Nervonik | Barry Keenan, CEO

Barry Keenan  0:00  
Thanks. So I'm Barry Keenan, CEO of Nervonik. I want to thank everybody for staying behind until the end, particularly those that I didn't have to bribe. So today I'm going to be going through our neuromodulation technology. So let's neuromodulation platform, and I'll tell you about our future plans. So, so the bioelectronic medicine market is exploding. I mean, it's poised for for significant growth, there's, there's no doubt about that. But the current technologies are just not suitable for peripheral peripheral nerve stimulation. Here you can see a picture of floor or X ray of a spinal cord stimulator Can you can see it's a big bulky device to the left is is a device which is which is uses wireless power transfer. And what that means is the power is transmitted from one side to the to a small implant inside the body. Now the implant is a micro implant because you don't have a battery, it can be extremely small, much, much smaller than today's technology. With that comes many, many benefits, particularly the surgical procedure, not only is it a lot cheaper, the device is a lot cheaper the surgical procedures a lot cheaper, it can be an outpatient procedure that takes 20 to 30 minutes, in comparison to your you know, spinal cord stimulator type device, which which requires requires general anesthetic, you know, a cath lab, etc. And this is much more concurrent with, with with where we're going with the value based healthcare system. So these are three of the devices are on the market currently, that utilize wireless power transfer will be the fourth coming to the market. And we are a 16th of the size of the smallest peripheral nerve stimulation device out there that uses a battery. And that's and that's a rechargeable battery of the primary battery there. They're even even larger. So our our first generation has shown shown here, we've tested it in several animal experiments. And we took it to the doctors a pin doctors and said, What do you think of it, they liked it, they liked the size, and they liked the fact that you could pour it externally to depth click right beside right beside deep nerves. However, when we asked them you know what, what what the patients want, what the pin doctors want, what what is the what is the most important aspect of this. And they said the wearable, the patient wearable has to be extremely small, at least get it as small as possible. So it's discrete, and it's an the patients are gonna adhere to the therapy. So that's what that's what we've developed in our second generation is a device that the lid goes closer to the surface. And as a coin shipped, designed, which collects a lot more energy and we lies for a smaller wearable, wearable device. The natural progression of this platform is to a spinal cord stimulator on a central nerve stimulator for treatment of migraine, which we're working on. We're also partnered with UCLA developing a sensing IC. So this sensing a C will will detect neural behavior and neural signals ecaps to be to be exact, that it will feed that information back and not allow us to fine tune the therapy. So do keep your therapy you know within the within the therapeutic window. So the market is growing, as I said, these devices are mostly 510 K devices and class two. And what that means is generally with the you know, the easy procedure, they're going to come you know, sooner on the treatment continuum. So the continuum of care, you'll be able to, you know, the pin doctors can recommend these devices prescribe these devices, as a potentially as an alternative  to opioids where as for the spinal cord stimulators, the bigger devices, you really have to f drug therapy, before you're going to be prescribed one of those devices. Now, these markets are growing incredibly fast. We're going after pain first. So peripheral nerve stimulation for neuropathic pain, of peripheral or origin. That market we know is growing incredibly fast and it's biting into the spinal cord stimulation market. They were also going to after stimulation with the spinal cord stimulation market, it's just a natural progression. And as we evolve our platform up market is is a mammoth. I mean that's that's going to be close to 6 billion and less less than four years. The big three are very active in that market, Allah however, they don't have a device that that exploits wireless power transfer so so nothing that has this kind of form factor. We're also looking at, at Sybil nerve stimulation for migrant. Now the big three have tried this because it's such a big, big market, but they've all failed their pivotal trials. And interestingly, some of the pivotal trials attempt the efficacy endpoint, but they failed due to adverse event

rates. So they fail with from a safety perspective. Now we've designed a device that fits right in here from central nerve stimulation. So it's right in the middle of the neck doesn't require leads coming up to To the area to treat the occipital nerves. And that's exactly what the problem was for, for the devices out there. So we're excited to to be the first to be going after potentially be the first of the market for that market. So it's all about the external control unit, it's got to be small, right for the patient that you know, the patient has to be comfortable to adhere to, it has to be able to get into location where you need to put it and you don't want to be wearing a big bulky thing that that others can see. Now the other devices sailor wireless power transfer devices out there suffer from a similar problem as the current technology, they're smaller implants are not as big as the other technologies, but they have a big external controller to power the device inside. Now we spoke to a number of pain doctors. So actually, some of the biggest implanters have peripheral nerve stimulators. And this is what they told us get the get the wearable down as small as possible. And that's, that's what we're doing. So this is just shooting side by side of our features compared to the devices that are out there. Now we got to look at the wearable, right that was that was number one, we want to get the wearables smallest possible we're a fraction of the size of the other devices out there, the implants are all pretty much the pretty much the same size, give or take. We're also working on digital health, that's going to be another offering and closed loop will be coming along. So we hope to be the first first to ever do closed loop with peripheral nerve stimulator. So why why is a form factor so important? Well, you know, as I mentioned before, small is essential for anything that a patient's wearing. Take carpal tunnel, right? I mean, how do you treat the nerves of the upper extremities, you know, with with these big devices, we can you can wear a watch simple and you can par you can par the implant that's that's that's in those locations. I talked about chronic headaches, we talked about migraine, this is the only device that will be able to go up there and won't suffer from all adverse events, the dealer that the big three have suffered from. And of course, our device because it's small, it can also can also control multiple implants. It can actually control up to sixteen with the one with one external device, but we only really need four or five. But neuropathic knee and and shoulder injury are classic examples where you need more than one implant to treat multiple nerves at the same time. This has been in development for quite some time and academia probably close to 10 years, over 5 million has been spent on on non dilutive funding 9 patent applications out there, it's been well published. And it's it's in product development now. So I just mentioned that, you know, we're through gen one, and gen two, the rest of the year is going to be product development. We want it when I get this finished and hopefully Yes, the FDA either q4 q1 Next year, we actually have our q sub with the FDA this month. So we're seeking six to 10 million in funding for series A and that's to take us all the way through product development and also a through commercialization and and also the continued development on the platform for the spinal cord stimulation and the occipital nerve stimulation. Indications. So we have a we have a great team has been working on this to take us this far. The series A will we will be we will be working on some FTAs. So we're some key hires that we've already we've already identified and we'll be hiring that. You know as soon as we as soon as we close around the funding, and things are going things are going well. So I want to thank you for your time and I look forward to talking further with anyone that wants to further discussions in the breakout room.

Thank you