Firefly Neuroscience Announces Publications Demonstrating the Utility of Advanced EEG Analytics in Drug Development and Neuropsychiatric Care
Firefly Neuroscience (NASDAQ: AIFF) has announced two significant studies demonstrating the effectiveness of their FDA-cleared BNA™ platform in drug development and neuropsychiatric care through advanced EEG analytics. The first study, conducted with Novartis, examined MIJ821's effects, showing dose-dependent EEG changes and validating EEG as a pharmacokinetic-pharmacodynamic tool.
The second study focused on Major Depressive Disorder (MDD) treatment, revealing that baseline brain activation latencies measured through BNA™ technology were longer in MDD patients compared to controls, but normalized after treatment. This demonstrated improved cognitive functioning independent of antidepressant effects.
The research validates BNA™'s capability to provide objective measures of treatment efficacy and cognitive change, supporting its potential role in advancing personalized psychiatry and drug development.
Firefly Neuroscience (NASDAQ: AIFF) ha annunciato due studi significativi che dimostrano l'efficacia della loro piattaforma BNA™ approvata dalla FDA nello sviluppo di farmaci e nella cura neuropsichiatrica attraverso analisi EEG avanzate. Il primo studio, condotto con Novartis, ha analizzato gli effetti di MIJ821, mostrando cambiamenti EEG dose-dipendenti e convalidando l'EEG come strumento farmacocinetico-farmacodinamico.
Il secondo studio si è concentrato sul trattamento del Disturbo Depressivo Maggiore (MDD), rivelando che le latenze di attivazione cerebrale basale misurate attraverso la tecnologia BNA™ erano più lunghe nei pazienti con MDD rispetto ai controlli, ma si normalizzavano dopo il trattamento. Questo ha dimostrato un miglioramento delle funzioni cognitive indipendente dagli effetti degli antidepressivi.
La ricerca convalida la capacità di BNA™ di fornire misure oggettive dell'efficacia del trattamento e del cambiamento cognitivo, supportando il suo potenziale ruolo nell'avanzamento della psichiatria personalizzata e dello sviluppo di farmaci.
Firefly Neuroscience (NASDAQ: AIFF) ha anunciado dos estudios significativos que demuestran la efectividad de su plataforma BNA™ aprobada por la FDA en el desarrollo de fármacos y el cuidado neuropsiquiátrico mediante análisis avanzados de EEG. El primer estudio, realizado en colaboración con Novartis, examinó los efectos de MIJ821, mostrando Cambios en el EEG dependientes de la dosis y validando el EEG como una herramienta farmacocinética-farmacodinámica.
El segundo estudio se centró en el tratamiento del Trastorno Depresivo Mayor (MDD), revelando que las latencias de activación cerebral basales medidas a través de la tecnología BNA™ eran más largas en pacientes con MDD en comparación con los controles, pero se normalizaban después del tratamiento. Esto demostró una mejora en el funcionamiento cognitivo independiente de los efectos de los antidepresivos.
La investigación valida la capacidad de BNA™ para proporcionar medidas objetivas de la eficacia del tratamiento y del cambio cognitivo, apoyando su potencial papel en el avance de la psiquiatría personalizada y el desarrollo farmacéutico.
파이어플라이 신경과학 (NASDAQ: AIFF)는 FDA 승인 받은 BNA™ 플랫폼이 약물 개발 및 첨단 EEG 분석을 통한 신경정신 치료에서 효과적임을 보여주는 두 가지 중요한 연구 결과를 발표했습니다. 첫 번째 연구는 노바티스와 함께 진행되었으며, MIJ821의 효과를 조사하였고, 용량 의존적인 EEG 변화를 보여주며 EEG를 약물의 약리동태-약리작용 도구로서 유효성을 검증했습니다.
두 번째 연구는 주요 우울장애 (MDD) 치료에 초점을 맞췄으며, BNA™ 기술을 통해 측정한 기초 뇌 활성화 지연 시간이 MDD 환자에서 대조군에 비해 더 길었지만, 치료 후 정상화됨을 밝혔습니다. 이는 항우울제의 효과와 무관하게 인지 기능이 향상되었음을 보여주었습니다.
이 연구는 BNA™가 치료 효과와 인지 변화의 객관적 척도를 제공할 수 있는 능력을 검증하여 개인화된 정신의학 및 약물 개발의 발전에 기여할 수 있는 잠재적 역할을 지원합니다.
Firefly Neuroscience (NASDAQ: AIFF) a annoncé deux études significatives démontrant l'efficacité de leur plateforme BNA™ approuvée par la FDA dans le développement de médicaments et les soins neuropsychiatriques grâce à des analyses avancées d'EEG. La première étude, réalisée en collaboration avec Novartis, a examiné les effets de MIJ821, montrant des changements EEG dépendants de la dose et validant l'EEG comme un outil pharmacocinétique-pharmacodynamique.
La seconde étude s'est concentrée sur le traitement du trouble dépressif majeur (MDD), révélant que les latences d'activation cérébrale de base mesurées par la technologie BNA™ étaient plus longues chez les patients souffrant de MDD par rapport aux contrôles, mais se normalisaient après traitement. Cela a démontré une amélioration du fonctionnement cognitif indépendamment des effets antidépresseurs.
La recherche valide la capacité de BNA™ à fournir des mesures objectives de l'efficacité du traitement et du changement cognitif, soutenant son rôle potentiel dans l'avancement de la psychiatrie personnalisée et du développement de médicaments.
Firefly Neuroscience (NASDAQ: AIFF) hat zwei bedeutende Studien angekündigt, die die Wirksamkeit ihrer von der FDA zugelassenen BNA™-Plattform in der Arzneimittelentwicklung und der neuropsychiatrischen Versorgung durch fortschrittliche EEG-Analysen demonstrieren. Die erste Studie, die in Zusammenarbeit mit Novartis durchgeführt wurde, untersuchte die Wirkungen von MIJ821 und zeigte dosisabhängige EEG-Veränderungen und validierte EEG als ein pharmakokinetisch-pharmakodynamisches Werkzeug.
Die zweite Studie konzentrierte sich auf die Behandlung von Major Depression (MDD) und zeigte, dass die basalen Aktivierungslatenzen des Gehirns, die mit der BNA™-Technologie gemessen wurden, bei MDD-Patienten im Vergleich zu den Kontrollen länger waren, sich nach der Behandlung jedoch normalisierten. Dies zeigte eine verbesserte kognitive Funktion unabhängig von den antidepressiven Effekten.
Die Forschung validiert die Fähigkeit von BNA™, objektive Maße der Behandlungswirksamkeit und kognitiven Veränderung bereitzustellen und unterstützt deren potenziellen Rolle bei der Förderung der personalisierten Psychiatrie und Arzneimittelentwicklung.
- FDA clearance for BNA™ platform validates technology's credibility
- Partnership with major pharmaceutical company Novartis demonstrates commercial viability
- Successful validation of EEG technology as a biomarker tool for drug development
- Clinical evidence shows BNA™'s effectiveness in measuring cognitive improvements in MDD patients
- None.
Insights
Two groundbreaking studies validate Firefly Neuroscience's BNA™ platform as a powerful tool for objective neurological assessment, representing a significant advancement in both drug development and clinical practice.
The Novartis collaboration is particularly noteworthy as it demonstrates the platform's ability to serve as a pharmacodynamic biomarker for drug development. This capability could substantially reduce the time and cost of clinical trials by providing objective, quantifiable measures of drug effects on brain function. The study's success with MIJ821 could position BNA™ as an essential tool for developing next-generation neuropsychiatric drugs, potentially creating a new revenue stream through pharmaceutical partnerships.
The MDD study's findings are equally impactful, showing BNA™'s ability to objectively measure cognitive improvements in depression treatment. This addresses a critical gap in psychiatric care, where treatment outcomes are typically assessed through subjective measures. The technology's ability to provide quantifiable metrics could:
- Accelerate insurance approvals for treatments by providing objective evidence of efficacy
- Enable more precise drug dosing and treatment optimization
- Create opportunities for value-based care models in psychiatry
- Reduce healthcare costs by improving treatment efficiency
The market implications are substantial. With the global neurology devices market projected to grow significantly, Firefly's positioning in both drug development and clinical care creates multiple revenue opportunities. The collaboration with Novartis, a major pharmaceutical company, validates the technology's commercial potential and could lead to additional partnerships.
However, investors should note that widespread adoption will depend on factors such as insurance coverage, clinical workflow integration and continued validation through peer-reviewed studies. The company's small market cap of
Growing body of clinical evidence supports use of Company’s FDA-Cleared BNA™ platform to provide objective measures of drug efficacy and cognitive change, driving innovation in brain health
Company highlights its potentially transformative role in Neuropharmacology and Psychiatry with two groundbreaking publications
KENMORE, N.Y., Jan. 24, 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 two impactful studies that demonstrate the utility of advanced Resting Electroencephalograms (EEG) and Cognitive EEG (ERP) data analytics in drug development and neuropsychiatric care.
As illustrated by the two studies, Firefly’s BNA™ system can uniquely provide objective measures of treatment efficacy and cognitive change:
Study 1: Advancing Neuropharmacology with Novartis’ MIJ821
The first paper, entitled "MIJ821 (onfasprodil) in healthy volunteers: First-in-human, randomized, placebo-controlled study (single ascending dose and repeated intravenous dose)," conducted by Novartis, explores the safety, pharmacokinetics, and pharmacodynamics of MIJ821. EEG was essential in assessing the drug’s ketamine-like antidepressant effects on the brain.
Key findings include:
- Dose-Dependent EEG Changes: Administration of MIJ821 showed clear trends linking post-dose resting EEG activity to dosage, supporting its role as a distal target engagement biomarker.
- Validation of EEG as a PK–PD Tool: EEG revealed changes consistent with ketamine’s known effects, including increased gamma power and decreased alpha power, potentially reflecting enhanced cognitive processing and sensory integration.
- Clinical Potential: These insights pave the way for EEG-driven biomarker development, improving drug dose selection and patient-specific treatment strategies.
Study 2: Objective Cognitive Assessments in Major Depressive Disorder (MDD) Treatment
The second paper, entitled "Evaluating an EEG-based tool for assessing acute clinical and cognitive changes in adult outpatients with MDD treated with open-label, flexible-dose vortioxetine: A pilot study," highlights the application of EEG in monitoring cognitive changes during treatment for MDD.
Key findings include:
- BNA™ Metrics as Cognitive Biomarkers: Baseline brain activation latencies, as measured through Firefly’s BNA™ technology, were longer in MDD patients compared to controls, but normalized post-treatment, reflecting improved cognitive functioning independent of antidepressant effects.
- Personalized Psychiatry: Firefly’s BNA™ pipeline for automatic EEG analysis offers a scalable solution for evaluating treatment efficacy, addressing both cognitive and emotional health in MDD patients.
“We are proud to be at the forefront of EEG innovation, and these studies exemplify how our proprietary technology can transform complex brain data into actionable insights for clinicians and researchers alike,” said Greg Lipschitz, Executive Chairman of Firefly.
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
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