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Firefly Neuroscience Announces Publications Demonstrating the Utility of Advanced EEG Analytics in Drug Development and Neuropsychiatric Care By Investing.com
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 (LON:0QLR) (SIX:NOVN)' 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: 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: 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 (LON:NETW) 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.
[2]
Firefly Neuroscience Announces Publications Demonstrating the Utility of Advanced EEG Analytics in Drug Development and Neuropsychiatric Care - Firefly Neuroscience (NASDAQ:AIFF)
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") 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 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. 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 AIFFFirefly Neuroscience Inc$3.7214.5%WatchlistOverviewMarket News and Data brought to you by Benzinga APIs
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Firefly Neuroscience's FDA-cleared BNA™ platform, utilizing AI and machine learning, demonstrates significant potential in providing objective measures for drug efficacy and cognitive changes in neuropharmacology and psychiatry.
Firefly Neuroscience, Inc. (NASDAQ: AIFF), an AI-driven company focused on improving brain health outcomes, has announced two significant publications demonstrating the utility of their advanced EEG analytics in drug development and neuropsychiatric care 12. The company's FDA-cleared Brain Network Analytics (BNA™) platform is showing promise in providing objective measures of drug efficacy and cognitive change.
The first study, conducted in collaboration with Novartis, explored the use of EEG in assessing the effects of MIJ821, a potential antidepressant drug. Key findings include:
The second study focused on using EEG-based tools to assess cognitive changes in patients with Major Depressive Disorder (MDD) during treatment. Notable outcomes include:
Firefly's BNA™ technology leverages artificial intelligence and machine learning to analyze a proprietary database of over 17,000 patient EEGs across twelve disorders. This comprehensive approach allows for:
Firefly Neuroscience is now launching BNA™ commercially, targeting two primary markets:
Greg Lipschitz, Executive Chairman of Firefly, expressed pride in the company's position at the forefront of EEG innovation, emphasizing the technology's potential to transform complex brain data into actionable insights 2.
As Firefly Neuroscience continues to develop its AI-powered solutions, the company aims to revolutionize brain health diagnostics and treatment monitoring for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD 12.
Reference
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Firefly Neuroscience, an AI company focused on brain health solutions, has closed a financing deal of up to $12.4 million to support the commercialization of its FDA-cleared Brain Network Analytics technology.
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Firefly Neuroscience announces a breakthrough in assessing cognitive brain age using its FDA-cleared BNA™ technology, potentially revolutionizing early detection and monitoring of neurological disorders like Alzheimer's.
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Firefly Neuroscience, an AI company focused on brain health, announces an inducement grant to its Executive Chairman and discusses its innovative Brain Network Analytics technology.
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Firefly Neuroscience, an AI company specializing in brain health diagnostics, announces its participation in two major investor conferences in October 2024, highlighting its innovative Brain Network Analytics technology.
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Firefly Neuroscience, an AI company developing innovative brain health solutions, announces its participation in the 8th Annual Florida Capital Event. The company's FDA-cleared Brain Network Analytics technology aims to revolutionize diagnostics and treatment monitoring for neurological and mental disorders.
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