FDA Clears NeuroOne’s OneRF Ablation System for Neurosurgerical Procedures

Dave Rosa

NeuroOne announced that the FDA has granted 510(k) clearance for its OneRF Ablation System, a stereoelectroencephalogram (sEEG)-guided tool used in neurosurgery to record electrical activity and ablate nervous tissue under temperature-controlled environments. The company is targeting a launch in early 2024.¹

OneRF includes a customized radio frequency (RF) generator with real-time temperature monitoring capabilities, allowing for greater control during ablation procedures for patients with epilepsy, Parkinson disease, dystonia, and essential tremor, among others. The combination system, comprised of both diagnostic and therapeutic capabilities, is believed to be a safer and more cost-efficient clinical option for patients, with lower number of invasive procedures and hospital stays.

"When NeuroOne was founded, one of our ambitious goals was to be the first to develop and commercialize thin-film electrodes capable of performing both diagnostic and therapeutic functions and offer a better methodology to treat patients suffering from a variety of neurological conditions,” Dave Rosa, chief executive officer, NeuroOne, said in a statement.¹ "We believe we have the potential to dramatically change the way these surgeries are performed so that patients may only need to go through surgery once for both diagnostic and therapeutic procedures."

This was the third FDA-cleared product for NeuroOne, following its Evo cortical and sEEG electrode product lines, which are used to primarily record electrical activity in the brain for less than 30 days. The Evo sEEG Electrode technology is also geared for monitoring and stimulation electrical signals at the subsurface of the brain, and may help clinicians identify the right pho size zones to determine the most suitable intervention for a patient.

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The Evo Electrode is considered over 7 times thinner than a silicone electrode, with flexibility and lowered volume that is expected to reduce pain and edema. It has a single-tail design through 1 incision, allowing for easy access to the brain and minimized infection risk and procedure time. In addition, a disposable cable assembly is sent with each Evo Electrode as an electrode kit, removing the need to source the correct cables for each electrode being used in surgery.

"The FDA clearance of NeuroOne's OneRF system will provide neurosurgeons with an important new tool in the surgical management of epilepsy, with the ability to provide ablative therapy using already implanted depth electrodes used for diagnosing the epileptic focus as part of stereoEEG," Robert E. Gross, MD, PhD, chair of the department of neurology at New Jersey Medical School and Robert Wood Johnson Medical School, said in a statement.¹ "This may lead to improved outcomes for patients with potential for fewer interventions, and an improved therapeutic window."

REFERENCES
1. NeuroOne receives FDA 510(k) clearance to market its OneRF Ablation System. News release. NeuroOne. December 11, 2023. Accessed December 11, 2023. https://www.globenewswire.com/news-release/2023/12/11/2793821/0/en/NeuroOne-Receives-FDA-510-k-Clearance-to-Market-its-OneRF-Ablation-System.html
2. Technology. NeuroOne. https://nmtc1.com/technology.html. Accessed December 11, 2023.