Neuraxis, Inc.

Good day and thank you for standing by. Welcome to the NeurAccess Reports Third Quarter 2025 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised in case conference is being recorded. I would now like to hand the conference over to your speaker today, Ben Shamzian, Invest Relations. Please go ahead.

Thank you. Good morning, everyone. And thank you for joining us for Neuraxis's third quarter 2025 financial results and corporate update conference call. Joining us on today's call is Brian Carrico, CEO of Neuraxis and Tim Hendricks CFO. At the conclusion of today's prepared remarks, we'll open the call to questions. If you're listening through the webcast, you can follow the operator's instructions to ask questions. If you are dialed into the call live, you can press star 11 button. Finally, I'd like to call your attention to customary safe harbor disclosures regarding forward-looking information. The conference call today will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations, and future potential operating results of Neuraxis. Although management believes these statements are reasonable based on estimates, assumptions, and projections as of today, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast replay. Actual results may differ materially as a result of risks, uncertainties, and other factors, including but not limited to the factors set forth in the company's filings with the SEC. NeurAccess undertakes no obligation to update or revise any of these forward-looking statements. With that said, I would like to now turn the event over to Brian Carrico, Chief Executive Officer of NeurAccess. Brian, please proceed.

Thank you, Ben. Good morning, and thank you for attending the third quarter 2025 earnings call. During today's call, I will highlight the continued execution of our commercialization strategy for IV stem, our neuromodulation technology for both the pediatric and adult patient populations, and RED, our product for patients with evacuation disorders. The continued execution has set the stage for continued growth in the recent quarters and stronger growth expected in 2026 and beyond. who will recap Q3 and discuss the milestones and growth plans for 2026. Following my remarks, Tim Hendricks, our CFO, will review our financial results for the third quarter of 2025. We'll start with commercial execution and reimbursement progress. Our strategy remains laser focused on expanding access through medical policy coverage, and accelerating utilization of IV STEM as we approach the effective date of the Category 1 CPT code on January 1, 2026. While revenue growth has strengthened in recent quarters, providers are still treating only a fraction of the addressable market because national policy coverage and the permanent CPT code are not yet in place. Our top priority remains securing coverage under medical policies. Our internal prior authorization team continues to expand, helping hospitals reduce administrative burden and improve patient access, a critical step toward broader adoption. We believe we are making progress with payers. Many of the nation's largest insurers are now in active dialogue as they approach policy review dates at many points between now and through the first half of 2026. Our advocacy emphasizes the urgent need for pediatric coverage and the clinical risks of the off-label drugs with FDA black box warnings. To strengthen our message, we've mobilized a coalition that includes formal letters of support from the academic societies, direct correspondence from leading children's hospitals and national key opinion leaders, detailed updates from Neuraxis to the payers, including the guidelines, the favorable ECRI clinical evidence assessment, the favorable up-to-date recommendations, and several additional strategies which we will not be disclosing. Based on expert opinion, we have the most comprehensive payer engagement effort in our industry. The tone has been constructive, and we're confident this multi-channel approach will drive favorable policy considerations. That said, we expect policy changes and prior authorization improvements to unfold gradually, not overnight. I want to now focus on and highlight the catalyst for what we expect to be continued revenue growth in the coming quarters. Two elements remain key to IV STEM success. Number one, insurance coverage for access. And number two, physician RVU compensation for adoption. We now have roughly 55 million covered lives and continue to see positive payer momentum supported by the clinical practice guidelines published earlier this year. Regarding commercial readiness for 2026, In addition to the two key elements just mentioned, the commercial execution utilizing these two elements is equally important and the primary focus of our commercial team. As the new CPT code takes effect and coverage becomes more available, it is paramount for children's hospitals to have enough dedicated time slots each week to treat the patients in need. Our commercial organization is fully aligned for the 2026 transition. We've prioritized target children's hospitals based on their utilization potential and launched comprehensive education and outreach, including direct engagement with the 75 children's hospitals who have previously ordered IV STEM, division chief meetings with detailed RVU and financial modeling, comprehensive partnership with NASPGAN, beginning with a CME-accredited presentation on November 12th, integrated marketing, which highlights the positive reimbursement shift, field programs focused on the clinical and economic value of the new CPT code, and we are working closely with all stakeholders to ensure there are dedicated weekly time slots available for patient treatment with IV stem. These coordinated efforts are cultivating awareness and positioning IV stem for broad adoption once the new CPT code takes effect. Our forecast remains conservative, recognizing that initial revenue conversion may lag as hospitals refine workflows and navigate early payer hurdles. As I just mentioned, we're coming off another quarter of growth year over year, with Q3 coming in at a 22% increase, marking the fifth consecutive quarter of double-digit growth. As this is our fifth quarter of double digit growth, we are pleased that this amount of growth is coming considering the organic growth from the small number of hospitals comfortable with the current category three CPT code. More importantly, we hit another milestone as the big picture comes more into focus. This milestone is the indication expansion to functional abdominal pain associated with IBS and functional dyspepsia with associated nausea symptoms in the adult population, significantly increasing our market opportunity. Regarding the Category 1 CPT code, the new Category 1 CPT code represents a true inflection point. Effective January 1, 2026, this will streamline coding and reimbursement, introduce work RVUs for providers, and should substantially lessen the no authorization required response barrier that currently limits access with the Category 3 CPT code. The reason this new CPT code is so critical is that it brings a permanent code with RVUs, making it much easier for providers to build a procedure. It will allow reimbursement amounts for transparency and consistency, and it will provide work RVUs, which is how physician productivity is measured. One could easily argue, as I've mentioned before, that physicians in a children's hospital setting are treating patients for free because there is no current work RVU associated with the Category 3 CPT code. This will no longer be the case come January 1st. As mentioned earlier, the new Category 1 CPT code was assigned by the American Medical Association CPT panel and will be effective for utilization on January 1st. Furthermore, the RVUs and payment values are now finalized for 2026, and we are very pleased with these numbers. This brings me to our commercial plan for IV STEM in adults, the FDA indication that was just awarded. As we all know, the Category 1 CPT code for IV STEM will translate to adults because it is the same physician work for the same device technology. What everyone may not know is that although we have FDA clearance for adults with IV STEM, it was based on extrapolation of adolescent data to adults. Thus, there is not a large study conducted in adult patients alone, so medical policy coverage is not immediately likely. This means there could be 2026 coverage and reimbursement issues for IV stem in adults. None of this is a big surprise to us and is why we have been and will be spending our focus on the pediatric side of the business. Having said all that, we are approaching the adult IV stem market from three angles. First, we are in the final stages of signing a contract with a prestigious institution to do a randomized controlled trial in adults. Second, we have submitted for a federal supply schedule contract, also known as an FSS contract, for access into the Veterans Administration. We are cautiously optimistic we will have an FSS contract by early 2026 with IV STEM on that contract. This will enable a commercial path into the VA, which is responsible for nearly 7 million active patients per year with a functional dyspepsia prevalence rate of 3%. We are dedicating sales resources to this endeavor and will expand as we get feedback and see results. Third, we are doing a limited market release on the private and commercial side for IV STEM to gauge the insurance acceptance of IV STEM in adults using the CAT I code and ultimately gauge whether there is a cash pay market if insurance is not favorable. Turning to red. our rectal expulsion device. REDD allows for earlier, more targeted treatment decisions for patients with chronic constipation, a meaningful improvement for patients and providers. We are selling the device and continue to see good physician interest, but being a new technology means practice flow changes and physician habit changes. Furthermore, there is an existing Category 1 CPT code and strong reimbursement, but we have learned that there will be a new CPT code effective January 1st, which may or may not be positive for REDD, and we expect to learn in detail what this means before January 1st. To this point, red in the private market is to be determined, but we will be exploring red in the VA due to the synergy of a sales force calling on adult gastroenterologists in that location. In summary, we're executing against the milestones that matter most, payer coverage expansion, CPT code implementation, and commercial readiness and execution. As we move into 2026, The focus is clear, drive national medical policy coverage, maintain disciplined commercial execution, and achieve cash flow break-even as adoption accelerates. Although we are far from satisfied, we're proud of the progress made this year to date and energized by the opportunities ahead for our shareholders, our team, and the one million patients who stand to benefit from our therapies. I will now turn the call over to our CFO, Tim Hendricks, to discuss the financials.