Good morning, ladies and gentlemen. Welcome to the NeuroOne Medical Technologies Corporation Virtual Investor Webinar. Today's call will be hosted by the company's Chief Executive Officer, Dave Rosa, and Chief Financial Officer, Ron McClurg. Before I turn the call over to Mr. Rosa, I'd like to remind you that this conference call will include forward-looking statements within the meaning of U.S. Federal Securities laws with respect to future operations, financial results, including our 2026 revenue guidance, events, trends, and performance, which are based on management's beliefs and assumptions as of today's call. Forward-looking statements may involve known and unknown risks, uncertainties and other factors which may cause actual results to differ materially from those expressed or implied by such statements. See NeuroOne's financial results, press release, and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ.
Except as required by law, NeuroOne undertakes no obligation to update such forward-looking statements. With that, I will turn the call over to Mr. Dave Rosa, CEO of NeuroOne. Please go ahead, sir.
Thank you, operator, and thanks everyone for joining us today. I'd like to welcome all of you to today's virtual investor webinar, where I hope to take you in more detail with what the company is looking to accomplish. Let's start. The company's goal from inception was to deliver a thin-film electrode platform technology that offered multiple functions using the same device. We intended that for a wide variety of neurological conditions. I would say that most of you are aware of epilepsy, Parkinson's disease, back pain, and maybe some of you have even heard about the promise that gene therapies and other brain tumor cancer drugs in development have. We always believe that if we were successful in developing these therapies, that patients, doctors, and other companies would also be interested.
Today, I'm pleased to say that I think we've accomplished this mission. Today we do have a total of four devices that have FDA clearance. As you can see on the slide, three are for brain applications and one is for facial pain. We also have a number of patents that have been granted or are pending. We've been fortunate enough to have two current partnerships, one with the Mayo Clinic as well as one with Zimmer Biomet. Zimmer is our exclusive distribution partner for our brain-related devices. Still believe there's a great opportunity to partner with other companies based on the interests that we currently have. We can go to next slide. What makes our technology unique? I get asked this question often. I would say really two properties. One, the thin-film design.
What that does is it really allows for less invasive placement, even to the point where it could be delivered through a small needle. There's been many companies that have attempted to accomplish this but have failed at it. Second, I would say is our ability to perform both diagnostic and therapeutic functions. By doing that, what we can offer is the potential to reduce the number of surgeries, the number of hospitalizations, as well as potentially improve patient outcomes. We're still the only company that has an FDA 510(k) clearance for both diagnostic and therapeutic use for using the same device. Next. The first partnership that the company formed was with the Mayo Clinic.
Doctors Worrell and Van Gompel had previously worked on the development of a similar thin-film technology and really became intrigued when we showed them our ideas and prototypes. They have participated in a great deal of the initial testing that were done with these devices. Today they really remain a close partner. More recently, they've become engaged with us on our drug delivery technology. Next. Our second partnership was formed in 2020 with Zimmer Biomet. Zimmer Biomet's a leader in robotic technology that's used primarily for brain-related neurosurgeries. To date, the company's received $8.5 million in licensing fees in exchange for exclusive distribution rights in the U.S. and then other certain international geographies.
What's been exciting more recently is that we've seen signs of device adoption ramping, as in the last quarter, we recently reported that almost half of all the patients that have received an ablation since Zimmer has launched the product were done in that quarter. We also believe there's upside internationally, as well, and we've been working to secure ISO 13485 certification, which is required to be able to ship product internationally. Next. With regards to market opportunity, all of our devices play in markets that have multi-billion-dollar opportunities. Now today, some of these markets like spinal cord stimulation, they're already generating revenue in the billions of dollars, while others, say for example, like drug delivery, epilepsy, and basivertebral nerve ablation for lower back pain, they all have the potential to grow into billion-dollar revenue-generating businesses. Next.
Moving on to our product portfolio, looking at the table, the first two devices received 510(k) clearance specifically for diagnostic purposes. The third device that's listed there, the OneRF Ablation System for the brain, that represents the majority of our revenue today. Given it has both the ability to perform the diagnostic function, as well as to ablate or destroy the tissue, in an effort to reduce or eliminate seizures. Next up, on the table is our Trigeminal Nerve Ablation System for facial pain, and then our Basivertebral Nerve Ablation technology, which is in development. Our thin-film paddle electrode that's intended for lower back pain, as well. Then finally our sEEG-based drug delivery system. All of these technologies are based on the same platform.
It's the thin film technology that we started out the company with. Today Zimmer Biomet has distribution rights for the first three products that are listed in the table. Next. The first product I'm going to cover are the Evo sEEG and cortical electrodes. As I mentioned in the last slide, these were the first devices that were commercialized and were primarily just for diagnostic use. Most of those devices have been cannibalized with the OneRF Ablation system. Speaking of which, we can go to the next slide. The OneRF Ablation system for brain is the first and only FDA-cleared technology for both diagnostic and therapeutic use. That's what we designed this for.
The intent was to reduce surgeries, the number of surgeries, hospitalizations, along with improving really the safety of the procedures. We did that through the incorporation of our proprietary temperature probe. So far our experience has been outstanding with the system. There's been no reported serious adverse events with many of the patients either reportedly seizure-free or experiencing a reduction in their seizures. That's all in a single visit. Another advantage of this technology is that it allows a neurosurgeon to ensure that there's no remaining seizure activity before the patient is discharged.
For example, once the ablation is performed, the doctor can then use the device to monitor the brain again, and if there's any evidence of remaining seizure activity, what they can then do is perform another ablation until the neurosurgeon's satisfied with the results. Because of the success the device has had, we're actively making efforts to provide the clinical results and share the results, so that other patients and doctors are aware of the outcomes. Just recently, there was an article published in PubMed by doctors from the Cleveland Clinic that highlighted their initial experience with the technology, as well as the different ways it was used. It's studies like this that we believe are essential to increasing interest and adoption in the technology. Next up is the OneRF Trigeminal Nerve Ablation System.
This technology is used to treat a condition referred to as trigeminal neuralgia. Trigeminal neuralgia is an excruciating facial pain condition that's triggered by the trigeminal nerve. It's also referred to in the medical community as the suicide condition. Some of the data that I was able to find show reports that say as high as 25% of patients diagnosed with the condition actually commit suicide. Our device really the benefits versus traditional therapies is that you only have to place the device once versus multiple times from competing devices to locate the trigger point on the trigeminal nerve that's actually causing the patient this excruciating pain. This obviously should reduce patient discomfort if you're only needing to place the device once as well as potentially shorten the procedural time.
To date, we have completed 9 cases in a limited market launch. All the patients are reportedly pain-free after the procedure was completed. We have additional cases scheduled for this month and expect to conclude the limited release by the end of the month. Then at that time, assuming the results continue to be what we're saying, we would open it up to other centers as well. We've been asked the question, you know, why did you even pursue this indication? It doesn't seem similar to the brain surgery for epilepsy. We actually learned about this through our advisory board, and that's the advisory board that we had for the OneRF Brain Ablation System.
The reason for that is the neurosurgeons that are performing the brain ablation procedures are often the same ones performing the facial pain procedures. We've mentioned this before, but we are in discussions with a few strategic organizations regarding licensing this technology for this specific application. Excuse me. Next. Moving on to our spinal cord percutaneous paddle lead. This is an electrode that can also be used for diagnostic and therapeutic purposes. For patients suffering with lower back pain, and this is where the pain is traveling down the leg. Spinal cord stimulation has really been well established as a potentially pain-reducing therapy. Today, it actually represents over $3 billion in annual revenue for devices sold for this application. Most devices today are similar in design to our SEEG device.
That's one of the first devices I showed you. They're wire-like devices. They use a significant amount of energy. They also lack the ability to customize the stimulation. Our device, even though it's not that needle like device and is more of a film technology, we have a proprietary delivery system that allows the pain specialist or neurosurgeon to actually deliver this film electrode through the same needle that these SEEG-like devices are implanted. The other advantages are, you know, less battery usage with a design like ours, which really equates to patients needing to recharge less frequently, which is one of the major complaints with some of the systems that are commercial today.
The other is our technology also allows really for the customization of where the doctor wants to deliver the stimulation, and that's more based on patient feedback with respect to pain relief. Many companies have attempted to develop a technology like this unsuccessfully. We're definitely excited by the progress we've made in this area and are really aiming to be ready to perform our first-in-man implant by the end of this calendar year. We have mentioned before that we're looking for a partnership with a company that already is established commercially in this space. The reason for that is it could significantly reduce our time to market. Next up is our BVNA technology. That's the basivertebral nerve ablation technology. Uses the same platform as brain ablation and facial ablation.
What this is being designed for is to perform ablations of the basivertebral nerve. The basivertebral nerve, for those of you that aren't familiar with it's located in the vertebral body, which is the bony area in between the discs in your lower spine, and changes in the end plates, which are on the below and above the disc. Changes in those end plates actually are what contribute to this lower back pain. What our design does is that, number one, it allows the neurosurgeon-sorry, the pain specialist to really improve the safety behind the procedure by utilizing our temperature probe.
It also gives the pain specialist more flexibility in where the device is placed, you know, due to the fact that we have multiple contacts and multiple areas on that electrode where you can ablate. In essence, we're giving the pain specialist a larger sweet spot. This procedure is actually becoming one of the faster-growing lower back pain procedures in the market. We also believe the technology has a shorter regulatory path to market, but that's based on the assumption that we can pursue a 510(k) regulatory path, which we believe we can. Boston Scientific and Stryker Corporation currently have systems on the market today for this application. As I mentioned with some of our other devices, we're also in discussions with multiple organizations regarding a potential partnership for this specific technology.
You can go to the next slide. Excuse me. The final technology I'm really going to cover is our drug delivery platform, which I'm extremely excited about. This technology was designed to record brain activity before, during, and after delivery of whatever therapeutic agent the doctor is administering, whether it's a gene therapy, a cell therapy, and they're able to deliver it directly through the lumen of our electrode, which looks very, very similar to our SEEG electrode or OneRF ablation electrode. One of the other features of it is it also, like our other electrodes that look like this, you're also able to stimulate as well using that device if the clinician so chooses.
Now, while these particular features are more unique, I'll say to our technology, the device, the other advantage is that it can be placed with Zimmer Biomet's robotic system, the one that's being used for brain ablations. You don't need the time and cost associated with placing these devices in an MRI lab. It also has an extremely low profile, so it's very small in size. And, you know, you also have the capability to place more than just one or two of these devices if needed, unlike some of the other systems that are available today.
We're designing the technology to be also used in a variety of animal models, different sized animals, so that as these, you know, novel therapies progress through development, our device can be actually used by the pharma company or whoever is developing the therapy all the way through human studies to commercialization. The other exciting thing is really the opportunity to offer improvements in treatment for patients that have and really suffer badly with glioblastomas. Stay tuned for more on that application. Excuse me. You can go to the next slide. In terms of leadership experience, we've got employees that have a blend of small, large company experience. I think that's critical, especially for developing companies.
A number of the companies that many of us have worked at, Boston Scientific, Medtronic, St. Jude Medical, Abbott, there's others as well. We also have technology experts that have come from companies like Neuralink, which is Elon Musk's brain company. For us, you know, this experience has been really critical to all the accomplishments we've achieved to date. We also recently announced the appointment of David Wambach, who I actually believe will be a key addition to help expedite our drug delivery development and commercialization efforts. Ron.
Thanks, Dave. You can go to the next slide, Larry. Just a very brief financial overview from our fiscal first quarter, which ended in December. We've got a debt-free balance sheet. We had $3.6 million in cash on hand, but we also had $2.7 million of accounts receivable from our current distribution partner, Zimmer Biomet. That has since been collected in full. For the first quarter, we had product revenue of $2.9 million, which is a 5.5% sequential increase. In Q1, we had product gross margin of 54.2%. Our gross profit increased 2.6% on a sequential basis as well. Some of the catalysts that we've got going forward are the new potential partnerships that Dave discussed, which are focused primarily on pain management and drug delivery.
We expect our product revenue to increase to at least $10.5 million in fiscal 2026, and that is a baseline forecast for us. It does not include things that Dave talked about, such as the trigeminal nerve ablation revenue and potential revenue for international sales. We're very excited and bullish on what this year is gonna bring for us. Dave, I'll turn it back to you.
All right. Next, Larry. In terms of upcoming potential catalysts, I'm not gonna read all the bullets that are on the slide. I would say, you know, to summarize those, the critical ones, revenue growth for the OneRF brain ablation system, you know, via Zimmer Biomet, that's clearly, you know, a catalyst that needs to be watched closely. The full launch of our trigeminal nerve ablation system, you know, being able to close our limited market release by the end of this month, and then expand the number of centers. Commercialization for drug delivery. Now, again, to be clear, this is for selling devices for animal studies as well as for any potentially approved IDE studies by pharma companies.
ISO certification, you know, checking that box to really open the door to allow us to start looking at different international markets, primarily through Zimmer. Then, you know, I've mentioned this before, but we have a number of discussions going on regarding licensing agreements, and slash partnerships for every device that we've talked about today. Trigeminal neuralgia, drug delivery, both back pain technologies, all of them. You know, keep your ears and your eyes open for updates on that. You can go to, excuse me, to the next slide. You know, maybe just some of the key takeaways. I guess, you know, when I think about the company and, you know, the message I'd like to give is that, you know, we do have a novel platform technology.
You know, to investors, what we're offering are really multiple shots on goal. That's multiple shots on goal with growing revenue, strong partnerships, the potential for additional partnerships, really in large markets. I mean, when you look at the company, we've proven that we can develop products. We've proven that we can develop regulatory strategies that can get these products successfully to commercialization that actually also offer unique benefits to not just doctors, but patients as well, for a whole variety of neurological conditions.
You know, when you look at it, I've personally worked in small and large companies, and I'm extremely proud of all the progress, all the accomplishments we've made, you know, when you look at the fact that, you know, at most we've had 16 employees or less. There's a number of different areas here, a number of different technologies, all of the technology that many companies have tried to develop and have been unsuccessful in doing so. With that, I would say that's the end of the formal presentation.
At this time, we will be conducting.
I think we can now.
Certainly.
Oh, I'm sorry. Go ahead, operator.
No problem. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Your first question for today is from Jeffrey Cohen with Ladenburg Thalmann.
Hey, good afternoon. Hi, Dave and Ron. A couple questions for you. Firstly, Dave, could you just review for folks out there, talk a little bit about the pharmaceutical space and talk about some of the trial work and number of trials that are going on and neurological indications that are being pursued by the pharmaceutical companies and how you anticipate that your drug delivery is superior on the developmental side?
Sure. Thanks for joining, Jeff. Maybe the first question about how many are there of these studies, too many for me to list. You know, when you look at the ones that really pertain to what we're doing, you know, you're talking about conditions like epilepsy, which, you know, are right in line with our other objectives, Parkinson's disease, those are probably the two larger that get attention, with epilepsy being number one right now. There are a number of studies. You know, when you look at what we're doing, you know, with respect to the therapies that are out there. Well, first, the therapies are primarily gene therapies.
There are some pharma companies pursuing cell therapies, but the fact that patients have to remain on immunosuppression is really a sticking point. I'm assuming that in most cases gene therapies will be preferred. You know, our device, especially from a development standpoint, can be utilized, and we've already sold some devices last year for this application for testing purposes. Could be used to really assist these companies in testing the therapies all the way from you know early stage through commercialization. We have different devices that can accommodate different animal sizes. It's kind of like as they grow and progress you know we grow and progress in being able to sell them devices from the beginning through the end.
Now, for studies that are already underway, human studies, I don't think there's any pharma company that would switch devices, because then it introduces, you know, a new question mark in the study. For any that haven't started, you know, the door is open for us. I think the other area that has generated extremely exciting interest is the glioblastoma area. You know, there are already drugs out there that are used for patients that suffer with these, you know, deadly like tumors. Being able to provide a better therapy, a better quality of life for patients is at the top of the list of every oncologist we've spoken to. There's a belief that our technology can do that.
We're also, you know, taking steps to really fully investigate that space. You know, I think it's a unique opportunity for us and one that really has a major need, not just for patients, but also for the oncologists that are treating them.
Thanks. That's helpful. Next, I wanted to ask you about your Evo platform and talk about Evo and current standard of care, or I should say wires predominantly. What's the benefit and what's the comparison on better control and delivery of energy in a larger area versus conventional therapy?
Yeah. You're talking about spinal cord stimulation for lower back pain, where the pain's radiating down the leg. If I put a tiny wire in front of you and I put a film that, let's just say, is four inches by two inches, you would look at that and you would probably come to the conclusion that the bigger device is gonna offer more stimulation. Number one of the differences is, we're just providing more stimulation because we're a larger device. Number two, when you use the wire-like devices, the contacts, they look like rings around the electrode. All the stimulation is traveling in a 360-degree path. You have stimulation that's going upward, sideways, downward. You want all your stimulation down towards the spinal cord.
When you use a film that's placing down to the spinal cord, all the energy goes down. You're basically wasting energy with these wire-like devices because you're not directing it to the target, which is the spinal cord. Our device, you can actually steer it if you need to ensure that it's actually placed in the proper position so that all the energy is emanating downward. That's why, even though we have a larger device, these types of devices are more energy efficient. Patients hate having to recharge frequently. It's one of the pieces of feedback that pain specialists tell us all the time. Then the third one is the ability to customize.
If you think of our film that has a number of dots that are contacts that stimulation goes through. You know, over the years, there's been a belief that their bodies become more adaptive to stimulation. Sometimes they experience pain maybe a year or two years later. Sometimes that's just because the area of stimulation needs to change. What you can do with our device, number one, is you don't have to stimulate through all the contacts. If the doctor is able to provide the patient with pain relief in, say, maybe four out of the 20 contacts. You're using even less energy there.
Then maybe six months from now, the patient comes back and says, "Doctor, I'm still not experiencing pain relief." He decides to stimulate maybe through two different rows or columns of electrodes, and he finds that, aha, now this is providing pain relief. You don't have those opportunities with the wire-like. They call them percutaneous leads, but they're wire-like devices. Some people would say, "Well, what you're doing has been attempted before and failed." That's because the devices weren't thin enough to place through the same type of needle that these wire-like devices are placed in.
You know, the value here is if you can give them all these benefits, but you're not changing the way the device is placed by the pain specialist, who, by the way, doesn't want to make incisions in a patient's back. He wants to put a needle in, put the device in. This gives him the opportunity, really, of having the best of both worlds.
I have one more quick one for you. I'm sorry for the nagging. Talk about your SEEG technology and how that compares with and/or how is it used with traditional EEG as far as procedures and interventions that are under imaging or on different mapping conditions. Thanks.
Yeah. You know, if you're just referring to diagnostic-only procedures, devices look pretty similar. Ours is slightly smaller. You know, from really the initiation of the company, the goal here was and the value here was is let's eliminate some of the procedures required for patients. Let's also give the doctor an ability to check his work. Now, when you have these devices placed in the brain, the purpose is, with all of them, is to find the problem area. We all can find the problem area. I'm not sure there's that much difference between all of them other than maybe size and flexibility.
when you add the therapeutic component to it, you immediately put yourself in a separate category, which really gives the patient the ability to come in potentially one time in one hospitalization when that ability isn't there today. Now, most of the doctors, you know, are using either what's called stereotactic frames or a robot platform to place the devices. If you don't have a robot, you use a stereotactic frame. In neither situation do you need MRI to place the devices. All of them, you know, are really performed similar way.
You know, to be able to treat the patient, to diagnose and treat them all in the same procedure and even perform the procedure while they're sitting in their bed at bedside and have an outcome that's like, you know, they have a very, very strong likelihood of not having seizures or having a greatly reduced number of them is extremely exciting. I mean, you know, we have a site that they ablate every single patient. The philosophy is, if I'm going in there to find the problem, I'm going to be going back in there if I need to remove, you know, the problem area. Since we're not having, I say "we" meaning the center, since they're not having, you know, safety issues, you know, why not ablate every patient?
That's the kind of data, Jeff, that we need to get out there that I think will even further accelerate adoption of the technology.
Thanks so much for taking the questions. Appreciate it.
Thanks, Jeff.
We will now take webcast questions.
Our first question asks, can you talk about potential partnership that could accelerate commercialization of the OneRF platform of our FDA-cleared product families?
Yeah, I think there's, you know, I would honestly say all of them, but I think the ones that could really accelerate the most quickly are trigeminal. You know, obviously, we have a product that we feel is close to saleable, if not saleable, and being able to get it into a larger group of hands, that would be one. I think, you know, the back pain technologies really lend themselves, but for different reasons. When you look at our BVNA, the ablation technology for the basivertebral nerve, you know, what we know and what we're good at is developing the ablation technology, the electrode. The area that we don't have capabilities in are the access devices. How do you get your device into that space?
A partnership with a company that already has the capabilities or already building devices like that can greatly reduce the time to market for us. That I would say that one, and then spinal cord stimulation for sure. You know, again, what we're good at is the electrode. For us to get to the market as quickly as possible, we would really need to partner with a company that already has an FDA-approved device for this indication. It would greatly reduce the amount of time, dollars, and effort to get to market if we were able to partner with them and they would just simply file an amendment to their existing approval that would allow us to be able to launch the electrode through them.
Our next question asks, "Can you expand on David Wambach's appointment and what that brings to the table? Clearly, he saw something and put his own capital into the company.
Yeah. This is kind of an interesting story. You know, you never know where things are gonna go in life, and this is a great example. What people really don't know is that David actually was the banker that completed a financing for the company years ago when he was a banker at Craig-Hallum Capital Group. He actually, at that time, became an investor, a personal investor into the company. You know, over the course of time, David would, you know, keep in touch with me and, you know, get updates on how things were going. He always seemed to have a personal interest in what we were doing.
Just by chance, when he became available, I reached out to him and, you know, we had a discussion, you know, regarding his ability to maybe accelerate our development and commercialization for drug delivery because he does have experience in the pharma space. He's got a great understanding of both our technology and the advantages of it, as well as the pharma world. I mean, he's only been with the company a few weeks and, I mean, I've been impressed with, you know, how much he knew going into it and how quickly, you know, he's getting up to speed.
Our next question asks, "Can you go into any additional detail on expectations and timing of anticipated milestones you talked about or upcoming incremental announcements we should be looking for?
Yeah. You know, in terms of some of them, like for example, the trigeminal limited market release that we had, I'm very confident that by the end of the month, you know, we will have gathered the information we need to be comfortable to release the product more broadly. We also, you know, are looking to be in a position to have the drug delivery system available by the end of calendar Q2 this year. Again, that's for animal use or approved IDE studies. I think we're in a very good position for that. I think, you know, the other ones there that most people, you know, become curious about are the strategic discussions, and those are much harder to predict.
You know, with every one of these devices, again, that we've mentioned, these companies are in different stages of diligence. You know, the problem with this is you can never control how long it's gonna take. You can only control how quickly you respond to the requests. That one's a little bit trickier. You know, I'm really excited by the number of companies that are interested and interested enough to actually do diligence.
Next question asks, "Are you still confident that fiscal year 2026 product revenue will come in at least $10.5 million?
Yes.
Our next question asks, "Across your different programs, which one do you feel is most likely to drive the next partnership? The Trigeminal Nerve Ablation System?
You know, I think trigeminal you know has probably the greatest potential to be the next one. Again, I always hesitate because you know it's you're never gonna be 100% sure. Yeah, given the fact that the product's already out being sold and that we are you know at the stage of discussions that we are, yes you know I would. If I had to you know make an educated guess, I would say that would be it, but there's no guarantee.
Our next question asks, with regard to the ablation system for the brain and what looks like a growing adoption, what is needed to continue this ramp up?
I'll go back to kinda what I touched on, and that is being able to get the results of the clinical cases you know to both neurologists and neurosurgeons. It's been interesting. I've had discussions with both over the course of the last couple years you know regarding adoption. Some of the feedback that you know I've received is that the gatekeepers for many of these procedures are neurologists. You know there are a large number of neurologists that are conservative in nature and obviously would you know if you can manage this condition through medications, then that's what you would wanna do. There's still you know a large population over a million people that aren't managed with it.
I think some of them are intimidated by the procedure and, you know, have concerns about safety. I gave the example of this one center that, you know, has said they ablate every patient as pretty much the standard practice. I think as more physicians, you know, hear about the safety profile of the device as well as the results and the other benefits we've mentioned, you know, I think it's gonna have, you know, a greater chance to drive that ramp, you know, that we saw occurring last quarter. It gets a little bit trickier to, you know, to get centers to be willing to provide that data.
It's one of the reasons why we set up a registry specifically with companies that signed up for this. I think it's really, really critical to share the success stories of patients being treated as well as just a broad set of data showing the efficacy and safety profile.
Our last webcast question asks, back pain appears to be the largest potential market by far. Can you talk more about the regulatory pathway for entry into that market?
Sure. With respect to the basivertebral nerve ablation system, you know, where we're ablating the nerve, that appears to be a straightforward 510(k), which, by the way, is the regulatory path that we followed for every device that we have that's commercial today. It seems pretty straightforward there. With respect to the spinal cord stimulation device, if we were to go this alone, in addition to having to develop the stimulator itself, the piece of hardware, we would likely have to conduct a large trial, and it would follow a PMA pathway, which is more expensive, more time-consuming, more complicated, more risky.
You know, going back to, you know, why are we so interested in the partnership, especially with this one, it's because if we are able to partner with an existing company that's selling today, assuming that all the safety testing went well, it would be a much faster path to commercialization, significantly less time than having to do it alone. These companies could literally add, as a supplement to their existing approval, our technology, to you know, to be able to gain clearance for them to commercialize it.
Thank you. That appears to be the last question at this time, and I would now like to turn the call back to Dave Rosa.
Thanks, operator. I just wanna thank everyone again for attending the webinar. Really look forward to providing you all with updates, not just on the platform and commercialization, but as well the partnership discussions. If we're unable to answer any of the questions that you had today, feel free to reach out to our investor relations firm, the MZ Group, who would be more than happy to help. Thank you again.
Thank you. This concludes today's virtual investor webinar. We thank you for your participation. You may disconnect your lines at this time, and have a great day.