Firefly Neuroscience To Participate In The 8Th Annual Florida Capital Event

NEW YORK AND VANCOUVER, British Columbia, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (Bright Minds or the Company) (NASDAQ: DRUG), a biotechnology company focused on developing novel therapies for neurological and neuropsychiatric disorders, today announced that it is once again collaborating with Firefly Neuroscience, Inc. (Firefly) (NASDAQ: AIFF), an Artificial Intelligence (AI) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, to provide a full analysis of the electroencephalogram (EEG) data in the Company’s BREAKTHROUGH study, an open-label Phase 2 clinical trial evaluating the safety, tolerability, and efficacy of BMB-101, a highly selective 5-HT_2C receptor agonist, in adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).

Bright Minds and Firefly have previously collaborated successfully to analyze the data of the Company’s first-in-human Phase 1 study of BMB-101 using Firefly’s advanced artificial intelligence, FDA-cleared BNA™ technology platform.

The BREAKTHROUGH study is designed as a basket clinical trial that will include patients diagnosed with either Absence Epilepsy (with or without Eyelid Myoclonia) or DEE. This group of disorders consists of a range of rare epilepsy disorders, including Epilepsy with Eyelid Myoclonia (known as Jeavons Syndrome). These conditions are characterized by refractory seizures that are often resistant to current treatments. The BREAKTHROUGH study is targeting enrollment of 20 adult participants aged from 18 to 65 years old.

“After successful use of the BNA platform to analyze the data from our Phase 1 study, we look forward to once again collaborating with the Firefly team at the conclusion of our Phase 2 program for our lead compound, BMB-101, to provide valuable insights into the EEG recordings during the study,” said Ian McDonald, Chief Executive Officer of Bright Minds Biosciences. “We believe BMB-101 has the potential to be a best-in-class 5-HT_2C agonist. This compound is not only poised to make a significant impact in both the DEE and Absence Epilepsy communities, but also has broad applicability across the 30% of all epilepsy patients who experience drug resistance.”  About BMB-101BMB-101 is a novel scaffold 5-HT_2C Gq-protein biased agonist developed using structure-based drug design. It was explicitly designed for chronic treatment of neurological disorders where tolerance and drug resistance are common issues. Biased agonism at the 5-HT_2C receptor is one of its key features and adds another layer of functional selectivity within a well-validated target. BMB-101 works exclusively via the Gq-protein signaling pathway and avoids beta-arrest in activation, which is crucial to minimize the risk of receptor desensitization and tolerance development. This provides a novel mechanism, anti-epileptic drug designed to provide sustained seizure relief in hard-to-treat patient populations. In preclinical studies, BMB-101 has demonstrated efficacy in animal models of Dravet Syndrome and numerous models of generalized seizures.

In Phase 1 clinical studies, BMB-101 was given to 64 healthy volunteers in a Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and food-effects study. BMB-101 was demonstrated to be safe and well tolerated at all doses. No Serious Adverse Events (SAEs) were observed, and Adverse Events (AEs) were mild in nature and in line with on-target effects for serotonergic drugs.

An extensive target-engagement study was conducted using both fluid biomarkers (transient prolactin release) and physical biomarkers (Quantitative Electroencephalogram, qEEG). Both methods confirmed robust central target engagement. A qEEG signature typical for anti-epileptic drugs was observed, with a selective depression of EEG power at frequencies observed during epileptic seizures. Furthermore, a potentiation of frontal gamma-power was observed in this study which could indicate the potential for improved cognition.

About Bright Minds BiosciencesBright Minds Biosciences is a biotechnology company developing innovative treatments for patients with neurological and psychiatric disorders. Our pipeline includes novel compounds targeting key receptors in the brain to address conditions with high unmet medical need, including epilepsy, depression, and other CNS disorders. Bright Minds is focused on delivering breakthrough therapies that can transform patients’ lives.

Bright Minds Biosciences has developed a unique platform of highly selective serotonergic agonists exhibiting selectivity at different serotonergic receptors. This has provided a rich portfolio of NCE programs within neurology and psychiatry.

About FireflyFirefly (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 StatementsThis news release contains “forward-looking information”. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements in this news release include design, progress, and completion of the BREAKTHROUGHStudy, future clinical development of BMB-101, and future intended use or therapeutic benefit of BMB-101 to treat refractory epilepsy disorders.  A variety of factors, including known and unknown risks, many of which are beyond our control, could cause actual results to differ materially from the forward-looking information in this news release. These factors include the company’s financial position and operational runway, regulatory risk to operating in the pharmaceutical industry, and inaccuracies related to the assumption made by management relating to general availability of resources required to operate the studies noted in this news release. Additional risk factors can also be found in the Company’s public filings under the Company’s SEDAR+ profile at www.sedarplus.ca. Forward-looking statements contained herein are made as of the date of this news release and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances, management’s estimates or opinions should change, except as required by securities legislation. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements.

The Canadian Securities Exchange has neither approved nor disapproved the information contained herein and does not accept responsibility for the adequacy or accuracy of this news release.

Contact InformationAlex VasilkevichChief Operating OfficerBright Minds Biosciences Inc.Phone: (414)7316422Email: alex@brightmindsbio.comWebsite: www.brightmindsbio.com

Investor RelationsLisa M. WilsonT: 212-452-2793E: lwilson@insitecony.com

TORONTO, Oct. 16, 2024 (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, today announced collaborating with Bright Minds Biosciences Inc. (CSE:DRUG) (NASDAQ:DRUG) (“Bright Minds” or the “Company”), a biotechnology company focused on developing novel drugs for the targeted treatment of neuropsychiatric disorders and refractory epilepsy, to analyze the data from its first-in-human Phase 1 study of its lead compound, BMB-101.

The study demonstrated positive results of the qEEG (Quantitative Electroencephalogram) data. During the EEG recording, subjects were seated with a U.S. Food and Drug Administration (FDA)- approved 19 electrode EEG headset provided by Firefly strategic partner, Zeto™ Inc. Channels were sampled at 250 or 500 Hz and referenced to A1/A2 channels (linked-ears reference) during recording. The EEG recording time was 10 minutes (~5 minutes resting with eyes closed and ~5 minutes resting with eyes open). There were four EEG recording timepoints: day 1 pre-dose (immediately before dosing) and post-dose (1h after dosing), and day 7 pre-dose and post-dose. Data was analyzed using the FireFly Neuroscience advanced EEG analysis platform.

“Our artificial intelligence platform has tremendous value for the advancement and insight of clinical studies,” said Jon Olsen, CEO of Firefly. “We are pleased to have successfully collaborated with Bright Minds to analyze the data of their phase 1 study and look forward to working closely with their team once again as well as other leading biotechnology companies.”

“The positive topline findings from our recently completed Phase 1 study of BMB-101, together with the observations from the qEEG portion of the study, validate our approach, as we continue to evaluate this important product candidate. BMB-101 is clearly [getting into the brain/achieving brain penetration] and activating the target receptors as we had predicted, setting us up for potential success in a number of indications that have been validated with the 5-HT_2C mechanism. With this study complete, BMB-101 is now a Phase 2 ready asset, and we intend to move forward with an investigative new drug submission immediately,” stated Ian McDonald, CEO of Bright Minds.

About FireflyFirefly (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.

About BMB-101BMB-101, a highly selective 5-HT_2C, Gq-protein biased agonist, has demonstrated compelling activity in a host of in vitro and in vivo nonclinical tests. Compared to Lorcaserin, BMB-101 exhibits strong Gq biased signaling, coupled with minimal beta-arrestin recruitment. Bright Minds believes that G-protein biased signaling translates to better tolerance profile for this second-generation 5-HT_2C agonist, making BMB-101 a best-in-class 5-HT_2C agonist. Mechanistically, Serotonin (5-Hydroxytryptamine, 5-HT) is a monoamine neurotransmitter widely expressed in the central nervous system, and drugs modulating 5-HT have made a major impact in mental health disorders. Central 5-HT systems have long been associated with the control of ingestive behaviors and the modulation of the behavioral effects of psychostimulants, opioids, alcohol, and nicotine. Results of clinical trials and animal studies indicate that 5-HT_2C receptor agonists may have therapeutic potential in the treatment of addiction by decreasing the intake of opioids as well as impulsive behavior that can escalate compulsive drug use. BMB-101 is a new chemical entity (NCE) and constitutes a novel scaffold 5-HT_2C agonist.

5-HT_2C agonism is a well proven anticonvulsant mechanism. In translational animal models, BMB-101 demonstrated a significant reduction in both the number and intensity of epileptic seizures and is a promising candidate for the treatment of Dravet Syndrome and other epilepsies. The Phase 1 trial (NCT 05397041) has been completed and BMB-101 is now Phase 2 ready.

About Bright MindsBright Minds is focused on developing novel transformative treatments for neuropsychiatric disorders, epilepsy, and pain. Bright Minds has a portfolio of next-generation serotonin agonists designed to target neurocircuit abnormalities that are responsible for difficult to treat disorders such as treatment resistant epilepsy, treatment resistant depression, PTSD, and pain. The Company leverages its world-class scientific and drug development expertise to bring forward the next generation of safe and efficacious drugs. Bright Minds’ drugs have been designed to potentially retain the powerful therapeutic aspects of psychedelic and other serotonergic compounds, while minimizing the side effects, thereby creating superior drugs to first-generation compounds, such as fenfluramine, psilocybin, LSD, and ibogaine.

Forward-Looking StatementsCertain statements in this press release and the information incorporated herein by reference 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 expenses associated with the Merger and other events 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 business combination; 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 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.

Firefly Neuroscience Investor ContactsKCSA Strategic CommunicationsValter Pinto / Jack Perkins(212) 896-1254Firefly@KCSA.com

Firefly Neuroscience Media ContactKCSA Strategic CommunicationsRaquel Cona, Vice President(516) 779-2630Rcona@KCSA.com

TORONTO, Oct. 15, 2024 (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, today announced that its FDA-510(k) cleared Brain Network Analytics (BNA™) biomarker discovery AI platform will be used to support Arrivo Bioventures’ (“Arrivo”) Phase 1 exploratory study of its first-in-class SIRT6 activator, SP-624, in healthy volunteers and patients with major depressive disorder (MDD).

The study, which has enrolled its first subject, is designed to evaluate the impact of the epigenetic mechanism of action of SP-624 on neurological pathways and assess changes in various cognitive domains. SP-624 is also currently being studied in a large Phase 2b study in patients diagnosed with MDD, with efficacy in females as the primary endpoint.

“We believe that utilizing Firefly’s BNA™ technology in the SP-624 study will help Arrivo better understand SP-624’s activity and uncover critical biomarkers that may inform future research across neurological conditions,” said Jon Olsen, CEO of Firefly. “Together with Arrivo, this study underscores our shared commitment to advancing targeted treatments for women with major depressive disorder, which continues to be an unmet medical need in mental health.”

In an earlier Phase 2 study of SP-624, Arrivo explored efficacy over placebo during a four week treatment period. In a post-hoc analysis, the company found statistically significant improvement versus placebo consistent across both investigator and patient measures of MDD in female subjects, which was achieved as early as week 2. In male subjects, there were no statistically significant changes detected. While differences in MDD between males and females have long been discussed, these results support recent published literature citing differences in gene expression between males and females with MDD. Using Firefly’s BNA^™ technology, Arrivo will also identify target engagement and biomarkers in the Phase 1 study that can be used in future studies across a variety of neurological conditions, including MDD.

“There is a growing body of literature suggesting that targeting SIRT6 can play an important role in multiple neuropsychiatric, neurodegenerative, inflammatory, and metabolic diseases,” said Steve Butts, CEO of Arrivo. “This study should help us in our ongoing efforts to characterize the activity of SP-624 and look for potential biomarkers.”

The Phase 1, single-center, double-blind, randomized, placebo-controlled study is being conducted at Alivation Research with Walt Duffy, M.D., founder, CEO and Chief Medical Officer, as the Principal Investigator.

About FireflyFirefly (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.

About Arrivo BioVentures Arrivo BioVentures is propelled forward by its insatiable curiosity and drive to solve complex problems and help millions of patients globally. Working in partnership with investors, innovators, and pharmaceutical companies, Arrivo is always seeking solutions for unmet medical needs. Arrivo has a portfolio of diverse drug candidates with the potential to be first-in-class or best-in-class. Arrivo is based in Morrisville, N.C., on the edge of Research Triangle Park. For more information, visit www.arrivobio.com.

Forward-Looking StatementsCertain statements in this press release and the information incorporated herein by reference 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 expenses associated with the Merger and other events 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 business combination; 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 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.

Arrivo Bio Media ContactICR HealthcareAlexis Feinberg, Vice PresidentAlexis.feinberg@westwicke.com

Firefly Neuroscience Investor ContactsKCSA Strategic CommunicationsValter Pinto / Jack Perkins(212) 896-1254Firefly@KCSA.com

Firefly Neuroscience Media ContactKCSA Strategic CommunicationsRaquel Cona, Vice President(516) 779-2630Rcona@KCSA.com

TORONTO, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly,” “we,” 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, today announced a strategic partnership with Zeto, Inc. (“Zeto”), a leading innovator in EEG brain monitoring technology. Under the agreement, Firefly will act as a non-exclusive distributor of Zeto’s FDA-cleared EEG headset devices, cloud platform and services, expanding Firefly’s accessibility to healthcare providers and institutions. This collaboration will also integrate Firefly’s proprietary Brain Network Analytics (BNA™) technology with Zeto’s advanced EEG platform, which is currently being used in more than 200 hospitals and neurology offices across the country.

"This collaboration of two progressive technology companies represents a major step forward in addressing an unmet medical need in brain health," said Jon Olsen, CEO of Firefly. "By combining Zeto’s innovative hardware with our proprietary BNA™ technology, this partnership will offer healthcare providers deeper insights into neurological conditions that will ultimately improve patient outcomes.”

Zeto’s EEG headsets - WR19 and Zeto ONE - are FDA-cleared, full-montage, and easy to use, making brain monitoring accessible across various clinical settings, including the ICU, ED, hospital, office, and home. Supported by a robust cloud-based platform, Zeto offers nationwide monitoring and interpretation services by neurologists, along with AI-powered seizure detection and video capabilities. As part of the distribution agreement, Firefly will offer Zeto’s devices and cloud services to its customers, allowing healthcare professionals to access, analyze, and store EEG data in real-time. The integration with Firefly’s BNA™ platform enables more precise analysis and expanded use of EEG technology, optimizing diagnostics for a wide range of neurological disorders.

Zeto’s Founder and CEO, Aswin Gunasekar, stated, “We are excited to partner with Firefly to offer customers more valuable tools, helping expand our user base and improving the value of EEG. By integrating Firefly’s BNA™ offering with Zeto’s EEG platform, we are able to advance our mission of positively impacting patients' lives through transformative, user-friendly, and best-in-class solutions.”

For more information on this partnership and the services offered, please visit: https://fireflyneuro.com/.

About FireflyFirefly (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.

About Zeto, Inc.Zeto, Inc., an award-winning medical technology firm, is at the forefront of advancing EEG brain monitoring and diagnostics for healthcare. Offering wearable devices, Zeto makes brain monitoring accessible across various clinical settings including the ICU, ED, hospital, office, and home. Supported by a feature-rich cloud-based platform, Zeto provides nationwide monitoring and interpretation services rendered by neurologists, alongside AI-enabled detection for conditions such as seizures and epilepsy. Zeto plans to expand its capabilities in the future to recognize and manage conditions such as depression and traumatic brain injury. 

Forward-Looking StatementsCertain statements in this press release and the information incorporated herein by reference 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 expenses associated with the Merger and other events 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 business combination; 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 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 ContactKCSA Strategic CommunicationsValter Pinto or Jack Perkins(212) 896-1254Firefly@KCSA.com

Media ContactKCSA Strategic CommunicationsRaquel Cona, Vice President(516) 779-2630Rcona@KCSA.com