Keith Warner Presents NeuraLace Medical at LSI Europe '23

NeuraLace Medical are the developer's of Axon Therapy, an FDA-cleared solution for the management of chronic pain.
Keith Warner
Keith Warner
CEO, NeuraLace Medical



Keith Warner  0:05  
Greetings. My name is Keith Warner. I'm the CEO of NeuraLace Medical. Our story is really simple. We all know someone who has had chronic pain or maybe we've had it ourselves. We all know what that's like. This company is set to revolutionize the world of chronic pain. It's done something really simple. It's perfected, it's developed a way to project a high intensity magnetic field onto a specific nerve. And in so doing, it is invented magnetic peripheral nerve stimulation, also known as Axon Therapy. As you may know, in the world of neuromodulation. Very few patients in the aggregate in the aggregate are in the population of those suffering from moderate to severe chronic pain, or restrict receiving neuro stimulation, it simply isn't accessible. Only 50,000 patients a year actually received this therapy, although millions and millions more could benefit from it for sure. We're out to solve that problem using using this device in the center of the slide the axon device. This is a device that projects the high intensity magnetic field onto a nerve. It is FDA cleared on the market and treating patients every day generating revenues every day, this patient's been incredible. This device has been incredibly successful across the range of chronic pain, including peripheral diabetic neuropathy. One of the reasons it's so successful, it uses a high intensity magnetic field 1.6 Tesla, which is approaching the range you would find in an MRI, it also is in a very small footprint. So wherever anatomically there's a source of pain, this device can be effectuated in that area. In terms of why it works. The biggest high level difference is all the other neuro stimulators use electrical leads that deploy electricity to stimulate the nerves they're trying to affect. We use magnetic therapy, which really does two main things, it's more comprehensive at stimulating the right nerve populations, and does so to a greater degree. Lastly, part of part of pain reduction occurs from the CNS or through the spinal cord to the central nervous system. And so our magnetic therapy affects and helps remodel that CNS, which can also decrease pain. Just a little bit of snippet of data. Our device is FDA cleared and on the market labeled for post surgery and post trauma. We're this week we're submitting data to the agency to expand our label to PDN painful diabetic neuropathy. This is a sample of that data. Across the x-axis you see time across y axis pain reduction, over 80% of patients are seeing at least a 50% reduction in pain scores. So really encouraging results for PDN patients and what isn't shown here, we're also seeing significant nerve restoration. So increasing sensory in there often which is their feet. So there's the feeling more of the ground underneath them, which prevents injuries and prevents costs. In an initial study that we did at one of our early sites, they did a 24 patients study, and of the two thirds of patients who responded to Axon Therapy, half of them cut their opioid dose by at least half in terms of competition, generally neurostimulation implantables are used frequently. But as I said, they don't they're basically inaccessible to nearly all patients. There are 10s and wearables but they have low intensity effects, and prescription drugs which can have side effects and can have uncertain efficacy. Just if we just look at painful diabetic neuropathy, which will be the extension of our label we expect to receive by the end of this year, there's about 30 million patients who have it, about half of them have painful diabetic neuropathy, we wouldn't be able to affect a significant portion of them at the earliest stages of their disease alongside prescription drugs. Whereas implantable neurostimulation an approach an approach of pushed by Boston, Medtronic Abbott, Nevro, the usual suspects, you know, they, they now have recently expanded their label to include PDN because they now are pursuing this population as well, although doing it for really only the sickest patients. How do we make money so we're coming to market with a more unique approach to gent monetizing this technology. So we push we offer hardware as a service. And so we provide the axon device at no charge, we provide service, we provide upgrades, and we're paying $350 for each and every 13 and a half minute treatment. Typically a patient treatment approach is a handful of treatments in the first month, five to six treatments, and then one treatment per month after that. So so for us to recover that $30,000 We pay for the device up front, you know only takes three to four months and then we're in some very high margin territory, in terms of why we're disruptive if you look At the logical acquirers, the multinationals in this space and neuromodulation, you know, they only get paid when they attract new patients and put an implant in them and sell the device, we get paid recurring revenue 350 Every single time the treatments given, we now have over a year experience at our early adopting customers in the US. And and and as I mentioned, the projection for neuromodulation is only around 50,000 patients per year, we can treat millions of patients at the top of the clinical algorithm as the entry level neuromodulation not the sickest patients where they're more likely to go with something like an implantable system if they have access to it in terms of go to market. So there's three basic pieces. So we're currently on the market selling and scaling up our commercial platform in the government sector. So there are 171 VAs in the United States, and about 50 DOD sites, those those sites have begun to adopt our product and and the utilization rates that we're seeing are extremely encouraging. There are treating about 30 treatments a week using our device, and we're making $350 for each and every treatment. And that's expanding. Now as more customers go through the contracting and evaluation process. Starting next year, we have applied for reimbursement in the Medicare market. So we're going to begin to treat Medicare patients treated in an ambulatory care care setting and that will be done through reimbursement coming from CNS, which we've applied for and expect to get early next year. And of course, the broad based nationwide category one CPT coverage is a process a process that will take us something like 24 to 36 months. But that's the last element in our reimbursement strategy. We we anticipate very high margin sales and increasing sales, especially as we're into the Medicare patient group starting next year. In terms of what we have achieved, so we've got a product on the market high efficacy treating patients every day FDA cleared, we're about to expand that clearance to PDN by the end of this year, and begin treating Medicare patients beginning of next year, we signed our first contract with the VA Health System earlier this year for 1.4 million over five years and expect that to continue to expand at other VAs. And as I mentioned, the reimbursement progress has been great for us we've we've we've got a category three code currently, and preparing to file a category one application in the next 24 months. The team is led by an experienced group of engineers and operating experts, Dr. Marshall betters the most reason to join our team. He's a 35 year well respected veteran in the pain space, he's treated millions of patients and, and with clinics, he has run and overseen and leads the pain service at a large VA in the United States, the societies that dominate neuromodulation, Nan's and Aspen, we have key advisors and folks who are part of those societies on our advisory board currently, and they're very helpful, we're raising five to 7 million, I've raised a little over four so far. So there's probably a million or so left in the board would be willing to go a little higher. So there's a little bit of room left, we're doing it at seven and a half million pre which is which is an aggressive pre money valuation, the company went through its own pivot, as many companies do away from a previous commercial model into the one that you now hear about. And so combining all of that together, the lead investors wanted to make this an appealing offering. And we're doing that at seven and a half pre. And as I mentioned, I have about a million left of that the use of funds will be to scale our commercial platform as we approach the VA and CMS business. And then and then conduct a large study that we'll need for our category one code application. And then And then lastly, we'll be expanding the marketing for our PDN approval that we expect. At the end of this year. We're speaking to all the likely strategics, Boston, Medtronic, Abbott, nevro and others. They certainly see the complementarity between implantable neuromodulation and early stage non invasive neuromodulation the two of them really go together and the conversations have gone really well and we expect them to continue to thank you very much for your attention.

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