Firefly Neuroscience Discovers Breakthrough Cognitive Brain Age Biomarker Using its FDA-Cleared BNA™ Platform
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.
Firefly Neuroscience (NASDAQ: AIFF) ha annunciato una significativa scoperta nella valutazione dell'età cerebrale utilizzando la sua tecnologia BNA™ approvata dalla FDA. L'azienda ha sviluppato un metodo per stimare l'età biologica del cervello utilizzando dati di EEG a riposo e di EEG cognitivo (ERP), segnando il primo utilizzo riuscito dei dati ERP cognitivi per la valutazione dell'età cerebrale.
Questa tecnologia è in grado di identificare disparità significative tra l'età cerebrale e l'età cronologica, che potrebbero fungere da potenziale fattore di rischio per la demenza. Questa scoperta rappresenta un possibile progresso nelle capacità di screening precoce e monitoraggio per i pazienti affetti da Alzheimer, offrendo un approccio proattivo e scalabile alla valutazione della salute cerebrale.
I risultati della ricerca sono stati presentati all'AD/PD 2024, dimostrando le capacità innovative della piattaforma a ricercatori e clinici nel campo dei disturbi neurologici.
Firefly Neuroscience (NASDAQ: AIFF) ha anunciado un importante avance en la evaluación de la edad cerebral utilizando su plataforma de tecnología BNA™ aprobada por la FDA. La empresa ha desarrollado un método para estimar la edad biológica del cerebro utilizando datos de EEG en reposo y EEG cognitivo (ERP), marcando el primer uso exitoso de datos ERP cognitivos para la evaluación de la edad cerebral.
Esta tecnología puede identificar disparidades significativas entre la edad cerebral y la edad cronológica, lo que podría servir como un posible factor de riesgo para la demencia. Este avance representa un progreso potencial en las capacidades de detección temprana y monitoreo para pacientes con Alzheimer, ofreciendo un enfoque proactivo y escalable para la evaluación de la salud cerebral.
Los hallazgos de la investigación fueron presentados en el AD/PD 2024, demostrando las capacidades innovadoras de la plataforma a investigadores y clínicos en el campo de los trastornos neurológicos.
파이어플라이 신경과학 (NASDAQ: AIFF) FDA에서 승인한 BNA™ 기술 플랫폼을 사용하여 뇌 나이 평가에서 중요한 돌파구를 발표했습니다. 이 회사 휴식 EEG와 인지 EEG(ERP) 데이터를 사용하여 생물학적 뇌 나이를 추정하 방법을 개발하였으며, 이 뇌 나이 평가를 위한 인지 ERP 데이터의 첫 번째 성공적인 활용을 의미합니다.
이 기술은 뇌 나이와 연대기적 나이 사이의 중요한 차이를 식별할 수 있으며, 이 치매의 잠재적 위험 요소로 작용할 수 있습니다. 이 돌파구 알츠하이머 환자에 대한 조기 스크리닝 및 모니터링 능력의 잠재적 발전을 나타내며, 뇌 건강 평가를 위한 선제적이고 확장 가능한 접근 방식을 제공합니다.
연구 결과 AD/PD 2024에서 발표되었으며, 신경 장애 분야의 연구자와 임상의에게 플랫폼의 혁신적인 능력을 보여주었습니다.
Firefly Neuroscience (NASDAQ: AIFF) a annoncé une percée significative dans l'évaluation de l'âge cérébral en utilisant sa plateforme technologique BNA™ approuvée par la FDA. L'entreprise a développé une méthode pour estimer l'âge biologique du cerveau à partir de données d'EEG au repos et d'EEG cognitif (ERP), marquant le premier utilisation réussie des données ERP cognitives pour l'évaluation de l'âge cérébral.
Cette technologie peut identifier des disparités significatives entre l'âge cérébral et l'âge chronologique, ce qui pourrait servir de facteur de risque potentiel pour la démence. Cette percée représente un avancement potentiel dans les capacités de dépistage précoce et de suivi pour les patients atteints d'Alzheimer, offrant une approche proactive et évolutive pour l'évaluation de la santé cérébrale.
Les résultats de la recherche ont été présentés à l'AD/PD 2024, démontrant les capacités innovantes de la plateforme aux chercheurs et cliniciens dans le domaine des troubles neurologiques.
Firefly Neuroscience (NASDAQ: AIFF) hat einen bedeutenden Durchbruch in der Beurteilung des Gehirnalters mit seiner von der FDA genehmigten BNA™-Technologieplattform angekündigt. Das Unternehmen hat eine Methode entwickelt, um das biologische Gehirnalter anhand von Ruhe-EEG- und kognitiven EEG-Daten (ERP) zu schätzen, was die erste erfolgreiche Nutzung von kognitiven ERP-Daten zur Beurteilung des Gehirnalters markiert.
Die Technologie kann signifikante Unterschiede zwischen Gehirnalter und chronologischem Alter identifizieren, die als potenzieller Risikofaktor für Demenz dienen könnten. Dieser Durchbruch stellt einen potenziellen Fortschritt in den frühen Screening- und Überwachungsmöglichkeiten für Alzheimer-Patienten dar und bietet einen proaktiven und skalierbaren Ansatz zur Beurteilung der Gehirngesundheit.
Die Forschungsergebnisse wurden auf der AD/PD 2024 vorgestellt und demonstrierten die innovativen Fähigkeiten der Plattform gegenüber Forschern und Klinikern im Bereich neurologischer Störungen.
- 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
- Technology still in research phase with no immediate commercialization timeline
- No clinical validation data provided for accuracy or reliability
Insights
The discovery of a brain age biomarker using EEG and BNA™ technology represents a potentially significant advancement in early Alzheimer's detection. The combination of Resting EEG and Cognitive EEG (ERP) data for brain age assessment is particularly innovative, as it could provide a non-invasive, cost-effective screening tool compared to traditional neuroimaging methods like MRI or PET scans.
The ability to identify disparities between biological brain age and chronological age could serve as an early warning system for cognitive decline. This is important because current Alzheimer's treatments are most effective when started early, before significant neurodegeneration occurs. However, the market impact may be in the short term as clinical validation studies and broader adoption will be necessary to establish this biomarker's reliability and clinical utility.
For investors in this
The integration of AI with EEG data analysis represents a sophisticated technical achievement. Traditional EEG interpretation is complex and often subjective, but Firefly's AI-driven approach could standardize and automate brain age assessment. The key technical innovation lies in successfully processing ERP (Event-Related Potential) data, which captures the brain's direct response to cognitive tasks.
The scalability of this technology is particularly noteworthy - EEG equipment is widely available in clinical settings, making potential deployment relatively straightforward compared to more expensive neuroimaging alternatives. However, the challenge lies in ensuring consistent data quality across different clinical settings and establishing robust AI algorithms that can handle variability in EEG recordings.
From a competitive standpoint, being first-to-market with ERP-based brain age assessment could create significant barriers to entry, especially given the FDA clearance. The intellectual property around the AI algorithms and data processing methods could become valuable assets for this small-cap company.
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.
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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
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