Fed Governor Adriana Kugler to resign
EDEN PRAIRIE, Minn. - NeuroOne Medical Technologies Corporation (NASDAQ:NMTC), a company specializing in neurological surgery technology with a market capitalization of $27.93 million, has announced an expedited submission timeline for its 510(k) application with the U.S. Food and Drug Administration (FDA). According to InvestingPro data, the company has demonstrated strong revenue growth of 104% in the last twelve months, though it continues to operate at a loss. The application for its trigeminal nerve ablation system, which utilizes the company’s patented OneRF® Technology Platform, is now expected in May 2025, ahead of the previously projected end of June 2025.
Trigeminal nerve ablation is a minimally invasive procedure that employs radiofrequency energy to destroy tissue causing severe facial pain due to trigeminal neuralgia. The technology aims to provide relief for patients suffering from this condition, which affects the main sensory nerve in the face.
The market for trigeminal neuralgia therapeutics, which includes both pharmacologic and surgical treatments, was valued at $262 million in 2024 and is projected to grow to over $416 million by 2030, according to a Research and Markets report from October 2024. This growth is attributed primarily to an aging population. InvestingPro analysis indicates the stock is currently trading below its Fair Value, with analysts setting a $2 price target. Subscribers can access 8 additional ProTips and comprehensive financial analysis through the Pro Research Report.
Dave Rosa, President and CEO of NeuroOne, stated that the accelerated submission could potentially allow the company to generate revenues from the ablation system in late 2025, a development not expected within the calendar year. He also mentioned that this would be the second radiofrequency ablation technology in their portfolio leveraging the OneRF® platform.
NeuroOne’s focus extends beyond trigeminal nerve ablation, with products already FDA-cleared for other neurological conditions such as epilepsy, Parkinson’s disease, and chronic pain due to failed back surgeries. The company also explores potential applications in other areas such as depression, mood disorders, pain management, incontinence, high blood pressure, and artificial intelligence.
The announcement from NeuroOne includes forward-looking statements regarding the company’s strategic plans and potential market opportunities. These statements are subject to various risks and uncertainties that could cause actual results to differ materially from those projected. InvestingPro data reveals the company maintains a healthy current ratio of 3.64, indicating strong short-term liquidity, though it faces challenges with a negative gross profit margin of -35% and significant cash burn rate.
This news is based on a press release statement and provides a current view of NeuroOne’s operations and future prospects in the neurological disorder surgical space. It should be noted that the device is restricted to sale by or on the order of a physician, as per federal law.
In other recent news, NeuroOne Medical Technologies Corporation reported a substantial increase in its financial performance for the first quarter of fiscal year 2025. The company achieved record product sales of $3.3 million, contributing to total revenue of $6.3 million, which marks a 235% increase from the same period the previous year. NeuroOne also reported a net income of $1.8 million, reversing a previous net loss, and achieved a gross margin of 58.9%. These financial results were bolstered by a $3 million license payment from an expanded partnership with Zimmer Biomet, which now includes exclusive distribution rights for the One RF ablation system in the United States. The company anticipates product revenue for the full fiscal year 2025 to range between $8 million and $10 million, with gross margins expected to be between 47% and 51%. Despite expecting a sequential revenue decline in the second quarter, NeuroOne forecasts a strong ramp-up towards the year-end. The company is also on track to submit a 510(k) application for its trigeminal nerve RF ablation system, aimed at treating facial pain, in the first half of calendar year 2025.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.