: FDA 510(k) clearance for the OneRF trigeminal nerve ablation system for chronic facial pain, and initiation of a new product development program for basivertebral nerve ablation for lower back pain. NeuroOne's strategy leverages the same OneRF generator platform across multiple neural ablation applications, with Zimmer Biomet's distribution network providing commercial reach for their brain ablation system (a deal expanded beyond SEEG electrodes in October 2024). CEO confirmed: "Our strategy is to leverage what we already have — which is the OneRF generator and SEEG probe — to perform this [basivertebral] procedure." Q4 2025 also saw NeuroOne's first preclinical drug delivery device sales to a large pharmaceutical company.
Why it matters
NeuroOne's basivertebral nerve ablation program — targeting lower back pain with the same RF generator used for brain and trigeminal applications — is the commercial diversification that transforms a niche epilepsy neural interface company into a broader pain management competitor. Lower back pain affects 65 million Americans annually with inadequate treatment options, and basivertebral nerve ablation has demonstrated durable pain relief in trials — backed by Zimmer Biomet's spine distribution network, NeuroOne's entry into this space has significant commercial potential.
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