Hello, everyone, and thank you all for joining us during the Lytham Partners Fall 2026 Investor Conference. My name is Ben Shamsian , Vice President of Lytham Partners. Today, Brian Carrico , CEO of NeurAxis, will be taking us through a brief slide presentation. NeurAxis trades under the ticker NRXS. Let's get started. Brian, welcome, and I'll turn the floor over to you for your presentation.
Thank you, Ben. Welcome to those who are new to the NeurAxis story and to those who've been following the story since the IPO several years ago. Who are we? NeurAxis is a first-to-market growth stage med tech company. We're focused on neuromodulation therapies for chronic and debilitating conditions in GI, specifically disorders of the gut-brain interaction in pediatrics, and now adults. We've always been a pediatric company. We're a pediatric company first, but we are transitioning into the adult space, which we'll talk about today. From a corporate overview standpoint, for those who follow med tech, you understand how critical it is to have a Category I CPT code. This is a seven or eight-year venture for a company that's first to market. We secured our Category I CPT code effective January 1, 2026, so we're about eight and nine months into that Category I CPT code.
We just recently had a large announcement around new insurance policy coverage with Cigna that added about 18 million covered lives, which took us following the Anthem announcement late last year, early this year. Anthem took us to about 100 million, and then Cigna took us to. We had some other small victories in there that took us to 120 million covered lives. This obviously translates to revenue. The Anthem, and the Category I CPT code translated to revenue. 2025 first half was $1.8 million. 2026 first half was $3.5 million. Gross margins from 2025 first half to 2026 increased from 84%- 86%. I expect as we continue to gain more insurance policy coverage in the coming months and quarters, that that gross margin continues to tick up a little bit. What indications do we have in the market today?
As I mentioned earlier, we are a pediatric company first. We had functional abdominal pain and functional dyspepsia and nausea in patients 8- 21 in children. Late last year, we were able to do a reverse extrapolation or an extrapolation, however you look at it, with the FDA, and that took us into the adult space. Now we have these indications for eight and over for both of these indications, abdominal pain and IBS, functional dyspepsia, and nausea. The important part around those indications are that 8- 21 years of age is where all of our insurance coverage lies, and over 21 years of age, we have no insurance policy coverage as a general rule because we've not done any adult-specific studies.
To combat that and to gain insurance policy coverage there, we just began what was started as an RCT double-blind placebo-controlled trial at the Cleveland Clinic. That's now turned into a multi-site RCT, which will be Cleveland Clinic, Stanford, Hoag, IU, Louisville, and Marshall. That will kick off this fall, and that will be a 350 to 400-patient RCT. The final point I would make about the adult space is we do have a Federal Supply Schedule with the Veterans Administration, VA hospitals. As I mentioned on our last earnings call, we just hired 10 or 12 1099 reps to sell IB-Stim in the VA for adults. What are some highlights about the company? First, I've always told investors we've been very disciplined when it comes to strong data.
We built this company on a foundation of data, and that strong data turns into strong policy coverage and reimbursement, and that turns into strong revenue growth. We've got a very large global market opportunity, with a significant unmet need. We have a clear commercial pathway as we were first to market through the FDA De Novo clearance. We now have a Category I technology-specific Category I CPT code, major insurance policy coverage in place, a unique innovative product. We have the highest grade evidence via the academic society guidelines, and we're now around 1,000 published patients. Our seasoned management board, which we have an exciting announcement about today, we just hired a Chief Commercial Officer.
We announced that this morning through a PR, and he comes, and we'll talk more about him later, but he comes with the experience necessary to take this company where we expect it to go in the coming quarters and years. This is a quick slide on the total addressable market, which breaks down into the serviceable available market in the pediatric side and the adult side. Right now we've got about a $5 billion market opportunity in the pediatric side and about a $2 billion market opportunity in the adult side with the adult FAP private side insurance policy coverage pending the RCT. Again, back to we'll touch high- level on the data.
Disorders of the gut-brain interaction, this is what we're treating, functional dyspepsia, Irritable Bowel Syndrome, and then cyclic vomiting syndrome is also a pediatric gastroenterology call point, and that RCT is in play right now, and we'll find out late next year what that data looks like. DGBIs, this is what we're treating. This is a problem with an unmet need. For 50 years, these children have just simply received medications that are off-label. They have FDA black box warnings, and there have been no FDA-approved therapies for children or adults with functional dyspepsia and only one peripheral acting drug approved for pediatric IBS. These are disorders that are negatively affecting kids' quality of life. This means they're not going to school, or they're missing school. They're missing sports. They're missing social activities. There's insufficient data to support the use of most prescribed drugs.
Many of these, as I mentioned, with serious side effects. What is the technology look like? This is what our current technology looks like. We are in the process of redeveloping this to make it look more like, I would tell you, an Apple product. It is smaller. It looks nicer. This technology right now is $1,200, and each patient gets four. It is a $4,800 to our company, to NeurAxis, and then the children's hospital bills the insurance company, and then they are reimbursed based on their contract. This technology is placed on a Monday, for example, by a physician, a pediatric gastroenterologist, or a nurse practitioner, or a PA, and then that patient wears that device for five days. They would wear it until Saturday.
The patient would take that device off and throw it away, come back on Monday for a second device, and they do that for four weeks. After that, at that point, we have significant research showing long-term relief at 12 months with that technology. This slide sums up who we are. I have mentioned three times now, strong data equals strong policy coverage and reimbursement equals strong revenue growth. We have 21 PENFS technology and NeurAxis-related studies. We have done 10 different types of research at 13 children's hospital study sites. We have done every type of research that you could possibly do with this technology, including long-term research head-to-head against pharmaceuticals, which is, quote-unquote, "the standard of care," just because there has been no other option. How does this technology work? There are needles. This is not painful. There is no anesthetic. There is no anesthesia, no local anesthetic.
These needles break the skin around the auricular, and we target the cranial nerves V, VI, IX, and X, including the vagus nerve. This neuromodulation frequency stimulates and stimulation reduces the firing of the amygdala. This changes and induces changes in the brain pathways and connectivity, and this is how we get long-term relief. As I mentioned about the pharmaceuticals earlier, there is no data to support the use of antidepressants in children with functional abdominal pain. Amitriptyline is a common pharmaceutical that is used. It did not beat placebo. Citalopram did not beat placebo. These are TCAs, SSRIs. These drugs have an increased risk of suicidal ideation. They have black box warnings. They cause mood changes, weight gains, increased long-term risk of dementia.
No physician wants to give a teenage boy or teenage girl this medication unless they really have to, and parents certainly don't want their children taking these unless they really have to. This IB-Stim technology has been a welcome gain to the pediatric GI community. In the double-blind, placebo-controlled trial that was published in The Lancet, we had improvement in global symptoms in patients with Irritable Bowel Syndrome. You can see the PENFS versus the sham device here. In this slide, you can see what is called a number needed to treat. That is the number of patients that need to be treated for one patient to get the targeted improvement of greater than 30% improvement. IB-Stim number needed to treat is three. IBS drugs in adults, that ranges from 6- 14. You can clearly see the superiority here with the IB-Stim technology and data relative to the pharmaceuticals.
Functional disability scores at long-term follow-up, this was outstanding. We moved from moderate to minimal disability, which is not easy. You can move from moderate disability with one check mark or one section on a scale, and we moved four sections. This was not easy, but we also were very successful in this functional disability, which if you listen to the physicians, the disability improves before the pain. We need to get these patients functioning back to school, and then the pain improves. We also did the largest pediatric registry in children with DGBIs. You can see here we had a pediatric registry at seven centers, around 300 patients. This was real-world data. We took all comers. There were no inclusion/exclusion criteria. We took everyone.
You can see that 61% of patients had failed at least four medications prior to treatment, and we had sustained efficacy in abdominal pain 6-12 months after the treatment. We went head-to-head with the medications, as you can see here, and we could talk more about this in detail on a separate call. We went head-to-head against the, quote-unquote, "standard of care," and were successful. That's the data. What's the go-to-market strategy look like? Well, number one, I'll tell you, we have a W2 sales force, and that W2 sales force is significantly increasing. I said all along that as we would begin to gain more insurance policy coverage, we would turn around and in parallel increase the commercial footprint, the commercial leadership, which I touched on earlier, and I'll touch on it in a second.
W2 sales force, it's significantly expanding in areas where we have insurance policy coverage. You can see on this slide that we have now over 30 insurance medical policy coverage plans. We have over 120 million covered lives. The Category I code is in effect as of January 1st, and our list price is $1,195. Each patient gets four devices, as I mentioned earlier. IP portfolio, very strong, runs through 2039 as of now. We're in the process of lengthening that as well. Contract manufacturing is here in the States. Everything except the needles are sourced here in the U.S., manufactured in the United States, and we also, of course, have a backup manufacturing site in case of a natural disaster, and significant product on hand, 9-12 months of product at all time. Medical advisory board.
You can se e some of the leading children's hospitals are represented here in Boston, nationwide, Boston, Cincinnati, UNC, and Yale. This advisory board has been very helpful to us as we've progressed through this process. Our management team, this is a big announcement as of this morning. We now have added Craig Blanchard as our Chief Commercial Officer. We wanted to bring someone in here that had the experience, and Craig started his career as an attorney with a law degree, but did not practice law. Went straight to Guidant Corporation and held multiple roles in the commercial side, HR, marketing, sales director, then went through that acquisition to Boston Scientific, was corporate sales director there. Then he went to NICO when that was in the early stages, and they were acquired by Stryker in 2024.
We're extremely excited to have Craig on board, and he started yesterday, and we made that announcement this morning, and we look forward to him helping us get to where we all expect to go in the coming quarters and years. Board of Directors, as we've talked about oftentimes before. I want to finish here with the capital structure. As Ben mentioned earlier, we're on the NYSE American, NeurAxis, NRXS. Our share price as of September 21st was $7.14. Shares outstanding, 13.6 million. You can see the warrants and the RSUs here. The cash position as of that date was $4 million with no debt. That is high level, where the company is today, where we expect to go. From a priority standpoint, it's very clear. Number one, continue to finalize insurance policy coverage across the country in the coming quarters.
Number two, significantly ramp our commercial force from a sales and marketing standpoint to drive the revenues we all expect in the children's hospitals. The third priority, of course, is to continue to work on this multi-site adult RCT to gain positive data is the goal, and then gain insurance policy coverage in the adult space, which would drastically increase our total addressable market. With that, thank you very much. Ben, I'll turn this over to you.
All right. Well, thank you, Brian, and thank you everyone for watching. If you have any questions or would like to schedule a meeting with NeurAxis, please send me an email at shamsian@lythampartners.com.