Detailed Narrative
International Expansion
NeuroOne achieved ISO 13485 certification, a critical milestone for entering international markets with its OneRF Brain Ablation, OneRF Trigeminal Neuralgia Ablation, and Evo Cortical/sEEG diagnostic product lines. The company plans to collaborate with its distribution partner, Zimmer Biomet, to target geographies with favorable economics and existing customer relationships, while exploring independent partnerships for other regions. The process involves varying requirements, from documentation to clinical data, depending on the specific geography.
OneRF Brain Ablation System Clinical Validation
The Journal of Neurosurgery published a retrospective observational study from the Mayo Clinic in Jacksonville, Florida, validating the use of NeuroOne's OneRF Brain Ablation System. The study demonstrated that procedures could be safely performed in patients with implanted neuromodulation devices without interference, leading to meaningful seizure reduction. This clinical evidence expands the treatable patient population and supports the system's efficacy.
OneRF Trigeminal Nerve Ablation System Commercialization
A recent patient success story, featured on Cleveland 19 News, highlighted the life-changing potential of the OneRF Trigeminal Nerve Ablation System, with the patient reporting to be pain-free after treatment. The U.S. market for disposables (excluding hardware) is estimated at $40 million, primarily concentrated in approximately 30 centers. NeuroOne plans to expand commercialization by leveraging existing personnel and engaging independent distributors, anticipating a short learning curve to minimize support costs.
StereoCED Drug Delivery System Progress
NeuroOne's StereoCED robotic-assisted platform is designed to improve brain-delivered therapeutics by enabling efficient, reproducible, and scalable delivery. It aims to significantly reduce procedure times through simultaneous multi-trajectory delivery, leveraging existing neurosurgical equipment. The company anticipates StereoCED will be ready for investigational human clinical studies by the end of September, with preclinical animal studies starting this month in collaboration with the University of Minnesota and Mayo Clinic.
BVNA Back Pain Management Program
The company completed user design requirements and initiated preclinical testing for its Basivertebral Nerve Ablation (BVNA) System for back pain. The strategy involves leveraging the existing OneRF generator and ablation electrode while outsourcing access tools. NeuroOne reconfirmed that the regulatory path is likely a 510(k) submission, with an expected FDA clearance submission in the second half of calendar 2027, building on past success with 510(k) clearances.
Manufacturing and Supply Chain
NeuroOne is actively working to expedite manufacturing to address a $1.7 million product backlog as of June 30, 2026, with the goal of clearing it by the end of the fourth calendar quarter of 2026. To increase capacity and reduce lead times, the company is qualifying a second, larger manufacturing site, which is expected to become operational in the first part of 2027. This initiative aims to improve efficiency and meet growing product demand.