NeuroOne Advances Trigeminal Nerve Treatment Through FDA Filing
Exciting Advances in Pain Management Technology
NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) has made significant strides in the medical field by filing its FDA 510(k) submission for the OneRF® Trigeminal Nerve Ablation System. This innovative system is designed to provide relief for those suffering from trigeminal neuralgia, a debilitating condition that affects around 100,000 individuals in the U.S.
Understanding Trigeminal Neuralgia
Trigeminal neuralgia is characterized by severe facial pain resulting from irritation or damage to the trigeminal nerve, which is responsible for sensation in the face. Current treatments often involve medications or invasive surgical interventions like microvascular decompression or radiosurgery, which can pose risks and complications. NeuroOne's OneRF® system offers a minimally invasive alternative that utilizes radiofrequency (RF) energy to precisely target and ablate abnormal tissue, providing a promising solution for those who may not respond well to traditional treatments.
Technology Behind OneRF®
The OneRF® Trigeminal Nerve Ablation System represents a leap forward in pain management technology. Its multi-contact probe is engineered for exceptional precision, allowing for effective mapping of the pain areas while simultaneously enabling tissue ablation. By employing a safe, temperature-controlled method, the procedure not only potentially reduces the length of operations but also significantly enhances patient comfort and safety.
Promising Outcomes and Future Potential
Clinical data highlights that RF ablation methods boast initial pain relief rates of approximately 95%, with enduring effectiveness particularly after repeated treatments. This technology is appealing for candidates who seek less invasive options, particularly if they are not suitable for substantial surgical procedures.
Dave Rosa, the President and CEO of NeuroOne, expressed optimism regarding the expansion of the OneRF® platform into the field of facial pain. He noted, "Our OneRF® ablation technology has achieved commendable success in treating various conditions, including epilepsy. Venturing into the realm of facial pain not only magnifies the clinical significance of our technology but also reinforces its versatility and scalability."
Commercial Prospects on the Horizon
With the hopeful clearance from the FDA, NeuroOne anticipates possible revenues from trigeminal nerve ablation as early as late 2025. Such prospects reflect the company’s commitment to enhancing patient treatment options while also contributing positively to its growth trajectory.
About NeuroOne Medical Technologies
NeuroOne is focused on developing and commercializing cutting-edge, minimally invasive solutions in the fields of EEG recording, brain stimulation, and nerve ablation. Their innovative approach targets various neurological disorders, including epilepsy, Parkinson's disease, and chronic pain linked to failed back surgeries. As the medical landscape continues to evolve, NeuroOne is also exploring applications to address other medical issues such as depression and high blood pressure, positioning itself at the forefront of transformative healthcare solutions.
For additional information about NeuroOne and its latest technological advancements, please reach out to the company through their investor relations contact, MZ Group – MZ North America, available at NMTC@mzgroup.us.
Frequently Asked Questions
What is the OneRF® Trigeminal Nerve Ablation System?
The OneRF® system is a minimally invasive technology developed by NeuroOne to alleviate pain associated with trigeminal neuralgia through targeted radiofrequency ablation of the trigeminal nerve.
How does the OneRF® technology work?
The technology employs a multi-contact probe that uses RF energy to precisely destroy abnormal tissue, thus relieving severe facial pain while ensuring patient safety with temperature control.
What are the expected benefits of the OneRF® system?
This innovative approach may lead to quicker procedural times, improved patient comfort, and enhanced overall safety compared to traditional surgical methods.
When does NeuroOne anticipate commercialization of this technology?
The company believes it may generate revenues from the trigeminal nerve ablation in late 2025, contingent upon receiving FDA clearance.
What other conditions is NeuroOne exploring for treatment?
In addition to trigeminal neuralgia, NeuroOne is developing technologies to address conditions such as epilepsy, Parkinson’s disease, and various pain-related disorders, showcasing its commitment to advancing neuromodulation therapies.
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