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LD Micro Main Event XIX Investor Conference

Oct 20, 2025

Brent Ness
CEO, Aclarion

Zero debt, no preferred shares outstanding, no near-term warrant overhang. We are fully NASDAQ compliant, meeting both bid price and shareholder equity requirements. We have private payer approvals in London, and we'll talk later about why that's so important to the future growth trajectory of the business. We have scan volume growth. Again, the second probably most important thing or the thing that follows the insurance coverage is scan volume growth. Consistent three quarters in a row, looking good for the fourth quarter, and really double-digit scan volume growth. We have expanding physician referrals, both the number of physicians referring as well as the numbers that they refer on a monthly basis. We have funded a national randomized control trial, really playing into the importance of evidence as you take a healthcare technology like the NOCISCAN, our product, into market.

The cost of that trial, the total cost all in, is under $5 million. We are very well positioned to execute on our strategy. Let's start with what matters most. There are 266 million people around the world that suffer from chronic low back pain. I'm not talking about weekend warrior, you know, you got off a long flight and your back was sore for a while. I'm talking about the kind of pain that keeps parents from coaching their kids' teams, keeps people from going to work, the kind of grinding chronic pain that frankly has led to the number one cause of opioid addiction in the United States of America. People seek all sorts of treatments for this pain. Ultimately, at the end of that road, they find themselves seeking fusion surgery or disc replacement surgery.

The average cost of these surgeries runs somewhere between $38,000 per procedure for a disc replacement up to $71,000 for a two-level lumbar fusion. The sad story is that only about half, 48% to 54% of the people that go through that invasive procedure actually report afterwards that they're pain-free or that they've had a significant reduction in pain. If you've got 80% of the folks that still are experiencing discomfort, 10% to 40% with persistent pain, it's no surprise that we end up with a revision rate of 6% of these cases going to revision. $2.2 billion in the United States alone is spent on revision surgery, aside from all the societal costs, the lost productivity from going to work, absenteeism, et cetera. I will reiterate, we are talking about the number one cause of opioid addiction in the United States.

Let's talk about the numbers a little bit relative to NOCISCAN and our market. It's a $10 billion market, that lumbar fusion market, in the United States. alone. If you take those 635,000 procedures at a price that we're going to market at of right around $950 per scan, it's a revenue opportunity of $603 million in the U.S. in that fusion market alone. Like I said, people go and seek treatment outside of just fusion. When you expand that out to laminectomies, discectomies, other types of still invasive procedures, we're talking about a $40 billion market. Multiply that $603 million by four. When you take it all the way out to chiropractic, physical therapy, acupuncture, et cetera, the market just explodes. You can see we are going after the largest single spend in all of healthcare in the U.S. and an incredible spend globally. What are we doing here?

What is the physician's quandary? When your back is in pain like these folks are, you go to the doctor and they'll typically take an MRI. If you see on the screen here on the left side of that screen, the doctor looks at this MRI and he really has a difficult time determining which of these discs is causing the pain or where the pain is coming from. This leads to a high degree of variability. If you were to show this MRI to four different surgeons, you would end up with probably six different recommendations, including here's some Tylenol, go home and sleep it off, or here are some opioids, or we're going to do a three-level fusion.

It is confusing, and I'm not disparaging anyone, it is a hard and complex problem to figure out, which makes it expensive and it leads to those outcomes I was talking about and by definition is low value. What we are doing is coming back with a technology that can identify the biomarkers inside the discs that are generating pain. I'll tell you more about that in the next slide. This leads to lower costs, better outcomes, and higher value care. Let's get a little sciencey here for a while if you don't mind. What we're talking about is the use of MR spectroscopy. I showed you the picture, an MRI picture before. MR spectroscopy does not create a picture with that data. What it does is it quantifies the area under the curve of different biomarkers inside the disc.

As it turns out, your disc can be full of acids and have low structural integrity biomarkers. As your disc degrades a little bit, nerves grow into that disc, and if it's full of acid, it screams off the charts in pain. Nobody can read these squiggly lines, right? Nobody reads MR spectroscopy data, particularly in the lumbar spine. What we've done is created a proprietary algorithm and have lots of patents around how to read this, and through all of our core science have determined that in a certain ratio of acids over structural integrity biomarkers, there is a clear delineation between painful and non-painful discs. This is the gold standard, if you will, of trying to determine what disc is causing the pain. Elevated acids, lower structural integrity biomarkers in a certain ratio that we can determine with NOCISCAN gives a clear look at what we're doing.

We are a SaaS-based model. In the MRI down the block from where you live, there's a pulse sequence capability called spectroscopy. This spectroscopy is those squiggly lines I'm talking about. We take that data from the MRI up into the cloud and produce our algorithms on it, our expert systems using AI-driven algorithms, and then we send back this simple, easy-to-translate report for the treating physician. They can look at this and say, wow, on this left-hand side of the report, I see a NociScore, and that L5-S1 disc is full of acids. When I look on the right-hand side, I look at the structural integrity biomarkers, proteoglycan, collagen, and I see, lo and behold, L5-S1 has low structural integrity biomarkers. I can confidently determine that L5-S1 is the source of pain in this particular patient.

Having done over 1,200 commercial scans, I can tell you that the results of these scans are all over the place, right? It will surprise you to look at a different scan and see L2, L3, which looks perfectly healthy on this MRI image, but it can too be screaming off the charts with pain biomarkers and have low structural integrity. Our eyes deceive us when we look at the anatomical nature of the disc, and really it is only the measurement of these biomarkers that help quote "see the invisible." That's really our company's superpower. We help physicians see the invisible. You can't see pain, but we can measure it. How do we measure it? With this very strong intellectual property asset that we have, 24 issued U.S. patents, 17 international, 12 pending. The team continues to work to advance our IP.

We've got the patent on measuring biomarkers for pain. We have the patent on using MR spectroscopy. We have the patent on AI, on utilizing AI with spectral data. We've really got the whole pizza covered here relative to this particular market. Of course, to personalize it, we've got a patent on the use of internal tissue controls when using MR spectroscopy, so using L3, L4 as a control disc when we're measuring the other discs. A very, very solid patent. Prior to NOCISCAN, what was the alternative? What is the "current gold standard?" It is a medieval procedure, frankly, called provocative discography. You're already in pain, but you go to your doctor and they put you on the table and you're wide awake, by the way, and they inject a pressurized solution into your disc and you say, okay, does that hurt?

They go to the next one and they pierce the disc and pressurize it, does that hurt? They go to the next one and pressurize it, and then you scream off the table in pain. I'm telling you, it is excruciatingly painful. It is invasive, it is expensive, but it works. If doctors are looking at that picture and they can't figure out which disc to treat, they would rather get it right than not. They put you through this. Our comparison, our gold standard we're chasing after is invasive, subjective, severely painful. It requires radiation, a CT scan, or a C-arm scan for guidance. It is medieval in its approach. We, on the other hand, non-invasive, objective, no pain. It's an MRI-like experience for the patient. You just lay there and get tested. We're about half the cost of that procedure.

We think along the value chain, patient, payer, as well as the physician who doesn't really want to do that, there's value all the way across the value chain. Let's talk about evidence. The Gornett trial, Dr. Gornett, single surgeon, single site in St. Louis, Missouri, saw 139 patients, 73 of which went through surgery. He was blinded to all of the NOCISCAN results. 97% of the patients that the surgery matched the NOCISCAN recommendations had a positive outcome, meaning I'm free or significantly reduced pain. For those where there was a mismatch, it went right back down to 54%, right back down to that average. This is very, very compelling. It was published, peer-reviewed, published article in the European Spine Journal, and these results are durable at two years.

Now, a single surgeon, single site is not enough to convince United or Blue Cross or Anthem or any of the payers to produce a reimbursement code for this. We have launched the Clarity trial, which I mentioned right in the introduction. The Clarity trial is a national randomized control trial, and we have some of the most respected surgeons and institutions around the country enrolled in this trial. We are already seeing patients. Dr. Nicholas Theodore is our PI. He just recently left Johns Hopkins, but Johns Hopkins is still participating in the trial. He is moving to the University of Arizona in Phoenix, and he is going to remain our PI. Here is this trial. 300 patients, 150 are blinded to the results of NOCISCAN, meaning the physician is blinded. 150 are going to get to see the NOCISCAN.

We are going to measure the outcomes of those two cohorts, blinded versus unblinded. We are also going to continue to measure the outcomes of matched versus mismatched. The insurance companies also want to know when the physicians see the NOCISCAN, do they change their mind? You know, it is clinical utility kind of measurement. This particular trial is going to be the mic drop. When our KOLs go up to the microphone and they present the results of the Clarity trial, a minimum of eight, we have already got eight up and running and going, but maybe up to 10 sites with 300 patients, multi-surgeon, these types of luminary academic institutions, it is going to be a mic drop type event. We are very excited about this. I talk about it in the introduction. Even one study of that caliber still is not enough.

The insurance carriers want to see multiple peer-reviewed published articles. We already have eight. We have got over 250 patients studied. We are launching because physicians are jazzed about this. They want to be involved in this. They want to get it in their hands and try it out themselves. We are allowing them to do 20 case trials here, 30 cases there. They will take it to their peers. We will get it reviewed and published over time. It is that tsunami of evidence that ultimately, and KOL advocacy, that ultimately will get the payers on board. In London, we are very fortunate to have three of the top four payers already reimbursing for NOCISCAN trials, which accounts for some of that scan volume growth that you are seeing. When reimbursement is there, it takes away that cost barrier, and then we see adoption.

This is just true of anything in healthcare. Nobody works for free, and patients don't like to pay out of their pocket for really anything. They feel like they pay their insurance company dutifully every month on their premium. They want it to be covered. The evidence with KOL support in London has actually produced the exact result that we're going after. This is a proxy market for us. When you see additional coverage take place in the U.S. and scan volume growth, you can extrapolate the kind of value that we'll be talking about. We have strong physician advocates in London. We've got strategic marketing initiatives going on. I am hiring somebody in London on Wednesday. I was just there last week interviewing. We'll have a local country manager in the UK driving growth. Of course, we will continue to see nice adoption.

In the U.S., we have AMA codes already. There's a pathway for billing the insurance companies already in place, which is great news. We will be converting those codes with the help of this population of key opinion leaders. Frankly, this group of surgeons is the envy of companies much larger and ingrained for decades in spine than what we are here at Aclarion. Through our personal relationships that we've had throughout our industry experience over time and the compelling story that being able to identify painful discs, even though you can't see them on an MRI, they're all in. I can tell you, having them call Blue Cross Blue Shield of California versus me, they don't care when I call them, but they do care when Sig. Berven calls them from UCSF.

They care when Juan Uribe from Arizona calls Anthem of Arizona because they're the scientists, they're the voice, and they're huge market movers, every single one of these surgeons. Our management team, Jeff Treyman, our Executive Chairman, who, by the way, is at the conference here, and if you meet with us later, he'll be around, is a board-certified neurosurgeon, came out of the BNI, one of the most respected neurosurgery programs in the world. As an aside, he's also an Ironman competitor and a West Point graduate. That's who I report to, a West Point grad surgeon and Ironman competitor. Love every minute of it because we never waste any time. We know exactly what we're thinking. Greg Gould, we just hired, a brand new CFO, outstanding, been the CFO of publicly traded companies in the past, already adding value.

Ryan Bond, our Chief Strategy Officer, has been leading the strategy all the way back since 2018, well before we were a public company, and helped us with the category three CPT code issuance. I've got some relevant experience as well, time in this AI model with HeartFlow and clearly in the cardiology space. HeartFlow just recently did an IPO and they're now sitting at a $2.7 billion market cap. It's the exact same model in a smaller market. We are taking everything that I learned at HeartFlow and deploying it here at Aclarion, but we benefit from the fact that multiple companies have moved through this pathway, this SaaS-based model from radiology information up to the cloud, back down using the AI-driven algorithms to help improve diagnosis and/or other factors. My time there has really helped inform the strategy.

I was also the Vice President of Global Sales and Marketing for Medtronic Navigation, which is the O-arm and other advanced robotic type technologies in the OR. Between all of us, we've got all sorts of experience here. Back to the financials. We've got cash on hand, well enough to get us all the way through our preliminary Clarity results. As of the 16th, we were trading at $8.70, so we're NASDAQ compliant. We've got no debt whatsoever. We've got an estimated cash burn rate of $2 million, like I said, runway through Q1 of fiscal 2027. Our average daily trading volume is 164,000 shares, and we've got a very low float, 646,000 shares outstanding. To sum it up, we are chasing the largest single expenditure in all of healthcare.

We have the first industry non-invasive diagnostic in this space to actually help physicians determine which disc is causing the pain. Strong balance sheet, as I mentioned, clean cap table. I also mentioned our catalysts are the Clarity results that are coming through, other real-world evidence results, volume growth in London, where we have payer, and then just seeing more and more physician adoption of the technology. We understand there's a pathway. We know how to do this from these other healthcare AI technologies. We are not wasting time chasing multiple strategies. We're disciplined and using every dollar to achieve the key catalysts that I just mentioned. We've got the CPT codes already in place. Our team honestly knows what we're doing, and again, we're super efficient, and we've been there, done that, I guess, is how I'll wrap it up.

I will say this, we've got a little bit of time, just a minute left. If you or anyone you know is suffering from this kind of back pain, and they're headed to some kind of treatment, I implore you to look at our website and empower them and the physicians treating them with the information. It can make, from 54% to 97% difference. I'm here to talk to you not just about the company, but about any of your loved ones or yourself if you're also suffering from this pain. With that, we've got a minute or two for questions if anyone has any. Yes, sir.

Yeah, when we came out, just before Putin invaded Ukraine, we were getting guidance to get $40 million on an $80 million valuation. Honestly, it felt right to me, knowing what I know about these other companies, and we came out with nine. We've had to really fight hard to frankly make all the progress that we've made to date, which is tremendous given the small team we have. Nobody's left, by the way. We had a CFO retire, but nobody's left. That's what happened. We had to do a reverse stock split to get cash in the door under not great terms. By the way, the money we raised last week was at the market. At the market, no warrants. That helped us shore up the balance sheet a little bit too. Any other questions? Yes, sir.

Two things. It looks to me I read the slide too quickly. Does your cash buy it in your pocket now? I'm sorry? Does your cash buy it in your pocket now?

Yes, it is. Yep.

I have another question. You said that you preferred it was $2 million if you owned the bank and you were 60 years in the burden?

I've got $2 million per month or per quarter per employee. Per employee, sorry. Yep. Okay. Other questions? Okay. It looks like I'm getting the cane, but thank you everyone for the time, and obviously we're here for the remainder of the conference. Thank you.

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