NeuroOne® Accelerates FDA Submission for Facial Pain Treatment

NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) has announced an accelerated timeline for its FDA 510(k) submission of the OneRF® Trigeminal Nerve Ablation System, now planned for May 2025, two months earlier than initially projected. This system is designed to treat facial pain caused by trigeminal neuralgia through minimally invasive radiofrequency ablation, marking the company's second radiofrequency ablation technology utilizing its proprietary OneRF® Technology Platform.

The trigeminal neuralgia therapeutics market is expected to grow significantly from $243 million in 2023 to $375 million by 2032, driven by an aging population. If FDA clearance is obtained, NeuroOne anticipates revenue generation from this product as early as late 2025, earlier than previously forecasted. This would expand NeuroOne's portfolio, which already includes three FDA-cleared product families.

The accelerated submission reflects NeuroOne's operational momentum and commitment to advancing innovative solutions for neurological disorders. However, the ultimate success of the OneRF® Trigeminal Nerve Ablation System depends on FDA approval, which is not guaranteed.

NeuroOne Advantages

NeuroOne's OneRF® Ablation System offers several key benefits for treating facial pain, particularly in conditions like trigeminal neuralgia:

1. Minimally Invasive Design: The system uses sEEG-guided electrodes, enabling both diagnostic monitoring and therapeutic ablation through a single incision. This reduces the risk of infection, shortens procedure times, and minimizes patient discomfort compared to traditional surgical methods.

2. Dual Functionality: The OneRF system combines diagnostic and therapeutic capabilities, allowing neurosurgeons to use the same electrodes for brain mapping and precise ablation. This eliminates the need for additional procedures, reducing hospital stays and associated costs.

3. Temperature Control for Safety: The system features real-time temperature monitoring via its proprietary Evo® sEEG-RF probe. This enhances precision during ablation and minimizes the risk of damage to surrounding healthy tissues.

4. Improved Clinical Outcomes: Early clinical cases have demonstrated promising results, including seizure freedom and improved mood and memory in patients treated with the system. These outcomes suggest potential for significant improvements in quality of life for patients with neurological disorders.

5. Versatility Across Neurological Disorders: While initially focused on epilepsy and trigeminal neuralgia, the system's technology is adaptable for treating other conditions such as Parkinson's disease, dystonia, and essential tremor, broadening its clinical applications.

6. Reduced Need for Multiple Surgeries: By integrating ablation with diagnostic tools, the OneRF system decreases the number of invasive interventions required, offering a safer and more efficient treatment pathway.

These features position NeuroOne's OneRF system as a transformative tool in neurosurgical care, offering a safer, more effective alternative to traditional approaches.

NeuroOne Status Report

NeuroOne Medical Technologies Corporation (NMTC) reported strong financial results for the first quarter of fiscal year 2025, showcasing significant growth and operational improvements. Below are the key highlights:

Financial Performance

• Total Revenue: $6.3 million, a substantial increase from $1.0 million in Q1 FY2024. This includes:

  • Product Revenue: $3.3 million, up 235% year-over-year.

  • License Revenue: A one-time $3.0 million upfront payment from Zimmer Biomet.

• Gross Margin: Improved to 58.9%, compared to 27.2% in Q1 FY2024.

• Operating Expenses: Decreased by 12% to $3.2 million, reflecting cost management efforts.

• Net Income: Achieved $1.8 million ($0.06 per share), reversing a net loss of $3.3 million in Q1 FY2024.

Strategic Developments

• Expanded its exclusive distribution agreement with Zimmer Biomet, which included the $3.0 million license payment and potential future milestone payments.

• The partnership is expected to drive meaningful revenue growth and improved margins through Zimmer Biomet's extensive distribution network.

Outlook for FY2025

• Product revenue is projected between $8.0 million and $10.0 million, representing growth of 132%-190%.

• Gross margins are expected to range between 47%-51%, a significant improvement from 31% in FY2024.

Operational Highlights

• NeuroOne remains debt-free with $1.1 million in cash and $4.1 million in working capital as of December 31, 2024.

• The company has successfully transitioned from primarily R&D-focused operations to commercial execution, as evidenced by record product sales.

These results reflect NeuroOne's strong momentum in scaling its business and leveraging strategic partnerships to enhance its financial performance and market presence.

Interested investors are encouraged to read the company’s Corporate Presentation.