About two years after landing the initial FDA clearance for its stereoelectroencephalography electrode—which can be used to record, monitor and stimulate brain signals for up to 30 days under a since-expanded indication—NeuroOne has now earned another agency nod that builds on the sEEG electrode’s capabilities.
While both the sEEG device and the Evo cortical electrode, which earned NeuroOne’s first-ever FDA clearance back in 2019, are designed to be used as diagnostic tools for neurological conditions like epilepsy and Parkinson’s disease, the newly cleared OneRF system is the company’s first to tack on a therapeutic indication as well, according to a Monday announcement.
The OneRF system conducts both monitoring and treatment through a single sEEG electrode that has been surgically placed underneath the surface of the brain. With that dual mechanism, not only can the system map out a patient’s brain signals to diagnose epilepsy and track seizures, for example, but the resulting analysis can also be used to direct radiofrequency ablation, where thermal energy is used to damage tissues associated with certain conditions.
On the ablation front, the OneRF system offers temperature control features, to give doctors more control over the tissue-destroying process, similar to what is used in the heart to treat irregular rhythms.
The regulatory clearance comes about a year after NeuroOne completed a feasibility study of the system and about six months after it submitted the technology to the FDA for review over the summer. Last month, the company said it had sent in some additional information after the agency had responded to the submission with questions.
In fact, NeuroOne has been looking forward to the OneRF system’s clearance even longer than that, according to CEO Dave Rosa, who said in the announcement that the goal of commercializing the first combination diagnostic-therapeutic electrode dates back to the company’s founding.
“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,” he said. “This may also reduce hospital stays, number of surgeries, and adverse events while offering significant benefits from a clinical perspective. The addition of temperature control at the point of ablation also may enhance patient safety.”
Even while facing follow-up questions from the FDA this fall, NeuroOne maintained its originally sketched-out plans of launching the OneRF system sometime in the first half of 2024. Indeed, Rosa confirmed this week that the commercial rollout of the system will begin sometime in that range.
The CEO said the launch will be conducted “either directly or through a strategic partner.” If it’s the latter, the OneRF technology would follow in the footsteps of the sEEG and Evo electrodes, both of which are distributed via Zimmer Biomet after NeuroOne handed over their exclusive global distribution rights in a 2020 deal.