Company Overview - Firefly Neuroscience, Inc.

Business Focus and Core Technology

• Industry: AI Technology Company specializing in Neuroscience
• Primary Goal: Improve brain health outcomes for patients with mental illnesses and neurological disorders.
• Main Product: BNA™ (Brain Network Analytics), an FDA 510(k) cleared neurophysiological assessment software platform.
• Technology Details:
  • Uses AI and machine learning (unsupervised learning, clustering analysis, functional modeling).
  • Analyzes EEG data (electroencephalograms) recorded during rest and cognitive tasks.
  • Processes data through proprietary algorithms to provide objective, data-driven insights.
  • Compares patient data to extensive proprietary normative database of over 18,000 patients (total of over 80,000 assessments).
  • Detects subtle neurophysiological deviations, aiding early detection and longitudinal monitoring of disorders.
  • Generates individualized reports on EEG, ERP components, behavioral performance, and scores expressed as z-scores against normative data.

Application & Utility

• Supports diagnosis and management of:
  • Mood and anxiety disorders
  • Neurodevelopmental and neurodegenerative diseases
  • Brain injuries
• Aims to optimize personalized patient treatment plans.
• Intended for use in clinical settings, supporting clinicians like neurologists, psychiatrists, nurse practitioners, and general practitioners.
• Facilitates objective assessment of brain electrophysiology, addressing limitations of traditional EEG interpretation.

Development History & Certification

• Over 15 years of R&D investment (~$60 million).
• FDA clearance received in December 2020.
• Previous FDA 510(k) clearance for earlier system (2014) for ages 14-24.
• Current indication in the U.S.: ages 12 to 85 years.

Commercialization & Market Strategy

• In early stages of market launch.
• Targeted outreach to clinical customers and pharmaceutical collaborations.
• Business model includes licensing, per-use fees for clinicians, and tailored contracts for pharma.
• Collaboration with neuroscience drug development companies to support clinical trials and biomarker discovery.
• Plans to expand market outreach in the second half of 2025, with direct sales initially, followed by partnerships.

Market Opportunity

• Target Customer Base: US neurologists (8,278 perform EEGs).
• Estimated TAM: ~$800 million based on neurologist EEG testing frequency (twice daily, 250 days/year, ~$200 per analysis).
• Growing global market driven by rising neurological and mental health issues, aging populations, and unmet treatment needs.

Research & Development

• Focus on advancing the BNA™ platform, discovering biomarkers, and expanding the normative database.
• Significant product enhancements and new biomarker development planned.
• Existing proprietary database includes EEGs of over 18,000 patients with various neurological and psychiatric disorders.

Employees & Staff

• As of March 2025: 13 full-time employees and 1 contractor.
• No unionized employees.

Revenue & Financials

• Revenue: Minimal; early commercialization phase.
• Net Income: Not specified, but the company reports an accumulated deficit of $87.1 million (for the fiscal year ended December 31, 2024).
• Cash Flows: Negative cash flow of approximately $6.2 million in 2024.
• Funding: Primarily through equity sales, convertible notes, and strategic collaborations.
• Market Capitalization: Outstanding shares as of March 25, 2025: 11,622,952 shares.
• Future Revenue Model: Licensing fees, volume-based per analysis fees, and potential hardware rental/purchase.

Summary

Firefly Neuroscience develops AI-based neurophysiological analysis tools, primarily the FDA-cleared BNA™ platform, to support the diagnosis and treatment of neurological and mental disorders by providing objective EEG assessments. The company is in the early stages of commercial launch, leveraging an extensive proprietary database and collaborating with pharmaceutical companies to support drug development. It has a small team of 14 employees, with minimal revenue and a significant accumulated deficit.