Neuraxis, Inc. IAccess Alpha Virtual Best Ideas Fall Investment Conference 2026

Thank you. My name is Brian Carrico, CEO of NeurAxis. I appreciate everyone joining today. As the host mentioned, we are NeurAxis. We have been public since August of 2023, so just over three years. I look forward to presenting today for about 20 minutes and opening it up for questions for the last 10 minutes. Who are we? For those of you who are new, and I hope many on the call are new, we are a first-to-market growth stage med tech company. We are focused on neuromodulation therapies for chronic and debilitating conditions in GI, specifically from disorders of the gut-brain interaction in pediatrics and adults. From a corporate standpoint, we secured a Category I CPT code for the PENFS technology. We obtained significant expanded commercial payer coverage, and we have the only FDA-approved or FDA-cleared treatment recommended in the academic society guidelines.

For those who invest in med tech, you understand or likely understand that in order to scale a medical technology, you need a Category I CPT code, which was awarded just about a year and a half ago and took effect in January of 2026. That is the foundation of this company. We built this company on discipline and execution with a strong foundation in evidence. Our evidence is extremely strong at this point, which is why we have the insurance policy coverage we do and why we were awarded the Category I CPT code. We now have over 100 million covered lives. Our first half 2025 revenue was $1.8 million. 2026 was almost double that, $3.5 million. Gross margins went from 84% in the first half of 2025 to 86% in the first half of 2026.

From a pipeline standpoint, we are currently focused on what we have in hand, which is the pediatric and adult version of functional abdominal pain and IBS, and functional dyspepsia and nausea. We are highly focused in the pediatric space today because that is where our insurance policy coverage is. As we announced on our last earnings call, we are expanding into the VA due to an FSS contract. From an adult standpoint, we are not in the private side. We are working through an RCT, a multi-site RCT. That will be six centers. Cleveland Clinic, IU, Hoag, Stanford, Louisville, Marshall are the six centers that are doing the adult RCT. The focus is primarily on the pediatric side, where we have significant insurance policy coverage. In the adult section of the VA, where we have an FSS contract, we are just entering that space today.

From a total available market, serviceable available market, we have got about a $22 billion serviceable available market. Almost two-thirds of that is in the adult space, which as I mentioned, is primarily in the research stage. About $8 billion of that is in the pediatric opportunity, which we will highlight today from a research and execution commercialization standpoint. What are we treating today? First of all, DGBI is what we are treating, and this today is a problem with an unmet need. There are no FDA-approved therapies for children or adults with functional dyspepsia outside of our technology, and only one peripherally acting drug approved for pediatric IBS, which as a general rule, doesn't compete with our technology. These disorders negatively affect impact, quality of life, and the ability to function. This means kids going to school, playing sports, social activities, et cetera.

There is essentially no data to support the use of the most prescribed drugs. In addition to that, most of these have serious side effects, and a growing number of families are seeking non-pharmacologic alternatives for children. What is the technology look like? This is our current device today. We are in the process of redesigning the device. We expect that out in early 2027. It will look more like an Apple product. From a growth margin standpoint, this device you are looking at here is $1,200. Each patient gets four devices over four weeks. Each device runs for 5 days. The patient throws it away. The patient comes back 2 days later and gets a second device, and that process continues for four weeks, and that is where the four devices comes in. Each one is $1,200, so that is $4,800 to the company when this is approved by insurance.

Why have we been so successful? For starters, the foundation of this company has been research. We have 21 technology and NeurAxis-related studies. We have done 10 different types of research, and we have done all investigator-initiated research. We have run very lean. We have been extremely disciplined. We have executed. We have done exactly what we said we would do, sooner than we said we would do it. At this point, with these 21 studies, all investigator-initiated research at these 13 children's hospital sites with 10 different types of studies, that research has allowed us to gain significant insurance policy coverage with significant more insurance policy coverage expected in the next 6 to 9 months. We have said for years that strong data equals strong policy coverage and reimbursement, equals strong revenue growth. We are starting to see that across the board throughout the country. How does the technology work?

Well, this technology gives us, through needles, this is not a transcutaneous device or transmagnetic device. This is a device that has four needles. This device breaks the skin around the auricular. We target cranial nerves 5, 7, 9, and 10, the vagus nerve. This gives us direct access to the central nervous system through these peripheral cranial nerves. Then we're stimulating a part of the brain called the amygdala, and that allows us to induce changes in the brain pathway and connectivity long term. I mentioned earlier that data does not support the standard pharmacotherapy. For 50 years, these children show up, and they get amitriptyline, SSRIs, TCAs. You can see here, these drugs, first of all, don't have data. They did not beat placebo. None of these drugs will beat placebo.

They cause an increased risk of suicidal ideation, mood changes, weight gain, long-term risk of dementia, and much more. That's why they have FDA black box labels. This is why we have such strong support from the academic society, both pediatric and adult. This is the growing body of clinical evidence. We've talked about this a little bit, but ultimately, we want to look at the fact that we had a landmark RCT to begin to kick this off in 2017, and that allowed us in 2019 to get the FDA indication, our first indication. You can see here the improvement of global symptoms. Pain is important, but the improvement in global symptoms is critical. This study, this RCT, was published in The Lancet. Another slide here, number needed to treat.

When you look at drugs, IBS drugs in adults, the number needed to treat is the number of patients that need to be treated for one patient to get the targeted improvement of at least or greater than 30%. The IB-Stim number needed to treat is 3. IBS drugs in adults, the number needed to treat ranges from 6 to 14. So you can see the superiority here in the data, which again, why we have such strong support from physicians, families, insurance companies, et cetera. Functional disability scores. In order to move a patient from moderate disability to minimal disability requires a one half point. We moved patients 2 full points or 4 levels, which is pretty remarkable in the randomized controlled trial. We did the largest pediatric registry in children with DGBI. This was 300 patients at 7 centers throughout the country.

Sixty-one percent of these patients have failed at least 4 medications prior to treatment. These were real-world evidence. We took all comers. Unlike pharmaceutical trials and most trials that are sponsored, where they have significant inclusion/exclusion criteria, we took all comers. No exclusion criteria, and this showed sustained efficacy at 6 to 12 months. We went head-to-head with medications at Cincinnati Children's, where we were superior. Let's talk more about now that we've talked a little bit about the research, and you start to see the foundation and why this has been so successful, and why we expect additional insurance coverage in the coming months. The go-to-market strategy. We've got almost 30 medical policy coverage plans now. We have over 100 million covered lives, and the Category I CPT code that took effect January 1st has been effective for 2 reasons. Number one, it streamlines billing.

It cements the technology into healthcare. It brings RVUs. It brings 1.5 RVUs to the physician, and if they choose to bill an additional E&M with that, those are additional RVUs. But the RVUs of 1.5 to place this are very good, and physicians have been very pleased with this. But ultimately, this brings credibility, and it brings the technology into mainstream medicine. IP portfolio of 13 issued patents, 9 pending patents, runs through 2039. Medical advisory board, 6 of the leading pediatric gastroenterologists from around the country in Boston and Cincinnati, University of North Carolina, Yale University, and Nationwide Children's Hospital in Columbus. Again, we have strong academic society support from the Pediatric Gastroenterology Academic Society, all 3 adult academic societies, and the American Academy of Pediatrics, who, by the way, co-sponsored our Category I CPT code application.

Our management team that's been here really most of this team's been here since the beginning, except for our chief financial officer, who joined us almost 3 years ago. Our board of directors, Beth Keyser, who's the president at Anthem, Bradley Mitch Watkins, who's got several commercial exits in med tech, Dr. Gil Aharon, who has his PhD. Dr. Aharon has been very successful in public med tech companies. To recap this, right now, the key investment highlights are very clear. We have an extremely large serviceable available market. We're first to market with an FDA De Novo clearance first to market. Category I CPT code, which is extremely difficult to gain, to get, but it's critical for success to mass scale a technology. When you're talking about $50, 100, $200 million in revenue expectation, this Category I code is critical. We have major insurance payer coverage momentum.