Earnings call transcript: Neuraxis Q4 2024 sees revenue growth, loss narrows

Neuraxis Inc. (NRXS) reported a strong fourth quarter for 2024, with revenue increasing significantly. The company’s revenue for the quarter rose by 43% year-over-year to $761,000, while the full-year revenue reached $2.7 million, marking a 9% increase from the previous year. According to InvestingPro data, the company maintains impressive gross profit margins of 86.59%, though current market valuation suggests the stock may be slightly overvalued relative to its Fair Value. Despite an operating loss of $1.5 million in Q4, Neuraxis improved its net loss by 73% compared to the same period last year. The company’s stock remained steady, closing at $2.29, with no change in price, reflecting a stable investor sentiment.

Key Takeaways

• Neuraxis reported a 43% increase in Q4 revenue year-over-year.
• The company’s net loss decreased by 73% in Q4 2024.
• Neuraxis expanded its FDA approvals and market reach.
• The company aims for cash flow breakeven with revenue growth.

Company Performance

Neuraxis demonstrated robust performance in Q4 2024, driven by a significant increase in revenue and a notable reduction in net loss. The company has expanded its product offerings and market reach, contributing to its growth. Neuraxis is positioning itself strongly within the pediatric gastrointestinal treatment market, with a focus on innovation and market expansion.

Financial Highlights

• Revenue: $761,000 in Q4 2024 (43% YoY increase)
• Full Year Revenue: $2.7 million (9% YoY increase)
• Gross Margin: 86.4% in Q4 2024
• Operating Loss: $1.5 million in Q4 2024 (10% improvement)
• Net Loss: $1.5 million in Q4 2024 (73% decrease)
• Cash on Hand: $3.7 million as of December 31, 2024

Outlook & Guidance

Neuraxis is targeting cash flow breakeven as it anticipates revenue growth through expanded insurance coverage and product offerings. The company expects significant revenue acceleration in 2025 and 2026, driven by the introduction of a second-generation IVStim device and broader market access.

Executive Commentary

CEO Brian Carrico expressed optimism about the company’s growth trajectory, stating, "We are still very early at what we see as strong top and bottom line growth over the next few quarters." CFO Tim Henricks highlighted the company’s strategic financial goals, saying, "Our goal as a company to reach cash flow breakeven is achievable and a function of our sales volume given our strong gross margins."

Risks and Challenges

• Market Penetration: Neuraxis currently treats only 0.1% of the potential market, indicating room for growth but also the challenge of scaling operations.
• Regulatory Environment: Changes in FDA regulations could impact product approvals and market access.
• Competitive Landscape: While Neuraxis has unique technology, increased competition in the pediatric neuromodulation sector could pose challenges.

Q&A

During the earnings call, analysts focused on the importance of the Category One CPT code for physician reimbursement and the promising feedback on the RED device. The company also addressed questions about patient treatment outcomes, noting that approximately 70% of patients experience long-term relief.

Full transcript - Neuraxis Inc (NRXS) Q4 2024:

Conference Operator: Good day, and thank you for standing by. Welcome to the Neurax’s Fourth Quarter twenty twenty four Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speakers’ presentation, there’ll be a question and answer session. To ask a question during the session, you’ll need to press star when one on your telephone.

You’ll then hear an automated message advising your hand is

Ben, Conference Moderator, Lytham Partners: Thank you, and good morning, everyone, for joining us for NeuroXis’ fourth quarter twenty twenty four financial results and corporate update conference call. Joining us today on the call is Brian Caraco, CEO of NeuroXis and Tim Hendricks, CFO of NeuroXis. At the conclusion of today’s prepared remarks, we’ll open the call to questions. If you are listening through the webcast, you could send in a question through the portal utilizing the Ask a Question button or simply emailing questions to nrxs@lythampartners.com. If you are dialed into the live call and would like to ask a question, you can follow the instructions provided by the operator.

Today’s event is being recorded and will be available for replay through the webcast information provided in the press release. Release. Finally, I’d also 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 further potential operating results of NARXIS. 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. Neuroaxis undertakes no obligation to update or revise any of these forward looking statements. With that said, I would like to turn the event over to Brian Carrico, Chief Executive Officer of Neuraxis. Brian, please proceed.

Brian Carrico, Chief Executive Officer, NeuroXis: Thank you, Ben. Good morning, and thank you for attending the fourth quarter twenty twenty four earnings call. During today’s call, I will highlight the continuing accomplishments in our commercialization strategies for IVStim, our IBS neuromodulation technology and RED, our product for patients with evacuation disorder. We will recap 2024 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 lead PENFS technology and is closer to the ability to mass scale nationally.

Following my remarks, Tim Henricks, our CFO, will review our financial results for the fourth quarter of twenty twenty four. First review of the recent achievements. As I just mentioned, we are coming off another strong quarter of growth year over year, continuing to increase in covered lives and receiving a new FDA indication. This is in addition to the milestones we mentioned on our last call, which were the Category one CPT code, which will become effective 01/01/2026, and the I. B.

Stim age expansion from 11 to 18 years of age to eight to 21 years of age, nearly doubling our market opportunity. I will speak about these announcements in more detail later in the call. We are continuing to execute 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 PE and FS revenues. In recent months, we’ve made significant achievements as we advanced and hit milestones with the goal of cash flow breakeven and profitability.

Regarding IV Stem, we are primarily focused on revenue trajectory and we had significant growth of 40% in Q3 and 43% growth in Q4. We also saw the very beginning of new insurance policy coverage taking effect. As such, I am excited to share with you that the strong momentum of Q3 and Q4 has continued into Q1. I now want to focus on and highlight the catalyst for what we expect to be significant revenue growth in the coming quarters. In the perfect world that we have been working toward and are getting very close to, children’s hospitals could access blanket insurance policy coverage for their patients and utilize a Category one permanent CPT code.

For mass scaling and exponential growth, the patient needs to be covered by insurance and simultaneously for that perfect world, the physician needs to be compensated for their time in the form of RVUs or relative value units, which happens with the Category one CPT code. We continue to move closer to this full picture being in place. As mentioned earlier, the category CPT code has been awarded by the American Medical Association CPT panel and will become effective this coming January 1. Regarding blanket insurance policy coverage, we went from 4,000,000 covered lives on January one of last year to approximately 51,000,000 covered lives today. So what does it take to earn the remaining payers?

As we’ve discussed and as we now know, the scientific community and physicians have accepted our flagship technology, but have been hindered by a lack of written insurance policy coverage on a national level. 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 payers generally accept as the standard. We announced on the Q3 call of 2024 that a systematic review by the academic society NASHOGAN, which is the Pediatric Gastroenterology Academic Society, was released at a conference in May 2024 showing the PENFS or IVStem technology has the highest grade certainty level and largest magnitude effect. NASPGAN, as I just mentioned, 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 an abstract form now, but believe we believe this information is the work being used to publish guidelines any week now.

We are told by the largest payers that this publication is an internal mandate for policy coverage, so we are eagerly waiting for this publication to get it 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 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 two sixty children’s hospitals have been aware and are supportive that the insurance policy coverage in Category one 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 IVStem often take up to one hundred and twenty days to get the technology loaded, their processes in place and begin ordering.

With all of that said, I’m happy to announce we have additional payers, as I mentioned earlier, bringing our total covered lives to about 51,000,000. Additionally, and as expected, we have countless payers still in the review process. Regarding the Children’s Hospital, many have been ordering for years,

Ben, Conference Moderator, Lytham Partners: but for

Brian Carrico, Chief Executive Officer, NeuroXis: a variety of reasons, we have not received 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 one hundred and twenty days to set up. Turning data into insurance policy coverage and then into revenue is a process that we believe is beginning to work well and the expected academic society guidelines will only expedite that process. The second part of the seamless treatment for patients along with the coverage is the Category one CPT code. On the last call, I mentioned we have achieved the company’s most important milestone to date in the form of a Category one CPT code, which will allow for more seamless billing and reimbursement.

This is a permanent billing code that will become effective on 01/01/2026. The reason this code is so critical is that it brings a permanent code, making it much easier for revenue cycle teams to build a 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 RBU and this will no longer be the case on January 1. Let’s switch to talk about some FDA milestones.

Moving to FDA expansions, we have expanded our IVStim label to include a patient population beyond the current eleven to eighteen years of age to eight to twenty one years of age, as I mentioned earlier, 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 actual test results in patients with chronic constipation. We submitted a five ten in early August and we received FDA clearance on that technology on December 6. As we look into 2025, we have submitted to the FDA for an expanded FDA indication for functional dyspepsia in children eight to 21 years of age. This is critical because it would double our total addressable market and the synergies within are the same providers treating functional dyspepsia patients.

Both IBS and functional dystepsy have fallen to the same umbrella of functional abdominal pain disorders, which creates synergy for all aspects of our business, including the sales force. Now I’d 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 one CPT code. We are beginning to see many of the achievements reflected in the numbers. The number of treated cases has increased over one thousand in the last twelve months, which represents just over one tenth of one percent of the six hundred thousand debilitated children in The U. S.

Who suffer from IVF and are in strong need of IVStem. I want to start by highlighting the sustained and increasing demand for IB Stem. 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 of the two factors we have discussed around national policy coverage and the CPT code. The positive change we do see here is largely due to accounts more comfortable with billing and coding, physicians seeing the academic society guidelines abstract stating PENFS has the highest grade of evidence and only the very slightest insurance policy coverage taking effect to date. On average, selling prices for patients receiving IV stim through financial assistance are roughly 65% below our list price.

The insurance barrier is causing us to leave significant dollars on the table as we have discussed on many calls previously. As insurance coverage continues to increase the cost of countries, percentage of sales through full purchase orders will also increase. This is why our number one priority with the Category one code imminent continues to be written insurance policy coverage as we know the CAT one code becomes effective in roughly nine months from now. Our plan of action is clear. We believe that strong peer reviewed publications and key society support from the likes of Nastigan and the American Academy of Pediatrics result in successful coverage from insurance companies, which result in strong revenue.

Our internal prior authorization team continues to grow and be successful as it reduces the workload for clinic staff, which allows greater access for pediatric patients and ultimately assisting and acquiring a permanent billing code. We believe that in time most accounts nationally will move the prior authorization to the NeuroAxis team as we see more and more added each quarter. We expect revenue growth to continue to accelerate meaningfully as we move toward our gold cash flow breakeven based on the two catalysts that we’ve discussed today in insurance coverage and the Category one CPT code and again the commercialization of RED. Let’s talk a little bit more about RED or the rectal expulsion device product, which we believe to be a great opportunity for NeuroAxis. We now have FDA clearance, which allows us to soft launch the technology.

RED is a self inflating balloon that is an easy to use office based point of care anorectal function test to identify patients with chronic constipation due to pelvic floor disinertion and who are unlikely to improve with increased laxative use. The current treatment involves much trial and error by the physician as to which treatment will work and RED will allow the physician to streamline the diagnosis and choose the best treatment option after the first visit, which is a real win for the patient. Because the technology already has a Category one 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. In summary, we are 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 make no mistake, we are inching very close to the final insurance policy coverage and effectiveness of the CAT one CPT code, which we believe sets the stage for seamless patient treatment and result in significant growth and profitability.

I’ll now turn the call over to our CFO, Tim Henricks, to discuss the financials. Tim?

Tim Henricks, Chief Financial Officer, NeuroXis: Thanks, Brian. And let me add my welcome to everyone joining us on the call this morning. These financial results, which I’m about to walk through, were included within our press release, which was issued earlier and also provided in more detail in our 10 K, which was also released this morning. I will add some color on key areas of the financial results as well as an outlook on certain areas. The hard work that our team has put in the last few years is beginning to bear fruit.

The strong momentum that began in the third quarter last year continued in the fourth quarter and we’re even seeing it into the first quarter as Brian previously mentioned. The good news is that we are only in the early innings of our ramp as we expect the number of covered lives to continue to grow. In addition, we are optimistic with regards to the commercialization of Red. We actually booked our first order in the first quarter of twenty twenty five and expect demand to pick up in the second quarter through the rest of fiscal year twenty twenty five. Given our current cost structure, our goal as a company to reach cash flow breakeven is achievable and a function of our sales volume given our strong gross margins.

Our recent successes in obtaining substantially more insurance coverage keeps us on that path. With that, I’ll go through the financial highlights in detail. Revenues in the fourth quarter of twenty twenty four were $761,000 up 43% compared to $531,000 in the fourth quarter of twenty twenty three. Unit sales increased approximately 45% due to growth from patients with undiscounted insurance reimbursement and the company’s financial assistance program that provides discounts to patients without insurance. The company has made great strides in recent months in gaining insurance coverage and recent results are indicative of that success.

Revenue in fiscal year twenty twenty four was 2,700,000 an increase of 9% compared to $2,500,000 in fiscal year twenty twenty three. Unit sales increased approximately 19% year over year due to continued growth in patients that have provided discounts through the company’s financial assistance program. As Brian mentioned, the strong momentum has continued in the first quarter of twenty twenty five, which we expect to be our third consecutive quarter of revenue growth year over year. And as mentioned before, we remain highly focused on expanding our insurance coverage despite the inherent lag from insurance coverage device orders, which we have spoken about before, recent performance indicates strong demand and acceptance on the part of healthcare providers and patients for our product. Gross margin in the fourth quarter of twenty twenty four was 86.4%, the same as the fourth quarter of twenty twenty three.

Although we saw a significant increase in discounted financial assistance units delivered outpaced the growth in the higher margin undiscounted full reimbursement program, we had substantial enough growth to maintain a steady gross margin year over year in the fourth quarter. And that trend is evidence of our future opportunity. With the category one CPT billing code in place for 01/01/2026, the devices currently sold at a discount will eventually transition to full reimbursement revenue upon insurance coverage, which will boost our future revenues and gross margin. Gross margin in fiscal year ’20 ’20 ’4 was 86.5 compared to 87.7% for the full year 2023. The 120 basis point decline is due to growth in device deliveries from the company’s financial assistance programs that are discounted to patients without insurance coverage.

Again, as the Category one CPT billing code takes hold in 2026 and beyond, we expect gross margin to expand. SG and A expenses in the fourth quarter of twenty twenty four were $2,100,000 an increase of 2% compared to the fourth quarter of twenty twenty three, which was $2,000,000 The increase was due to one, the hiring of market access, sales and finance team members and two, the introduction of a short term incentive plan in 2024, mostly offset by cost savings of third party service spend as the key personnel hires performed the work of previous vendors. SG and A expenses in fiscal year twenty twenty four were $9,500,000 an increase of 7% compared to $8,800,000 in fiscal year twenty twenty three. The increase was due to one, incremental headcount to build out the market access sales and finance teams two, severance charges related to the company’s prior Chief Operating Officer three, one time advisory costs four, the annualization of legal, insurance, investor relations, Board of Directors and stock exchange listing costs as a publicly held entity as the company went public in August of twenty twenty three five, the introduction of a short term incentive plan in 2024 and ’6, higher advertising costs to expand market awareness, partially offset by post IPO consulting and recruiting fees and IPO bonuses in 2023 that did not recur in 2024.

Operating loss in the fourth quarter of twenty twenty four was $1,500,000 an improvement of 10% compared to $1,600,000 in the fourth quarter of twenty twenty three. That improvement was primarily due to higher sales volumes, partly offset by slightly higher SG and A costs that I previously discussed. Operating loss in the full year 2024 was $7,200,000 an increase of 7% compared to $6,700,000 in fiscal year twenty twenty three. The increase was due to higher SG and A costs, partly offset by higher sales volume. Net loss for the fourth quarter of twenty twenty four was $1,500,000 a decrease of 73% compared to $5,300,000 in the fourth quarter of twenty twenty three, primarily due to a lower operating loss and a $3,700,000 charge related to the extinguishment of debt upon the company’s IPO in 2023.

Net loss in fiscal year twenty twenty four was $8,200,000 a decrease of 45% compared to the 14,600,000 loss in fiscal year twenty twenty three, primarily due to the absence of debt discount, issuance costs and debt extinguishment charges relating to the company’s IPO in 2023, partially offset by a higher operating loss. Our cash on hand as of 12/31/2024 was $3,700,000 The company held no long term debt as of 12/31/2024. However, we did have $154,000 of short term debt related to the standard financing of our annual business insurance premiums. Cash used in operations in fiscal year twenty twenty four of $6,100,000 was $595,000 lower than fiscal year twenty twenty three due to more issuance of common stock instead of cash for certain services and lower interest payments from the conversion of debt in the prior year. And with that, let me turn the call back over to Brian.

Brian Carrico, Chief Executive Officer, NeuroXis: Thanks, Tim. To sum this up, as many critical milestones as we have recently seen come to fruition, We are still very early at what we see as strong top and bottom line growth over the next few quarters. The consistent execution of our commercialization strategy is beginning to bear early fruit as we see from the growth acceleration in the last two quarters. We are also achieving milestones that will enable continued growth as I spoke to the Category one code, increased insurance coverage and the expansion of our five ten clearances. Furthermore, we remain excited about our opportunity with RED, which we have just recently soft launched and has the potential to drive significant revenues in the coming quarters.

With that, operator, we’d be happy to take any questions.

Conference Operator: Thank you.

Ben, Conference Moderator, Lytham Partners: Okay. We have some questions that have been sent to us by investors. Brian, can you talk about the significance of receiving the Category one code and the five ten extensions?

Brian Carrico, Chief Executive Officer, NeuroXis: Well, I’ll speak to the Category one code. Look, we’ve been talking this is something we’ve been working on for five or six or seven years. It’s extremely difficult to get a Category one code due to the utilization requirements and the data requirements, which speak to the accomplishments in those two areas. It’s hard to explain the significance of the Category one code to the audience that if especially if you’re not familiar with the med tech space and RBEs. If you are familiar with RBEs, you understand that physicians, especially ninety five percent of our physicians that we work with are pediatric gastroenterologists employed by the children’s hospitals and their measuring stick on a daily, weekly, monthly, annual basis or RVUs.

And so to be able to receive RVUs for a procedure, in a sense that’s their currency. So to do IVStim without an RVU, as I mentioned in the call, is essentially donating their time. So that’s the first aspect of the CPT code is that these physicians will be recognized for their time and it will actually it goes towards their annual goal. So I think that speaks for the obvious. Number two, most Medicaids and many commercial insurance companies don’t recognize a Category three code, which we have now, which makes the prior authorizations very difficult.

The Category three code also means that the children’s hospitals have to build what’s called a charge bundle, which is very time consuming. And between that and the prior authorization difficulty, there’s a reason that the revenues are where they are today. So that will streamline the prior authorizations and it will make it much easier for the Chief Revenue Officer and the billing teams at the Children’s Hospital and it brings significant credibility to the payers when you have a Category one CPT code. So there and there are other angles to the CAT one code, but it’s that’s the first part. The 510 extension, look, there are a lot of kids that are eight, nine, 10, 19, 20, 20 one that are equally sick as the 11 to 18 years of age.

So we went from 11 to 18 to eight to 21. So it’s about a 75% increase, 80%, eighty five % increase in total addressable markets. And we’ve seen just since this age expansion, I don’t know exactly what percentage of the increased revenue it is, but we’ve significant feedback from the physicians that they’re very appreciative of the age expansion and they’re utilizing this in full force and we expect that to expand or continue to be utilized.

Ben, Conference Moderator, Lytham Partners: Okay. We have a question for you, Tim. Can you talk about the variability of the gross margins and how to think about gross margins on a go forward basis?

Tim Henricks, Chief Financial Officer, NeuroXis: Sure. So our reported gross margins are in the mid to high 80s. When we sell an IV stim device to a patient that’s covered by insurance, our gross margins are higher than that. However, the reason that you see the gross margins in the high mid to high 80s is because of our financial assistance program, which we’re very excited about and it continues to grow. One of our guiding principles is that we want to make sure that we treat all patients.

And in many cases, patients do not have insurance coverage or they have inadequate insurance coverage. And so they will come to us seeking treatment and we want to make sure that they receive that treatment. So what we will do is we will discount based on income levels of the patients. And Brian previously mentioned in the call today, on average in financial assistance, we discount up to 65% off our list price $11.95 dollars But even at that discount, our gross margins are pretty healthy because you can see as a blend throughout the whole company, we’re in the mid to high 80s. And what that is going to translate in the future, in particular when the CAT one CPT code takes hold, we obviously expect covered lives to increase, insurance coverage to increase and it will then take our patients out of inadequate or no insurance coverage into insurance coverage, allowing the higher full reimbursement price to be charged and we fully expect that our gross margins when we move into 2026 and beyond will increase as a result of that transition from the CPT category one code.

Ben, Conference Moderator, Lytham Partners: Okay. We have another question that’s more sent to us. Brian, what are some of the early learnings from the red in the commercial mode that you’re doing now?

Brian Carrico, Chief Executive Officer, NeuroXis: Great question. We had done some market feedback, significant market feedback before we when we considered licensing this technology from the University of Michigan. And some of the key points were and reasons we licensed this where it had a Category one CPT code, it has a Medicare reimbursement, it’s reimbursed by commercial insurance already. And we knew there was an unmet need. Since the soft launch, look, we just launched this and I would just tell you the feedback has been what we expected.

I think from an if we underestimated anything, it’s the size of the practices and they have boards and they have practice administrators and CEOs and there’s a process, although most are private and not academic. There’s still a process to get through. But their feedback, I think, from a positive standpoint has been the numbers and the feedback we’re getting are the usage expectation from the physicians is higher than what we thought it would be. So look, the physicians are excited. The commercial force is very, very happy, very excited.

The conferences are going well. We’re excited. Look, Q2 will be telling. We’ll see how Q2 goes, Q3 and Q4. But we’re bullish that these are meaningful revenues for

Ben, Conference Moderator, Lytham Partners: us. Okay. A question for you, Tim. Given the expected cost structure, what level of revenue do you need to achieve breakeven?

Tim Henricks, Chief Financial Officer, NeuroXis: So at our current run rate, our current cash burn run rate is about $6,000,000 annually. And if you take that and then translate into revenues depending on when we break even, right, in the not too distant future, those break even revenues will be in that $10,000,000 to $12,000,000 range.

Ben, Conference Moderator, Lytham Partners: Okay. Thank you. A product question, where are your products manufactured and what is your exposure to any potential tariffs?

Brian Carrico, Chief Executive Officer, NeuroXis: That’s a phone call I have in thirty minutes, but 95% of our technology is sourced and manufactured here in The United States. And I believe the one component we get from overseas is with a country that has no tariffs either way and I don’t believe there’s a planned tariff either way. So minimal to zero. And again, I have that call in thirty minutes to discuss that. But as of right now, it doesn’t appear that we’ll be affected.

Ben, Conference Moderator, Lytham Partners: Okay. Thank you. What is the development timeline for a second generation IB stim device and how will that differ from the current version?

Brian Carrico, Chief Executive Officer, NeuroXis: We’re working on generation two and sometime in 2026, we expect to have that. It will have, I would tell you, a different look, a more modern look. It would we haven’t finalized this. I mean, the one question we get are calls sometimes as patients don’t feel the device, which is a good thing and they think it’s not working. So we’re looking at putting some type of infrared light that blinks once every sixty seconds to show that it’s working.

But there’s and there are some other things we’re working on in the background that are really going to advance and should improve outcomes in children. And we should be able to predict who responds and who doesn’t around heart rate variability and autonomic dysfunction, but and vagal insufficiency. But these are things we’re working on and would be part of a potentially this next device, it would be part potentially part of the next version. But these are all things that are in the future. We have a lot of ideas.

We’re in the research phase of different things. We’re in the development phase of version two. But the device we have works outstanding. We have virtually no complaints. So, yes, I hope that answers the question.

Ben, Conference Moderator, Lytham Partners: Okay. We have another question for you, Brian. What is the response after a three or four week course of IV stem treatment? And what percentage of patients come back for additional treatment courses?

Brian Carrico, Chief Executive Officer, NeuroXis: That’s a good question. We’ve got good data right now at six and at twelve months. We have a seven center, a multi center of route 300 patient registry. It was published last year. It had good data, statistically significant data.

We don’t have the physician feedback is pretty straightforward. They’re roughly seventy percent of patients. This is anecdotal. This is not the data. But if somebody wants to schedule a separate call with Doctor.

Miranda to go into the data, we’d be happy to do that. But roughly seventy percent of patients have significant long term relief. That’s the feedback from physicians. You obviously have non responders and you obviously have patients that have some response. But this is not something that once someone has four weeks of treatment that next month you need or two months from now you need four weeks of treatment again.

These results are sustained and we’ve got multiple studies and we’ve got 16 studies now on this, including two placebo controlled trials. We’ve done 10 or 11 different types of studies. And this all goes into the fact that was part of why we had such strong support from the American Academy of Pediatrics. And they submitted the Category one CPT code application alongside us. But the data are really strong and the longevity of the treatment is sustainable and statistically significant.

Conference Operator: This does conclude today’s Q and A session. I’d like to go ahead and turn the call back over for closing remarks. Please go ahead.

Brian Carrico, Chief Executive Officer, NeuroXis: I’d just like to say thank you to everyone for joining us today. We appreciate the questions and we look forward to communications with you again very soon via press release and obviously we’ll have quarter one results out in the coming weeks in quarter one call in May and we’ll announce that. So thank you again. Have a great rest of your Thursday.

Conference Operator: Thank you all for joining today’s conference call. You may now disconnect.

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