NeuroOne files early FDA 510(k) for nerve ablation system

Published 23/04/2025, 14:06
NeuroOne files early FDA 510(k) for nerve ablation system

EDEN PRAIRIE, Minn. - NeuroOne Medical Technologies Corporation (NASDAQ:NMTC), a medical technology firm with a market capitalization of $25.37 million, has submitted its 510(k) application to the U.S. Food and Drug Administration (FDA) for its trigeminal nerve ablation system ahead of schedule. The company’s OneRF® Ablation System RF generator is designed for the treatment of trigeminal neuralgia, a facial pain disorder affecting around 100,000 individuals in the U.S. According to InvestingPro data, the company has demonstrated strong revenue growth of 104% in the last twelve months, suggesting growing market traction for its innovative medical solutions.

The OneRF® Trigeminal Nerve Ablation technology is a minimally invasive procedure that employs radiofrequency energy to destroy tissue causing severe chronic pain. It offers an alternative to pharmaceutical and more invasive surgical treatments currently used for trigeminal neuralgia, such as microvascular decompression and radiosurgery.

The company’s technology is said to reduce procedural time and improve patient comfort and safety by using a multi-contact probe that can map pain points, stimulate, and ablate with a single electrode. This feature is also seen in the FDA 510(k) cleared OneRF sEEG Ablation System for brain procedures.

NeuroOne’s CEO, Dave Rosa, expressed optimism about the potential market impact of the technology, stating that if the FDA clears the submission, it could generate revenue from trigeminal nerve ablation by late 2025. While InvestingPro analysis indicates the company is currently trading below its Fair Value, analysts anticipate continued sales growth in the current year. The company has previously seen success with its technology in treating epilepsy through lesioning nerve tissue. Want deeper insights? InvestingPro offers 8 additional key tips and a comprehensive Pro Research Report for NMTC, helping investors make informed decisions.

The press release also highlighted that radiofrequency ablation has demonstrated high initial relief rates and long-term efficacy with lower complication risks, making it a preferred option for patients not suitable for major surgery or seeking less invasive treatments.

NeuroOne focuses on developing minimally invasive and high-definition EEG recording, brain stimulation, and ablation solutions for various neurological disorders. The company’s potential applications extend to other conditions, including pain management and mood disorders. Financial data from InvestingPro shows the company maintains a healthy current ratio of 3.64, indicating strong short-term liquidity to support its development initiatives. The company is one of over 1,400 US stocks covered by InvestingPro’s detailed research reports, which provide comprehensive analysis and actionable insights for investors.

The information in this article is based on a press release statement from NeuroOne Medical Technologies Corporation.

In other recent news, NeuroOne Medical Technologies Corporation reported significant financial growth in the first quarter of fiscal year 2025. The company achieved record product sales of $3.3 million and total revenue of $6.3 million, marking a 235% increase from the same period last year. This financial success is attributed to strong sales and a $3 million license payment from its expanded partnership with Zimmer Biomet. NeuroOne has also announced that it is fully funded through fiscal year 2026, following a successful capital raise of $8.3 million. Additionally, the company set the price for its public stock offering at $0.50 per share, expecting to raise $8 million in gross proceeds. NeuroOne is accelerating its FDA submission timeline for the trigeminal nerve ablation system, now expected in May 2025. The company projects product revenue to increase significantly for fiscal year 2025, ranging between $8 million and $10 million, with an anticipated product gross margin between 47% and 51%. These developments highlight NeuroOne’s ongoing strategic efforts and financial stability.

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