NeuroOne Medical Technologies (NMTC) FDA Approvals

NeuroOne Medical Technologies' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by NeuroOne Medical Technologies (NMTC). Over the past two years, NeuroOne Medical Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as OneRF. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

OneRF FDA Regulatory Timeline and Events

OneRF is a drug developed by NeuroOne Medical Technologies for the following indication: Ablation System for creation of radiofrequency ("RF") lesions in nervous tissue for functional neurosurgical procedures. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

FDA Clearance - August 18,2025

• Drug: OneRF
• Announced Date: August 18, 2025
• Indication: Ablation System for creation of radiofrequency ("RF") lesions in nervous tissue for functional neurosurgical procedures.

NeuroOne Medical Technologies Corporation announced that it has received U.S. Food and Drug Administration ("FDA") clearance to market its OneRF® Trigeminal Nerve Ablation System for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.

NeuroOne Medical Technologies Corporation announced it received FDA clearance to market its OneRF® Trigeminal Nerve Ablation System, which creates radiofrequency lesions to treat pain or for functional neurosurgical procedures.

The system addresses trigeminal neuralgia, a chronic facial pain disorder affecting about 150,000 people in the U.S. each year. It delivers targeted RF energy to ablate nerve fibers, disrupting pain signals and offering an alternative to medication or invasive surgery.

Its proprietary RF generator platform features a first-of-its-kind multi-contact RF probe that enables precise localization and temperature-controlled, tailored ablation of pain-conducting nerve tissue, improving safety and accuracy.

This minimally invasive technology may shorten procedure times, enhance patient comfort, and reduce procedural risks compared with existing treatments. NeuroOne plans a limited commercial launch in the fourth quarter of 2025, aiming to generate revenues from trigeminal nerve ablation.

NeuroOne will continue discussions with strategic partners to expand the use of its OneRF® platform in other pain management and neurological applications.

Guidance - April 23,2025

• Drug: OneRF
• Announced Date: April 23, 2025
• Indication: Ablation System for creation of radiofrequency ("RF") lesions in nervous tissue for functional neurosurgical procedures.

- NeuroOne Medical Technologies Corporation announced that has filed its 510(k) submission to the FDA for trigeminal nerve ablation earlier than previous guidance.

NeuroOne Medical Technologies Corporation has moved forward with its plans by filing a 510(k) submission to the FDA for its trigeminal nerve ablation technology earlier than expected. The submission, now scheduled for May 2025, uses the company’s proprietary OneRF Ablation System. This system is designed as a minimally invasive treatment that uses radiofrequency energy to target the trigeminal nerve, which is responsible for severe facial pain in patients suffering from trigeminal neuralgia. The earlier submission date could help speed up the review process, potentially allowing NeuroOne to begin generating revenue from this treatment later in 2025 if approved. This step is part of the company’s broader mission to develop hi-definition, minimally invasive solutions for pain relief and neurological conditions.

Provided Update - March 11,2025

• Drug: OneRF
• Announced Date: March 11, 2025
• Target Action Date: May 1, 2025
• Estimated Target Date Range: May 1, 2025 - May 31, 2025
• Indication: Ablation System for creation of radiofrequency ("RF") lesions in nervous tissue for functional neurosurgical procedures.

NeuroOne Medical Technologies Corporation a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, has accelerated the anticipated timeline of its 510(k) submission to the FDA for trigeminal nerve ablation to May 2025, which leverages the Company's patented OneRF® Technology Platform. The Company had previously projected a submission by the end of June 2025.

NeuroOne Medical Technologies Corporation has moved up its planned 510(k) submission to the FDA for a new trigeminal nerve ablation system to May 2025. This device uses the Company’s patented OneRF® Technology Platform to treat trigeminal neuralgia, a condition that causes severe facial pain. The minimally invasive procedure uses radiofrequency energy to eliminate abnormal tissues along the trigeminal nerve, potentially offering a valuable new option for patients suffering from chronic facial pain. By accelerating its schedule by about two months, NeuroOne aims to be positioned for earlier FDA clearance and earlier revenue generation if approved. The company’s swift submission demonstrates its commitment to advancing surgical care methods and improving patient outcomes in the field of neurological disorders.

Provided Update - September 10,2024

• Drug: OneRF
• Announced Date: September 10, 2024
• Indication: Ablation System for creation of radiofrequency ("RF") lesions in nervous tissue for functional neurosurgical procedures.

NeuroOne Medical announced that the OneRF Ablation System was recently used in a breakthrough patient procedure at the University Hospitals in Cleveland to successfully complete forty four ablations in one patient.

NeuroOne Medical recently announced a breakthrough procedure at University Hospitals in Cleveland using its OneRF Ablation System. The system was used to perform 44 ablations in one patient over a two-day period. Guided by sEEG recordings that identified the patient’s epileptic zones, six implanted electrodes delivered the ablations. This unique procedure exceeded the typical range found in clinical literature and was well-tolerated by the patient.

The patient is now reported to be seizure-free, with improvements in mood and memory. Both Dr. Michael Staudt, who led the procedure, and NeuroOne’s CEO praised the system’s performance and safety. They believe that the success of this case may lead to more widespread use of the OneRF Ablation System in treating patients with challenging neurological conditions.