NeuroOne Grabs FDA Clearance For Ablation Tech

NeuroOne has now received another agency nod that expands upon the capabilities of its stereoelectroencephalography electrode, which was initially approved by the FDA approximately two years ago. This electrode can record, track, and stimulate neurological signals for a period of up to 30 days based on an indication that has since been broadened.

In spite of the fact that both the sEEG instrument and the Evo cortical electrode, which received NeuroOne’s very first FDA authorization in 2019, are intended to be utilized as indicators for neurological diseases such as epilepsy and Parkinson’s disease, the recently cleared OneRF system is the first product of the company to also include a therapeutic indication, as revealed in a statement made on Monday.

Through the use of just one sEEG electrode that is installed surgically under the exterior of the brain, the OneRF system is able to perform both monitoring and therapy. With this dual mechanism, the device is able to not just trace out an individual’s cerebral signals to identify epilepsy and track seizures, but the analysis may also be used to guide radiofrequency ablation – a technique in which heat radiation is used to harm tissues linked with specific disorders.

When it comes to ablation, the OneRF system has temperature control characteristics, which allow medical professionals to exert a greater degree of control over the process of tissue destruction. These features are akin to those that are utilized in the treatment of abnormal heartbeats.

The regulatory endorsement comes almost one year after NeuroOne finished the feasibility evaluation of the system and approximately six months after the company sent the technology to the FDA for assessment over the summer. Following the agency’s response to the submission, which included inquiries, the company released a statement announcing that it had added in some new material.

The CEO of NeuroOne, Dave Rosa, stated in the release that the company’s aim of marketing the first combined diagnostic-therapeutic electrode goes back to the company’s formation. As a matter of fact, the firm had been anticipating the system’s approval even longer than that, he added.

He further remarked, “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. 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.”

Although NeuroOne was confronted with follow-up concerns from the FDA this fall, the company continued to adhere to its initial goal: deploy the OneRF system before the end of the first half of next year. As such, Rosa has acknowledged this week that the commercial implementation of the system would start somewhere within that range.

The CEO has stated that the launch will be carried out either by the company itself or by a strategic alliance. In the case of the latter, the OneRF technology would be distributed by Zimmer Biomet, just like the sEEG and Evo electrodes, which were acquired by NeuroOne in a deal that allowed them exclusive global distribution rights in 2020.

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