NeuroOne Evo sEEG electrode device available commercially in US
Technology is implanted closer to the brain to reach deeper structures
NeuroOne Medical Technologies‘ Evo stereoelectroencephalography (sEEG) electrodes for measuring or stimulating brain activity in people with neurological diseases like Parkinson’s disease or epilepsy are now available commercially in the U.S.
The electrodes were approved by the U.S. Food and Drug Administration (FDA) in October for less than 30 days of use.
“The commercial launch of the Evo sEEG platform represents one of the most impactful milestones in our company’s history,” Dave Rosa, CEO of NeuroOne, said in a press release.
Electroencephalogram (EEG) technology has long been used to measure the brain’s electrical activity and identify evidence of neurological diseases like Parkinson’s.
In contrast to a traditional EGG, where recording electrodes are placed on the scalp, sEEG uses electrodes surgically implanted closer to the brain to reach deeper brain structures.
NeuroOne’s Evo technology is designed to have thinner and more flexible electrodes than other sEEG devices. That lets them be implanted through tiny holes drilled in the skull without requiring pieces of the skull to be surgically removed.
Other benefits include better signal clarity and precision, as well as the ability to produce it in a mostly automated manufacturing process, the company maintains.
How the sEEG electrode came to be cleared for under 30 days
The Evo technology is also cleared for brain stimulation.
The device earned marketing clearance for short-term use of less than 24 hours in 2021, after which NeuroOne appealed for for longer-term use. Regulatory authorities initially rejected that request, citing not enough evidence the product was as safe as others on the market.
NeuroOne resubmitted its application last fall, including additional safety data, prompting the agency to approve the device for recording and stimulating brain activity for less than 30 days.
Zimmer BioMet, NeuroOne’s development partner, holds the exclusive worldwide distribution rights to Evo products, as well as NeuroOne’s cortical electrodes, which were approved in 2019 to record or stimulate from the brain’s surface.
The Evo product line is intended to be used with Zimmer BioMet’s ROSA One Brain, a robotic platform to help surgeons plan and perform complex but minimally invasive procedures.
“Paired with Zimmer Biomet’s ROSA One Brain robotic platform and broad distribution network, we believe the company is well positioned in the market given the synergies that exist between our novel thin film electrode platform and Zimmer Biomet’s robotic platform,” Rosa said.
Evo technology may also apply for spinal cord stimulation or tissue ablation (removal), according to NeuroOne.
The company announced plans to ask the FDA to approve its OneRF ablation system this year following positive data from a feasibility study in animal models.
That system would employ sEEG electrodes to destroy target regions of the brain as a way to control tremors in Parkinson’s disease patients.
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