NeuroOne Medical Technologies has achieved a significant regulatory milestone with FDA 510(k) clearance for its OneRF trigeminal nerve ablation system, designed to treat trigeminal neuralgia through minimally invasive radiofrequency ablation. The clearance enables the Eden Prairie, Minnesota-based company to market the system for generating radiofrequency lesions to alleviate pain and for lesioning nerve tissue in functional neurosurgical applications.
Addressing a Significant Medical Need
Trigeminal neuralgia affects approximately 150,000 people annually in the United States, according to the American Association of Neurological Surgeons. The condition causes severe, chronic facial pain due to irritation of the trigeminal primary sensory nerve, which provides sensation to the face. The disorder predominantly affects individuals over 50 years of age and women, with a form of the condition also associated with multiple sclerosis.
Current treatment approaches typically involve medication management or various invasive procedures including microvascular decompression (MVD), radiosurgery, or other percutaneous methods. NeuroOne's system offers an alternative approach through targeted radiofrequency energy delivery.
Technology Platform and Clinical Benefits
The OneRF ablation system employs a sophisticated multi-contact RF probe that facilitates precise localization and customized ablation of pain-conducting nerve tissue. The system operates under temperature-controlled conditions, delivering targeted RF energy aimed at trigeminal nerve fiber ablation to interrupt pain signals.
According to NeuroOne, this technology platform may contribute to minimizing procedural times, increasing patient comfort, and improving safety outcomes compared to existing treatment modalities.
Strategic Commercial Expansion
The FDA clearance represents NeuroOne's first venture into pain management therapies, building upon the company's existing OneRF brain ablation system used in neurosurgery. CEO Dave Rosa highlighted the strategic alignment, stating: "One of the key aspects of the OneRF technology platform is its potential to be effective across multiple neurological disorders and pain management functions. This newest technology aligns well with current commercial efforts with our OneRF brain ablation system."
Rosa noted that some current users of the OneRF brain ablation system also perform nerve ablation procedures for facial pain, potentially allowing existing medical practices to further justify their investment in the technology platform.
Market Launch and Future Applications
NeuroOne completed its FDA submission in April, ahead of the previously anticipated timeline. The company now expects to launch the device on a limited commercial basis in the fourth quarter of 2024.
Looking beyond trigeminal neuralgia, NeuroOne plans to leverage its technology platform for additional pain management applications. "We expect to pursue additional opportunities leveraging our technology platform in pain management and other therapeutic applications, such as treatment of lower back pain," Rosa stated.
The company maintains a distribution agreement with Zimmer Biomet for its existing OneRF sEEG brain ablation system, providing an established commercial infrastructure that may support the rollout of the new trigeminal nerve ablation system.
