Good morning. The Next Presentation with MicroCap is Aclarion. This is Brent Ness.
Good morning, and thank you for attending this session where we'll be talking about a global epidemic of chronic low back pain. First, let me hit the strategic highlights of the business. We have nearly $14.6 million in cash on hand as of the 10-K filed this month, which gives us a cash runway into Q3 of 2026. We have a clean cap table, zero debt, no preferred shares outstanding, no near-term warrant overhang. We are fully NASDAQ compliant, meeting both bid price and shareholder equity requirements. On the operational side, we've secured meaningful payer approvals in England. We've expanded physician referral and commercial support for Nociscan, which is our product name in the United States. Our national randomized control trial called CLARITY is fully funded all the way through the initial results, that interim results that are expected about a year from now.
The total cost of that CLARITY trial is $4.6 million. Let's talk a little bit about this global epidemic that we're working on. It is extremely costly. It is the number one cost ailment in all of healthcare in the United States, diagnosing and treating back pain. 266 million people suffer from chronic low back pain worldwide. There are 635,000 fusion surgeries in the United States every year. The average cost of those fusion surgeries or those procedures is $58,000 for a one level, $71,000 for a two level, and then a disc replacement is about $38,000. Now, you would think if we're spending all of that money that we'd get some pretty good success rates out of that, but unfortunately, it's nearly a coin toss: 48%-54% surgical success rate on these expensive surgeries.
Post-surgery, 80% have discomfort, and 10%-40% have persistent pain after surgery. This is the big number. 6% of these procedures have to go in, have to come back for a revision surgery. Now, let's just do some quick math. 635,000 spinal fusion surgeries, 6% coming back times an average cost of $58,000 per procedure. You mathematicians out there are quick to realize this is over $2.2 billion that the healthcare system is spending on revision surgery, let alone the societal costs: 20%-30% reduction in work productivity, absenteeism, and work-related issues. The one that really breaks my heart is chronic back pain is the leading cause of opioid addiction in the United States. Let's take this to a business market opportunity level.
If we just look at that first addressable market, the fusion market and the disc replacement market, and you take that 635,000 cases times our ASP of $950, we've got $603 million revenue opportunity in this initial market. If you go out to other spine procedures, like pain management procedures, you can multiply that by four. Over, again, $2 billion. The numbers get crazy when you start looking at chiropractic care and other types of back pain, people walking around with back pain who just want it diagnosed accurately. The market is absolutely huge. This is the number one spend in all of healthcare in the United States. Those numbers I just cited were U.S.-only numbers. Why is this? What's going on? This is the question that the scientists that invented our technology really were trying to answer.
This is the physician's quandary. If you showed this picture on the right to five different spine surgeons, you would get five different treatment suggestions. It could be different levels. It could be everything from go home with a bottle of Tylenol to I'm going to fuse you here today. This variability leads to it's very expensive. It leads to those poor outcomes I referenced, and really is the definition of low-value care. What's the solution? It's having a technology that labels each disc as painful or pain-free. It's a personalized treatment path, which is optimized through that, which lowers costs, improves outcomes, and really becomes the definition of high-value care. Now, what is it? Here's the product.
In the MRI in the hospital down the street from where you live, there's a sequence called spectroscopy, which doesn't create a picture out of that MRI image, but rather it quantifies the biomarker content inside an area of interest. Inside your disc, we literally measure the acidic pain biomarkers that are living inside your disc, but we also measure the structural integrity biomarkers, proteoglycan and collagen, which create the integrity of the boundary of the disc. What we've learned is that under certain ratios, there is a clear delineation between discs that are comprised of a certain ratio versus discs that don't have those high acidic biomarkers and low structural integrity markers. I always try to describe this like I'm describing it to my aunt Verna. When the disc degrades, nerves can grow into the disc. Acid hitting nerves causes pain.
The quandary from the slide above is you can't see pain. You can't measure those things in a normal picture. The existing world is wanting. Now, we don't expect any clinician to be able to look at those squiggly lines and make any sense out of them. What we've done is we've created this very easy-to-interpret physician report. The information from the spectroscopy comes up to us in the cloud. We apply our algorithms to it, measuring those biomarker contents, and we send back a report that is comprised of these two main measurements, the pain and the structural integrity. It's a translating exercise of complex radiographic information into simple, actionable information that can lead to better patient outcomes.
Our technology is patented. We've got over 40 patents worldwide, and it is very broadly covering everything from the biomarkers and ratios that we identify to the post-processing techniques, which makes it easier for us to uniquely pull that information out of that small disc space, as well as AI patents that are going to tie these algorithms to outcomes. Of course, use of internal tissue controls, really personalizing the exam. We're heavily patented. Now, without NOCISCAN, if a physician really needed to know which disc is causing pain, what would they actually do? There's a procedure called the discogram. This, by its very design, is invasive. They take a needle and push it into the disc and then pressurize that disc. Invasive, highly subjective, severely painful, again, by design. There's radiation involved.
There's an additional need for an additional exam after the MRI, half day out of work, and twice as expensive as NOCISCAN, whereas NOCISCAN is subjective, non-painful, no radiation. It's a standard MRI-type-like procedure, and it's half the cost. Nothing gets to standard of care in healthcare without evidence. Our foundational evidence is from Dr. Matt Gornet, who studied 139 patients, 73 of which underwent surgery. 85% of the patients improved when the NOCISCAN -positive discs were treated, and only 63 improved when it was not treated. Now, the one-year outcome measurements, which I think, frankly, are more compelling, was 97% improved when it matched NOCISCAN back to that 54%, that number, that average surgical success rate. We've got this great foundational science. The problem here is this is one surgeon, one site. What have we done with the money that's been invested in us to date?
We're launching a national randomized control trial called CLARITY. CLARITY is being led by Nick Theodore, who's the chair of neurosurgery from Johns Hopkins. We have other marquee institutions across the United States who are participating in this trial. We fully expect that the CLARITY trial, multi-site, multi-surgeon, national randomized blinded, unblinded cohorts, are going to give us the mic drop kind of evidence that we saw in the GARNET trial, but really irrefutable by the payer community. We currently have eight peer-reviewed publications already in the stratosphere. 250 patients have been studied. We've got seven ongoing clinical trials as well, because the bottom line is evidence in healthcare is the catalyst that drives societal endorsements, physician adoption, and then ultimately payer approval.
Now, we've got some great news. In the United Kingdom, three private payers have already approved the use of NOCISCAN . We get to, you know, the first dominoes have fallen on the evidence side, and they've done that even without the CLARITY trial. We had strong physician advocacy in this market, in the private U.K. healthcare market, which is 41% of the private market is covered by private insurance. We have over 50% of the private insurers covered already, which represents 5.2 million people in the population of England, of course, which is about 70 million. Lots of work yet to do there. We've got great plans in place for the U.K. market, and that'll be a catalyst that you should look for from us in the months to come, the scan volume growth in an environment where we have payer coverage. Obviously, we have strong tactical plans in place. I just got back from London two weeks ago.
I plan on being there again, you know, relatively soon with my colleagues and working with the London Clinic, which is really the marquee institution in London treating back pain. They bought the London Spine Clinic. And we've got that physician advocacy. We're starting the actual, you know, sales and marketing tactics in that market. This is a market you should definitely be looking at us reporting out on in terms of, you know, when we reduce the barriers, the reimbursement barriers, good things happen. Back to the United States. We have Category III CPT codes, which is really the, you know, the starting point of enabling reimbursement in the United States. We need to transition those to category I. We obviously need to drive more scan volume. Then we need to partner with surgeons and KOLs and societies to engage the payers with our evidence.
The good news is we've done a tremendous amount of hard work and leveraged our personal relationships to bring a list of key opinion leader surgeons in the United States that companies, you know, way bigger than us would, you know, it's the envy. Many of these are participating in the CLARITY trial, but they're all going to the podium at society meetings advocating for the use of NOCISCAN , certainly over provocative discography. Let me just briefly talk about the management team, who's all been in place with zero turnover. The entire team is at zero turnover from the time of our IPO three years and two days ago. Jeff Thramann , our Executive Chairman, is a board-certified neurosurgeon, a serial entrepreneur. He's got lots of public company experience. He's sold healthcare companies to private equity and beyond.
I've worked with Jeff both here at Aclarion as well as at a company called ProNerve, where we worked together. If anyone wants to, after the discussion, talk about what it's like to report to a neurosurgeon and Ironman competitor, I could have some time with you on that. It's actually great. We don't waste any time. John Lorbiecki and I worked together at Medtronic. He's our Chief Financial Officer. John is a seasoned financial executive. He actually ran the entire division of Kyphon when we did that acquisition at Medtronic as the CFO of Kyphon. It's really a blessing to have on the team. Ryan Bond, our Chief Strategy Officer, has spine experience from NuVasive and has really been leading the strategy since prior to the IPO back in 2018. He was instrumental in helping us get those Category III CPT codes and continues to be just a tremendous asset to the team.
For myself, I have relevant experience at GE, at Philips from the imaging side. The MR stuff I've got dialed in. Medtronic, I was the VP of global sales and marketing for Medtronic Navigation. Rolling out disruptive technologies globally in spine is in my background. I was also the president of ProNerve, a nerve monitoring company. My experience becomes even a little bit more relevant in this SaaS-based model, this imaging to the cloud, back to the referring physician for improved decision support as the Chief Commercial Officer of HeartFlow, which did the exact same business model in the cardiology space, and then the president and Chief Commercial Officer of Clearly in the same cardiology space.
Lots of relevant experience here from the management team. We really understand this migration from novel technology, KOL advocacy to reimbursement, and then to standard of care. You can burn a lot of money chasing cash pay business in healthcare. That is not what we're doing. What you don't do is as important as what you do. We're very focused on moving through the key catalysts that we have out there. The key takeaways here are really that we're driving this technology to the largest single spend in all of healthcare, that it is the first and, to my knowledge, only non-invasive diagnostic that can measure pain biomarkers and identify those levels. That has a strong value proposition for payers, for physicians who don't want revision surgeries, and obviously for patients.
Our financial strength, we are really fortunate at this point, again, to have a strong balance sheet with nearly $15 million in cash on hand, a clean cap table, zero debt, no preferred shares outstanding, no near-term warrant overhang whatsoever. Our catalysts were driving for that CLARITY trial. The CLARITY trial is going to be a mic drop bit of evidence across multiple centers to the payer community. We are going to drive success with the payers in the U.K. and that market. We are going to continue to expand our commercial footprint here in the United States as well. We have got a clear roadmap, established path, success for AI algorithms, back to the HeartFlow and Clearly examples. This is a business model that everybody now, the coding and everything, is appreciating that there is lots of value that can be created in cloud-based AI algorithms from radiological information.
There is a clear pathway there. Our patent portfolio is incredibly strong. We intend to, you know, maintain that and even expand that moving forward. We have CPT codes issued, clear regulatory path. We are FDA cleared, CE marked. We will be expanding into Australia as well with another key opinion leader. Again, the team, we know what we are doing. We know the plan. The plan has been tested, and it is all vetting out according to plan. With that, I will take any questions.
Yeah. The question is, how do the physicians perceive this additional information? And could it potentially hurt their practice where they do not get to fuse more levels?
I would tell you that I just recently saw an example of a physician in the pain management or the personal injury space, where a lot of times the payer says, "We don't believe you." He was able to show objective information of pain biomarkers in the disc, and then the surgery got authorized. Back to your example, your more, you know, kind of local traditional example, knowing which level to operate on and having objective information that can point to doing the right surgery. You know, like, I mean, your example is perfect. Thank you for sharing it. I say you three doctors and two different ideas of what to do with you.
Had they had this information, had they been able to look at these gray bars and say, "I don't want to go to that next level because that next level has very strong structural integrity. It's going to be okay." Conversely, if that next level had a very small gray bar, then the odds of you having adjacent level issues if you fuse the two levels below are very high. You will come back in six months because that disc just can't take the pressure of being fused beneath it. I realize this is a non-clinical audience, but it's really kind of obvious, isn't it? If you know which levels are causing pain, you can make better treatment decisions.
That's the essence of the value that we're providing. It cascades from physician decision-making all the way through the payer to a macroeconomic to the mom who can't take her kid to soccer. That is why we jump out of bed every morning, because we're making a difference for those 266 million people. You bet. Thanks for the question. Anything else?
Yeah. With societal support, the question was, will we have challenges introducing this into hospitals? Without reimbursement, yes, because nobody wants to work for free. Nobody wants to pitch a patient to get cash out of their wallet to pay for something. Until we get reimbursement, yes, there's going to be challenges. That is why we're so laser-focused on KOL advocacy, on societal support, and on evidence, because sooner or later, the overwhelming evidence, it wins in healthcare. That is why we designed that CLARITY trial. We're spending $4.6 million on a post-market trial to overwhelm the objections that we might hear on that front. That's a good question. Thank you. Follow up.
The question was, are there other challenges? Introducing a new technology into the payer community, really, it's tactical warfare, right? You got to get one at a time. The Blue Cross of Arkansas doesn't necessarily follow, you know, Blue Cross of California. There's a lot of work to do. I think that's our biggest challenge, right? We've got a tremendous amount of work in front of us relative to that. Armed with the data, with the KOL advocacy and the societal support, we will prevail. You know, I'm from North Dakota. We grew up farming. I mean, it's just work. We know the plan. We know what to do. We're just going to get to work doing it. I'm not telling you it's going to be easy. Yeah. Thank you. Good question. Anyone else?
It's been a pleasure. I love telling the story. Thank you for being here today.