NeuroOne® Submits 510(k) Application to FDA for OneRF™ Ablation System 

 // News

June 12  

Potential for transformative improvement in neurosurgery as first known sEEG-guided RF system that records and ablates nervous tissue with the added benefit of temperature control

EDEN PRAIRIE, Minn., June 12, 2023 (GLOBE NEWSWIRE) — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announced today its submission of a 510(k) application to the U.S. Food and Drug Administration (FDA) for its OneRF Ablation System. This technology uses the already implanted sEEG electrodes to record brain activity and allow for ablation of nervous tissue when connected to a proprietary radio frequency (RF) generator. If cleared by the FDA, NeuroOne’s OneRF 510(k) submission represents the first step in bringing to market an innovative RF ablation system in the field of neurology and neurosurgery.

As the Company’s first therapeutic device, OneRF is a combination system that includes both diagnostic and therapeutic capabilities. The system utilizes a customized RF generator with real-time temperature monitoring capabilities, allowing clinicians to have greater control over temperature management during the ablation. Designed to both record brain activity and ablate nervous tissue using the same electrode, the system is designed to offer the potential for a safer clinical option for patients as well as lower costs by reducing the number of invasive procedures and hospital stays for patients. NeuroOne estimates the current brain ablation market to be at least $100M worldwide and growing rapidly, with the potential to grow multiple fold based on large addressable patient populations with unmet clinical needs.

Dave Rosa, CEO of NeuroOne, commented, “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 probe to ablate nervous tissue. In addition, it marks the Company’s first complete system combining hardware, software, and our novel electrode technology. 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. We also believe this system has applications beyond ablation of nervous tissue in the brain, offering a larger opportunity than we initially envisioned. I am proud of our entire team and their efforts which allowed us to complete this before the end of June as planned.”

NeuroOne anticipates receiving initial feedback from the FDA no later than August 7th, 2023.

About NeuroOne

NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries, and other related neurological disorders that may improve patient outcomes and reduce procedural costs. The Company may also pursue applications for other areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence. For more information, visit

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