Good afternoon, everyone. Suraj Kalia, Senior Medical Device Analyst at Oppenheimer. Pleased to have my friend, CEO of NeuroOne Medical, Dave Rosa, here, and CFO, Ron McClurg, here. Gentlemen, always a pleasure. I'll let you take the floor, and I'll resurface four-five minutes towards the end with Q&A.
Thank you.
Sounds great. Thanks, Suraj. I'd like to first start out by thanking Oppenheimer for inviting us to present our story today at their conference. As well to all of you that are tuning in to learn more about NeuroOne Medical Technologies Corporation. Before we get started, I just wanna direct your attention to our forward-looking statement disclaimer on this slide. I'm sure you've seen this many times. We can move on. Let's start with a little bit about what NeuroOne does. NeuroOne's a company that developed and commercialized what we refer to as a true thin film electrode platform technology. This technology offers multiple functions using the same device for a variety of neurological conditions.
These devices are intended for epilepsy, Parkinson's disease, back pain, and drug delivery for gene and cell therapies that are currently in development by pharmaceutical companies, and possibly brain tumor drugs as well. We have a total of four devices that have FDA 510(k) clearance. Three are for brain-related applications, and one is for facial pain. Regarding our patent portfolio, you can see that we've got 17 patents that have either been granted or are pending for both the U.S. and Europe. We also have two current partnerships, the Mayo Clinic, as well as Zimmer Biomet. We also believe we've got a great opportunity to partner with other companies as well for other technologies that we currently have in development. You can go to slide four. What makes our technology special?
I would say really two properties. One, the thin film design allows for less invasive placement, including being able to place it through a 14-gauge needle. There's also been a number of companies that attempted to develop this type of platform but failed due to the complexity. Second, I would say the ability to perform both diagnostic and therapeutic functions using the same device. This is really a key aspect of the technology because it provides the potential to reduce the number of surgeries, hospitalizations, while also potentially improving patient outcomes. We currently remain the only FDA 510(k) cleared device for both diagnostic and therapeutic use. You can go to the next one. I mentioned two partnerships. The first partnership we formed was with the Mayo Clinic. Dr. Greg Worrell and Dr.
Jamie Van Gompel were actually developing a similar thin film technology, but became excited with the potential that our initial prototypes offered. Over the years, these gentlemen and others at the Mayo Clinic have been very involved in testing our newer devices and using many of them, more recently, our drug delivery platform. You can go to the next one. Excuse me. Our second partnership was formed in 2020 with Zimmer Biomet. Zimmer manufactures a leading robotic technology that's used for a number of brain-related neurosurgeries. To date, we've received $8.5 million in licensing fees for exclusive distribution rights in the U.S., as well as specific international geographies. With respect to the device performance, the device adoption has been increasing.
We recently reported that last quarter, almost half of all the patients that have received ablations to date, since the device was launched, were actually done last quarter. We're seeing a very nice ramp of the technology for these brain ablations. We're also preparing for international distribution by working to secure ISO 13485 certification. From there, we'll prepare whatever regulatory requirements are necessary to enter some of our targeted international geographies. You can go to the next. With respect to market opportunity, all of our devices have multi-billion dollar overall opportunities. Today, spinal cord stimulation already generates between $3 billion and $4 billion in revenue, while others like drug delivery, epilepsy, and basivertebral nerve ablation have the potential to grow into billion-dollar revenue generating businesses. Go to the next slide. Yep.
Moving on to our product portfolio, the first two devices that you see on this table, excuse me, received FDA 510(k) clearance for diagnostic-only purposes. The third device that you see, which is the OneRF Ablation System for brain, that represents the majority of our revenue, given its combined diagnostic and therapeutic use. The fifth device on the table is our trigeminal nerve ablation system for facial pain, then our basivertebral nerve ablation technology, which is currently in development, our thin film paddle electrode, which is intended for lower back pain, and then finally, our drug delivery device. All of these technologies utilize the same platform, thin film technology. The first products that I mentioned in our portfolio that I'm gonna cover are the Evo sEEG and cortical electrodes.
The devices you see on this slide were the first devices that we received FDA 510(k) clearance for. And then we commercialized these devices through Zimmer Biomet. These were primarily for just diagnostic purposes and really have been cannibalized to a great extent by our OneRF ablation system, which I'm gonna cover next. The OneRF ablation system for the brain is the first, the only FDA 510(k) cleared technology for both diagnostic and therapeutic use using the same device. It was really designed to reduce the number of surgeries and hospitalizations required along with also providing enhanced safety utilizing this proprietary temperature probe technology that we developed. To date, the results using this technology have been excellent.
In these epilepsy procedures, there's been no reported procedural adverse events, and most patients are either reported to be seizure-free or have experienced a significant reduction in their number of seizures. Another advantage of the technology is that after the ablation surgery is performed, the neurosurgeon can confirm if there's no remaining seizure activity before discharging the patient. If he does find additional activity, he can go back, perform a touch-up ablation until he's really comfortable with the results. Because of the current success of the device, we've actually initiated a registry to share the results so that other patients and doctors can become aware of the technology.
Most recently, this morning, we put out a press release regarding a study that was published, just recently published in PubMed, that was highlighting the initial experience of doctors from the Cleveland Clinic using this technology. It's really studies like this that we think are critical to expanding device utilization. Excuse me. You can go to the next one. Next up is our OneRF Trigeminal Nerve Ablation System. This technology is used to treat a condition referred to as trigeminal neuralgia. Trigeminal neuralgia is an exceptionally painful condition that affects the face. It's known in the medical community as the suicide conditions. You know, I personally read some reports that said that patients diagnosed with this have a 25% suicide rate, which is just unbelievable.
The main advantage of our device is that the neurosurgeon only needs to implant the device once. When you look at some of the competitive devices on the market, they need to reinsert the device multiple times to really locate the point of the trigeminal nerve that's triggering the pain. Because of this, the device obviously can improve patient comfort while reducing just the procedural times. To date, we've announced that we've completed nine cases in a limited market release. All the patients are reportedly pain-free, which we're excited about. I also expect that by the end of this month, we'll conclude the limited market release, feel we've gathered the information that we need to gather to be comfortable to expand distribution to other centers in the country.
You may ask why we pursued this indication. It was actually based on requests from neurosurgeons that were using our OneRF brain ablation system as they often perform these procedures. It was a nice fit. You can go to the next slide. Next up is our spinal cord percutaneous paddle lead. This particular device is really intended for patients suffering with lower back pain, and this is where the pain is traveling down their legs. Most of the devices today to stimulate the spinal cord look like thin wire devices. They look like our sEEG devices. Because of the design, they use a significant amount of energy, and they really don't have the flexibility to customize the stimulation based on the patient's needs.
Our device can be placed percutaneously just like those thin wire devices, using our proprietary delivery system. Our technology also has the advantage of providing broader area of stimulation using lesser energy. You can see the size of the device is much larger than these wire devices, and therefore, that allows us to provide broader stimulation. This also reduces the frequency for patients to have to recharge their battery since it's utilizing less power. Then again, our technology also offers that customization of where the surgeon or pain specialist wants to deliver the stimulation. Where we are with this program is by the end of the year, we're really targeting to be ready to perform our first in-man implants. Currently, we're in chronic animal studies with the device.
Now for this technology, we are interested in partnering with a company that already has gained FDA, PMA approval, which will dramatically reduce the time to commercialization for us if we're able to partner with existing technology. Next slide. So next, this is our BVNA technology, which stands for basivertebral nerve ablation. It's a system that again leverages the same ablation platform that we're using in the brain and the face. Really what it does is it allows us to ablate the basivertebral nerve. You may wonder where the basivertebral nerve is located. It's right in between the vertebral body or the discs in your lower spine.
The issue here is there's changes that occur in the end plates, which the plates are below and above the discs in your lower back. In addition to the temperature probe that I've mentioned before, that offers the enhanced safety during the ablation, our design also offers the ability to perform multiple ablations because we have a number of contacts on the device. In essence, what does this mean for pain specialists? It means they have a larger sweet spot to perform the ablation. We've been told that this procedure in particular is becoming one of the fastest growing lower back pain procedures. We're also fairly convinced that the regulatory path for this technology is also a 510(k).
Currently, Boston Scientific and Stryker have systems on the market for this application. As is the case with other technologies, we're also in discussions with a number of organizations regarding potential partnership. Now we're up to the final technology that I'll discuss, and that's drug delivery. This technology has the capabilities to record brain activity before, during and actually after the delivery of either one of these gene or cell-based therapies. That is infused directly through the center lumen of the device. It also has the ability to stimulate tissue as well. Now, while these features are unique to our technology, our device can also be placed using Zimmer Biomet's robotic system.
It doesn't require the time or cost associated with needing MRI for device placement. It's as well as having a low profile. We can also place a large number of devices if needed, unlike other systems today. We also designed the technology to be used and sold for a variety of animal models. As companies develop these novel gene cell therapies or even drugs for brain cancer, they can use our device all the way from the initial development cycles through human studies to commercialization. We're extremely excited about the opportunity with that technology. Again, all using the same platform. You can go to the next slide.
In terms of leadership experience, I won't go into a great deal of depth here, but we've got employees that have a blend of small, large company experience. Many of us on this table or on this chart have experience at Boston Scientific, Medtronic, St. Jude Medical, and Abbott, just to mention a handful. We also have technology experts that have come from companies like Neuralink, which for those of you that are not aware, is Elon Musk's brain company. We also recently announced the appointment of David Wambeke, who I personally believe will be a key addition to help expedite all the work we're doing in drug delivery, as well as the commercialization efforts.
Now I'm going to turn the call over to our Chief Financial Officer, Ron McClurg, to discuss our financial overview.
Thanks, Dave. As of December 31st, which was our last 10-Q that we filed, we had cash of $3.6 million on hand, and in addition to that, we had accounts receivable of $2.7 million, which has since been collected and converted to cash. We had no debt on our balance sheet. We had product revenue in our fiscal first quarter of $2.9 million, which was an increase of 5.5% sequentially. We had gross profit margin of 54.2%, and the gross profit increased 2.6% on a sequential basis. Our modeling shows that we can get through the end of our fiscal year, which is the end of September of 2026, with the cash that we have on hand.
That modeling does not include any of the potential partnerships that Dave discussed, focused on either drug delivery or pain management. We have announced publicly that we expect the product revenue to be at least $10.5 million this year, which would be a minimum of 17% increase over the prior year. We do think that the other item that's not included in here that Zimmer would have access to, and Dave discussed, is some of the international product revenue. We are in the process of getting our ISO 13485 certification so that we can start to address that market. That will most likely come in the next fiscal year.
Dave, I'll turn it back to you.
All right. Thanks, Ron. Next up, our upcoming potential catalysts. I won't read through this line by line, but I would say, you know, the summary of really the main ones that we think could happen this year, obviously continued revenue growth for the RF brain ablation system. Ron mentioned that we're expecting at least a 17% increase. The full launch of trigeminal, which should occur next quarter. The potential licensing agreements, whether it's trigeminal, drug delivery, we have, you know, both back pain technologies, lower back pain technologies that we're having discussions with. You know, commercialization for drug delivery. That commercialization would be obviously for animal use, as well as any approved IDE studies. That's an exciting milestone for us.
Ron mentioned the ISO certification. You know, we've done nothing from a revenue standpoint overseas. We think there's a great opportunity there, so does Zimmer. This is the first major step to getting there. You can go to the final slide. Key takeaways, maybe a way to summarize this is, you know, when, you know, I've looked at the company and the business, you know, what I really wanna stress is NeuroOne's got a novel platform, thin film technology. What it offers investors is really multiple shots on goal. We've got growing revenue, we've got strong partnerships in large markets as well that we're looking to participate. We have demonstrated our ability to develop products. We've demonstrated the ability to get FDA regulatory clearance.
You know, our last technology took four months from the time of submission, which is not an easy thing to do. You know, I think most importantly, you know, our technologies, I mean, we're not working on these technologies unless there's benefits to patients as well as doctors. This is in a wide variety of different neurological conditions. Everything from, you know, epilepsy to back pain to really drug delivery. You know, I think for a company our size, you know, we've been able to achieve some significant milestones over the years. With that, you know, I hope you'll continue to follow our progress and Suraj will be more than happy to answer some questions.
Dave, first and foremost, you know, I have followed you guys for a long time, and it's amazing to see how much progress has been made. Dave, you mentioned a registry for your OneRF. As part of the registry, are you collecting presumably a reduction in seizure burden at 12 months or whatever timeframe? The reason I ask is that has been one of the issues with existing technologies where there is seizure recurrence or the burden is not, you know, the frequency and the intensity, there's always a dance around it, right? Whether it's inadequate ablation. I'm curious if you guys are gonna map that over time, and that would eventually lead into a publication, 'cause that has.
I mean, we hear anecdotes about your patients who have gotten epilepsy treatment with OneRF, but I'm more curious if you translate that into a publication at some point in time through your registry?
Yeah. We absolutely are doing that. You know, I remember having a discussion with one of the neurosurgeons using our device last year, and we were asking this particular surgeon if he would be willing to participate, and he said, absolutely. The reason why he was excited by this was not just for patient acceptance, but, you know, his belief, his strong belief was that what will really allow these types of therapies to advance more rapidly is to be able to provide data that supports the use of them to convince neurologists that they should refer patients for procedures like this. The more traditional neurologists, you know, have been trained to be much more conservative.
You know, in the presence of data that you know that demonstrates, look, there's the safety issues are minimal. I mean, today we've had none doing a brain ablation. We've even had as many as 44 ablations done on one patient. We haven't had one single adverse event, and that really speaks to the safety, the way we designed this device. It's critical, and we recently had one neurologist who was part of a team that strongly believes in ablation. His comment to me was, "We have over 20 patients worth of data.
I wanna make this information available now, so retrospectively because, you know, the results have been so outstanding. You know, he's very passionate about it, and it's one of our top goals is to get this data out there. If we can gather retrospective data from other sites as well, you know, we would include that. This particular registry that we just recently established is really designed for forward-looking patients, but I'd like to include as many treated patients as possible because the results have been outstanding.
Fair enough. Dave, for the drug delivery, is there a limitation on the molecule size, whether it's chemotherapeutic, gene therapy, you know, biologic? Could be anything.
Yeah. Excellent question. Really, the pharma company that's developing their therapy in every instance will have to test that with the device. We've done our own testing using benchtop models. We've had you know centers like the Mayo Clinic test it on some of the therapies they've been working on. So far, we haven't had anyone say that their molecules or their viscosity is too high, you know. Today, you know, the answer would be we haven't run across any. With all the different therapies out there, you know, there is the possibility, and they will be responsible for testing that with our device.
Fair enough. Dave, one last from my side, and I know this might be a little tricky. Obviously, you have BVNA, you have TNA, you have drug delivery. How should we think about the cadence or, you know, maybe timing is the better word, of potential partnerships, maybe later in 2026, 2027? How do you think it evolving?
Yeah. I think it's this year, Suraj. I mean, we've been having discussions and saying publicly that we've been having discussions for all the technologies that you just referred to, and I think they're. You know, all these companies are in different periods of diligence with us. You know, some very far along, others trying to catch up. I think there's an extremely strong possibility that we have one or more of these relationships that occur in 2026.
Perfect. Gentlemen, thank you so much for the time today. Congrats on all the progress, and I hope to continue this conversation. We appreciate it.
Thanks a lot, Suraj. Appreciate, having you.
Thanks.
Take care.
Bye.