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.