NeuroOne receives FDA clearance for OneRF Trigeminal Nerve Ablation System.

NeuroOne Medical Technologies has received FDA clearance for its OneRF Trigeminal Nerve Ablation System, which creates radiofrequency lesions for pain treatment or lesioning nerve tissue for functional neurosurgery. The clearance leverages the company's OneRF Ablation System RF generator platform and targets a limited commercial launch in Q4 2025. This further validates the technology platform, offering alternatives to pharmaceutical and invasive surgical treatments.

NeuroOne Medical Technologies (NASDAQ: NMTC) has achieved a significant milestone with the receipt of FDA 510(k) clearance for its OneRF Trigeminal Nerve Ablation System. This system, designed to treat facial pain through radiofrequency lesioning, leverages the company's proprietary OneRF Ablation System RF generator platform.

The OneRF Trigeminal Nerve Ablation System targets trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 people annually in the United States. This debilitating condition is characterized by severe facial pain triggered by the trigeminal nerve. Traditional treatments include medications and invasive surgical interventions like microvascular decompression. The OneRF system offers several technical advantages over existing treatments, including a novel multi-contact RF probe that enables precise localization and tailored ablation using a single instrument. Temperature-controlled conditions enhance safety and accuracy, potentially reducing procedure time and improving patient outcomes.

NeuroOne plans a limited commercial launch in the fourth quarter of 2025, with potential revenue generation beginning in late 2025. The company aims to expand its OneRF technology platform to address additional pain management applications, including lower back pain treatment. This clearance represents NeuroOne's expansion into pain management therapies beyond its existing neurological applications, demonstrating the versatility of its technology platform and opening potential new market opportunities.

The FDA clearance validates NeuroOne's technology platform and offers an alternative to pharmaceutical and invasive surgical treatments. The company's strategy appears to leverage existing relationships with medical practices already using its OneRF brain ablation system, creating potential cross-selling opportunities. Management has indicated ongoing discussions with strategic partners and the possibility of generating revenue from this new indication by late 2025.

NeuroOne Medical Technologies Corporation is a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders. The company develops and commercializes minimally invasive and hi-definition solutions for EEG recording, monitoring, ablation, drug delivery, and stimulation. For more information, visit nmtc1.com.

References:
[1] https://www.stocktitan.net/news/NMTC/neuro-one-receives-fda-510-k-clearance-for-one-rf-trigeminal-nerve-20ge1nzqwf16.html