Firefly Neuroscience Discovers Breakthrough Cognitive Brain Age Biomarker Using its FDA-Cleared BNA™ Platform

Rhea-AI Summary

Firefly Neuroscience (NASDAQ: AIFF) has announced a significant breakthrough in brain age assessment using its FDA-cleared BNA™ technology platform. The company has developed a method to estimate biological brain age using Resting EEG and Cognitive EEG (ERP) data, marking the first successful use of cognitive ERP data for brain age assessment.

The technology can identify significant disparities between brain age and chronological age, which could serve as a potential risk factor for dementia. This breakthrough represents a potential advancement in early screening and monitoring capabilities for Alzheimer's patients, offering a proactive and scalable approach to brain health assessment.

The research findings were presented at AD/PD 2024, demonstrating the platform's innovative capabilities to researchers and clinicians in the field of neurological disorders.

Positive

• First-ever successful use of cognitive ERP data for brain age assessment
• FDA-cleared BNA™ technology platform already in place
• Potential early screening tool for Alzheimer's and dementia risk

Negative

• Technology still in research phase with no immediate commercialization timeline
• No clinical validation data provided for accuracy or reliability

Measuring brain age with EEG and BNA™ could lead to a proactive and scalable approach to early screening for Alzheimer's patients

KENMORE, N.Y., Jan. 14, 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 announced the advancement of research to assess a patient’s brain age - an estimation of the biological age of a person's brain – via its FDA-cleared BNA™ technology platform.

Gil Issachar, Chief Technology Officer of Firefly, commented, “I had the opportunity at AD/PD 2024 to unveil data to an esteemed audience of researchers and clinicians that demonstrated the ability of our groundbreaking BNA™ system, which harnesses Resting EEG and Cognitive EEG (ERP) data, to assess patients' brain age. To my knowledge, this marks the first instance where cognitive data measured by ERP has been successfully utilized by any technology platform for assessing biological brain age. This innovative approach has the potential to illuminate various facets of human brain aging. BNA™ data assessment, for example, is capable of finding a significant disparity between brain age and chronological age, which could serve as a valuable risk factor for dementia. By being able to measure brain age with EEG, we are potentially paving the way for a proactive and scalable approach to early screening and monitoring for Alzheimer's patients.”

Greg Lipschitz, Executive Chairman of Firefly, said, “This breakthrough underscores our commitment to pushing the boundaries of innovation in brain health, ultimately with the aim of making a meaningful impact on patients' lives. I'm incredibly proud of our team for their dedication and ingenuity in bringing this vision to fruition.”

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 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: risks related to development and commercialization of BNA™ technology; risks related to Firefly’s ability to recognize the anticipated benefits of the merger (the “Merger”) with WaveDancer, Inc. (“WaveDancer”); risks related to Firefly’s ability to correctly estimate its operating expenses and unanticipated spending and costs that could reduce Firefly’s cash resources; the ability of Firefly to protect its intellectual property rights; competitive responses to the Merger; unexpected costs, charges or expenses resulting from the Merger; potential adverse reactions or changes to business relationships resulting from the completion of the Merger; legislative, regulatory, political and economic developments; and those factors described under the heading “Risk Factors” in the registration statement on Form S-4 filed by WaveDancer with the Securities and Exchange Commission on January 22, 2024, as amended, and declared effective on February 6, 2024. 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 is the breakthrough technology announced by Firefly Neuroscience (AIFF)?

Firefly Neuroscience has developed a method to assess biological brain age using their FDA-cleared BNA™ platform, which combines Resting EEG and Cognitive EEG (ERP) data, marking the first successful use of cognitive ERP data for brain age assessment.

How can AIFF's brain age assessment technology help in Alzheimer's screening?

The technology can identify disparities between brain age and chronological age, which could serve as a risk factor for dementia, potentially enabling early screening and monitoring of Alzheimer's patients in a proactive and scalable way.

When was AIFF's brain age biomarker research presented?

The research was presented at AD/PD 2024 to an audience of researchers and clinicians.

What makes AIFF's brain age assessment technology unique?

It is the first technology platform to successfully utilize cognitive data measured by ERP (Event-Related Potential) for assessing biological brain age, combined with Resting EEG data.