Barry Keenan, Nervonik - Miniaturized Neuromodulation device | LSI Europe '22

Transcription

Barry Keenan  0:07  

Good morning, everybody. It's a pleasure to be here. I'm Barry Keenan, CEO of Nervonik. Today I want to I want to discuss are your modulation platform. This is a wireless power transfer device, which is really a it's a, it's a wearable that powers an implant inside. And that's your implanted pulse generator that provides neuro stimulation, or first indication is neuropathic pain enough peripheral peripheral nerve origin, just to show you what the devices that are out there and what wireless power transfer devices look like. On the right here you can see a spinal cord stimulator and that's your traditional neuro stimulation device to block pin signals in the spine, going to the brain, and I was peripheral nerve stimulation, you treat the the problem locally. So you interface with the with the peripheral nerve, there you can see which which device the patient would prefer. Now when you're when you're going after peripheral nerves, you need a much, much smaller device. And that's what you have with the wireless power transfer. To have a small device, you got to take the battery out. And that's why you have to you have to follow this, this profile. Spinal cord stimulators have been have been attempted in peripheral nerve stimulation, but they're just too big. As you can see, the size of the con that houses a battery in electronics just isn't suitable for this sort of therapy. Now, there are three other devices out there on the market. So this is this is a 510 K device. And there's there's three predicates available. Now the implants are all pretty much the same, they're all extremely small, and they don't have a battery, where we were trying to differentiate on the wearable. So the wearable that powers the device and controls the waveforms, be it being sent to the implant. Now the wearables with the with the competitor devices are large. And that is a that is a patient problem. I mean, when you've got a large, horrible, you can't treat certain areas, it's uncomfortable, you know, where do you put the device? Can you wear it on your arm for let's say treating something like like like carpal tunnel? Or just just in general, you know, can you work we're at your back if you're if you're trading, lower lower extremities, and patients, of course, won't be the scrape up by treating their disorder. So this is this actually a major differentiator for the patient that we have, here's our first generation which was which was tested in a few animal studies. But it wasn't really practical it was it was too big. And so by working with several several lab peon physicians, we determined what the device should look like. And what we realized was, we could run a lead with the with the APG, at the end the implantable pulse generator, up up to up to the surface of the skin, put it in a in a subcutaneous compartment. And the wearable sits above that. What that allows us is to have a much smaller battery and a much smaller wearable. And that's really what that's really our key differentiator. Now, this is a platform. And it's very easily turned into a spinal cord stimulator, if you want by by putting connectors and more leads, and more IPS on the actual on the actual PCB board. We're also we're also working on a little nerve stimulation indication for migraine, which is a highly sought after market. And in partnership, UCLA, we're developing sensing chips, where we can eventually do closed loop control. So the PNS market is is growing quite a bit. Right now, there's only three small companies in the market, the spinal cord stimulation market is massive. And that's actually accounts for 50% of the whole neuromodulation market. So think about that by electronic medicine. I mean, spinal cord stimulation has revenues that are close to 50% of that whole market. Of course, it's dominated by the big three. And so it's a it's a difficult market to get into. However, none of the big three have have a horse in the PNS risks, because the SES devices don't work well and PNS because of the mechanical design and being able to get the most tricky nerves. Plus there's so many different nerves outside of the central nervous system to get sir. The other thing is the PNS devices will cut and less yes market because you're treating the same disorders you're treating the CM, the cm neuropathy. And by treating it treating it locally, you can have a minimally invasive procedure to put this device in. So definitely cut in the lab market and without a doubt, it'll be prescribed so neuroma treatment continuing before you get the spinal cord stimulator We're also looking at the central nerve stimulation market for migraine migraine is is a massive market at effects there's actually 2 million Americans have chronic migraine, which is migraine for longer than 15 days of the month. And they've also got drug refractory so they have absolutely no therapy at all. So this is the syslogd wearable we're shooting for. It's really going to be governed by the by by the size of the battery that goes into it. So we're looking at a rechargeable coin cell battery. And this is just a comparison with with the competitive devices. So here's a side by side on the on the sizes of the wearable, you can see the size of the implants. I mean, these are micro implant. They're extremely small, the patient's not going to feel anything like you do with other other devices that are wearable. As you can see, 3.2 cc's is a fraction of the size of the competitors. And that's our real differentiation. Also, we have with this technology, we can power multiple implants with the one wearable. Now that's important for for certain indications such as neuropathic knee pain or shoulder. This is an example of a wearable treating carpal tunnel. So you can imagine you're treating carpal tunnel, you're stimulating the median nerve. Where do you put your wearable? Well, this this wearable will fit nicely as a watch where the the the receiver on the pulse generator will sit underneath the watch and then the ladle go right to the nerve. The other devices as you saw that the wearables are just too big for loose, flat kind of disorders. For chronic headache, the big three did massive pivotal studies. And they all had their clinical efficacy endpoints, but actually filled with safety, because they had leads coming up past the neck. With this wireless power transfer device, we can get the same efficacy by deliberateness in therapy, but we can place the implant above the neckline. And we think we can get kicked around all adverse events from these previous studies. To date, we've got nine patent applications and for the technology, we just got one patent approved for the telemetry of the device. So that's neuromodulation therapy with two way radio communication. So right now we are we're on our gen two device, we finished our first pilot study, there was there was some migration in the study. So we've we've changed the mechanical design to put in more anchors and under treat that migration. So we'll go back into the lab next month and test that. Following that we'll we'll be ready to do our GLP large animal study for FDA submission, and should finish that and back and pull it back compatibility testing q1 next year. So we're looking for we're looking for FDA clearance with this device, the latter part of the latter part of next year. While we continue to add features, we'll do another we'll do another special 510 K before we flew to market, so we're looking to raise anywhere between six and 10,000,006 will take us to market it'll take us to market it'll get us to market ready to face and but then we'll need a series B to you know to launch and figure out you know, what are you know, you know how much salespeople you want to put on the road. But with the 10 million we can do a soft launch. So we have a we have a great team behind this every most mostly people are consultants right now. Once we once we raise series A we will we will hire FTAs and fill out the management team but we're working with all the top contract manufacturers and developers and we're removing the removing quite quick and we hope to get the market in '24. Thank you for your time