Spotlight 🔍 Firefly

Disseminated on behalf of Firefly Neuroscience Inc.

Firefly’s AI-Platform Decodes Brainwaves to Revolutionize Brain Health Care

• With an FDA-cleared proprietary database of over 77,000 brain images, Firefly is transforming health care with AI-driven diagnostics, providing a clear, data-backed understanding of brain health.
• After more than a decade and over $60 million in investment, Firefly is advancing the commercialization of its Brain Network Analytics (BNA™) platform, bringing the technology to clinicians and pharmaceutical partners.
• Firefly is enhancing the diagnosis and treatment of conditions such as depression, dementia, anxiety disorders, concussions, and ADHD, while also accelerating drug discovery and early screening for conditions, like Alzheimer’s.

“Very rarely do you get a public healthcare company with FDA clearance, a massive and growing database, published science, and commercialization underway. Usually, investors fund companies like ours to get FDA clearance. We’re already there.”
— Greg Lipschitz

When therapy and medications were not helping Heather overcome her anxiety and depression, the South Florida resident found herself slipping deeper into despair. Everyday tasks became overwhelming — simple routines like doing laundry or washing her hair felt impossible.

"I had tried so many things, therapy, medications, and I was getting really discouraged, because I really didn't think that there was anything out there that was going to work for me,” Heather recalls.

That was until she discovered Brain Network Analytics (BNA™), a breakthrough medical technology developed by Firefly Neuroscience Inc. (NASDAQ: AIFF), that was improving outcomes for patients with neurological and mental health disorders.

Unlike traditional therapy, which often relies on conversations with clinicians and trial-and-error with medications, Firefly’s platform provided real data on her brain’s activity, something she could see and understand.

The technology recorded Heather’s brain activity in real time, providing an objective analysis and revealing patterns that were linked to her anxiety and depression. This gave Heather a clear understanding that her struggles were not "all in her head" but had a neurological basis.

With this insight, doctors at the Delray Center for Integrative Medicine (DCIM) customized a treatment plan based on how Heather’s brain functioned, rather than a one-size-fits-all approach.

The BNA™ platform also helped track changes over time, showing Heather’s progress and reinforcing that the treatment plan was actually working.

“This has turned my life around. It made me into a person, back into a normal human being who has feelings, who has dreams again, who is not afraid of other people and just wants to live a happy, normal life," said Heather.

Dr. Raul Rodriguez, Medical Director at DCIM, stated that Firefly’s technology empowers patients like Heather to become more engaged and invested in their treatment plans while providing healthcare professionals with critical neurological insights.

Nearly 3,000 patients across the U.S. are now benefiting from Firefly’s AI-driven and machine-learning BNA™ platform, which has been in development for over a decade at a cost exceeding $60 million, according to Greg Lipschitz, the company’s Executive Chairman.

At the heart of this technology is Firefly’s proprietary database — the world’s most extensive collection of high-definition, standardized longitudinal electroencephalograms (EEGs), featuring data from more than 17,000 patients across twelve neurological and mental health disorders, alongside clinically normal patients.

This BNA™ database of over 77,000 brain images, when used in conjunction with an FDA-cleared EEG system, provides clinicians with a comprehensive view of brain function, aiding in the diagnosis and treatment of conditions such as depression, dementia, anxiety disorders, concussions, and ADHD.

“This isn’t a science project; it’s real, and it’s changing lives. We’ve helped patients who felt like they were ‘going crazy’ find the right treatment path and return to normal, healthy lives,” said Lipschitz.

“If you break a bone, you get an X-ray. If you might have cancer, you get an MRI. But if you have a neurological or mental health disorder, there’s no objective way to diagnose it, until now. We are bringing imaging into brain health,” he said.

Last month, the company highlighted two more studies, adding to the 19 scientific publications that validate and exemplify how Firefly’s proprietary technology can transform complex brain data into actionable insights for clinicians and researchers.

The company also announced advancements in research aimed at assessing brain age — an estimate of the biological age of a person's brain — using its BNA™ technology platform. This may pave the way for a proactive and scalable approach to early screening and monitoring of Alzheimer’s patients.

As Firefly advances toward commercializing its platform, the company is focusing on pharmaceutical firms involved in drug research and clinical trials, along with medical practitioners for clinical applications.

To accelerate growth and expand its capabilities, Firefly has established strategic partnerships with globally recognized pharmaceutical leaders, including Bright Minds Biosciences, Novartis, and Takeda.

It is also working with Arrivo BioVentures on the first potential treatment designed for women with major depressive disorder.

"We believe these collaborations will not only drive innovation in drug development but also enhance our ability to deliver impactful solutions to neurologists and psychiatrists," said Lipschitz.

A Top Pick at the 2025 AlphaNorth Capital Event

With the global mental health market projected to reach US$573 billion by 2033, Firefly’s AI-driven neurodiagnostic platform positions it as a standout investment opportunity, deemed the Investor Breakout Exchange at last month’s AlphaNorth Capital Event.

As a Top Pick at the event, investors said the company’s commercialization strategy demonstrates strong growth potential in the rapidly expanding market for AI-driven mental health solutions.

Stock Information NASDAQ: AIFF

1. As of market open on Wednesday February 5, 2025
2. As of market open on Tuesday January 21, 2025 after being selected as a Top Pick at the CEM AlphaNorth Capital Event

After Firefly was recognized as a Top Pick, I had the opportunity to speak with Greg Lipschitz, the company’s Executive Chairman, to get deeper insights into its growth strategy and technological advancements.

What sets Firefly apart from others in this market?

“In the world of AI, data quality is everything. What sets Firefly apart is its database of brain scans, which is the largest of its kind in the world. This gives our AI and machine learning platform a significant edge, ensuring the analyses are precise and insightful.

It’s one thing to build a platform but getting FDA clearance is a game-changer. Firefly’s journey has been more than 10 years in the making. We have used that time to perfect the AI-powered mapping of brain signals, which involves an enormous amount of computation. Now, the technology is FDA-cleared, making us one of the few companies in this field with this level of credibility and trust.

One of the most impressive things about Firefly is that we are transforming brain health care from subjective to objective.

In most areas of medicine, doctors rely on objective tests like X-rays or electrocardiograms to diagnose and treat conditions. But when it comes to neurological and brain health, that kind of objective measurement is still surprisingly rare. For example, psychiatric care often depends on subjective patient self-reporting, based on questions like, ‘How do you feel today?’

Having objective, quantifiable data is crucial and ensures more accurate diagnoses, consistent treatment plans, and ultimately, better patient outcomes. That’s why Firefly Brain Network Analytics is so important — it brings the same level of precision to brain health that other medical fields have been using for years."

What’s the scalability and growth potential of Firefly’s technology?

"Firefly’s growth potential is massive … we have a two-pronged business model that targets both clinics and pharmaceutical companies.

On the clinical side, we offer a Software as a Service (SaaS) model designed for psychiatrists, neurologists, and primary care physicians. What’s exciting about this is that each brain scan not only provides value to doctors and patients but also feeds into our AI-powered database, making it even richer and more powerful over time. The more scans we process, the smarter our system gets.

Then there’s the pharmaceutical side, where we’ve already licensed our database to major industry players like Takeda, Novartis, and Bright Minds; and we’re just getting started. Here’s an example of why that’s important: the average central nervous system (CNS) drug costs around $2 billion and takes about 12 years to develop. We believe our technology can cut both the time and cost in half. If we can help pharma companies save $300 million per drug, we expect to capture a significant share of that value, either through direct fees, equity deals, or becoming a companion diagnostic tool.

As for scalability, the numbers speak for themselves. In the U.S. alone, there are about 60,000 neurologists and psychiatrists, plus 300,000 primary care physicians. Even if we capture just 1,000 clinics at $1,000 per month, that translates to $1 million in monthly recurring revenue. And that’s just scratching the surface.”

Why is Firefly attracting investors?

“Very rarely do you get a public healthcare company with FDA clearance, a massive and growing database, published science, and commercialization underway. Usually, investors fund companies like ours to get FDA clearance. We’re already there.”

Our View

• A Game-Changer in Mental Health Diagnostics and Treatment: Firefly is revolutionizing brain health by bringing objective, AI-driven diagnostics to a field that has long relied on subjective assessments. With the largest proprietary brain scan database of its kind in the world, an FDA-cleared system, and clinical validation from over 19 scientific publications, Firefly is poised to set a new standard in neurological and psychiatric care.
• Strong Commercialization Strategy & Growth Potential: Firefly’s two-pillar business model — targeting both clinics and pharmaceutical companies — ensures long-term scalability. The Software-as-a-Service (SaaS) model addresses a potential U.S. market of 360,000 clinicians. Collaborations with pharma giants like Novartis, Takeda, and Bright Minds strengthen its position in drug development and clinical trials.
• Compelling Investment Opportunity in a Booming Market: With the global mental health and neurology markets projected to reach $573 billion and $8 billion by 2033, respectively, Firefly’s AI-driven BNA™ technology places it at the forefront of one of the fastest-growing healthcare sectors. Unlike many health-tech companies that require funding to achieve FDA approval, Firefly already has clearance, a proprietary database of brain wave tests, and an established set of real-world BNA™ applications. This makes it a rare and compelling investment opportunity in the AI-driven healthcare space.

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