Firefly Neuroscience Researchers Uncover Powerful New Way of Objectively Measuring SCD, MCI, and Dementia in Alzheimer’s Patients

Rhea-AI Summary

Firefly Neuroscience (NASDAQ: AIFF) has made significant progress in Alzheimer's research, developing a method to differentiate between subjective cognitive decline (SCD), mild cognitive impairment (MCI), and dementia using EEG/ERP and volumetric MRI technology. The study showed that EEG measures alone achieved ~80% accuracy in categorizing cognitive conditions, while combining EEG with vMRI increased accuracy to ~87%. The research, conducted on real-world patients in memory clinics, identified three key EEG measures and left temporal lobe size as crucial predictors. This breakthrough builds upon Firefly's FDA-cleared BNA™ AI platform and recent Evoke acquisition, leveraging a database of over 180,000 standardized EEG/ERP assessment records. The company aims to develop a more accessible, cost-effective, and scalable approach to early Alzheimer's detection and staging.

Positive

• Study achieved high accuracy (~87%) in differentiating cognitive conditions using combined EEG/ERP and vMRI technology
• Research utilized real-world data from memory clinics, demonstrating practical applicability
• Company possesses large proprietary database of >180,000 standardized EEG/ERP assessment records
• Technology offers a less invasive and more cost-effective alternative to traditional testing methods
• Solution builds upon FDA-cleared BNA™ AI platform

Negative

• EEG measures alone show lower accuracy (~80%) compared to combined approach
• Study size was relatively small (161 for EEG, 111 for MRI)
• Technology still requires both EEG and MRI for optimal results

Insights

Neuroscience Research Analyst

Firefly's research shows EEG combined with brain imaging offers promising objective measurement tool for Alzheimer's progression stages.

This research represents a significant advancement in the objective assessment of Alzheimer's disease progression. The study demonstrates that using electroencephalography/event-related potentials (EEG/ERP) combined with volumetric MRI can differentiate between subjective cognitive decline (SCD), mild cognitive impairment (MCI), and dementia with approximately 87% accuracy (AUC = 0.87).

What's particularly noteworthy is that even EEG measures alone achieved ~80% accuracy, highlighting three key predictive metrics: reaction time, commission errors, and P300b amplitude. This finding has profound implications for accessibility and scalability in clinical settings. The research employed real-world patient data from memory clinics (161 for EEG, 111 for MRI), validating its practical applicability.

The potential integration of this approach with Firefly's existing FDA-cleared BNA™ AI platform and their recently acquired Evoke technology creates a powerful diagnostic ecosystem. The company now maintains what they describe as the largest proprietary database of standardized EEG/ERP assessments with over 180,000 records.

From a clinical perspective, this development addresses a critical challenge in Alzheimer's management: early and accurate diagnosis. By providing objective physiological markers rather than relying solely on subjective cognitive assessments, clinicians could potentially identify and categorize patients earlier in the disease process when interventions may be more effective. The left temporal lobe volume emerged as a particularly significant MRI predictor, establishing a measurable biomarker that correlates with cognitive decline.

Healthcare Technology Investor

From an investment perspective, this research strengthens Firefly's position in the neurotechnology market in several important ways. First, it validates their recent acquisition of Evoke Neuroscience by demonstrating how the combined technologies create enhanced diagnostic capabilities. The study effectively showcases the company's expanding intellectual property portfolio around neurological assessments.

The market implications are substantial. By developing accurate, less invasive, and more accessible diagnostic tools for Alzheimer's progression, Firefly addresses a significant unmet need in a massive market. Alzheimer's disease affects millions globally, with diagnostic challenges being a major obstacle to effective treatment.

What's particularly valuable is the dual approach. While the combined EEG/vMRI methodology achieved the highest accuracy (87%), the finding that EEG measures alone reached ~80% accuracy creates a tiered market approach. This allows for broader implementation in various healthcare settings with different resource availability.

Firefly's strategy aligns with healthcare's shift toward earlier intervention and objective biomarkers. Their BNA™ technology platform, being FDA-cleared, provides regulatory validation. The combination of proprietary technology, large datasets (180,000+ EEG/ERP records), and AI capabilities creates significant barriers to entry for competitors.

Importantly, this approach addresses cost-effectiveness concerns in healthcare by potentially reducing the need for more expensive or invasive diagnostic procedures. If successfully commercialized, this technology could become part of standard clinical practice for cognitive assessment, representing substantial recurring revenue potential in the growing neurological disorders market.

– Research supports combined use of EEG/ERP and vMRI for accurate differential diagnosis of SCD, MCI and dementia –

– Also highlights that low-cost and off-based EEG/ERP alone also delivered reasonably accurate predictions of cognitive impairment typology –

– Underscores the value of recent Evoke acquisition that builds upon Firefly's FDA-cleared BNA™ AI platform and unique integrated normative reference group –

– It’s well accepted that earlier dementia course detection can improve outcomes and open up additional treatment opportunities –

KENMORE, N.Y., June 20, 2025 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly” or the “Company”) (NASDAQ: AIFF), an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, today highlighted a leap forward in Alzheimer’s research to distinguish between subjective cognitive decline (“SCD”), mild cognitive impairment (“MCI”), and dementia in a scalable, accessible way to promote earlier detection and intervention.

In the study, while EEG/ERP and volumetric magnetic resonance imaging (“vMRI”) each helped alone, the best results came when both were combined. Just using EEG measures, three EEG measures stood out: (1) reaction time; (2) commission errors; and (3), P300b amplitude. Using these EEG assessments, researchers could categorize subjects with ~80% accuracy (AUC = 0.79). With respect to vMRI assessment, of all the brain areas, only the left temporal lobe size was a powerful MRI predictor, where smaller size tended to correlate to cognitive issues. Combing EEG measures with the size of the left temporal lobe from the MRI boosted accuracy to ~87% (AUC = 0.87). This study demonstrates the potential of a primarily physiological diagnostic model for differentiating SCD, MCI, and dementia using EEG/ERP , especially when combined with volumetric brain MRI. In addition, the accessibility of EEG/ERP and vMRI means that these tools can be used as adjuncts to clinical assessments to help increase the diagnostic certainty of SCD, MCI, and dementia.

Gil Issachar, Chief Technology Officer of Firefly, commented, “Immediately after the completion of Firefly’s acquisition of Evoke Neuroscience, the two companies’ respective research teams joined forces to conduct a comprehensive review of brain wave research to-date, with the aim of effectively and efficiently leveraging what is now the largest known proprietary database of >180,000 standardized, EEG/ERP assessment records. Earlier this year, we announced the discovery of a breakthrough cognitive brain age biomarker using our FDA-cleared BNA™ technology platform. We are now working to link that with this important study, thereby potentially paving the way for a proactive, scalable and objective approach to both early screening for, as well as staging of, Alzheimer's disease.”

Greg Lipschitz, CEO of Firefly, said, “It is important to note that this was not a lab study. It utilized patients in memory clinics (161 for EEG, 111 for MRI), so it was real-world data. The research supports the use of office based electrophysiology and imaging to reliably spot who was starting to decline, and who had dementia — with nearly the same accuracy as more invasive and costly tests. The bottom line is that combining our BNA™ technology with vMRI imaging is faster, easier, and can be done in more places.”

About Firefly
Firefly (NASDAQ: AIFF) is an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders. Firefly’s FDA-510(k) cleared Brain Network Analytics (BNA™) technology revolutionizes diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has built a comprehensive database of brain wave tests, securing patent protection, and achieving FDA clearance. The Company is now launching BNA™ commercially, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as medical practitioners for clinical use.

Brain Network Analytics was developed using artificial intelligence and machine learning on Firefly’s extensive proprietary database of standardized, high-definition longitudinal electroencephalograms (EEGs) of over 17,000 patients representing twelve disorders, as well as clinically normal patients. BNA™, in conjunction with an FDA-cleared EEG/ERP system, can provide clinicians with comprehensive insights into brain function. These insights can enhance a clinician’s ability to accurately diagnose mental and cognitive disorders and to evaluate what therapy and/or drug is best suited to optimize a patient’s outcome.

Please visit https://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 teams’ 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) or 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 accuracy did Firefly Neuroscience's AIFF technology achieve in detecting Alzheimer's stages?

The technology achieved ~80% accuracy using EEG measures alone and ~87% accuracy when combining EEG with volumetric MRI.

What are the key EEG measures identified in Firefly's AIFF Alzheimer's research?

The study identified three key EEG measures: reaction time, commission errors, and P300b amplitude.

How many patient records does Firefly Neuroscience (AIFF) have in their EEG/ERP database?

Firefly possesses a proprietary database of over 180,000 standardized EEG/ERP assessment records.

What advantages does Firefly's AIFF technology offer over traditional Alzheimer's testing?

The technology is faster, less invasive, more cost-effective, and can be implemented in more locations compared to traditional testing methods.

How many patients were included in Firefly Neuroscience's AIFF clinical study?

The study included 161 patients for EEG testing and 111 patients for MRI analysis from memory clinics.