NeuroOne’s ablation system cleared by FDA for neurological disorders
Commercial launch of OneRF Ablation System expected in first half of 2024
The U.S. Food and Drug Administration (FDA) has cleared NeuroOne’s OneRF Ablation System, a brain electrode-guided tool employed in neurosurgical procedures, including those for Parkinson’s disease, to capture electrical activity and selectively destroy nervous tissue within controlled temperature settings.
The request was submitted through a 510(k) application, which is used to seek marketing approval for medical devices in the U.S.
OneRF uses the company’s Evo stereoelectroencephalogram (sEEG) electrodes, which have already been approved and are commercially available in the U.S. for recording and stimulating brain activity. The new system adds a component that allows the targeted ablation of brain tissue. Ablation is a minimally invasive procedure doctors can use to destroy tissue.
“We are now preparing for a commercial launch either directly or through a strategic partner in the first half of calendar 2024,” Dave Rosa, NeuroOne’s CEO, said in a company press release.
Parkinson’s caused by progressive dysfunction, death of dopaminergic neurons
Parkinson’s disease is caused by the progressive dysfunction and death of nerve cells responsible for producing dopamine, called dopaminergic neurons. This causes problems with brain signaling and leads to disease symptoms.
Removing small specific regions of the brain may be used to control some Parkinson’s motor symptoms. While tissue ablation in the thalamus — a structure that acts like a “switchboard” for sensory information — may help to control tremors, tissue ablation in the globus pallidus can ease stiffness and uncontrolled movements. The globus pallidus is a part of the brain involved in coordinating and regulating voluntary movements.
According to the company, OneRF uses its sEEG system, composed of thin-film, flexible electrodes implanted close to the brain to measure electric activity. sEEG electrodes are thought to offer better signal detection and reach deeper brain regions, using a minimally invasive procedure.
These electrodes were approved by the FDA to be used to measure the brain’s electrical activity for less than 30 days.
To perform tissue ablation, the implanted electrodes connect to a radio frequency generator that uses radio waves to heat and destroy the cells in the targeted region. Moreover, the system has a temperature control to monitor the precise temperature during the ablation process.
“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,” Rosa said, adding “this may also reduce hospital stays, number of surgeries, and adverse events while offering significant benefits from a clinical perspective.”
In preclinical feasibility studies, a team at the Mayo Clinic implanted five sEEG electrodes and recorded brain electrical activity in an animal model. Then, researchers performed radio frequency tissue ablations using different temperatures and times, which were confirmed through an MRI scan.
OneRF system may be used for other neurological conditions
The OneRF system may also be used for other neurological conditions, such as epilepsy, involuntary muscle contractions, and essential tremor, among others.
“The FDA clearance … 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,” said Robert E. Gross, MD, PhD, chair of the neurosurgery department at New Jersey Medical School and Robert Wood Johnson Medical School.
“This may lead to improved outcomes for patients with potential for fewer interventions, and an improved therapeutic window,” he added.