OneRF® Ablation System

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NeuroOne® Reports Second Quarter Fiscal Year 2025 Financial Results; Gross Margin Improves Significantly YoY to 55.6%
GlobeNewswire News Room· 2025-05-13 11:30
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]
NeuroOne® Issues Letter to Shareholders
Newsfilter· 2025-04-16 13:00
Company Now Fully Funded Through at least Fiscal 2026; Company Confirms No Material Impact from Global Tariffs EDEN PRAIRIE, Minn., April 16, 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 issued a letter to shareholders from CEO, Dave Rosa. Dear Shareholders, In recent months, NeuroOne has achieved sever ...
NeuroOne® OneRF® Technology Success Story Featured on Fox News
Newsfilter· 2025-04-14 13:00
Core Insights - NeuroOne Medical Technologies Corporation has developed the OneRF® Ablation System, which has successfully treated a pediatric epilepsy patient, Clara Fuller, who previously experienced up to 10 seizures per night, resulting in her being completely seizure-free post-treatment [1][2][3] Company Overview - NeuroOne is focused on improving surgical care options for patients with neurological disorders, including epilepsy, Parkinson's disease, and chronic pain, through minimally invasive and high-definition solutions [4] - The company is exploring additional applications for its technology in areas such as depression, mood disorders, and pain management [4] Technology Impact - The OneRF® technology allows for minimally invasive radiofrequency ablation of seizure-causing brain tissue, significantly improving the quality of life for patients like Clara [2][3] - The successful treatment of Clara Fuller highlights the potential of the OneRF® platform to advance care for patients with debilitating neurological conditions [3]