Manfred Franke Presents Neuronoff at LSI USA '24

Manfred Franke  0:03  
My name is Manfred Franke. I'm the founder and CEO of Neuronoff, as was just mentioned, and we are working on providing a easier, simpler and more cost efficient treatment to chronic pain that is much closer to drug comparison than to a device comparison but with reliability of a device as our claimers so my focus today is your ROI. With that, I mean, we have done a lot of steps taken a lot of steps as a small startup of de risking what we've developed, that's your return off investment. And obviously, likewise, you're not just looking at return off investment, but likewise return on investment in the multiples of five and above. That is where we are stakeholder aligned. So this is my one minute pitch to listen to the next five minutes. We are clinical stage, we have just, we're in the process of completing our first in human clinical trial. In the US, we're reading for the 510 K submission to the FDA. And we're our goal is to have the first device for therapy sold. By the end of this year. When I speak of customer alignment, aka stakeholder alignment, I'm looking at who is either paying for the therapy or who's using our product. Specifically, we've got the payers, meaning insurance, that are looking at this as a much earlier treatment, because it's more cost efficient to them. We're looking at the physicians because it's faster to them, and easier than current treatment approaches that are available. We're looking at the providers and the clinics, because they have a better way to utilize their utilities, or is, et cetera. And obviously the patient, then patients smile if you actually take care of them without leaving scars. We call this privacy is beautiful as a mindset, but still have the ability to provide neuromodulation out of a needle, we're looking at a $70 billion market and a sliver of that market being the having a compounded annual growth rate right now of about 40%. We achieve this with what we call an electrode and injectable electrode. And we're raising a seed plus round right now in order to reach that point of sales for sale by the end of this year. already alluded to the market. Chronic Pain is a condition that affects approximately 51 million adult individuals in the United States. It is very dominated by drugs and to some degree needle ablation. The reason for that is that it has to be fast if you want to treat that many patients and devices are simply not as fast today, because if you have to schedule several visits and surgical visit included, then you're not as a vacation in the clinic not as time effective in the clinic. Which is why within the peripheral nervous system, things have gotten more and more invasive, more and more minimally invasive. And our approach actually lead reaches a point where we have a very small needle. So in order to avoid that, we basically said can we remove surgery to place devices surgery to remove devices, and maybe even the experience of what currently is the standard of care what's called a trial lead, meaning even before you are allowed to treat in the clinic with those devices, you have a device that sticks out as a wire, that the patient walks around for a while. But as a result of that initial trial, and then follow up chronic you looking at cost of about $30,000 to the insurance company insurance companies want to treat earlier, if you are more cost efficient. The benchmark is CMM conventional medical management, that's 8000 per chronic pain patients on average per year. Our approach is to be below that. So we can actually fit in that and save the insurance company money. As mentioned, we fit a clinic schedule of about 15 to 20 minutes per patient. And we avoid wires sticking out bulges or scars. As now recently documented in our clinical trial as well. What we aim to provide is first a temporary treatment because several patients want to try out neuromodulation. So just like you try out an aspirin, if you have a headache, for example, or a cold glass of water, you start with the least invasive option first and you try something before you commit to something stronger. Our approach is let's try it and then have the ability to actually convert it to permanent option. So summarizing the clinical needs, let's be invisible, let's be fast. And let's treat more patients as a result of it because you're aligned with the clinic, the clinician and the insurance company, the payer. How do we do that? The standard of care is on the left side that is a needle injection of a steroid for an inflamed nerve. In order to treat the pain. We basically said for repeat steroid injections, why don't we take the injection concept but take the drug out and put a device into the needle specifically a lead that when it comes out of the needle, it folds over on itself similar to a embolization coil and it creates a pocket during the injection process which is different from an embolization coil and widens that pocket so that it's self anchors. That's why we have that little bubble of bunched wire in the middle at both ends of the injector road. And this device is fully injected, meaning nothing sticks out. And then we apply what you can see here, this white device shown on the left side, an external pulse generator short for EPG. On the right side, you see happy patient, that's a poor sign example. It was happy because we fed it pretty well. And as the pig grew in size by a factor of two, or a device extreme stretched out, which documented as an unexpected side effect that our device is able to not move inside the body against the tissue, but actually stretch with the tissue, and thereby fixes the biggest problem that you have in peripheral nerve neuromodulation today, but basically, from a patient perspective, it looks like a mosquito bite. So looking at where we are today, we have this device on the left side, that's an example of an electrode as it comes out of the needle. And on the right side, you have a depiction of our implant kit, the patient EPG, that's the device with the three buttons that clicks on to the external patch. And on the left side to that you've got the patient programmer, the physician programmer. This is how our competition stands up to us. So you obviously can see it's significantly more invasive. If you have chronically placed devices or even temporary placed devices. There's a company that offers a 60 day treatment, which has to some degree a carryover effect for the pain treatment. But many patients afterwards want to have a chronic treatment, we basically said let's have something that's virtually invisible, we call it self care for treatment of pain. Oh, and I would like to point out that one centimeter mark, we had to actually blow it up in order to show you something. We're working with a very established clinical advisory board. All of our clinicians have either been or are currently involved, top level of pain societies. And likewise, we have a very experienced executive team and strategics over 150 years, if you take all the years of of executives that you can see there on the slide with 1.2 marginal MCRA. He's a consultant, he's not an executive want to point that out, but everybody else driving. So where are we today, we've, we're rounding out our first inhuman. We have data for the device being very, very MRI compliant, we've had it implanted for 30 to 30 days to 400 days, we're reading our first fight and key submission by the end by by in the third quarter of this year, in order to have the first device assault and then follow up for the DRG dorsal root ganglion case in 2025. And last but not least, we're very much aligned with the placement codes, removal codes, and also follow up codes. So you can utilize that. And I mentioned we're very much aligned with strategics. Because there's value if you design your company to be able to be integrated, be strategic, because you fit a hole, and you're not trying to replicate something that they already have in their existing portfolio. And we designed that as we have a tuck in solution that allows patients to try out neuromodulation earlier with our electrode. And then we have an adapter in r&d not currently in the clinic that connects to that electrode and then on the other side connects to for example, Medtronic sabots, a Boston sipg. Basically, if a patient tries with neuromodulation really likes it, nothing is visible but wants to have the ability to connect the battery powered device, they can use that and we can partner with somebody. That's a quick summary of where we are today and where we're heading to. And with that, I think my time is up. Thank you