EXCLUSIVE: NeuroOne Submits FDA Marketing Application For OneRF Trigeminal Nerve Ablation System For Facial Pain

NeuroOne Medical Technologies Corporation NMTC filed its 510(k) submission to the FDA for trigeminal nerve ablation on Wednesday, earlier than previously guided.

NeuroOne Medical is developing and commercializing minimally invasive and hi-definition solutions for EEG recording, brain stimulation, and ablation.

In March, the company accelerated the anticipated timeline of its 510(k) submission to the FDA for trigeminal nerve ablation to May 2025. The company had previously projected a submission by the end of June 2025.

Also Read: AbbVie's Pipeline May Be A 2026 Story, But Analyst Likes The Setup Now

The submission leverages the company's proprietary OneRF Ablation System RF generator platform for trigeminal neuralgia, a chronic pain condition affecting approximately 100,000 people in the U.S.

The trigeminal nerve is the main sensory nerve in the face associated with triggering excruciating pain for this condition.

Trigeminal neuralgia is typically treated with medication or invasive procedures, including microvascular decompression, radiosurgery, or other percutaneous techniques.

The OneRF trigeminal nerve ablation technology features a minimally invasive surgical procedure that uses radiofrequency (RF) energy to destroy abnormal tissue and relieve severe, chronic pain in the face.

According to the October 2024 report, the trigeminal neuralgia therapeutics market, comprised of pharmacologic and surgical technologies, is expected to grow from $262 million in 2024 to over $416 million by 2030, primarily due to an aging population.

The multi-contact probe is designed for multi-point mapping of pain location, stimulation, and ablation, all using the same electrode and with the safety of temperature-controlled ablation.

These features are also present in the FDA 510(k) cleared OneRF sEEG (brain) Ablation System.

Previously published data have shown that RF ablation offers high initial pain relief rates (~95%) and long-term efficacy, especially with repeat treatments, while maintaining a low complication rate.

Dave Rosa, President and CEO of NeuroOne, stated: "Our OneRF ablation technology platform has already achieved successful commercialization and patient outcomes in lesioning nerve tissue for functional neurosurgical procedures, such as the treatment of epilepsy. Expanding into facial pain broadens the clinical impact of our technology and further validates the versatility and scalability of our platform."

"If cleared by the FDA, we believe there is a potential to generate revenues from trigeminal nerve ablation in late calendar year 2025."

Earlier in April, NeuroOne Medical priced an underwritten registered public offering of 16 million shares at 50 cents per share, around $8 million in gross proceeds.

Price Action: NMTC stock closed at $0.54 on Tuesday.

Read Next: