FDA asked to approve OneRF ablation system for Parkinson’s
NeuroOne technology may be more effective option for patients' motor symptoms
NeuroOne Medical Technologies is seeking approval from the U.S. Food and Drug Administration (FDA) for its OneRF ablation system, which aims to remove select regions of brain tissue as a way of treating neurological conditions like Parkinson’s disease.
The company submitted its request in the form of a 510(k) application, which is the pathway used to receive marketing approval for medical devices in the U.S.
OneRF leverages the company’s Evo stereoelectroencephalography (sEEG) electrodes, already FDA-cleared and commercially available in the U.S. for recording and stimulating brain activity. It adds a component that would allow for targeted, therapeutic destruction — ablation — of brain tissue.
Initial feedback from the FDA on the application is expected in early August.
Ablation of brain tissue seen as way of treating Parkinson’s disease
“This is a monumental day for NeuroOne as it represents the first known FDA 510(k) submission of an sEEG electrode intended to record brain activity and also be used as an RF [radio frequency] probe to ablate nervous tissue,” Dave Rosa, CEO of NeuroOne, said in a company press release.
“In addition, it marks the Company’s first complete system combining hardware, software, and our novel electrode technology,” Rosa added.
Removing small, specific areas of brain tissue can be used to control certain motor symptoms of Parkinson’s. Specifically, tissue ablation in a brain region called the thalamus, known as a thalamotomy, may help to ease Parkinson’s-associated tremors, whereas ablation in the globus pallidus (a pallidotomy) could ease stiffness and uncontrolled movements.
OneRF is NeuroOne’s technology for such tissue ablation. The company reports the technology uses its sEEG system, a set of thin, flexible electrodes implanted close to the brain to record electrical activity there.
While electroencephalogram (EEG) is a long-standing approach for measuring brain activity, the sEEG electrodes are thought to offer better signal detection than others now available, reaching deeper brain structures, and the procedure for implanting them is not overly invasive.
They have been cleared by the FDA for recording and stimulating brain activity for up to 30 days.
OneRF uses already implanted sEEG electrodes to perform tissue ablation. The electrodes are connected to a radio frequency (RF) generator, which uses radio waves to heat targeted sections of nervous system tissue and kill cells living there.
The system has real-time temperature monitoring capabilities allowing for more precise temperature control during the ablation procedure, NeuroOne reports. As such, the company expects that OneRF could be a safer and more cost-effective alternative for patients, allowing for fewer invasive procedures and hospital stays than existing technologies.
OneRF was reported to successfully record and ablate brain tissue in preclinical feasibility studies.
“Over the past few years, we have been excited with the feedback we have received from our advisory board as well as the performance of the system in animal feasibility studies,” Rosa said.
NeuroOne also markets Evo cortical electrodes, which were approved in 2019 to record or stimulate from the brain’s surface. Both the cortical and sEEG electrodes are intended to be used with Zimmer BioMet’s ROSA One Brain, a robotic platform designed to assist surgeons conducting reasonably noninvasive but complex procedures.
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