NeuroOne ablation system launched in US earlier than expected
Company to seek FDA approval for 'other targeted ablation indications'
NeuroOne has begun a limited U.S. commercial launch of its OneRF Ablation System, a device that can be used for mapping and targeting brain areas with abnormal neuronal activity to treat a range of neurological conditions such as Parkinson’s disease.
The company said it’s rolling out the system earlier than it had expected. The U.S. Food and Drug Administration in December 2023 cleared the device for measuring brain electrical activity and selectively destroying damaged nervous tissue during functional neurosurgery, or surgery to restore neuronal function. NeuroOne said at the time it expected to launch the system in the first half of 2024.
“Today is an exciting day for NeuroOne as we begin the limited commercial launch of our OneRF ablation system,” Dave Rosa, NeuroOne’s CEO, said in a company press release. “We expect to start shipping systems this week to centers participating in our limited launch, with cases already scheduled starting in April.”
Some people with Parkinson’s are offered lesioning, or ablation, surgery. This procedure creates small, irreversible lesions in brain areas where neuronal loss has occurred, with abnormal signaling contributing to both motor and nonmotor symptoms.
By destroying problematic brain areas, this type of surgery is designed to prevent the transmission of the abnormal signals that result in result in symptoms.
Diagnostic, therapeutic functions using same electrode
OneRF uses its Evo stereotactic electroencephalographic (sEEG) system, a set of thin-film electrodes that can be implanted to record electrical signals in the brain, helping doctors locate target areas.
In OneRF, the FDA-cleared sEEG system is connected to a radio frequency generator that sends low-energy radio waves through the minimally invasive electrodes to the target area. This creates a current that heats the small area of nervous tissue and destroys it, which is thought to ease symptoms and help avoid additional, more invasive surgery.
“We are proud to be the first to market with a thin-film electrode technology capable of performing both diagnostic and therapeutic functions utilizing the same electrode,” Rosa said.
The OneRF system has a built-in, real-time temperature monitor that allows for more precise temperature control during ablation surgery, which may help make the procedure safer, according to NeuroOne.
“We believe physicians and patients will benefit from our technology, given it may reduce hospital stays, number of surgeries, and adverse events, while offering significant clinical benefits including temperature control to enhance patient safety,” Rosa said.
OneRF is the company’s third FDA-cleared medical device and the first with a therapeutic indication in the U.S.
“Looking ahead, we plan to leverage the system for other targeted ablation indications by submitting additional FDA 510(k) applications,” Rosa said. A 510(k) application is used to seek marketing approval for medical devices in the U.S.
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