All right. Take it away, my friend.
That was a great introduction. Thank you. Today we will be making some forward-looking statements. Here is the standard disclaimer, as I am sure you are all very familiar with. As you mentioned, my name is David Wambeke. I am the Chief Business Officer at NeuroOne. I joined the company about six months ago. Prior to that, I was at pharma, and prior to that, I was an Investment Banker. When I did join the company, I did invest personally. I put about $700,000 of my own money into it in a direct PIPE. I had previously been an investment banker with the company, so helped raise NeuroOne money in follow-on offerings and just got to know the company for a very long time.
I think that this slide, just at a big picture, really represents some of what the technology enables for patients. This is Clara. She is 18 years old. She had drug-resistant epilepsy. She had, on average, 10 seizures a night. All drugs had been failing her, and she is really in a pretty tough spot. She was treated with our OneRF Ablation System, so this is actually where we burn brain tissue, and we were able to deliver seizure freedom for one year for Clara. Our technology definitely has some profound implications for these patients who are suffering and need better treatments. Really quickly, about us and part of why I joined the company is, so we have a proven technology. We have four 510(k) FDA cleared devices. We also have a strategic partnership with Zimmer Biomet .
This is a $16 billion market capitalization company, and I will get a little bit more into them, but they have a ROSA ONE Brain robot that really kind of synergizes with what we have. They are a natural partner for us to partner with, and they are currently our main source of revenue. This year we are going to do about $9 million to $10 million of revenue. That was our guidance. We have these core markets, and the biggest one is epilepsy, which is served by Zimmer Biomet. It is about a $200 million market opportunity. When we look at our platform, I think what we see is the most exciting parts ahead. I will go into each of these. There is a significant expansion opportunity that we are going to be moving into in basivertebral nerve ablation. This is a market that is going from $200 million to $1 billion.
It went from $70 million to $200 million over the last three years, and it is in chronic lower back pain, and it is transformative for young surgeons in kind of defining their career. Drug delivery, I will get into that some more. That is the business that I lead and that I came on to do. We are also going to be looking at spinal cord stimulation. Very importantly, all three of these market opportunities are served by the same underlying thin film technology that we have developed, and we have kind of followed a playbook with the regulators where we are able to just adapt our platform. We are not starting from scratch every time. We are making modifications to the RF probe or to the RF generator, et cetera, and we have been successful in getting 510(K ) clearances.
We do believe that, especially for BVNA, drug delivery, and spinal cord stim, that these are largely de-risked in our development approach. As I said, this is kind of our secret sauce, and it is the competitive moat behind every technology that we build. It is our thin film technology. What this enables us to do is produce circuits that are very, very flexible, very, very thin, and they allow us to keep the lumen of our devices wide open so that we can either, A, put drug through them, B, put an RF probe in it with a temperature monitor and ablate tissue. It is very challenging to make these and have them hold up in the brain parenchyma for up to 30 days. It is very challenging to get the right yields on these and to have the circuits not break.
We have this competitive moat that we think is very differentiated, both from a patent perspective, so we have 13 issued and pending patents. We also have OUS patents, but also just on the proprietary trade secrets. People who try to do this are going to very much struggle. It is not something that is easy to do. One of our lead engineers came from, gosh, I am forgetting the Elon Musk brain company, but Neuralink. Came from Neuralink, so has a strong background in this thin film technology, and that is really kind of what enables all of our products. We address some very large market opportunities. The first one there is in epilepsy and trigeminal neuralgia. Today, that is about a $200 million market opportunity. That is largely served by our distribution partner, Zimmer Biomet, who we think is the right partner to help us go to market with.
As I said, they will generate about $10 million of revenue for us this year. Drug delivery is an emerging and novel approach to delivering drug right into the brain. Cell and gene therapies, they are very large. You cannot give them intravenously, subcutaneously, or orally. They do not traverse the blood-brain barrier. They do not make it into the brain parenchyma, and they cannot do what they are intended to do. Next year, uniQure, which is a publicly traded company, should have the very first, I would say, large-scale drug approved for intraparenchymal delivery. This is a gene therapy for Huntington's disease. That drug is expected to do up to $2 billion of revenue.
It is really just the starting gun here for cell and gene therapies that are going to be delivered into brain parenchyma, and we have a very elegant solution that we think can dramatically reduce the procedure time. The procedure I just mentioned for uniQure, it takes 12 hours. It needs to be done under MRI the entire time, so it takes up a costly and consuming resource. We think that with our technology that we can get this procedure down to four times. It can be done in a CT scan outside of the MRI, and it can be potentially, from a commercial standpoint, very, very viable. BVNA, which I mentioned. Relievant Medsystems was acquired by Boston Scientific about three years ago. It was doing $70 million of revenue, and it has since grown to $200 million of revenue and represents the majority of the market.
We've now seen competitors like Medtronic get in. They've licensed Merit Medical Systems' technology. We've seen Stryker get in. BVNA is a transformative growth opportunity for lower back pain. You go into the spine and the basivertebral nerve, and you ablate that nerve, and it has tremendous outcomes for patients who are suffering from lower back pain. What we think our technology can do is we can dramatically reduce the procedure time. Currently, it takes about 10 minutes to create these lesions using existing systems. We believe that we can cut that down to five, so the doctor doesn't have to sit there twiddling his thumbs. He can get on and do more procedures, get more billable codes. We also don't think you have to be as precise in the placement of the device.
We have much more degree of freedom because we can ablate at any different contact. We can ablate at contact one, two, three, four, five, six, whereas other devices are fixed in terms of the contacts. The positional placement for our BVNA device is much more forgiving if the surgeon isn't completely accurate in how they crack open the spine and get the probe in there. Then spinal cord stimulation, this is more of a longer-term opportunity for us. We're focused on it. It's a very big, mature market. What we have is with our thin film technology I described, we can roll up the paddle leads, and we can be able to do a spinal cord stimulation implant leads using a percutaneous placement. That means putting it into a needle and putting it into the back versus having to run a surgical procedure right now.
We think that's a chronic implant, so we do have more development work that we need to do it. Right now, our main focus is on BVNA and drug delivery. Our drug delivery devices will be ready for commercialization at the end of this month, and that's the business that I'm spearheading, and I think it represents a very large growth opportunity. By reference, there's a company called ClearPoint, CLPT is the ticker. They're about a $500 million market capitalization company. They're the ones that I mentioned. It takes about 12 hours to do their procedure under MRI, and that's our biggest competitor. We started the company. I'm based in Minneapolis. There's a bustling med tech community up in Minneapolis. We have a lot of great engineers and just talent up there. We also have the Mayo Clinic, and they've been a great partner to us.
There's two neurologists there that we showed that they were early investors in the company, and we work with them a lot. We're working right now on drug delivery with them and diffuse midline glioma, other people. It's just a great partnership that we've been able to foster. Then this one is our most important partnership, Zimmer Biomet. It's a $16 billion market capitalization company. Very, very large. They're known for hips and knees. Their bread and butter business is in that category. They also have this ROSA ONE robot here. All the epilepsy procedures, not all, but the majority of epilepsy procedures now that are done, we're actually implanting depth electrodes into the brain, go through this ROSA ONE robot. They have the largest market share. There are other people who are developing their own robots as well.
We can work on any one of them, but we've chosen to partner up with Zimmer Biomet to date. They're the commercial partner for us for our epilepsy products. They've paid us $8.5 million to date in licensing revenue. It's been a great partnership. They've given us non-dilutive capital, and we think they're the right partners to help us grow in the epilepsy market. This is our complete portfolio of products. I've kind of went through them. I'm not going to double-click into them much. Right now we focus on brain and pain. What you see are the FDA-cleared devices there on the right, which is our sEEG electrodes and our OneRF Ablation System. I'll just spend a little bit of time on the brain ablation system in a bit.
We have our drug delivery system, which is the business I lead. That's going to be kicking off here in the next month. We're going to have our devices ready. On the pain side, I've kind of talked about this basivertebral nerve ablation. We hopefully will be able to have a system developed and ready for commercialization in about a year's time. Right now, one of the next milestones that we're hoping to and we're working towards is trying to find a strategic partner who can work with us to commercialize that. There are a lot of very large companies that need this type of solution to have in their bag and be relevant with these pain docs. More to report on that in the future. In the interest of time, this is what a depth electrode looks like on the right-hand side.
If you have epilepsy, then you're drug-resistant, and you're trying to diagnose where the focus is happening for the seizure, they will implant on that right-hand side there up to 20 to 30 of these devices in your brain. What they're doing is recording electrical activity, and then they're hoping to be able to find out where the seizure focus is, where the disruptive network is, and then they can go from there and diagnose how they want to treat it. They could use, A, our OneRF Ablation System, where you can go in and burn it, create a small lesion. B, you could use LITT, which is a laser where you burn it, or you could even do a focal resection where they go in and remove it.
What they're trying to do is intending to disrupt that seizure network, break it up through one of those modalities, and to get the patient relief from seizures. What's unique about our OneRF Ablation System is that we are the only FDA 510(K) cleared device that can use that same device for recording and also for ablation. How we're able to do that is we have this thin film technology, like I mentioned, that allows us to leave the middle lumen of the device. It's wide open. There's nothing inside the lumen of the device. Every other electrode out there, the lumen of the device is packed full of wires because they don't use a thin film technology, and so it's obstructed. What we have is with the lumen of the device open, we can then say, okay, they have 20 electrodes planted.
They say, okay, on electrode three, at depth four, we're seeing some abnormal activity. Great. The patient already has the devices implanted. We can go in with our RF probe and our temperature probe and ablate right there at that exact region and hope to disrupt the seizure network. There's been some great publications recently from Cleveland Clinic and other early adopters of the technology. It's been very well received. It represents a very large growth opportunity for us. Similarly, people like the Cleveland Clinic are also using it as a diagnostic. If they say, "Okay, if I go and burn here, and say seizures go from having five a week down to one a week, okay, good. We saw something. Maybe that means we should go in and be more invasive. Let's do a resection. Let's do laser.
We already know where to go, and let's go at this problem more fulsome." Conversely, if they're not seeing any at all improvements, they might want to just say, "Okay, why would we go in, do something invasive, and resect a bunch of tissue in the brain where there's potential loss of motor function or other eloquent cortex that could be problematic for the patient?" It's getting a lot of great traction. Again, it's the only system that you can do both recording and ablation through the exact same electrode. Currently, what they have to do is they implant these electrodes, they find out where the seizure activity is happening, they explant the electrodes, patient goes home, comes back in, and then they come in and have laser or some other therapy.
There's a lot of workflow efficiency, and there's a lot of just not having to bring the patient back in and do two medical procedures. This is our most recent 510(K) clearance for Trigeminal Neuralgia. It is a debilitating condition. It's a harrowing condition. If you see some of our videos, this is extreme facial pain. One of our patients who we testimonialed, she said she would rather go through 10 childbirths than go another day with this pain. It's very debilitating. What we have, we've been able to adapt the same technology that we basically use for brain ablation. We use the same power generator, same capital equipment, same temperature monitoring. We tweaked the accessory a little bit, just to be able to access the trigeminal nerve more adequately. Its underlying principle is it's the same as our brain ablation system.
We got that recently approved last year, and we're commercializing this right now as we speak. We're doing a double-pronged effort, both a direct sales force, just with some employees internally, as well as distributors. This is our most recent 510(K) clearance, and pretty much this exact same approach that we use for trigeminal neuralgia, we're going to be using it for basivertebral nerve ablation. This is a very large market opportunity. We're extremely excited about it. Like I said, it's went from $70 million of sales to $200 million of sales most recently, and analysts have it forecast to $1 billion in sales. It's transformative for these young surgeons. It's the biggest development in their career. It's getting paid for. That's very important. It's a very high growth opportunity.
What our system does is for our Gen1 system is, again, I think we can make bigger lesions, and we can take the burn time down from 10 minutes to five minutes, which is very important for these doctors who are trying to rapidly book and move through procedures instead of sitting there twiddling their thumbs. Also, you do not have to be as precise because like I said, we are hollow. We can burn through any of the contacts on the probe. If you do not position it directly perfectly, no harm, no foul. We can still help you get there. So that is our Gen1 system. We are also developing a Gen2 system, which first we will get the Gen1 system approved. The Gen2 system is really unique because as I mentioned, our devices in the lumen of the probe is always open.
When it is open, that means you can infuse drugs through it. So our Gen2 system will allow you to be able to not only do the ablation of the basivertebral nerve, but we can also have you put pain medicines in, put steroid in, or any other type of different, whether it is something more exotic like a biologic, into the basivertebral nerve space. So we think that, again, is another differentiator. More to come on this, but we are very excited about it. It represents a very high growth opportunity, and it is basically custom fit for our technology. We have already done it in brain. We have done it in the face. Now we are just going to modify, again, the same probe. It will use the same generator, and the 510(K) process is not a daunting one for us. We have done it three times before.
We think that we will be able to do it here with a very high probability of success. Oh, good. It is working. You can see over on the right-hand side there a time lapse of drug delivery. So this is the business that I lead. If you have a cell and gene therapy, you cannot give these, and you want to get them into the brain, you cannot give these subcutaneously, intravenously, or orally. They are very large biologics. They will not cross the blood-brain barrier. They will not make it into the intended space. So these next-generation modalities, cell therapies, gene therapies that you are seeing for Parkinson's disease, that you are seeing for epilepsies, that you are seeing for Huntington's disease, glioblastomas, all rely on direct delivery into the brain. That is exactly what we do perfectly. So we can bring our robotics in. They can quickly map the trajectory.
If they want, you want to get four trajectories into the hippocampus, good, we will have four trajectories there within an hour. Very fast, very precise. Again, the open lumen of our devices allows you to stick a catheter in that. So we have adapted our technology. We have added steps into it so that there is no reflux around the back end, but so that we can deliver drugs directly into the brain. So I mentioned ClearPoint Neuro, great company. Their system right now for Huntington's disease, that is going to be the first major intraparenchymal delivered gene therapy that is going to hopefully be approved next year. They think there will be 6,000 patients that will get it annually, and they charge $1.5 million a patient. It requires 12 hours in the MRI. It is done completely under MRI. You drill two trajectories on both hemispheres. Drill one trajectory, put it in.
They got to take off the towers, reput them again. Take off the towers, reput them again. That is three processes all done under MRI, and it actually takes 12 hours. We can put 22 trajectories in within an hour. We can get to 1.5-mm precision in terms of where we are going to land the distal tip of the electrode. We think we can cut that procedure time down from 12 hours to sub four hours, and it can be done under CT. You will always do a pre-surgical MRI just to map the vasculature, but then they take that MRI and they append it with the CT, and they overlay them so that they know where the vasculature is. We think we can get the patient out of a very bottlenecked MRI suite that is highly in demand and cut the procedure time.
At the end of the day, pharma companies really want to sell drug, and we think that we can help them move more rapidly. I do believe, personally, it will become a surgical bottleneck to do a 12-hour procedure under MRI, and that they will be incentivized to find solutions like ours, and find technology. We are being implanted into thousands of brains every year. We are not unproven. We are going into brains. We are sitting there. We are dwelling there for 30 days. We are burning tissue. We think this is a very big opportunity. We will see if I am successful. I lead this business, but we are out there right now, and we will have our devices ready at the end of this month, and we have just released some successful large animal studies and more to come in the future on this business, but it is something that we are very excited about.
This is, again, a longer term. What we do right now is mostly subchronic, less than 30 days. Spinal cord stimulation, this is a chronic implant, and so it requires more testing on our part. It is a mature market. It is a $3 billion market for spinal cord stimulation. It is not really growing, but what we think is very unique is that you see that thin film technology, and I mentioned this earlier, we can roll it up, we can put it into a needle, and now we can percutaneously place these leads. That will allow other surgeons to perform the procedure without having to do something more invasive, and we think that is going to be a bit of a differentiator for this technology. As a small company with finite resources, we have got to focus.
Our core focus right now is drug delivery and BVNA, because BVNA is a very low-hanging success for us. We have done it many times before. This is something that we have that we are developing in the background, making strides towards it, but probably not going to spend an enormous amount of money and time on it. It is something that we will circle back to in the future. This is the management team. Like I mentioned, I only joined six months ago. I came from the pharma world, and prior to that, the banking. Dave Rosa is our CEO. In general, we have a very strong bench. Minneapolis has a very strong bench of med tech talent, and so we develop these products right from a regulatory perspective. We develop them right from an engineering perspective.
We got some of the best engineers that are out there from Boston Scientific, Medtronic, et cetera. We have a very good team, and I mentioned Camilo. He actually came from Neuralink, that Elon Musk company, so he's been kind of a secret power of ours in terms of making sure we get the yields on these thin film technologies. We got a very good team that's been around, and we're all very focused on making this a reality. Just quickly, on the balance sheet, we got $2 million of cash. We have no debt. We're currently running quite a bit of backlog, so we hope to be able to clean up a lot of this backlog this quarter.
This quarter should be, assuming we get through our backlog, one of our best quarters ever, and we've guided most recently that we'll do between $9.2 million and $10.5 million of revenue for this fiscal year. 9 million shares outstanding, 10.7 million fully diluted. I think I mentioned this, but again, no debt outstanding. Then those are the three analysts that cover our stock. Near-term catalyst, just real quick, I know we're out of time, but the drug delivery system, which is going to become available. We've done some nice stuff on the pre-clinical stuff. Do we need to get into humans? I think that could be a very transformative event, could be very accretive to market capitalization if we start to show that we're getting to a pipeline of these clinical studies.
Like I said, ClearPoint has a $500 million market capitalization company and barely any revenue from that business. Again, I think the other big partnership is potentially for basivertebral nerve ablation. Thank you, everyone.