Firefly Neuroscience CEO Issues Letter to Stockholders Following Closing of Merger and Listing on Nasdaq
Firefly Neuroscience (NASDAQ: AIFF) has completed its merger with WaveDancer and is now listed on Nasdaq. The company focuses on using AI to improve brain health outcomes through two key strategies:
1. Commercializing FDA-cleared Brain Network Analytics (BNA™) technology for neurologists in the US.
2. Partnering with CNS drug companies to advance new treatments for brain disorders.
BNA™ has shown promising results in patient care, reducing medication changes and improving recovery times. Firefly plans to make BNA™ commercially available to neurologists in 2025. The company has already partnered with Novartis, Takeda, and STALICLA SA, featuring in three publications in 2024. Firefly's proprietary database of over 17,000 patients across 12 disorders gives it a competitive advantage in developing clinical biomarkers.
Firefly Neuroscience (NASDAQ: AIFF) ha completato la sua fusione con WaveDancer ed è ora quotata al Nasdaq. L'azienda si concentra sull'utilizzo dell'IA per migliorare i risultati della salute cerebrale attraverso due strategie principali:
1. Commercializzazione della tecnologia Brain Network Analytics (BNA™) approvata dalla FDA per i neurologi negli Stati Uniti.
2. Collaborazione con aziende farmaceutiche specializzate nel CNS per sviluppare nuovi trattamenti per i disturbi cerebrali.
BNA™ ha mostrato risultati promettenti nella cura dei pazienti, riducendo i cambiamenti di terapia e migliorando i tempi di recupero. Firefly prevede di rendere BNA™ disponibile commercialmente per i neurologi entro il 2025. L'azienda ha già collaborato con Novartis, Takeda e STALICLA SA, con apparizioni in tre pubblicazioni nel 2024. Il database proprietario di Firefly, con oltre 17.000 pazienti affetti da 12 disturbi, le conferisce un vantaggio competitivo nello sviluppo di biomarcatori clinici.
Firefly Neuroscience (NASDAQ: AIFF) ha completado su fusión con WaveDancer y ahora está listada en Nasdaq. La empresa se enfoca en utilizar IA para mejorar los resultados de la salud cerebral a través de dos estrategias clave:
1. Comercialización de la tecnología de Análisis de Redes Cerebrales (BNA™) aprobada por la FDA para neurólogos en los EE. UU.
2. Colaboración con compañías farmacéuticas del SNC para desarrollar nuevos tratamientos para trastornos cerebrales.
BNA™ ha mostrado resultados prometedores en el cuidado de pacientes, reduciendo los cambios en la medicación y mejorando los tiempos de recuperación. Firefly planea hacer disponible comercialmente BNA™ para neurólogos en 2025. La empresa ya ha formado alianzas con Novartis, Takeda y STALICLA SA, destacando en tres publicaciones en 2024. La base de datos exclusiva de Firefly, que abarca más de 17,000 pacientes con 12 trastornos, le da una ventaja competitiva en el desarrollo de biomarcadores clínicos.
파이어플라이 신경과학 (NASDAQ: AIFF)은 웨이브댄서와의 합병을 완료하고 나스닥에 상장되었습니다. 이 회사는 뇌 건강 결과 개선을 위한 AI 활용에 중점을 두고 두 가지 주요 전략을 통해 운영됩니다:
1. 미국의 신경과 의사를 위한 FDA 승인 Brain Network Analytics (BNA™) 기술 상용화.
2. CNS 약물 회사와 협력하여 뇌 장애 치료법을 개발.
BNA™는 환자 치료에서 유망한 결과를 보여주었으며, 약물 변경을 줄이고 회복 시간을 개선하는 데 기여했습니다. 파이어플라이는 2025년까지 BNA™를 신경과 의사에게 상업적으로 제공할 계획입니다. 이 회사는 이미 Novartis, Takeda 및 STALICLA SA와 파트너십을 체결했으며, 2024년 3개의 출판물에 소개되었습니다. Firefly의 12가지 장애에 걸쳐 17,000명 이상의 환자로 구성된 독점 데이터베이스는 임상 바이오마커 개발에서 경쟁 우위를 제공합니다.
Firefly Neuroscience (NASDAQ: AIFF) a finalisé sa fusion avec WaveDancer et est désormais cotée au Nasdaq. L'entreprise se concentre sur l'utilisation de l'IA pour améliorer les résultats en matière de santé cérébrale à travers deux stratégies clés :
1. Commercialisation de la technologie d'Analyse des Réseaux Cérébraux (BNA™) approuvée par la FDA pour les neurologues aux États-Unis.
2. Partenariat avec des entreprises pharmaceutiques spécialisées dans le SNC pour faire avancer de nouveaux traitements contre les troubles cérébraux.
BNA™ a montré des résultats prometteurs dans les soins aux patients, réduisant les changements de médication et améliorant les délais de récupération. Firefly prévoit de rendre BNA™ disponible commercialement pour les neurologues en 2025. L'entreprise s'est déjà associé à Novartis, Takeda et STALICLA SA, apparaissant dans trois publications en 2024. La base de données propriétaire de Firefly, qui comprend plus de 17 000 patients concernés par 12 troubles, lui confère un avantage concurrentiel dans le développement de biomarqueurs cliniques.
Firefly Neuroscience (NASDAQ: AIFF) hat seine Fusion mit WaveDancer abgeschlossen und ist nun an der Nasdaq gelistet. Das Unternehmen konzentriert sich darauf, KI zur Verbesserung der Gehirngesundheitsergebnisse mittels zweier Hauptstrategien einzusetzen:
1. Kommerzialisierung der von der FDA zugelassenen Brain Network Analytics (BNA™) Technologie für Neurologen in den USA.
2. Partnerschaften mit CNS-Pharmaunternehmen zur Entwicklung neuer Behandlungen für Gehirnerkrankungen.
BNA™ hat vielversprechende Ergebnisse in der Patientenversorgung gezeigt, indem es Änderungen der Medikation reduzierte und die Genesungszeiten verbesserte. Firefly plant, BNA™ im Jahr 2025 kommerziell für Neurologen verfügbar zu machen. Das Unternehmen hat bereits Partnerschaften mit Novartis, Takeda und STALICLA SA geschlossen, die in drei Publikationen im Jahr 2024 vorgestellt werden. Fireflys proprietäre Datenbank von über 17.000 Patienten mit 12 Erkrankungen verschafft einen Wettbewerbsvorteil bei der Entwicklung klinischer Biomarker.
- Successful merger and Nasdaq listing, providing working capital for strategic objectives
- FDA-cleared Brain Network Analytics (BNA™) technology showing promising results in patient care
- Partnerships with major pharmaceutical companies like Novartis and Takeda
- Proprietary database of over 17,000 patients across 12 disorders
- Planned commercialization of BNA™ to neurologists in 2025
- BNA™ not yet commercially available, with launch planned for 2025
- Potential challenges in scaling commercialization and market adoption of new technology
Insights
Firefly's Brain Network Analytics (BNA™) technology represents a significant advancement in neuroscience diagnostics. The FDA clearance and planned commercialization in 2025 could potentially revolutionize how neurologists diagnose and treat brain disorders. The technology's ability to provide objective assessment of brain function addresses a critical need in the field.
The reported real-world results are promising: fewer medication changes, faster recovery and improved treatment compliance. These outcomes, if consistently replicated, could lead to improved patient care and reduced healthcare costs. However, it's important to see more extensive, peer-reviewed studies to fully validate these claims.
The company's partnerships with major pharmaceutical firms like Novartis and Takeda lend credibility to their technology and suggest potential for wider industry adoption. This could accelerate CNS drug development, potentially reducing costs and time to market for new treatments.
Firefly's recent merger and Nasdaq listing mark a significant milestone, potentially improving its financial position and market visibility. The injection of working capital is important for executing their strategic objectives, particularly the commercialization of BNA™ technology.
The company's dual-pronged strategy - commercializing BNA™ to neurologists and partnering with CNS drug companies - could create diverse revenue streams. If successful, this approach could lead to steady income from clinical use and potentially lucrative partnerships in drug development.
However, investors should note that commercialization is slated for 2025, indicating a period before potential revenue generation. The company's financial stability during this pre-revenue phase will be critical. Additionally, the CNS drug development market is highly competitive and Firefly's success will depend on continued validation of its technology and effective partnership strategies.
Firefly's AI-driven approach to brain health assessment is at the forefront of the convergence between technology and healthcare. The BNA™ technology, leveraging a proprietary database of over 17,000 patients across 12 disorders, represents a significant competitive advantage in developing clinical biomarkers.
The company's focus on data science and clinical research positions it well in the growing field of AI-assisted healthcare. The ability to provide objective, data-driven insights into brain function could be a game-changer for both clinical practice and drug development.
However, as with any AI-based healthcare solution, issues of data privacy, algorithm transparency and clinical validation will be crucial. The company's ability to navigate these challenges while scaling its technology will be key to its long-term success in this rapidly evolving sector.
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).
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
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
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 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
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