Good day, everyone, and thank you for joining us today for the Lytham Partners Fall 2026 Investor Conference. My name is Joe Diaz. I am a managing partner at Lytham Partners. I would like to welcome Aclarion, Inc., which trades on the Nasdaq under the ticker ACON. Today, Brent Ness, Aclarion's Chief Executive Officer, will be taking us through the company presentation. Let's get started. Brent, welcome, and thanks for spending a few minutes of your busy schedule with us.
You bet.
I will turn the floor over to you.
Thanks so much, Joe, and thanks, everyone, for taking the time to learn about the Aclarion story and our groundbreaking technology called NOCISCAN. We have a disruptive opportunity to help in one of the largest spends in all of healthcare. This is a NOCISCAN platform that enables proprietary AI-powered detection of biomarkers to identify areas in the spine that are the source of pain. We have up to 97% surgical success rate versus 54% with our current evidence that has been published, and it is a $32 billion global market opportunity, so one of the largest spends in all of healthcare. We have private payer approvals in England, 141% year-over-year NOCISCAN volume growth in the first half of 2026 versus 2025, so we are an absolute growth story. We are expanding physician referrals and commercial support throughout the United States.
We've launched the CLARITY Trial, which is a national randomized control trial, which is going to help us engage with the payer community and physician adoption as we continue to grow. The first patient has been enrolled in CLARITY back in 2025. We have 11 sites that are actively enrolling today, the CLARITY Trial is up and running, and we'll release results when they're available. We have $16 million of cash in hand as of June 30th. And we've got a cash runway that'll take us deep into 2027, which enables us to really get through most of that CLARITY Trial and continue our growth story. We have a clean cap table, no debt, no preferred shares out, no near-term warrant overhang. There are 266 million people around the world that suffer from chronic low back pain. I'm not talking about the weekend warrior sore back.
This is the type of pain that really is disabling. These people can't go to work. They're unable to live a robust life. To address that, 330,000 spinal fusion and disc replacement procedures are done in the United States each year at an average cost of somewhere between $38,000 and $71,000 per procedure. The problem is that the success rate of those procedures hovers around 48%-54%. Post-surgery, these people are still in pain, and 6% of these procedures actually end up in a revision surgery. If you just back in and do some math here, that's over $1 billion spent in the U.S. alone on revision surgeries. The cost of this epidemic is absolutely staggering, and not just in dollars and cents, but work-related absenteeism. It is the leading cause of opioid addiction in the United States. The problem is huge.
The market is huge. Again, globally, 22 million lumbar MRIs without contrast are performed. In the markets where we're currently actively commercializing, the United States and the United Kingdom, there are 6.7 million MRIs done, and that equates to a $9.8 billion revenue opportunity for Aclarion if we had 100% penetration for every lumbar MRI that was done if a NOCISCAN was done in conjunction with that. If we go right to our beachhead segments and start thinking about this from the procedures that treat the back pain back up, 4.6 million injections and pain management procedures are done in the U.S. alone. That would equate to $6.7 billion in Aclarion revenue if an NOCISCAN was done for each of those.
If we go to the most acute form of treatment, surgery, either disc replacement or fusion surgery, 330,000 of those are done in the United States each year, which again, if you extrapolate out the math on that equals a $478 million revenue opportunity at full penetration. The market is huge. The revenue opportunity is very large. Now, why do we need it? What's the case being made for us to actually ask physicians to get NOCISCANs on their patients? I think the picture on the left-hand side of this slide really tells a story that it's difficult to look at that and say which of these discs are causing the pain. Where is the pain in that picture?
Which, of course, leads to high surgical decision variability and treatment variability, which is expensive. It leads to poor outcomes, and really is the definition of low value of care. Current imaging approaches fail to identify discogenic pain. You can't see pain on that image. What we're doing is providing objective measurements that enable the treating physician to identify those discs in the spine that correlate to the standard of provocative discography in terms of which of these are painful, which, of course, is a personalized way to really optimize the treatment, which lowers costs, leads to better outcomes, and by definition, is high-value care. In the weeds of all of this, it is the use of MR spectroscopy that enables us to get to this personalized data.
What we've done is we use MR spectroscopy to measure the area underneath these curves of these acid pain biomarkers and structural integrity biomarkers. We've learned that in a certain sequence or algorithm of those biomarkers, there's clear delineation between those that correlate to pain to the standard of discography and those that do not. What happens in the disc is, as the structural integrity degrades, nerves can grow into the disc tissue. If there's acids inside that disc tissue, acids hitting nerves causes pain. Nobody can really read these squiggly lines up here that I referenced on the previous slide. It's hard, it's difficult, it's almost nonsensical, and frankly, impossible without our algorithms. What we've done is we've created an easy-to-interpret physician report.
These are the two primary components of the report, the NOCISCORE on the left-hand side, the color-coded and numerically supported identification of those ratios that I was referencing earlier to delineate painful versus non-painful. Then on the right-hand side, the structural integrity report. This is important, the SI-Score report, because it helps the doctors understand what is the strength of that disc, what is the likelihood that the nerves have been able to grow into the disc tissue, and really important information when we think about adjacent level treatment decisions. We've translated those squiggly lines, that highly complex radiographic information, into an easy-to-interpret report that physicians can use to make better treatment decisions. We're completely solid on the intellectual property front. We've got over 64 issued and pending patents around the world that broadly cover the use of the technology.
With that, I want to talk briefly about if you don't use a NOCISCAN today, how do we determine which disc is painful? Well, it's called a discogram. I've referenced it before. By design, it is very painful. You inject the discs of the back and pressurize them, asking the patient while they're awake, "Is that painful?" "No." Okay. They go to the next one. "Is that painful? Is the next one painful?" When the patient jumps off the table and screams in pain, then you know you've got the right painful disc. It's invasive, subjective, painful. It requires radiation. It's expensive. As opposed to the NOCISCAN, which is non-invasive. It's objective. It's not painful. There's no radiation. This is an MRI-like experience for the patient, and it costs about half as much.
The evidence, which is what should really drive all adoption in healthcare, is very strong and getting stronger. The Gornet Trial, the first year's results were published in 2019 in the European Spine Journal, paints the story of improved outcomes. 139 patients were enrolled, 73 went through surgery. 97% of patients improved if all of the NOCISCAN positive discs were treated, where only 54% improved if the NOCISCAN positive disc was left untreated. That's incredible. 54% to 97% outcomes improvement. This is a single surgeon, single site study. What we've done to improve our clinical evidence story is launch the CLARITY Trial, which I mentioned in the opening slide. This is the national randomized control trial. Our PI is Dr. Nicholas Theodore from the University of Arizona College of Medicine in Phoenix.
Dr. Theodore, when he first took the role, was the Chair of neurosurgery at Johns Hopkins, who, by the way, is participating in the trial. We will take 300 patients. There'll be a blinded and unblinded cohort of 150 a piece, and we're going to measure outcomes with the primary endpoint being 12 months. But we'll measure them at three months, six months, 12 months, and 24 months. And we'll be able to identify between the blinded and unblinded cohorts, as well as the missed and matched treated levels, how the use of NOCISCAN can improve outcomes on a large, national, randomized trial basis. We're very excited about the ongoing pursuit of the CLARITY Trial, but we're not done there. We've got several ongoing trials currently in flight.
Everything from continuing to validate the correlation to the gold standard of discography, the comparison to other imaging modalities, and the efficacy thereof of NOCISCAN, and really on and on and on. The community out there of physicians is leaning in on the evidence regarding the use of NOCISCAN. In the U.K., which should really be considered a proxy market for us because we've successfully earned treatment coverage decisions for the scans with three of the four largest payers in the U.K. market. AXA, Aviva, and Vitality are currently paying for NOCISCAN at The London Clinic today. We will expand that, of course, to Bupa and other private insurance coverages in time, as well as expand into other sites of care throughout the U.K. The model is really quite simple. We have strong physician advocates.
We put marketing initiatives in place, including a U.K. Commercial Director who's on-site living there and working in the area, and that has led to rapid and deep product adoption. The strategy will be replicated both in the U.K. as more places come on board, as well as throughout the United States when we get coverage decisions. We have Category III CPT codes today, so there's a billing pathway in the market. We'll transition those to Category I codes by increasing the number of utilizations and submissions of those codes to the payers, as well as partnering with our surgeon KOLs to drive societal endorsement. Our KOL list is impressive, as you can see here. Companies significantly larger than us would love to have this group of committed clinicians to help us with this journey, and they have been incredibly helpful.
Our management team is comprised of Dr. Thramann, our Executive Chairman. Jeff is a board-certified neurosurgeon and spine fellow. He is a West Point graduate, a serial entrepreneur with several exits, as well as a patent holder. Greg Gould joined us about a year ago, and Greg is a seasoned CFO with seven public companies to his name in terms of his experience. Ryan Bond, our Chief Strategy Officer, has been with the business now since 2018. He has been instrumental in moving the business forward and is a very committed executive in the spine space. He had experience at NuVasive previously. In summary, we are going after the largest healthcare market, the treatment of back pain, and we have the first industry non-invasive diagnostic with a strong value proposition for patients, doctors, imaging centers, and payers.
We have a strong balance sheet with cash that will take us deep into 2027. We have a clean cap table, no debt, no preferred shares outstanding, no near-term warrant overhang. We have clearly defined value-creating catalysts that are in front of us with both the CLARITY Trial as well as other evidence that will be published, peer-reviewed, and published. We have success with payers. We are expanding and growing. We have a clear roadmap. We understand this, and my own experience at HeartFlow and clearly in the cardiology space really helps us kind of look around the corner in terms of taking something from earlier stage through early commercialization to the point where at scale, the incredible business that we are riding here today will be realized and shareholder value will be realized, of course, from that.
Our patent portfolio is incredibly strong, so we are well-positioned for exponential growth in the months to come, and I definitely look forward to visiting with many of you in the future. Joe, with that, I will turn it back to you.
Thank you, Brent. Great presentation. Thank you again for your time, and thanks to everyone for watching. If you have any questions or would like to schedule a meeting with Aclarion, send me an email at diaz@lythampartners.com. That is diaz @lythampartners.com. Again, thank all of you for participating, and I hope you have a great day. Thanks again, Brent.
You are welcome. Thanks, Joe.