Hello. Thank you so much for being with us. It is my pleasure to introduce to you Brent Ness, CEO of Aclarion. Take it away.
Thank you, Kate. For anyone in the audience or listening to this on webcast who has suffered an acute back pain episode, or who has a loved one that is suffering from chronic low back pain, I want you to know that help is on the way. Aclarion is a publicly traded entity on NASDAQ. Our symbol is ACON, and we are in absolute growth mode. We will be in your neighborhood soon. What we offer is a disruptive solution through our Nociscan platform, where we are measuring the chemical composition of the discs inside the back. Evidence has shown that when Nociscan is utilized, surgical outcomes improve from the average of 54% up to 97%. The size of this market is absolutely incredible. It is a $32 billion global market opportunity. I will dive more into the actual addressable market in subsequent slides.
We have commercial traction with private payer reimbursement occurring in three of the top five commercial payers in the U.K., and much of our investment and energy right now is focused on converting U.S. payers or bringing U.S. payers on board. We have tremendous expansion in our physician referral patterns, both in the United States and in the U.K. We have launched a national randomized control trial called the Clarity Trial, where 300 patients will be evaluated, again, on a surgical outcomes basis, which is really quite unique for a diagnostic platform to be evaluated on a surgical outcome basis. But we are confident that that early single-surgeon, single-site evidence that I mentioned earlier will be replicated. We have now, as of today, $14.2 million of cash on hand, which fully funds the Clarity Trial and moves us well into 2027.
When I was referencing your loved ones earlier that maybe suffer from chronic low back pain, they are not alone. 266 million people suffer from this debilitating ailment, and I can tell you that the costs associated with the treatment and diagnostic of back pain is the number one expenditure in all of healthcare. So we are helping to solve a massive problem. There are 330,000 fusion procedures. When you think about the treatment of back pain, massage and chiropractic are kind of early stages. But it goes to the other end of the spectrum as a highly invasive fusion procedure. These are very expensive procedures, $58,000 for a one-level procedure, $71,000 for a two, and the costs go up from there, and $38,000 for a total disc replacement. Unfortunately, in spite of the invasive and sophisticated nature of these procedures, the average success rate hovers around 54%.
$6 billion are spent in the U.S. alone on revision surgeries. What we're trying to do here is make sure that the physicians are armed with all of the information, the chemical, before the structural information, so we don't have to bring these people back in for surgery later. When you think about the indirect costs, 20%-30% reduction in work productivity, absenteeism from back pain is off the charts. Unfortunately, a really tragic outcome of this is that back pain is the leading cause of opioid addiction in the U.S. Again, I'm setting the stage here because we're really trying to solve a very perplexing problem that is very large. From a company perspective, the annual revenue opportunity is depicted below.
I'm not going to talk about the $22 million lumbar MRIs so much as I want you to focus on these beachhead segments when you think about our company and our financial performance and opportunity moving forward. When you take our revenue per scan, times the number of pain management injections and basivertebral nerve ablation procedures, things that address the back pain market, if a Nociscan were applied to those prior to doing those procedures, we would be looking at a $6.7 billion revenue opportunity for that pain management alone. Then you add the surgical decision support, and you add another $478 million. Roughly a $7 billion beachhead segment that we're going after in terms of revenue opportunity, so tremendous. Here's the problem.
When you go to your doctor and you bring him your MRI, he or she is trying to make a decision about, "What am I going to do to treat this patient?" They look at that, and there's nothing obvious wrong with that particular spine. You might see a little bulge down there at L5, S1, the bottom one, but it's just not indicative of the pain symptoms that you're describing to the physician. It really leads to a high degree of surgical variability. We know that variation in any process really is the evil to any process, and therefore poor outcomes follow, and it's really the definition of low-value care.
What Nociscan provides for a physician is a personalized measurement of the chemical nature of the discs inside that MRI picture that really, if you want to talk about our superpower, we help physicians see the invisible, the chemical nature of the disc. I'll explain to you how this actually works anatomically in just a minute, but when they know this information, it lowers costs, it improves outcomes, and ultimately drives higher value of care. What do we actually do? Well, in the MRI down the street from where you live, there is a sequence called spectroscopy, little known and kind of a niche little way of an MRI to pull data out of an area of interest.
What the brilliant scientists that founded our company discovered is that when there are high levels of acids inside the disc and the structural integrity of that disc has degraded a little bit, the nerves have grown into the disc tissue, and as nerves hit acid, it causes pain. The problem is, as I described on the slide before, you cannot see that. You cannot see the chemical nature of pain inside the disc, and yet it could be the exact source of pain that brings people back after surgery that was unaddressed in the original procedure. We measure alanine, lactic acid, propionate in the numerator of our algorithm and carbohydrate, collagen, and proteoglycan in the denominator of the algorithm that is up in the cloud. The squiggly lines on the right is spectral data. That is a spectral plot, spectroscopy.
There is no picture being generated by our scan, but nobody knows how to read that. That is highly complex information. We could talk about where does proteoglycan live on the spectral plot on this and try to figure that out. What we have done is we have taken this complex information, and we have translated it into a simple-to-interpret report and clinically actionable information for the physician. It is not being used in its spectral raw spectral format, but we can derive tremendous value from that data. What we have learned in the early trials is that there is a clear separation with these algorithms when the ratios come out between painful and non-painful discs. You can see here the different plots on this.
Painful up and to the right, not painful down to low, and it really comes down to that proteoglycan strong structural integrity has remained in place, whereas the high acids, if the proteoglycan is low, that is a painful disc. That is to highly simplify it. Having that clear delineation between painful and not painful enables us to deliver this. This is the segments of our physician report that goes back to your treating physician that clearly points out where those acids are high and the proteoglycan is low. We also include this, we call it the SI score, the structural integrity score. That is on the right-hand side. Because when a physician is making a decision about what to do with you, understanding the adjacent level strength will play into whether they are going to treat that level or not.
The physicians that are using this test now, the early adopters, they absolutely love it. This is insight that they did not have before. Pain is chemical before it is structural. We are moving upstream on all of this. We have a tremendous patent portfolio, 62 active patents in the use of spectroscopy to identify painful discs, in the use of AI to identify painful discs, and a lot of kind of in the weeds type patents around how do we separate those spectral plots to ensure that we have accurate data assessment. We have better patents on spectroscopy than the big gear players in our space, and we are really quite proud of that. I would like to talk to you about what physicians have to do where there is not Nociscan available if they want to really pinpoint the discs that are causing pain. This is a test.
We'll call it the prevailing gold standard. It's called provocative discography, and it's as painful as it sounds by design. The patient is awake on the table, and their discs are being injected and pressurized. They're asking when they inject the first disc, "How does that feel?" It's somewhat subjective, isn't it? Then they go to the next disc. "How does that feel?" Then they hit a disc that is actually full of acids, and the patient is screaming off the table. It's somewhat barbaric. Effective, but barbaric. What we're replacing is an invasive, expensive, subjective, and painful test with a non-invasive, not painful, much less expensive, and objective measurement of what's actually going on inside the disc. We feel pretty well-armed in terms of displacing discography.
Our early studies, the Gornet trial, showed that 97% success rate when a Noci positive disc was treated, as opposed to when that was missed, the performance actually dropped down to 54%. Right in line with national averages, by the way. Go figure. That was durable evidence at two years. The insurance companies are looking for more than a single surgeon, single site evidence to hang their hat on to make coverage decisions on. With our limited resources, we have launched a national randomized control trial called the CLARITY trial. Nick Theodore, former chairman of neurosurgery at Johns Hopkins, is our PI. Nick now has made the move to the University of Arizona Health Sciences, and obviously retained the PI role for us and added the University of Arizona to the trial.
We have 11 active sites participating in the trial with a strong funnel of world-renowned names that are coming in. But even the names that are in there, University of Miami, Advocate Aurora Health System, Northwestern, Scripps, USC, it goes on and on. Our KOL relationships are absolutely fantastic. This trial, 300 patients, blinded, unblinded, will measure outcomes at three months, six months, 12 months, and will measure missed and matched, just like the Gornet trial did. Missed and matched as well as blinded, unblinded. Did the physician change their mind after they became familiar with Nociscan? Because that speaks to clinical utility. This is an ongoing trial. We are very committed to it and committed to all evidence. Just last week in the European Spine Journal, another peer-reviewed published paper was published on the use of Nociscan and its correlation to provocative discography.
In other words, can we replace the gold standard? Fortunately, the conclusion of that is absolutely. As they learn their technique and whatnot, they see a pathway to replace discography. We've got eight current, or nine now, current peer-reviewed publications, and we're going to continue to build on that evidence over time. With the CLARITY trial, of course, that's the primary thrust of what we're doing. Our proxy market, the U.K., three of the top four health insurers are already paying for Nociscans. We're seeing nice enhanced adoption when that removal of the payer barrier is removed. We're thrilled to have that, and we certainly will leverage our strong physician advocates, our strategic marketing initiatives, to approach the fourth and largest private payer, Bupa, in the months to come. We're actually already engaging with Bupa through our colleagues at the London Clinic.
Look for more success on the payer front in the months to come. In the U.S., we have Category III CPT codes. There is a billing mechanism in place right now where we can bill the private insurance companies with these codes. The point over time is to increase scan volume, which fortunately, if you have read the letter to shareholders that got published this morning, we are seeing nice scan volume growth in the U.S. It is to transition to a Category I coverage decision. But along the way, we will get coverage decisions from payers, from individual payers, private payers in the U.S. as we engage them. Not really we, believe it or not, they do not really care when I call UnitedHealthcare. But when our KOL surgeons in markets where there are lots of patients, United patients, they take the call.
Here is a list of our key opinion leaders that work tirelessly on our behalf. We are thrilled to have them. Companies much larger than us are envious of this list of professionals. We are really, when you look at the brand names of those health systems underneath there, it is a powerful lobbying group. Many of these sit on chairs and presidents of societies, and getting society support is super critical. I am thrilled with our team. We have 13 full-time employees. We have had zero turnover. Jeff Thramann, our Executive Chairman, is a board-certified neurosurgeon and a serial entrepreneur. He has been instrumental. It is nice when your Chairman is actually a sample of your customer, so we can bounce things off of him, and he is also a West Point grad and an Ironman competitor. Imagine reporting to a guy like that, right?
Fortunately, we have a great relationship, and we never have to waste any time wondering what each other is thinking, which is super healthy. Greg Gould, our CFO, he has been on board for just over a year. He has been the CEO of multiple public companies. He has been a tremendous asset. We are thrilled to have Greg on board. Ryan Bond, our Chief Strategy Officer, has been leading this strategy since 2018. He has got a strong background in healthcare and spent time at NuVasive, which of course is a powerful player, or was a powerful player before the acquisition to Globus in the spine marketplace. I have been around the block a little bit with GE and with Philips on the imaging side. I was also the Chief Commercial Officer of a company called HeartFlow. HeartFlow is now a $4.5 billion market cap.
The strategy that we are deploying is that strategy that I was involved in executing there. It is the same business, but in the cardiology space, imaging up to the cloud, put your algorithms to it, and bring back a better decision support tool, so the treating physician can make better decisions. The difference between the two companies is our market is bigger. We are executing the same strategy that has been proven in the marketplace, and it is nice having been there and at Cleerly, a company in the cardiology space as well, because I have already traveled this journey. I can see around the corner of the things that we need to do, so we do not waste a lot of time or money on things that are not going to be effective. With that, let us just wrap it up. Key takeaways here.
The largest spend in all of healthcare, back pain. We are the industry's first non-invasive diagnostic to help physicians understand to pinpoint where that pain is coming from a chemical nature. We have a very strong balance sheet now with $14.2 million in the bank. That gives us a nice cash runway all the way through halfway, let's just call it into the third quarter of 2027. Clean cap table, no debt, no preferred shares outstanding, no near-term warrant overhang. Our evidence path, I think I hammered that pretty hard. We are very committed to evidence because that's what the payers demand. Again, we're not wasting any time. We're getting the work done that the payers will demand because once those insurance coverage dominoes start to fall, that puts us in an incredible position to scale quickly in a high-margin, SaaS-based model. At scale, this thing is beautiful.
We help a lot of people, and we're fairly compensated for it, and our shareholders will benefit greatly from that. We've got a clear roadmap moving forward, utilizing AI appropriately, as well as our patent portfolio is fantastic. We've got the CPT codes. We've got a management team that knows what we're doing. Frankly, dare I even say, we're having fun. We're having fun because we're winning and executing, and that's probably the most important telltale sign as to whether we'll be successful in the future. With that, I welcome your questions. Yes.
What a fantastic presentation.
Thank you.
I know you summed everything up. Thank you. I'm curious, since you have this clean cap table, cash in the bank for a runway, are there any acquisition targets, or is there a pipeline, or is that not even something that you're interested as you grow?
Yeah, I'm absolutely interested. We changed the name from Nocimed, Noci is Latin for pain, to Aclarion because we believe that the platform nature of these SaaS-based businesses is a perfect way to aggregate and to create, generate value. So we are always looking for opportunities, and yet I feel in the short run here, it's important for us to execute and to demonstrate that the capital that we would require to make an acquisition is actually something you'd trust me with, or not me, but trust our team with. So we're going to execute here, but long-term vision, for sure. Even within our own technology, spectroscopy, the patents that we have can be used breast, brain, prostate.
As we work with GE and Siemens and Philips and Canon to bend the laws of physics further with bigger magnets and better technology, maybe other areas of joint and orthopedic pain. So lots of expansion opportunities. I can't wait to get there, but we got to get after this and execute here first. Other questions. Yes, sir.
Does the Nociscan currently focus on invasive procedures like spinal fusion, disc replacement? Could it be used for-
Great question. Your chiropractor would benefit from knowing if your disc is full of acid. Any type of analysis of what treatment you might need, be it a, like I said, a basivertebral nerve ablation procedure, a disc replacement, an injection. The other thing, I love the question, and by the way, just to repeat it, he was asking, can this be utilized for other procedures other than just fusion and disc replacement? Great question. As we see lots of dollars being invested in therapies, like the injectionable things into the disc, we're the perfect complement to that. Where are you going to inject it? You got to know where to put the goop. If you're going to spend all this money making therapies, know where to put it.
And by the way, helping them execute their clinical trials, it's brutal when they're having to measure results of going into a disc that isn't going to show any results. They want to show results. Thank you for that question. Good one. Any other? Yes. Yes. Yeah, so great question. We actually had the inclusion criteria too tight. We've recently, just in the last month, expanded the inclusion criteria, which is going to make it statistically a little messier, but it's real-world. At the end of the day, we're going to see, and we are already seeing increased adoption at those nine sites where the change in protocol has been adopted.
We haven't changed the end date, which was three years after the first patient, which was mid-2025. Because this is not an FDA trial, we are capable of utilizing that information and bringing that forward so that the shareholders can benefit from it as well along the way. I see that I am wrapping up here with 12 seconds to go. I promised Kate I wouldn't go over. I'd be happy to meet with any of you throughout the conference as well. Thank you very much.