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NeuroOne® Issues Letter to Shareholders
Newsfilter· 2025-04-16 13:00
Core Viewpoint - NeuroOne Medical Technologies Corporation has achieved significant milestones and is now fully funded through at least fiscal 2026, with no material impact anticipated from global tariffs [1][3][5]. Company Developments - The company expanded its partnership with Zimmer Biomet, gaining exclusive distribution rights for the OneRF® Ablation System, which includes a $3.0 million upfront license payment [2]. - A successful capital raise of $8.3 million in net proceeds was completed, indicating strong institutional interest in the company's technology platform [4]. - The company is focused on disciplined execution and aims to reach cash flow breakeven while supporting long-term growth plans without additional dilutive financing [5]. Product and Market Opportunities - The anticipated 510(k) submission to the FDA for trigeminal nerve ablation has been accelerated to May 2025, targeting a market of 100,000-200,000 patients suffering from facial pain in the U.S. [6]. - Other growth areas include the Spinal Cord Stimulation (SCS) program and sEEG-Based Drug Delivery Program, with advanced discussions ongoing with strategic partners [7]. Financial Guidance - For fiscal year 2025, product revenues are expected to increase to between $8.0 million and $10.0 million, representing a growth of 132%-190% compared to $3.5 million in fiscal year 2024, with expanded product gross margins of 47%-51% [9].