Firefly Inks Latest Commercial Agreement for Use of its FDA-Cleared BNA Platform in Groundbreaking Precision Neuroscience Research

– Institute of Human Genetics at Heidelberg University Hospital ongoing EEG biomarker study on 15q13.3 CNVs –

– Collaboration aims to uncover novel insights into the brain’s functional architecture in rare genetic conditions –

– Building and growing a license business is an increasingly important pillar of Firefly’s commercial strategy –

KENMORE, N.Y., July 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, is pleased to highlight its ongoing collaboration with Prof. Dr. med. Christian Schaaf, Director of the Institute of Human Genetics at Heidelberg University Hospital and Chairman of Human Genetics at the Medical Faculty of Heidelberg University, on a groundbreaking study investigating the neurophysiological impact of 15q13.3 copy number variants (“CNVs”). This engagement builds on prior work between Firefly and Prof. Schaaf, including a joint publication on CHRNA7-related phenotypes.¹

The current study leverages Firefly’s FDA-cleared technology to analyze Electroencephalograms (“EEG”) data from 30 subjects — 15 with deletions and 15 with duplications of the 15q13.3 chromosomal region. Study subjects undergo resting state and two cognitive paradigms running automatically through Firefly's BNA platform.

The study is scheduled to run through 2026, with Firefly commercially engaged to provide EEG systems, training, and full analytic support, including the comparison to its proprietary, FDA-cleared normative Resting and Event-Related Potential Cognitive tasks database.

The study aims to:

1. Identify electrophysiological biomarkers associated with 15q13.3 CNVs;
2. Characterize neurocognitive profiles linked to deletions vs. duplications; and
3. Support future diagnostic and therapeutic strategies for neurodevelopmental disorders.
   
   

“This collaboration reflects our shared commitment to advancing precision neuroscience,” said Gil Issachar, Chief Technology Officer of Firefly. “By combining Heidelberg’s clinical expertise with our proprietary technology, we aim to uncover novel insights into the brain’s functional architecture in rare genetic conditions. But our mission goes well beyond any single study — deepening our understanding of cognitive disorders, both common and rare, is essential to transforming how we diagnose, monitor, and treat these conditions. Every insight we gain from rare genetic variants like 15q13.3 helps illuminate the broader landscape of neurodevelopmental and neuropsychiatric disorders. We believe that by decoding the brain’s electrical language, we can bridge the gap between genotype and phenotype, and ultimately bring more personalized, effective care to patients worldwide.”
  
Greg Lipschitz, Chief Executive Officer of Firefly, said, “As pharma and medtech organizations increasingly look to leverage the use of objective measures of brain activity such as EEG across various stages of new product development, from ideation up to and including commercialization, there is growing industry awareness and adoption of our highly differentiated, AI-powered technology. We are truly honored that a world-renowned physician scientist, like Prof. Schaaf, is the latest to see the value of his institution licensing our technology, and we look forward to updating our stakeholders as this important research is completed.”

Source

¹ Stern T, Crutcher EH, McCarthy JM, Ali MA, Issachar G, Geva AB, Peremen Z, Schaaf CP. Brain Network Analysis of EEG Recordings Can Be Used to Assess Cognitive Function in Teenagers With 15q13.3 Microdeletion Syndrome. Front Neurosci. 2021 Jan 28;15:622329. doi: 10.3389/fnins.2021.622329. PMID: 33584189; PMCID: PMC7876406.

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.

About Prof. Christian Schaaf

Professor Schaaf is the Medical Director at Heidelberg University Hospital and Department Chair of the Institute of Human Genetics at the Heidelberg University in Germany. He studies the genetic causes of neurodevelopmental and neuropsychiatric disorders, including copy number variants of 15q13.3. His work led to the discovery of multiple new disease genes, and three disorders have been named after him: Schaaf-Yang syndrome, Bosch-Boonstra-Schaaf Optic Atrophy syndrome, and Marbach-Schaaf Neurodevelopmental syndrome.

Professor Schaaf’s groundbreaking work has been recognized with many awards, including the William K. Bowes Award for Medical Genetics by Partners Healthcare and Harvard Medical School and the inaugural Seldin-Smith Award for Pioneering Research by the American Society for Clinical Investigation.

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
[email protected]