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NeuroOne Medical Technologies Trading Halted, News Pending
NeuroOne Medical Technologies trading halted, news pending
NeuroOne Medical Secures FDA 510(k) Approval for OneRF Device
NeuroOne Medical Technologies has received U.S. Food and Drug Administration, FDA, clearance to market its OneRF Trigeminal Nerve Ablation System for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. As previously announced, the company completed the FDA submission earlier than anticipated and now targets a limited commercial launch in the fourth quarter of calendar 2025. This clearance leverages the Company's proprietary OneRF Ablation System RF generator platform for the treatment of trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 people in the United States annually. The trigeminal nerve is the main sensory nerve in the face associated with triggering excruciating pain for this condition.
NeuroOne Medical sees FY25 product revenue $8M-$10M vs. $3.5M last year
The Company continues to expect product revenue for fiscal year 2025 to range between $8.0 million and $10.0 million, representing an increase of between 132% and 190% when compared to product revenue of $3.5 million in fiscal year 2024. The Company is increasing its expectations for product gross margin in fiscal year 2025 to range between 50% and 53%, compared to product gross margin of 31% in fiscal year 2024.
NeuroOne Medical reports Q3 EPS (3c) vs. (10c) last year
Reports Q3 revenue $1.7M vs. $825,776 last year. "The third quarter of fiscal 2025 was highlighted by significantly improved year-over-year financial results, as well as several operational milestones that improve our competitive positioning and market potential," said Dave Rosa, CEO of NeuroOne. "On the heels of our continued successful launch of the OneRF Ablation system, we showed dramatic improvements in revenue-which increased 105% year over year-as well as gross profit, which increased to 53.9%. We were also pleased to report that the first OneRF ablation patient surpassed one year with seizure freedom, significantly improving her quality of life. The positive results we are experiencing with patients showcases that our technology platform can significantly improve the quality of life for people with debilitating neurological disorders. We've also continued to make progress in expanding our market opportunity by leveraging the same NeuroOne electrode technology platform. To that end, we submitted our 510(k) application to the FDA for our OneRF Trigeminal Nerve Ablation System ahead of schedule and expect to receive a response shortly. Conditional to receiving FDA 510(k) clearance, we have the ability to generate revenues from trigeminal nerve ablation in calendar year 2025. In addition, we are excited to have received the first order for our sEEG-based drug delivery system, which is in development, from a biopharmaceutical company planning to test our system in preclinical research. Discussions are ongoing with a number of top-tier strategic partners for other potential applications, including basivertebral nerve ablation and spinal cord stimulation for lower back pain management. "We also began efforts this quarter to prepare the company to enter international markets by launching a program to apply for ISO 13485 certification. We expect that obtaining ISO 13485 certification will allow for additional growth that is not factored in our current operational plan. With 17 issued and outstanding patents in the U.S. and internationally, we have made steadfast progress on growing our IP portfolio. In July, we received notice of allowance from USPTO that a key patent will be issued surrounding how our neural and spinal cord stimulation electrodes are manufactured, representing a significant competitive advantage for NeuroOne. Today, we stand in a stronger position than ever, given our expanding IP portfolio, ramping of revenues and solidified financial position following our $8.2 million capital raise. Ultimately, the steps we have taken provide a clearer path to potential profitability, especially as we continue to work closely with our strategic partner, Zimmer Biomet, as well as other potential partners," concluded Rosa.
NeuroOne Medical receives notice of allowance for key patent from USPTO
NeuroOne Medical Technologies has received a notice of allowance for a key patent from the U.S. Patent and Trademark Office, USPTO titled, "Methods for Making Probe Devices and Related Devices". The U.S. Patent Application 17/392,773 is strategic in nature and covers novel methods of making neural probe devices, including specific steps for the arrangement of probe components and deposition of electrode contact material. In addition to this allowed patent application, NeuroOne's patent portfolio includes 17 issued and pending patents in the United States and internationally, covering a wide variety of thin-film electrode technologies. Among these include both neural and spinal cord electrodes with unique structures to optimize the functionality and minimize the profile of those electrodes.
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