Firefly Neuroscience, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsFirefly Neuroscience, Inc. is an AI-driven precision neuroscience company commercializing an FDA-cleared EEG/ERP platform for point-of-care brain assessments.
What they do
Firefly builds and sells a vertically integrated hardware-software platform, the Evoke System, that captures standardized EEG and ERP data at the point of care, analyzes it in the cloud, and returns structured reports to clinicians. The company uses a subscription-based commercial model and operates across more than 85 U.S. clinical sites as of December 31, 2025.
Revenue drivers
- Evoke System subscriptions — Recurring revenue from clinical sites using the Evoke System; revenue scales with utilization; 2025 annual revenue was $1.1M.
- Hardware and data services — Hardware deployment and cloud analytics bundled into the subscription; additional per-scan or report fees could be part of the model, though not explicitly detailed.
Recent performance
For the quarter ended June 30, 2026, revenue was $514,000, up from $388,000 in the quarter ended September 30, 2025. Cash and equivalents rose to $9.2M at June 30, 2026, from $2.7M at December 31, 2025. The company continues to incur losses, with a 2025 net loss of $19.9M and negative operating cash flow of $8.2M.
Strategy
Management is scaling clinical adoption to expand the Firefly Flywheel, where each assessment generates revenue and enriches the proprietary database. They are investing in analytics to enable more granular reference groups and clinical subgroup comparisons. The company is also pursuing additional capital through equity and debt financings and implementing cost-reduction measures to address liquidity.
Risks
- Going concern risk — The company has stated substantial doubt about its ability to continue as a going concern, with accumulated deficit of $111,615 and insufficient capital for the next twelve months.
- Revenue dependence — Revenue is minimal ($1.1M in 2025) and depends on early-stage commercialization adoption; failure to scale could materially harm the business.
- Financing uncertainty — Continued operations rely on raising additional capital; there is no assurance of securing funding on favorable terms or at all.
- Regulatory and market adoption — The Evoke System is FDA-cleared, but broader adoption depends on clinician integration and reimbursement; delays could impact revenue growth.
Outlook
Management expects to grow clinical site count and utilization, which would drive recurring revenue and database expansion. They are actively raising capital and cutting costs to extend runway. There is no assurance of achieving profitability, and future operations depend on successful financing.