Firefly Neuroscience highlights two studies supporting its BNA™ platform in evaluating drug efficacy and cognitive changes for brain health.
Quiver AI Summary
Firefly Neuroscience, Inc. has announced two significant studies supporting its BNA™ platform, which uses advanced EEG technology to enhance drug efficacy evaluations and cognitive assessments in neuropharmacology and psychiatry. The first study, conducted with Novartis on the drug MIJ821, illustrated that EEG can effectively measure treatment effects, including the identification of dose-dependent changes in brain activity. The second study focused on major depressive disorder, showing that Firefly's BNA™ metrics could serve as cognitive biomarkers that reflect treatment-induced improvements in brain function. Firefly emphasizes that its technology can help clinicians better assess and tailor treatments for patients with neurological and mental disorders, marking a transformative advancement in brain health analytics.
Potential Positives
- Growing clinical evidence supports Firefly's FDA-Cleared BNA™ platform, enhancing its reputation in brain health.
- Significant findings from studies demonstrate BNA™'s unique ability to provide objective measures of treatment efficacy, which could improve drug development.
- Firefly's strategic focus on personalized psychiatry positions it as a leader in addressing both cognitive and emotional health in patients with Major Depressive Disorder.
- Commercial launch of BNA™ targets pharmaceutical companies and medical practitioners, indicating potential for revenue growth and broader market adoption.
Potential Negatives
- Potentially significant risks are associated with the company's forward-looking statements, including uncertainties in the development and commercialization of their BNA™ technology and the impact of their merger with WaveDancer, which could materially affect performance.
- Firefly’s reliance on cutting-edge technology and AI raises concerns about the potential for unanticipated challenges in implementation, adoption, and validation in clinical settings.
- The press release emphasizes a pending merger and highlights many uncertainties related to financial resources and operational spending, which may undermine investor confidence.
FAQ
What is the BNA™ platform by Firefly Neuroscience?
The BNA™ platform is an FDA-cleared technology that provides objective measures of drug efficacy and cognitive changes using EEG analytics.
How does the BNA™ technology improve drug development?
BNA™ technology enhances drug development by offering insights into treatment efficacy and aiding in personalized patient treatment strategies through EEG data.
What clinical studies were highlighted in the press release?
The press release highlights two studies: one on Novartis' MIJ821 and another assessing cognitive changes in Major Depressive Disorder treatment.
What are the benefits of using EEG in neuropsychiatric care?
Using EEG in neuropsychiatric care can provide objective cognitive assessments, improve biomarker development, and support personalized treatment approaches.
How does Firefly Neuroscience contribute to brain health?
Firefly Neuroscience develops AI-driven solutions like BNA™ that enhance diagnosis and treatment monitoring for neurological and mental health disorders.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
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.
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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
[email protected]