Firefly Inks Latest Commercial Agreement for Use of its FDA-Cleared BNA™ Platform in Groundbreaking Precision Neuroscience Research
Firefly Neuroscience (NASDAQ: AIFF) has announced a new commercial agreement with the Institute of Human Genetics at Heidelberg University Hospital to utilize its FDA-cleared BNA™ Platform in a groundbreaking neuroscience study. The research focuses on investigating the neurophysiological impact of 15q13.3 copy number variants (CNVs).
The study involves analyzing EEG data from 30 subjects (15 with deletions and 15 with duplications) using Firefly's technology through 2026. The company will provide EEG systems, training, and analytical support, comparing results to its proprietary FDA-cleared normative database.
This collaboration builds on previous work between Firefly and Prof. Dr. med. Christian Schaaf, including a joint publication on CHRNA7-related phenotypes, and represents an important step in Firefly's commercial licensing strategy.
Firefly Neuroscience (NASDAQ: AIFF) ha annunciato un nuovo accordo commerciale con l'Istituto di Genetica Umana dell'Ospedale Universitario di Heidelberg per utilizzare la sua piattaforma BNA™ approvata dalla FDA in uno studio neuroscientifico innovativo. La ricerca si concentra sull'indagine dell'impatto neurofisiologico delle varianti del numero di copie (CNV) 15q13.3.
Lo studio prevede l'analisi dei dati EEG di 30 soggetti (15 con delezioni e 15 con duplicazioni) utilizzando la tecnologia Firefly fino al 2026. L'azienda fornirà sistemi EEG, formazione e supporto analitico, confrontando i risultati con il proprio database normativo approvato dalla FDA.
Questa collaborazione si basa su precedenti lavori tra Firefly e il Prof. Dr. med. Christian Schaaf, inclusa una pubblicazione congiunta sui fenotipi correlati a CHRNA7, e rappresenta un passo importante nella strategia di licenza commerciale di Firefly.
Firefly Neuroscience (NASDAQ: AIFF) ha anunciado un nuevo acuerdo comercial con el Instituto de Genética Humana del Hospital Universitario de Heidelberg para utilizar su plataforma BNA™ aprobada por la FDA en un estudio innovador de neurociencia. La investigación se centra en analizar el impacto neurofisiológico de las variantes en el número de copias (CNVs) 15q13.3.
El estudio implica analizar datos EEG de 30 sujetos (15 con deleciones y 15 con duplicaciones) usando la tecnología de Firefly hasta 2026. La empresa proporcionará sistemas EEG, capacitación y apoyo analítico, comparando los resultados con su base de datos normativa aprobada por la FDA.
Esta colaboración se basa en trabajos previos entre Firefly y el Prof. Dr. med. Christian Schaaf, incluyendo una publicación conjunta sobre fenotipos relacionados con CHRNA7, y representa un paso importante en la estrategia comercial de licencias de Firefly.
Firefly Neuroscience (NASDAQ: AIFF)는 하이델베르크 대학병원 인간유전학 연구소와 새로운 상업적 협약을 체결하여 FDA 승인 BNA™ 플랫폼을 획기적인 신경과학 연구에 활용한다고 발표했습니다. 연구는 15q13.3 복제 수 변이(CNVs)의 신경생리학적 영향을 조사하는 데 중점을 둡니다.
이 연구는 Firefly의 기술을 사용하여 30명 대상자의 EEG 데이터(결손 15명, 중복 15명)를 2026년까지 분석합니다. 회사는 EEG 시스템, 교육 및 분석 지원을 제공하며, 결과를 자체 FDA 승인 표준 데이터베이스와 비교합니다.
이번 협력은 Firefly와 Christian Schaaf 의학박사 간의 이전 연구(특히 CHRNA7 관련 표현형 공동 출판)를 기반으로 하며, Firefly의 상업적 라이선스 전략에 중요한 진전입니다.
Firefly Neuroscience (NASDAQ : AIFF) a annoncé un nouvel accord commercial avec l'Institut de Génétique Humaine de l'Hôpital Universitaire de Heidelberg pour utiliser sa plateforme BNA™ approuvée par la FDA dans une étude neuroscientifique innovante. La recherche porte sur l'étude de l'impact neurophysiologique des variantes du nombre de copies (CNV) 15q13.3.
L'étude consiste à analyser les données EEG de 30 sujets (15 avec des délétions et 15 avec des duplications) en utilisant la technologie de Firefly jusqu'en 2026. La société fournira les systèmes EEG, la formation et le soutien analytique, en comparant les résultats à sa base de données normative propriétaire approuvée par la FDA.
Cette collaboration s'appuie sur des travaux antérieurs entre Firefly et le Prof. Dr. med. Christian Schaaf, incluant une publication conjointe sur les phénotypes liés à CHRNA7, et représente une étape importante dans la stratégie commerciale de licence de Firefly.
Firefly Neuroscience (NASDAQ: AIFF) hat eine neue kommerzielle Vereinbarung mit dem Institut für Humangenetik am Universitätsklinikum Heidelberg bekannt gegeben, um seine FDA-zugelassene BNA™-Plattform in einer bahnbrechenden neurowissenschaftlichen Studie einzusetzen. Die Forschung konzentriert sich auf die Untersuchung der neurophysiologischen Auswirkungen von 15q13.3 Kopienzahlvarianten (CNVs).
Die Studie umfasst die Analyse von EEG-Daten von 30 Probanden (15 mit Deletionen und 15 mit Duplikationen) unter Verwendung der Firefly-Technologie bis 2026. Das Unternehmen stellt EEG-Systeme, Schulungen und analytische Unterstützung bereit und vergleicht die Ergebnisse mit seiner eigenen, von der FDA zugelassenen Normdatenbank.
Diese Zusammenarbeit baut auf früheren Arbeiten zwischen Firefly und Prof. Dr. med. Christian Schaaf auf, einschließlich einer gemeinsamen Veröffentlichung zu CHRNA7-bezogenen Phänotypen, und stellt einen wichtigen Schritt in der kommerziellen Lizenzierungsstrategie von Firefly dar.
- New commercial agreement with prestigious Heidelberg University Hospital demonstrates market validation
- Expansion of licensing business as a growing revenue stream
- Building on existing successful collaboration with previous published research
- Utilization of FDA-cleared technology in precision neuroscience research
- Study results not expected until 2026, indicating long timeline for potential benefits
- Limited sample size of only 30 subjects in the study
Insights
Firefly's new commercial agreement with Heidelberg University demonstrates their technology's scientific credibility and growing licensing revenue stream.
Firefly Neuroscience's commercial agreement with Heidelberg University Hospital represents a strategic advancement in their license-based business model. The collaboration leverages Firefly's FDA-cleared BNA technology to analyze EEG data from 30 subjects with genetic variants (15q13.3 CNVs) through 2026, providing the company with a predictable revenue stream for systems, training, and analytical support.
This engagement builds upon previous successful collaboration that resulted in a peer-reviewed publication, demonstrating scientific validation and ongoing relationship development with prestigious research institutions. The study's focus on identifying electrophysiological biomarkers for rare genetic conditions has significant potential for expanding Firefly's technology applications in precision neuroscience.
From a commercial perspective, this agreement aligns with the company's explicit strategy to grow its licensing business as "an increasingly important pillar." The engagement with a renowned institution like Heidelberg provides validation that could attract additional pharmaceutical and medical technology partners seeking objective brain activity measurements for product development.
Particularly valuable is the company's proprietary, FDA-cleared normative database of resting and cognitive task measurements, which creates a competitive moat and recurring revenue opportunity. While the financial terms aren't disclosed, this represents another data point showing market acceptance of Firefly's AI-powered neuroscience platform in the scientific community.
This agreement demonstrates Firefly's dual-track approach: advancing neuroscience research while simultaneously commercializing their technology through institutional partnerships and licensing arrangements, potentially creating multiple revenue streams from their FDA-cleared platform.
– 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:
- Identify electrophysiological biomarkers associated with 15q13.3 CNVs;
- Characterize neurocognitive profiles linked to deletions vs. duplications; and
- 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
stephen.kilmer@fireflyneuro.com
FAQ
What is the purpose of Firefly's collaboration with Heidelberg University Hospital?
How many subjects are involved in Firefly's (AIFF) 15q13.3 CNV study?
When will the Firefly (AIFF) Heidelberg University Hospital study be completed?
What technology is Firefly using in the Heidelberg University Hospital study?
How does this agreement fit into Firefly's (AIFF) business strategy?
