NeuroOne Initiates Commercial Launch of OneRF™ Ablation System

NeuroOne Medical Technologies (Nasdaq: NMTC) has initiated a limited commercial launch of its OneRF Ablation System, a stereoelectroencephalogram (sEEG)-guided tool used in neurosurgery to record electrical activity and ablate nervous tissue under temperature-controlled environments. It is NeuroOne’s first device with a therapeutic indication, and the company’s third FDA 510(k)-cleared device.

NeuroOne is targeting a significant addressable market in brain ablation with the OneRF system. The global brain ablation market is currently valued at $100 million and is growing rapidly due to large patient populations with unmet clinical needs.

Dave Rosa, CEO of NeuroOne, commented, “Today is an exciting day for NeuroOne as we begin the limited commercial launch of our OneRF™ Ablation System. 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.”

NeuroOne expects to start shipping OneRF™ Ablation systems this week to centers participating in its limited launch, and says that patient treatments are scheduled to begin in April 2024.

“We believe physicians and patients will benefit from our technology given it may reduce hospital stays, the number of surgeries, and adverse events, while offering significant clinical benefits including temperature control to enhance patient safety,” said Mr. Rosa.

NeuroOne’s OneRF™ Ablation System has received FDA 510(k) clearance for creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures, and the company plan to leverage the system for other targeted ablation indications by submitting additional FDA 510(k) applications.

NeuroOne offers a full line of electrode technology to address patients requiring diagnostic brain mapping procedures as well as RF ablation using the same sEEG electrode. The company’s FDA-cleared devices include the Evo® cortical and sEEG electrode product lines which are used primarily for recording electrical activity in the brain for less than 30 days.

About NeuroOne

NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and high 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 www.nmtc1.com.

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NeuroOne Initiates Commercial Launch of OneRF™ Ablation System

Catie Corcoran

Biotech Editor