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Firefly’s AI-Driven Evoke System Powers Discovery of Novel Electrophysiological Biomarker for PTSD

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Firefly Neuroscience (NASDAQ: AIFF) reported discovery of a novel electrophysiological biomarker for PTSD using its FDA-510(k)-cleared Evoke System. The finding stems partly from its public-private partnership with the U.S. Department of War to support assessment and treatment of active-duty service members and veterans.

The biomarker, identified via deep-learning analysis of EEG and ERP data on NVIDIA L40S GPU infrastructure, may support PTSD diagnostics and treatment decisions. Firefly sees potential applications across defense health, pharmaceutical clinical trials, and clinical psychiatry, aligning with its goal to build an EEG/ERP-based brain foundation model.

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AI-generated analysis. Not financial advice.

Positive

  • Identification of a PTSD-specific electrophysiological biomarker using the FDA-510(k)-cleared Evoke System
  • Active public-private brain health partnership with the U.S. Department of War for PTSD/TBI
  • Use of NVIDIA L40S GPU-accelerated deep learning for large-scale EEG/ERP analysis

Negative

  • None.

Key Figures

PTSD prevalence (annual): 13 million Americans Lifetime PTSD risk: 6% of U.S. population Veteran PTSD prevalence: 11–20% +2 more
5 metrics
PTSD prevalence (annual) 13 million Americans Number of Americans affected by PTSD in any given year
Lifetime PTSD risk 6% of U.S. population Share of U.S. population expected to have PTSD at some point
Veteran PTSD prevalence 11–20% Operation Iraqi Freedom/Enduring Freedom veterans with PTSD annually
U.S. PTSD economic burden $232.2 billion Estimated total annual U.S. economic burden of PTSD
Military PTSD burden $42.7 billion Portion of U.S. PTSD economic burden attributed to military population

Market Reality Check

Price: $1.7150 Vol: Volume 200,142 is below t...
normal vol
$1.7150 Last Close
Volume Volume 200,142 is below the 20-day average of 251,165, suggesting limited pre-news participation. normal
Technical Shares at $1.72 trade 54.51% below the 52-week high and modestly below the $1.82 200-day MA.

Peers on Argus

AIFF was down 3.39% pre-news while sector peers were mixed: some application sof...
1 Up 1 Down

AIFF was down 3.39% pre-news while sector peers were mixed: some application software names showed gains (e.g., BMR, NUKK, WETO), and momentum peers had one stock up and one down, pointing to stock-specific drivers rather than a sector-wide AI move.

Previous AI Reports

1 past event · Latest: Sep 20 (Positive)
Same Type Pattern 1 events
Date Event Sentiment Move Catalyst
Sep 20 AI drug-development update Positive -6.0% AI-driven BNA™ progress and pharma collaborations with Takeda and Novartis.
Pattern Detected

The only prior AI-tagged event saw a negative price reaction despite positive AI drug-development collaboration news, hinting at a tendency for investors to fade AI partnership headlines.

Recent Company History

Recent history shows Firefly using its AI and EEG/ERP platform to support neuroscience drug development and generate objective biomarkers. On Sep 20, 2024, an AI-tagged update on BNA™ collaborations with Takeda and Novartis led to a -6.01% move despite positive strategic implications. Today’s PTSD biomarker update and DoW partnership context continue that AI-centric, biomarker-focused trajectory aimed at pharma and clinical applications.

Historical Comparison

-6.0% avg move · AI-tagged news for AIFF previously saw an average move of -6.01%, as investors faded a positive AI d...
AI
-6.0%
Average Historical Move AI

AI-tagged news for AIFF previously saw an average move of -6.01%, as investors faded a positive AI drug-development collaboration update, providing context for how markets have treated similar AI advances.

Historically, AI updates focused on pharma collaborations and BNA™ for drug development. The new PTSD-specific biomarker and DoW deployment extend this AI electrophysiology strategy into government brain health and potential clinical psychiatry use.

Regulatory & Risk Context

Active S-3 Shelf
Shelf Active
Active S-3 Shelf Registration 2026-05-20

An effective Form S-3 shelf dated May 20, 2026 registers up to 22,500,000 shares of common stock for resale by selling stockholders tied to recent warrant-based private placements. Firefly will not receive proceeds from these resales and may receive cash only if the warrants are exercised.

Market Pulse Summary

This announcement details a PTSD-specific electrophysiological biomarker discovered using Firefly’s ...
Analysis

This announcement details a PTSD-specific electrophysiological biomarker discovered using Firefly’s FDA-510(k)-cleared Evoke System and NVIDIA L40S GPU-accelerated AI stack. It builds on a public-private partnership with the Department of War and echoes prior AI-tagged work in drug development that averaged a -6.01% price move. Investors may track validation of the biomarker in government, pharma trials, and clinical psychiatry alongside the company’s reliance on equity financing and resale registration of 22,500,000 shares.

Key Terms

electroencephalogram (EEG), FDA-510(k)-cleared, deep learning, GPU-accelerated, +1 more
5 terms
electroencephalogram (EEG) medical
"analysis of multi-channel electroencephalogram (EEG) and Event-Related Potential (ERP) waveforms"
A noninvasive test that records the brain’s electrical activity using small sensors placed on the scalp, producing waveform patterns that reflect how brain cells are firing—think of it as a seismograph for electrical signals in the brain. Investors care because EEGs are widely used to diagnose and monitor neurological conditions, evaluate drug or device effects in clinical trials, and support regulatory and commercial decisions; changes in EEG results can influence trial outcomes, approvals, and market prospects.
FDA-510(k)-cleared regulatory
"using brain scans collected on its FDA-510(k)-cleared Evoke System"
A device described as FDA-510(k)-cleared has been reviewed by the U.S. Food and Drug Administration and found sufficiently similar in safety and basic performance to an already allowed device, allowing it to be marketed in the U.S. without the longer approval route. For investors, this clearance signals lower regulatory hurdles and faster access to customers compared with novel devices, meaning quicker revenue potential and reduced development risk — like getting a green light because your product closely matches an accepted model.
deep learning technical
"The biomarker discovery leverages Firefly’s deep learning architecture running on NVIDIA L40S"
Deep learning is a type of artificial intelligence that uses multiple layers of computer models to recognize patterns and make decisions from large amounts of data, similar to how someone improves at a task by practicing many examples. Investors care because companies that harness deep learning can automate work, improve products, cut costs or create new revenue streams — but adoption also involves investment, data and regulatory risks that can influence profits and valuation.
GPU-accelerated technical
"NVIDIA L40S GPU-accelerated infrastructure, enabling high-throughput analysis"
Using graphics processing units (GPUs) to run compute‑heavy tasks much faster than standard central processors by handling many small operations at once. For investors, GPU‑acceleration can shorten time to insight and lower costs for advanced workloads like artificial intelligence, large‑scale data analysis, or simulations, potentially boosting product performance, enabling new services, and improving competitive position—think switching from a bicycle to a high‑speed train for moving large data loads.
biomarker medical
"The identification of a novel PTSD-specific electrophysiological biomarker could potentially open commercial pathways"
A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

AI-generated analysis. Not financial advice.

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– Comes just weeks after Firefly confirmed its active public-private partnership with the U.S. Department of War –

KENMORE, N.Y, June 02, 2026 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly” or the “Company”) (NASDAQ: AIFF), an Artificial Intelligence (“AI”) company advancing precision neuroscience, today announced the identification of a novel electrophysiological biomarker for Post-Traumatic Stress Disorder (“PTSD”) using brain scans collected on its FDA-510(k)-cleared Evoke System.

The biomarker discovery emanates partly from Firefly’s previously announced public-private partnership with the U.S. Department of War (“DoW”) to support the assessment and treatment of active-duty U.S. service members and veterans suffering from PTSD and/or Traumatic Brain Injury (“TBI”). The identification of a novel PTSD-specific electrophysiological biomarker deepens the scientific foundation of that DoW deployment and positions Firefly as what it believes to be the only company with both an active government brain health partnership and a identified neural signal marker for the condition.

PTSD affects approximately 13 million Americans in any given year, and about 6% of the U.S. population will have PTSD at some point in their life.1 The disorder is disproportionately prevalent in military personnel; with 11–20% of Operation Iraqi Freedom and Enduring Freedom veterans experiencing PTSD annually.2 The total U.S. economic burden of PTSD has been estimated at $232.2 billion, of which $42.7 billion is attributed directly to the military population.3

The biomarker discovery leverages Firefly’s deep learning architecture running on NVIDIA L40S GPU-accelerated infrastructure, enabling high-throughput analysis of multi-channel electroencephalogram (EEG) and Event-Related Potential (ERP) waveforms at unprecedented scale. The Evoke System’s dual-signal approach, capturing both resting-state hyperarousal patterns and abnormal cognitive ERP responses, is particularly well-suited to PTSD diagnostics.

“By applying our AI models to a dataset that we believe to be unmatched in scale, we have identified a consistent and reproducible electrophysiological pattern distinguishing PTSD patients from healthy controls,” said Gil Issachar, Firefly’s Chief Technology Officer. “Given our previously announced DoW deployment, this discovery holds potential for providing military healthcare providers with not just a powerful assessment tool, but a scientifically grounded neural signal to anchor it.”

Greg Lipschitz, Firefly’s Chief Executive Officer, commented, “Our proprietary database is an important asset that continues to generate breakthrough cognitive brain biomarker discoveries. The convergence of this PTSD biomarker finding with our previously announced DoW partnership represents a significant milestone: we are deploying FDA-cleared technology to support the assessment and treatment of active-duty U.S. service members and veterans while, at the same time, generating the neuroscience that could support how PTSD is objectively assessed for both them and civilians going forward. Our NVIDIA L40S GPU-accelerated foundation model architecture creates a potential competitive advantage in biomarker discovery that we believe positions Firefly well across defense health, pharma partnerships, and clinical psychiatry.”

The identification of a PTSD-specific electrophysiological biomarker could potentially open commercial pathways across three channels: within the existing Firefly-DoW partnership, where an objective neural marker could deepen and expand Firefly’s government engagement; in pharmaceutical clinical trials, where it could serve as an objective efficacy endpoint addressing a longstanding bottleneck in CNS drug development; and in clinical psychiatry, where the Evoke System’s objective signal data could inform more personalized treatment decisions for the millions of people living with PTSD.

This discovery further advances Firefly’s mission to build the world’s first EEG/ERP-based brain foundation model, a large-scale AI architecture trained across all disorder categories to serve as a universal brain health intelligence platform for neurology, psychiatry, and drug development.

Sources

1 U.S. Department of Veterans Affairs, National Center for PTSD. “How Common Is PTSD in Adults?” https://www.ptsd.va.gov/understand/common/common_adults.asp

2 U.S. Department of Veterans Affairs, National Center for PTSD. “How Common is PTSD in Veterans?” https://www.ptsd.va.gov/understand/common/common_veterans.asp

3 Davis LL, Schein J, Cloutier M, et al. “The Economic Burden of Posttraumatic Stress Disorder in the United States From a Societal Perspective.” The Journal of Clinical Psychiatry, 2022.

About Firefly

Firefly Neuroscience, Inc. (NASDAQ: AIFF) is an Artificial Intelligence (“AI”) company advancing precision neuroscience, applying AI and large-scale electrophysiological data to give clinicians a more complete, objective picture of how an individual patient's brain is functioning. Firefly’s proprietary database now consists of over 200,000 EEG/ERP brain scans, making it the world’s largest known standardized EEG/ERP repository. Firefly’s EEG-based, AI-driven, and FDA-510(k)-cleared Evoke System has the potential to transform diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, ADHD, and PTSD.

Please visit www.fireflyneuro.com for more information.

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” for purposes of the federal securities laws concerning Firefly. These forward-looking statements include express or implied statements relating to Firefly’s management team’s expectations, hopes, beliefs, intentions, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Firefly will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Firefly’s control) and other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors” in the reports and other filings of Firefly with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of Firefly’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. It is not possible to predict or identify all such risks. Forward-looking statements included in this press release only speak as of the date they are made, and Firefly does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Investor & Media Contact

Stephen Kilmer
(646) 274-3580
stephen.kilmer@fireflyneuro.com


FAQ

What did Firefly Neuroscience (NASDAQ: AIFF) announce about its PTSD biomarker on June 2, 2026?

Firefly Neuroscience announced discovery of a novel electrophysiological biomarker for PTSD using its Evoke System. According to Firefly, this PTSD-specific neural pattern was identified through AI-driven analysis of large-scale EEG and ERP data on NVIDIA L40S GPU-accelerated infrastructure.

How does Firefly’s FDA-510(k)-cleared Evoke System support PTSD assessment for AIFF?

The Evoke System captures resting-state EEG and cognitive ERP signals to characterize brain activity. According to Firefly, its dual-signal approach helps identify hyperarousal and abnormal ERP responses, providing objective data that may aid PTSD diagnostics and future treatment decisions in both military and civilian settings.

What is the role of the U.S. Department of War partnership in Firefly’s PTSD biomarker work (AIFF)?

Firefly’s public-private partnership with the U.S. Department of War supports assessment and treatment of service members and veterans. According to Firefly, part of the biomarker discovery stems from this deployment, potentially deepening government engagement around objective neural markers for PTSD and traumatic brain injury.

How is AI and NVIDIA L40S GPU infrastructure used in Firefly’s PTSD biomarker discovery (AIFF)?

Firefly applies deep learning models on NVIDIA L40S GPU-accelerated infrastructure to analyze multi-channel EEG and ERP data. According to Firefly, this high-throughput platform enabled identification of a consistent, reproducible electrophysiological pattern distinguishing PTSD patients from healthy controls at substantial analytical scale.

What commercial opportunities could Firefly’s PTSD biomarker create for AIFF shareholders?

Firefly sees potential commercial pathways in defense health, pharma trials, and clinical psychiatry. According to Firefly, the biomarker could enhance its Department of War engagement, offer objective efficacy endpoints for CNS drug studies, and support more personalized PTSD treatment decisions using Evoke System data.

How does Firefly’s PTSD biomarker discovery align with its brain foundation model strategy (AIFF)?

The PTSD biomarker is presented as progress toward Firefly’s EEG/ERP-based brain foundation model. According to Firefly, this large-scale AI architecture is being trained across disorder categories to function as a universal brain health intelligence platform for neurology, psychiatry, and drug development.