NeuroOne's Ablation System Used in First Procedures on Humans

The OneRF Ablation System is NeuroOne’s first device with a therapeutic indication.

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NeuroOne said its OneRF Ablation System was recently used at a hospital located in Jacksonville, Florida to successfully complete five ablations in one patient.

The patient was suffering from multifocal epilepsy, a condition whereby seizures are triggered from multiple areas of the brain. In this procedure, ten Evo sEEG electrodes, were placed in various locations of the patient’s brain. Four electrodes identified problematic areas of the brain that were triggering seizures. Ablations were performed at the targeted areas using the temperature control safety feature, and two of these ablations occurred at different contacts on one electrode. Using the same electrodes, the successful ablations were confirmed by post ablation sEEG recordings demonstrating lack of brain activity at the point of tissue ablation. The procedure was performed at the patient’s bedside saving both the time and cost of having to conduct the procedure in an operating room.

The OneRF Ablation System is NeuroOne’s first device with a therapeutic indication and its third FDA 510(k)-cleared device. NeuroOne now boasts a full line of thin film electrode technology to address patients requiring diagnostic brain mapping procedures as well as RF ablation using the same sEEG electrode. In addition to the OneRF Ablation System, NeuroOne’s other FDA-cleared devices include the Evo cortical and sEEG electrode product lines which are used primarily for stimulation, recording and monitoring of electrical activity in the brain for less than 30 days.

NeuroOne estimates the current brain ablation market to be at least $100 million worldwide and growing rapidly, with the potential to grow multifold based on large addressable patient populations with unmet clinical needs.

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