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).
Mr. Olsen and David Johnson, Executive Chairman,
encourage stockholders to view this video message and investor
presentation regarding the global brain health problem today and
Firefly’s vision for the future.
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 CEOFirefly 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 FireflyFirefly (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.
Please visit https://fireflyneuro.com/ for more
information.
Forward-Looking Statements
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 ContactKCSA Strategic
CommunicationsValter Pinto or Jack Perkins (212)
896-1254firefly@kcsa.com
Media ContactKCSA Strategic
CommunicationsRaquel Cona, Vice President(516)
779-2630rcona@kcsa.com
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