NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) has announced an accelerated timeline for its 510(k) submission to the FDA for its OneRF Trigeminal Nerve Ablation System. The company now expects to submit the application in May 2025, approximately two months earlier than the previously projected timeline of June 2025.
The OneRF Trigeminal Nerve Ablation System is designed to provide relief for patients suffering from trigeminal neuralgia, a condition characterized by severe, chronic facial pain. The system utilizes radiofrequency (RF) energy to destroy abnormal tissue through a minimally invasive surgical procedure, targeting the trigeminal nerve, which is the main sensory nerve in the face.
Market Opportunity and Growth Potential
According to a Research and Markets report from October 2024, the trigeminal neuralgia therapeutics market is expected to experience significant growth, expanding from $262 million in 2024 to over $416 million by 2030. This growth is primarily attributed to the aging global population, which is more susceptible to developing this painful neurological condition.
Dave Rosa, President and Chief Executive Officer of NeuroOne, expressed optimism about the accelerated timeline: "Building on the success of our three product families that have already achieved 510(k) FDA clearance, we have accelerated our submission timeline for the OneRF Trigeminal Nerve Ablation System, approximately two months ahead of schedule."
Rosa further noted the potential financial impact of this development: "If cleared by the FDA—we believe there is a potential to generate revenues from trigeminal nerve ablation in late 2025, which was not previously expected in calendar year 2025."
Expanding the OneRF Technology Platform
The trigeminal nerve ablation system represents the second radiofrequency ablation technology in NeuroOne's portfolio that leverages their patented OneRF Technology Platform. This platform technology appears to be a cornerstone of the company's growth strategy, with Rosa indicating plans for expansion: "As we move ahead, we believe there are several additional ablation applications we can introduce and look forward to updating you on our progress as we move throughout the year."
Clinical Significance
Trigeminal neuralgia is known for causing some of the most severe pain experienced by patients, often described as electric shock-like sensations that can be triggered by routine activities such as brushing teeth, eating, or even exposure to wind. Current treatment options include medications and more invasive surgical procedures, leaving room for improved minimally invasive alternatives like NeuroOne's system.
The OneRF system could potentially offer advantages over existing treatments by providing a targeted approach that may reduce side effects and improve quality of life for patients suffering from this debilitating condition.
Company Background
NeuroOne Medical Technologies Corporation is focused on developing and commercializing minimally invasive and high-definition solutions for patients with neurological disorders. The company's portfolio includes technologies for EEG recording, brain stimulation, and ablation solutions targeting conditions such as epilepsy, Parkinson's disease, dystonia, essential tremors, and chronic pain.
The company has already successfully received FDA clearance for three product families, establishing a track record that supports their confidence in the regulatory pathway for the OneRF Trigeminal Nerve Ablation System.
Regulatory and Commercialization Outlook
With the 510(k) submission now expected in May 2025, NeuroOne is positioning itself to potentially enter the market with this new application of its technology by late 2025. The 510(k) pathway typically requires demonstrating substantial equivalence to a legally marketed device, which may streamline the approval process compared to other regulatory routes.
If the FDA grants clearance, NeuroOne will join a growing market of companies offering solutions for trigeminal neuralgia, with the advantage of leveraging their established OneRF Technology Platform and existing commercial infrastructure.
Future Applications
Beyond trigeminal neuralgia, NeuroOne has indicated interest in exploring additional applications for their technology, including potential treatments for depression, mood disorders, pain, incontinence, high blood pressure, and applications involving artificial intelligence. This suggests a broader strategic vision for the OneRF Technology Platform as a versatile foundation for multiple medical applications.
The accelerated timeline for the trigeminal nerve ablation system submission may indicate confidence in the technology's performance and the company's ability to navigate the regulatory process efficiently, potentially setting the stage for further expansions of their product portfolio.
