Neuraxis, Inc.

Good day and thank you for standing by. Welcome to the NeurAccess first quarter 2025 results and update 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'll need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. If you wish to ask a question via the webcast, please use the Q&A box available on the webcast link anytime during the conference. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Ben Shamsian, Investor Relations. Please go ahead.

Thank you, and good morning, everyone. Thank you for joining us for NARAC's first quarter 2025 financial results and corporate update conference call. Joining us on today's call is Brian Carrico, CEO of NeurAxis, and Tim Hedricks, CFO of NeurAxis. At the conclusion of today's prepared remarks, we will open the call for questions. If you are listening via the webcast, you can send in questions through the portal, or you can simply email me at neuraxis, N-R-X-S, at lithiumpartners.com. If you're dialed into the live event, you can press star and one, one button. Today's event is being recorded and will be available for replay through the webcast information provided in the press release. Finally, I'd like to call your attention to the 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 and 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 first quarter 2020-25 earnings call. During today's call, I will highlight the continued execution and our commercialization strategies for IV stem, our neuromodulation technology, and RED, our product for patients with evacuation disorder. We will recap Q1 and discuss the milestones and growth plans for 2025 as we come off another strong quarter of execution and growth. We continue the commercialization of our market-leading PENFS technology an inch closer to the ability to scale nationally. Following my remarks, Tim Hendricks, our CFO, will review our financial results for the first quarter of 2025. Let's first review the recent achievements. As I just mentioned, we are coming off another quarter of growth year over year, marking the third consecutive quarter of double-digit growth. As I mentioned on our last call, we are laser focused on the new CAT I CPT code, which will become effective January 1, 2026, and claiming the remaining policy coverage needed to give access to the children who need IV STEM. I will speak about these announcements in more detail later in the call. We are continuing to execute at a high level on our growth objectives, rooted in the foundation that strong published data will drive insurance expansion, leading to sustainable revenues and margins. We laid out these objectives in previous calls and continue to put the final pieces in place to allow blanket insurance coverage and, in turn, the scaling of PENFS revenues. In recent months, we've made significant achievements as we advance and hit milestones, aiming for cash flow breakeven and profitability. Regarding IV STEM, we are primarily focused on revenue trajectory, and we had significant growth of 40% in Q3 of 2024, 43% growth in Q4 of 2024, and 39% in Q1 of 2025. We continue to see only the very beginnings of new insurance policy coverage taking effect. As such, I'm excited to share with you that the momentum has continued into Q2. I now want to focus on and highlight the catalyst for what we expect to be continued revenue growth in the coming quarters. In the perfect world that we have been working toward in our nearing, children's hospitals could access blanket insurance policy coverage and utilize a Category 1 CPT code. For mass scaling and exponential growth, there are two critical components. First, the patient needs to be covered by insurance. And second, the physician needs to be compensated for their time in the form of RVUs or relative value units, which happens with a Category 1 CPT code. We continue to move closer to this full picture being in place. As mentioned earlier, the category one CPT code has been awarded by the American Medical Association CPT panel and will become effective this coming January 1st. Regarding insurance policy coverage, we went from 4 million covered lives just over a year ago to 51, about 51 million covered lives today. So what does it take to earn the remaining payers? As we all know, the scientific community has accepted our flagship technology, but stronger revenues have been hindered by a lack of written insurance policy coverage. The most important recognition any medical technology can receive is independent guidelines by the academic society because this is an independent review of the literature and a grade is assigned, which the payer generally accepts as the standard. We announced previously that a systematic review by the academic society NASPGAN was released, showing our technology has the highest grade certainty level and largest magnitude effect. NASPGN is the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and they are the academic society for pediatric gastroenterology, where our technology resides. This systematic review is in abstract form now, but we believe this information is the work being used to publish guidelines in the coming weeks. We are told by the largest payers that this publication is needed for policy coverage, so we are eagerly waiting for this publication to get to the payers. Sticking with insurance policy coverage, I want to go into detail about the most important aspect of our growth. As we have stated consistently, policy coverage is the key to exponential revenue growth. Again, we have had this indication long enough that the academic society and the physicians within the society who treat these patients at the 260 children's hospitals in the United States have been aware and are supportive. But the insurance policy coverage and Cat 1 CPT code are imperative for seamless treatment. We also stated that once the insurance policy coverage is written and in place, the children's hospitals that were not already utilizing IV STEM take about 120 days to get the technology loaded, their processes in place, and begin ordering. With all of that said, our total covered lives today stand at about 51 million. Additionally, as expected, we have countless payers currently in the review process. Regarding children's hospitals, Many have been ordering for years, but for a variety of reasons, we have not received early insurance policy coverage in those geographic regions. Once insurance policy coverage is written in these areas, the children's hospitals are expected to increase revenue very quickly because the product is already in their system, therefore not needing the 120 days to get set up. The second part of the seamless treatment for patients, along with policy coverage, is the Category 1 CPT codes. As everyone now knows, we have achieved the company's most important milestone to date in the form of a Category 1 CPT code, which will allow for more seamless billing and reimbursement. This is a permanent billing code that will become effective on January 1st. The reason this code is so critical is that it brings a permanent code, making it much easier for revenue cycle teams to bill the procedure. It will bring a permanent reimbursement amount, and it will provide RVUs, which is how most physicians' productivity is measured. One could argue that physicians in the children's hospital are currently treating patients for free because there is no RVU, which will no longer be the case come January 1st. I want to move to the FDA milestones. Moving to FDA expansions, we have expanded our IBSIM label to include a patient population beyond the current 11 to 18 years of age to 8 to 21 years of age, significantly increasing the number of children we can treat. Regarding RED or the rectal expulsion device, our point-of-care device identifies patients with pelvic floor dysfunction and provides immediate, actionable test results in patients with chronic constipation. We received FDA clearance on that technology on December 6, and they are in the middle of a soft launch phase. As we look into 2025, we have submitted to the FDA for an expanded FDA indication for functional dyspepsia in children 8 to 21 years of age. This is critical because it would nearly double our market opportunity. Additionally, this indication will rely on the same Category 1 CPT code, the same insurance policy coverage, the same children's hospital call point, the same pediatric gastroenterologist physician, and will utilize the same W-2 sales force. Now I would like to focus on how our efforts translate to revenue growth and why we continue to be bullish on significant revenue growth as we move closer to national insurance coverage and the effective date for the Category 1 CPT codes. We are beginning to see many of the achievements reflected in the numbers. In the first quarter alone, 300 patients were treated through full purchase order or patient assistance programs, an annualized rate of 1,200 patients. While this marks important growth, it still represents just 0.2% of the 600,000 severely affected children in the United States suffering from IBS who are in urgent need of IV stims. Additionally, we had 130 patients via the patient assistance program who did not utilize the program, which would have taken our treated patients to 413 for the quarter. I want to highlight the sustained and increasing demand for IV stims. While our revenue growth has accelerated in recent quarters, the facts remain that we are still treating a minuscule portion of the addressable market because national policy coverage and the cap one have yet to be put in place. The positive change we do see here is largely due to accounts getting more comfortable with billing and coding. Physicians seeing the academic society guidelines abstract stating PENFS has the highest rate of evidence and only the very slightest insurance policy coverage taking effect. On average, selling prices for patients receiving IV spend through financial assistance or our patient assistance program are about 65% below our list price. The insurance barrier is causing us to leave significant dollars on the table. As insurance coverage increases across the country, the percentage of sales through full price purchase orders will also increase. This is why our number one priority continues to be written insurance policy coverage, as we now know the Cap One Code will be effective on January 1st. The point of action is clear. We believe that strong peer-reviewed publications and key society support from the likes of NASPG and the American Academy of Pediatrics result in successful coverage from insurance companies, which results in strong revenues. Our internal prior authorization team continues to grow and be successful as it reduces the workload for clinical staff, which allows greater access for pediatric patients, and ultimately assisting in acquiring a permanent billing code. We believe that, in time, most accounts will move their prior authorizations to the NeurAccess team, as we see more and more added each quarter. We expect revenue growth to accelerate meaningfully as we move toward our goal of cash flow breakeven based on two catalysts, the continued gain of policy coverage from the carriers for IV STEM, along with the Category 1 CPT code. As mentioned earlier in the call, we received FDA clearance for RED for adult patients on December 6, 2024. I want to talk a little bit more about REDD. The rectal expulsion device product, which we believe to be a great opportunity for neuraxis. We now have FDA clearance, which allows us to soft launch the technology. REDD is a self-inflating balloon that is an easy-to-use, office-based, point-of-care interrectal function test to identify patients with chronic constipation due to pelvic floor dysinertia and who are unlikely to improve with increased lack of use. The current treatment involves much trial and error by the physician as to which treatment will work, and REDD will allow the physician to streamline the diagnosis and choose the best treatment option after the first visit, which is a win for the patient. Because the technology already has a Category 1 CPT billing code assigned to the procedure and strong national reimbursement, we believe the providers will be able to bring this clinically beneficial technology to their practice immediately. As we continue the soft launch, we will learn much more about revenue expectations in the coming months. In summary, we're pleased with continued and consistent execution of building the foundation of strong data and academic society support. Nothing happens as fast as we want, but we are inching much closer to the final insurance policy coverages and effectiveness of the Cat 1 code, which we believe will set the stage for seamless patient treatment and result in significant growth and profitability. I will now turn the call over to Tim, our CFO, to discuss the financials. Tim?