AI Technology to Assist Clinicians to Drive Better Outcomes in Brain Health
TORONTO, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly,” “we,” or the “Company”) (NASDAQ: AIFF), an Artificial Intelligence (“AI”) technology company developing innovative neuroscientific solutions that improve outcomes for patients with mental illnesses and neurological disorders, today issued a letter to its stockholders from its Chief Executive Officer, Jon Olsen, following the closing of its merger transaction with WaveDancer, Inc. (NASDAQ: WAVD).
Dear Fellow Firefly Stockholders,
This week’s closing and the addition of working capital puts us in a position to execute on our strategic objectives. This is an extraordinary milestone for us and our stockholders. Firefly is focused on using AI to bring objective assessment of brain function to the front lines of healthcare. We are dedicated to improving outcomes for people suffering with brain health illnesses and disorders such as dementia and depression. The right diagnosis and treatment, the first time, is something that drives us forward at Firefly.
We plan to execute upon two key strategic pathways to support better outcomes. First, the commercialization of our FDA-cleared Brain Network Analytics (BNA™) technology to neurologists in the United States, and second, partnering with Central Nervous System (“CNS”) drug companies to advance the development of new treatments for people with brain health disorders and illnesses.
Firefly’s BNA™ arrives at a critical time to help clinicians looking for innovative technologies that can provide an objective understanding of how the brain is functioning. BNA™ reinforces precise and timely diagnosis, and the optimization of patient care pathways. In fact, real world use of BNA™ in the United States has shown that when BNA™ is part of a patient care plan, patients required fewer medication changes, recovered faster, and were more compliant with their treatment. 1 Based on these promising results, we are very excited to make BNA™ commercially available to neurologists in 2025.
Through our partnerships with CNS drug development companies, we have already been featured in three publications in 2024. These include partnerships with Novartis, Takeda, and STALICLA SA. We are very proud of these collaborations, and their findings provide the impetus for us to pursue other partnerships in the CNS drug development space. If BNA™ is integrated into the clinical strategy, we believe that the cost of CNS drug development can be dramatically reduced, can help de-risk critical decision making, and potentially expedite time to approval.
We believe that Firefly’s distinct advantage lies in our expertise in data science and clinical research. For example, our FDA-cleared age-matched normalized database is part of a standardized proprietary database of over 17,000 patients across 12 disorders and illnesses. We believe our database and proprietary technology gives us a strong competitive advantage in developing clinical biomarkers to help fundamentally change how clinicians manage their patients. We ascribe great importance to the value initial accurate diagnosis and effective treatment play in a patient’s overall treatment plan. Furthermore, being in the advantageous position to commercialize BNA™ supports product development as our database grows with every BNA™ assessment, further establishing our leadership position in the CNS space.
In closing, I want to extend my appreciation for the hard work and passion exhibited by the entire Firefly team, and I would like to thank our stockholders for their patience and belief in our vision. Without your commitment and support, none of this would have been possible. Today our team is very well positioned to continue its commitment to improving patients’ lives. Your trust and confidence in Firefly have helped us build the remarkable company we have become, and one whose future has never been brighter.
Sincerely, Jon Olsen CEO Firefly Neuroscience, Inc.
1 Findings presented in 2023 white paper study “Brain Network Analytics (BNA(TM)) in the Psychiatric Practice: Real-Life Data Analysis” by Charlotte Baumeister, Ph.D.
About Firefly Firefly (Nasdaq: AIFF) is an Artificial Intelligence (“AI”) technology company dedicated to developing groundbreaking neuroscientific solutions that enhance outcomes for patients with mental illnesses and neurological disorders. Firefly’s FDA-510(k) cleared Brain Network Analytics (BNA) platform revolutionizes diagnostic and treatment methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has invested approximately $60 million in developing its BNA platform, building a comprehensive database of brain wave tests, securing patent protection, and achieving FDA approval. The Company is now launching the BNA platform commercially, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as medical practitioners for clinical use.
The BNA platform is a software as a medical solution (SAMS) that 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. The BNA platform, in conjunction with an FDA-cleared EEG system, can provide clinicians with comprehensive insights into brain function (cognition). These insights can enhance a clinician’s ability to accurately diagnose mental illnesses and cognitive disorders and to evaluate what therapy and/or drug is best suited to optimize a patient’s outcome.
Certain statements in this press release and the information incorporated herein by reference may constitute “forward-looking statements” within the meaning of the federal securities laws. These forward-looking statements include express or implied statements relating to Firefly’s 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 Firefly’s continued listing on the Nasdaq Capital Market; the outcome of any legal proceedings that may be instituted against Firefly or any of its respective directors or officers; the ability of Firefly to protect its intellectual property rights; 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, Inc. with the SEC on January 22, 2024, as amended, and declared effective by the Securities Exchange Commission (the “SEC”) on February 2, 2024, as well as discussions of potential risks, uncertainties, and other important factors included in later filings, including any Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. 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 undertakes 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 Contact KCSA Strategic Communications Valter Pinto or Jack Perkins (212) 896-1254 firefly@kcsa.com
Media Contact KCSA Strategic Communications Raquel Cona, Vice President (516) 779-2630 rcona@kcsa.com
