NeuroOne Medical Technologies Corp. (NMTC) on Wednesday announced that it has completed its 510(k) submission to the U.S. Food and Drug Administration for its OneRF Trigeminal Nerve Ablation System, a device intended to treat trigeminal neuralgia, a severe and chronic facial pain disorder.
The submission was completed earlier than anticipated, noted the company.
The OneRF Trigeminal Nerve Ablation System features a minimally invasive, temperature-controlled RF procedure that uses a multi-contact probe capable of pain location mapping, stimulation, and ablation—all with a single electrode. This design aims to enhance procedural safety, reduce operative time, and improve overall patient comfort.
"We're excited to expand our OneRF platform into treating facial pain, a highly debilitating condition with limited non-invasive treatment options," said Dave Rosa, President and Chief Executive Officer of NeuroOne. "This milestone reflects both the scalability of our technology and our commitment to broadening its clinical impact."
Trigeminal neuralgia affects around 100,000 people in the U.S. and is often treated with medications or invasive surgical interventions.
RF ablation, which NeuroOne's system utilizes, has demonstrated initial pain relief rates of approximately 95 percent and favorable long-term outcomes with repeat treatments, according to previously published studies.
If cleared by the FDA, NeuroOne anticipates to potentially begin generating revenue from trigeminal nerve ablation in late 2025.
Currently, NMTC is trading at $0.57 up by 7.56 percent on the Nasdaq.
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