Firefly Neuroscience Presents Studies Supporting FDA-Cleared BNA Platform For Drug Efficacy And Cognitive Change In Neuropharmacology And Psychiatry; Highlights Role In Brain Health Innovation.

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.