We have Jeff Thramann for Aclarion.
Thank you. Thank you everyone for showing up. My name is Jeff Thramann. I'm the Executive Chairman of Aclarion. Aclarion is a healthcare technology company where we're utilizing biomarkers to essentially identify painful discs in conjunction with some augmented intelligence algorithms that we've developed. I come to this space with a background as a neurosurgeon, fellowship-trained in spine surgery. I left neurosurgery in 2008 after I invented a new way to fuse the spine together, built a big medical device company around that, and then sold it to a public company. This is our standard disclaimer statements, goes over the risks associated with forward-looking statements, which I'll be making today. I'm going to start by just going over some of the strategic and financial highlights.
I like to start with the first bullet up here, and the second bullet on this thing under the disruptive solution, because this is what we're really about. This is the value proposition that Aclarion is bringing to the marketplace. When you look at spine surgery, it's a very complex decision-making process as to what surgery you do in the first place in the area that we're focused on, which is chronic low back pain. If you have a herniated disc, it's pretty easy to figure out what the problem is. If you have a tumor, a fracture, something like that, pretty easy. When you have somebody coming in with pain and MRI imaging that just shows degenerative changes that are essentially equivalent to wrinkles on your face, just basically shows that you're old, where do you do the surgery? That's the biggest problem.
If you look at the literature for these cases, it shows that about 54% of the time, we get it right on the first surgical intervention. Our early studies show that with our technology, when you utilize that to make your surgical decisioning, we're showing that you can have the potential to get 97% correct the first time. That's really what this is all about. Now, to get there is obviously a process of driving commercialization, getting payer coverage, and getting the surgeons on board. Commercial traction is something that we highlight and that we push for, and you can see here that we're making significant progress on that, especially with our year-over-year Q1 results, about 196% year-over-year growth there. A lot of that's coming from what we did in the U.K. We got our first payer coverage decisions in the U.K.
The U.K. market's much different than the U.S. market. It's much smaller, and you go piece by piece. Really the equivalent group of population that we have in the U.K. that is covered by an insurance company is about five million. We use that really as a test bed to show what could possibly happen in the U.S. as we start to go through the process, we get the commercial payers to approve this in the U.S., we'll be going through some of where we are on that. On the next bullet, a main highlight here is the CLARITY trial. This is a prospective randomized trial designed to really prove that those 97% outcomes on the first surgery are real. We have it in a trial right now with 73 patients. It's a retrospective study.
We're now doing it multi-center prospective in a head-to-head trial. It is very difficult to argue with the clinical results. 150 people in one group, 150 people in the other group. In the one group, everybody has a Nociscan done, which is our technology. In the one group, the surgeon doesn't get to see it. In the other group, they do. We're going to see how that matches up, we've got great centers behind us on that, we'll talk about a little bit who they are. Of course, we have the financial strength to execute through some key catalysts, the biggest one being the CLARITY trial, we're going to put out our early results on that. The first interim results in Q4 of this year.
Just to give you a picture of the overall problem, it's a huge market. There's a lot of patients that are dealing with chronic low back pain worldwide. A lot of folks in the U.S. who are dealing with this, when you go in and you do that surgery that I was talking about, it's extremely expensive. It's very important to get it right, that's essentially what we're going after, we're doing that by attacking the market in steps.
The first step here is really this $10 billion opportunity that we're putting here, if you look at some of the subheadings there, you see what the real opportunity is, which we think for us is those number of cases times the $950 ASP, which is what we think we're going to get from CMS, that pricing follows what HeartFlow and Cleerly have done. HeartFlow, they were the leaders in taking AI algorithms to CMS and to the payers, they created these codes. We got pushed into those same codes, the only one for back pain. There's three different companies that have those codes for cardiology. We're the only one in the chronic low back pain space with that.
When we're looking at the first market there, the $10 billion, what we're looking at is those are chronic low back pain patients where the surgeon has made a decision that it's the disc that's causing the problem, and they're going to replace that disc either with an artificial disc, or they're going to take the disc out and they're going to fuse it, and so that's our first approach. If surgeons start to get very comfortable with that, if they're seeing anything close to the 97% improvement that we think we're going to drive, the surgeon's going to want this information on most of their cases. That's where you jump up to the $40 billion piece. That's the non-fusions, that's the laminectomies, the decompressions. That's where the surgeons are going to want that information. That's about four times the size of just the fusion market.
As you move further up the decision cascade, up to the patient has chronic back pain, what are we going to do? Are we going to send them to physical therapy? Are we going to do injections? Are we going to do regenerative technologies? Are they eventually going to go to surgery? What's the best path? That's really the triage space. We think long-term, that's where we wind up, and that's the most expensive diagnosis we have in the U.S., and that's low back pain at about $135 billion. That $135 billion number also includes cervical. We're not addressing cervical, but the bulk of that $135 billion is really lumbar. This is just a little bit about what the surgeon is faced with when a patient comes in.
Again, if there's not a herniated disc, if there's not a tumor, if there's not a fracture, you're basically looking at a normal MRI with degenerative changes. You have a patient that's been through the process of knowing that they have chronic pain, and you're saying, "Where am I going to do this operation?" The answer is, you don't really know for sure. You know that L4, 5, which is the second to the bottom level, and you know that L5, are one of the most common, so you could potentially do those. If you have degeneration at the other levels, you're talking to the patient, and you're basically saying, "Listen. We can go and we can do one level. We can do L5, S1. It's the most common, and that's the one that looks the worst, maybe, on this image.
We'll just leave it at that, and we'll see how you do. We could be more aggressive and do two of these levels, L4, 5 and L5, S1, because they're very common, and we can see how that goes." The point is, you don't know. You could decide to do L5, S1, and that could be the main source of the pain, but the other one, L4, 5, could be close. Now you're transferring additional stress to the next level, and you may do a perfect operation, and now you made L4, 5 painful. It's a very complex procedure, or decision-making process. With our technology, this is essentially what we provide. We basically tell them which one has the biomarkers and the structural integrity markers that indicate it's a painful disc.
Obviously, much easier to make a decision what surgery you want to do when you're looking at this than when you're just looking at an MRI and telling the story. We did a study with a surgeon by the name of Dr. Matt Gornet. He is in St. Louis. He had 73 patients went on to surgery. All the patients had the Nociscan technology performed. He didn't get to see it in any of them, so he was just making his decisions the way he normally does. He happens to use discography, which is a competitive technology that's out there. It's a gold standard up until recently, when it was indicated that it's creating some problems. He was still a user of discography when he did this. Long story short, after the surgery was done on all these 73 patients, we broke them up into two groups.
In one group, we looked at all the patients where the surgery he did matched up with where Nociscan said the disc was painful. In the other group, we looked at it and said, "Okay, this group, it doesn't match. It's a different surgery." What were the results? In the group where there was no match, it was 54% hit the criteria for significant clinical improvement, and in the other group, it was 97%. That's the data, and this holds pretty well for out to two years. That's the data that we're counting on here. That's the value proposition we're bringing to the table, and that's what we're trying to prove out in the CLARITY trial through that prospective randomized trial. I'm going to give you this next slide. I'm going to give you a surgeon.
This is the guy in the U.K. who we contract with. He has payer coverage there. He's the head of spine surgery at The London Clinic. It's the biggest private center in the U.K. for spine surgery. This is a one-minute video, but it really just gets to what I've been saying from another surgeon that's out there. What's super interesting about this guy and his group is we first went to them. They were the biggest discography users in the U.K. They thought there was no chance that they would use the Aclarion technology, but they were intrigued, and they wanted to test it out. They wanted to do a trial of 30 patients where they would go through that and compare it. They got to 20 patients, and they said, "We've seen enough.
We're flipping over to this technology." They've been leading the charge in the U.K. That model of taking this to the surgeons, letting them understand what it is, letting them compare it to what they typically do, that's what drives this, and that's what we're trying to do in the U.S. as well.
I'm interested in Nociscan because it's the first advance we've had in MRI scanning of the lower back for over 40 years. We can now finally identify damaged discs in the back which are actually causing pain. I've incorporated Nociscan into my clinical practice to accurately diagnose where the patient's pain may be coming from when other tests have failed to demonstrate this. The value that Nociscan has provided to me and to my patients is our ability to diagnose accurately where their pain has been coming from, and therefore, to target treatments to those areas. One patient who clearly demonstrated how Nociscan has helped had been treated for many years for damage to his L4, 5 disc, as seen on a conventional MRI.
He had had facet joint injections and was even considering surgery to that disc. We performed a Nociscan, and that clearly demonstrated that the pain was actually all coming from his L5-S1 disc below. We treated that disc, and his pain settled down completely.
Again, that really just highlights really what it's all about and what we're driving towards. A little bit about the product. Well, how do we do this? Every MRI scanner that's out there, any modern MRI scanner, they have what's called a spectroscopy sequence. When we order an MRI as a surgeon, you see it as MRI of the lumbar spine. We get back T2-weighted images, T1 images, FLAIR sequences, fat sat sequences, spin echo. We get all this extra stuff that's part of that to see all this additional information. That's what allows us to interpret what's going on. One of the sequences that these MRI scanners can run is called spectroscopy. The difference between spectroscopy and all the other sequences, all the other sequences feed into software that gives you an image. The data from spectroscopy doesn't give you an image. It's unreadable.
That data then goes directly from the MRI machines. It comes out to us. We have proprietary technologies, 60-something patents that cover all of this, that take that unreadable data and turn it into this graph that you're seeing here. What this is all the biomarkers in the spine that are able to be picked up by spectroscopy. We take the area under the curve there, and we're looking and we're measuring acidic pain biomarkers and structural integrity biomarkers. We take those, We stick them into our algorithms, Then you can see that there's a really good separation between painful and non-painful discs. Then we give the surgeon a report that looks like this. There's a bunch of data behind this they can drill into if they want, but this is generally what they get and what they see.
Covered by strong intellectual property across the board internationally. We've had this vetted extensively. There is essentially nobody that can do this other than us. A little bit about the competition, because discogram is out there. It's been the gold standard historically, but it's much different. It's an invasive procedure, and if anybody's ever had a discogram or had a loved one that had one, you have to stay awake for the discogram. You go in, and you meet up with this doctor, and he's going to take a needle and stick it into your disc. He's going to pressurize that disc, and he's going to ask you if that's the same pain you have when you're having a bad episode of your back pain.
As you can imagine, that's not a pleasant thing, and the results are very determinant on how good that examiner is and how good they are at fleshing out. Even that, under the best conditions, you pressurize a disc, you transmit pressure to the level above and below, and you can get a false reading. It's subjective. It's invasive, it's painful, it's expensive, and there can be some complications associated with it. We essentially took a bunch of that data, along with some outcomes data, put it into algorithms, and trained our model to reflect this. We correlate pretty well with discogram. We think we're better, and the reason we think we're better is because we do better on that Gornet trial. 97% is better than discogram ever was.
We think it's really the objective nature of identifying these biomarkers that is really driving this, and we're going to find out when we put out the results of the CLARITY trial. Here's the CLARITY trial. I talked a little bit about this already. The principal investigator is a guy by the name of Nick Theodore. He was at Johns Hopkins when he started. He was the head of spine there. He now took the chairman position at the University of Arizona for the neurosurgery program in Phoenix. He's organizing this study. We had our first patient was enrolled last year in June, and like I mentioned, we're going to put our first results out in the fourth quarter of this year.
What we're hoping to be able to say is that, because the whole trial goes on for a long time, and with these trials, you follow these patients for two years. One year is our primary endpoint. The data that we'll be putting out into Q4 is data related to the first visit from these patients, which is three months. We think we're going to have enough there to give a pretty good idea of whether we're tracking towards this 97% versus 54% grouping. In addition to CLARITY, we've had a bunch of publications that we've put out already. Eight have been published in peer-reviewed journals so far. Covers about 250 patients. We continue to do this, and a lot of these are led by surgeons. They come to us, and it's very much like the group in the U.K. They say, "We're interested.
We want to look at our results as part of a study. We'll do it. We fund a little bit of it, but it doesn't really cost us much. They mostly are doing it. One of the reasons it doesn't cost us much is because our margins on this are phenomenal for a med tech product, right? If you know anything about med tech, you know that cost of goods is a big issue. This is software is new, and our costs are whatever it costs to send this thing through the airwaves over to the computer to analyze it. Very significant gross margins in the space. U.K. payer coverage. Talked a little bit about this already as well, I'm not going to go over it, but we have three of the top four private payers in the U.K. have approved this.
The big difference between the U.K. and the U.S. is when you get approval, you get approval at a facility. We have approval at The London Clinic. If we want to get approval at the HCA hospitals over there, that's a different pitch. It's usually led by the hospital, we're in the process of working that. We have commercial folks on the ground there, as I said, a significant portion of our growth is related to what we're doing there. We look at the U.K. as a proxy as to what's possible once you have the coverage decision. I'm not going to go through this one because it's just a rehash of what I already said of how we got into The London Clinic, getting those strong physicians, putting marketing dollars behind it, then driving the volume there. These are the codes that we have.
These are the CPT III codes. This is a big part of the game, big part of every med tech product. You got to get from category 3 codes over to category 1 codes. The way you do that is you get key opinion leader physicians behind the product. These are people who head up the societies at big institutions, go to the podium at the meetings, they're talking about this technology. You've got to get the private guys to use it too, because there you don't have as many restrictions as you do in the academic centers. It's a cleaner, faster process to get through. We're working on all of that, on driving this surgeon adoption at all of these different places. This is our group of key opinion leader surgeons that we have. You can see they're coming from significant institutions.
I'll point out Eric Potts, he's the President of the Spine Section for the Congress of Neurological Surgeons. Juan Uribe is right behind him. He's down at the Barrow. The Barrow is the busiest neurosurgical center in the U.S. That's where I did my residency program, I know those guys well. Dean Chou heads up the Advocate Aurora program, got us put in there. We have Northwestern, we have UCSF, one of the top two orthopedic programs in the country. Very strong KOL groups that we have here. We have the management team. I spoke a little bit about my background, Brent Ness is our CEO. Brent has long experience in this space, really interestingly, he is the guy who is the first commercial officer for both HeartFlow and Cleerly.
Those are the other groups that got our codes in the cardiology space and pushed those through. Brent ran this playbook for those guys, and as you know, HeartFlow, or you may not know, HeartFlow went public last year. I think they went out at somewhere in the $2 billion range, ran up to $3 billion. Did very well. They had a difficult path, a much harder path than us. I'll say it because not only did they take forever to get these codes, because you're going to the AMA to get these codes. It's a process. They got the codes, took them a long time. They spent a lot of money doing that. Here's the other thing they had. They were taking out the two biggest cash cows for cardiologists. The two biggest things they do, that's cardiac catheterizations and the stress tests.
No reason for them if you use their algorithm. They had to get the cardiology societies to adopt that, and you can imagine what that looked like. Ultimately, the clinical evidence was so overwhelming that they couldn't do anything about it, and they had to go forward with it. We come in in a completely different situation on the spine world. Spine surgery, because of that 54% result, you can imagine how much pushback there is on trying to approve surgical interventions in the spine. It's huge. It's every surgeon's number one problem.
If you can come up with a technology that facilitates that, where you can send that to the payers, they can see it, and then they say, "Okay, if the surgery's going to match up and we have clinical data that says they're going to do very well," it's going to be required, in my opinion, on every single fusion case. You will not get a fusion case approved through an insurance company without having this technology done. That's where I think the promise goes on this. Brent's been through that process. He's driven it through a much harder process, and his background is more associated with spine than it is with cardiology. Greg Gould, he's a new CFO that came in and is joining us. He has a ton of experience in the public markets, particularly in the microcap space.
Ryan Bond's been with us for a long time. He's the Chief Strategy Officer, got us the CPT III codes. He's working on the CLARITY trial, does really well with surgeon interface and getting them to adopt this and driving those KOL groups to continue to use. In summary, this is really just a summary of everything that I've said and addressing huge markets. We're in a great position financially to execute on these key catalysts. The next key catalyst is really going to be these early results of the CLARITY trial. I think if those are looking positive, that's a real trajectory changer for us. We have a clear roadmap. It almost couldn't be simpler for a med tech type product. We have to execute on this trial.
The results have to show that they're good, the surgeons are going to adopt this, in my opinion, very easily. Then we're ready to roll and we got a great team behind it to drive it. With that, I'll open it up to any questions. Yes.
Technical load up of blinding in CLARITY, whether the ultimate evaluator is unblinded in any way?
Well, they don't get to see the result, so they won't see the result of the Nociscan. Everybody in the trial is getting a Nociscan, so everybody knows that everybody got one, but they will not see the result.
How is that tying with what you're going to say in three?
Well, what's nice about our study is it's not an FDA study, right? We're already cleared for marketing approval here in the U.S. We're cleared overseas and we're actually running the cases. Obviously if it was an FDA study, we wouldn't be able to say a word about anything. It's not. This is a post-market study. We can say whatever we want as long as it doesn't interfere with the quality of the results. Yes.
What percentage of the patients across those studies have a negative Nociscan? Whether they're coming in with low back pain, they've been evaluated for surgery, and the scan comes back saying that none of these discs are problematic. That's what the insurers want.
Yeah. That's-
I don't have that data to tell you what that looks like overall. I can probably get it, and I think that's something that we would be able to put out because we have the data on everybody, whether they're normal or not. Now, you have to have pain to get this to work because the way the algorithm works is it compares one level to another. If you don't have any pain and you do this on a normal person, it can be all over the place because you don't know where the pain threshold is in that one individual. That's one of our core patents actually, that compares one to the other. Spectroscopy has failed in the past in the brain, and it's also failed in the prostate, and the reason is, we believe, because they didn't have something to compare it to.
They were looking to create a scale and say, "Okay, if the score is 25, it's painful." Well, that might be painful for you and not painful for me, right? It's completely different. You need that internal control, and we have the IP on that. We look at this as a platform technology, and we can go on to prostate, brain, and breast as other things that we can bring this to. Any other questions? Okay. Thank you. Appreciate it.