Core Insights - NeuroOne Medical Technologies Corporation has made significant operational progress with its OneRF® Ablation System, including a successful 510(k) submission to the FDA for the Trigeminal Nerve Ablation System to treat facial pain ahead of schedule [3][6] - The company completed an oversubscribed capital raise of $8.2 million, which is expected to fully fund operations through at least fiscal year 2026 [5][6] - The company anticipates potential revenue generation from the trigeminal nerve ablation as early as late calendar year 2025, contingent upon FDA clearance [4][6] Recent Company Highlights - The OneRF® Ablation System has shown clinical success, with patients remaining seizure-free after treatment [3] - The company has strengthened its management team by hiring Dr. Parag Patil as Chief Medical Advisor and Emily Johns as General Counsel [6] - Significant media interest has been secured, including features on major news outlets [6] Financial Performance - Product revenue for the second quarter of fiscal 2025 was $1.4 million, consistent with the same quarter of the previous year, while for the first six months, it increased by 98% to $4.7 million compared to $2.4 million in the same period of fiscal 2024 [9][10] - License revenue of $3.0 million was recorded in the first six months of fiscal 2025, derived from an expanded distribution agreement with Zimmer [9] - Product gross profit increased to $0.8 million, or 55.6% of revenue, in the second quarter of fiscal 2025, compared to 28.3% in the same quarter of the prior year [10] Operating Expenses and Losses - Total operating expenses for the second quarter of fiscal 2025 were $3.5 million, slightly higher than $3.3 million in the same quarter of the prior year [11] - The net loss improved to $2.3 million, or ($0.07) per share, compared to a net loss of $2.9 million, or ($0.11) per share, in the same quarter of the prior year [12] Future Outlook - The company maintains its fiscal year 2025 product revenue guidance of $8.0 million to $10.0 million, representing an increase of 132% to 190% compared to fiscal year 2024 [15] - Expected product gross margin for fiscal year 2025 is projected to range between 47% and 51%, compared to 31% in fiscal year 2024 [15]

Multi-Contact Probe Provides Alternative to Pharmaceutical and Invasive Surgical Treatments Submission Completed Earlier Than Anticipated EDEN PRAIRIE, Minn., April 23, 2025 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (NASDAQ:NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, has filed its 510(k) submission to the FDA for trigeminal nerve ablation earlier than previous ...