NeuroOne Medical Technologies Corporation has announced that the OneRF ablation system was recently used at a prestigious hospital located in Jacksonville, USA to successfully complete five ablations in one patient.
According to a company press release, the patient was suffering from multifocal epilepsy—a condition whereby seizures are triggered from multiple areas of the brain.
In this procedure, 10 Evo stereoelectroencephalography (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.
“It was exciting for the company to witness the first clinical ablations performed using the OneRF ablation system,” said NeuroOne chief executive officer Dave Rosa. “The ability to safely perform these procedures at the patient’s bedside will reduce operating room time and cost, freeing up the operating room to conduct additional procedures. We look forward to additional procedures utilising the system, with the goal of providing a safe therapy for patients to both monitor and ablate problematic brain tissue. In the future, the company intends to leverage the OneRF generator with future FDA [Food and Drug Administration] submissions for additional ablation applications.”
The OneRF ablation system is NeuroOne’s first device with a therapeutic indication and its third US FDA 510(k)-cleared device. The company announced a limited commercial launch of the device in March 2024 and was granted an ICD-10 procedure code by the US Centers for Medicare and Medicaid Services (CMS) earlier this month.
NeuroOne now claims to boast a full line of thin film electrode technology to address patients requiring diagnostic brain mapping procedures as well as radiofrequency (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.
