Good day, ladies and gentlemen, and welcome to the Nevro Analyst & Investor Briefing. Good day, everyone. This is Julie Dewey, Nevro's Vice President of Investor Relations and Corporate Communications. I'd like to welcome you to the Nevro Analyst & Investor Briefing. Here with me today are Keith Grossman, Nevro's Chairman, CEO, and President, Dr. David Caraway, Nevro's Chief Medical Officer, and Rod MacLeod, Nevro's Chief Financial Officer. For those of you who have dialed into the call, you will also need to log in to the webcast in order to view the presentation slides that we will be using today, as they will not be posted on our website in order to protect our ability to publish the results in a peer-reviewed journal. You can access the webcast on the nevro.com website at nevro.com in the Investor Relations section under Events and Presentations. Our speakers will refer to the slide numbers as they present, so you can follow along during the presentation. Moving to slide two, I'd like to review the agenda for today. First, Keith will provide a brief overview and cover recent business updates. Next, Dr. David Caraway will cover clinical research results for our Painful Diabetic Neuropathy, or PDN, and Non-Surgical Refractory Back Pain, or NSRBP, randomized clinical trials. We're very excited to share data from both of these trials at this briefing. Following the clinical data presentation, Keith will provide closing comments, and then we will have time for Q&A with Keith, Dr. Caraway, and Rod. Before I turn it over to Keith, I'd like to remind you that our discussion today will include forward-looking statements, which are on slide three. Please refer to our most recently filed SEC filings, which are available on our website at nevro.com, for a more detailed presentation of risks and uncertainties that could impact actual results. The forward-looking statements in this call speak only as of today, and we undertake no obligation to update or revise any of these statements. Today's call is scheduled for 60 minutes, and we will do our best to get to everybody's questions in that timeframe. One final reminder for those of you on the conference call to please log in to the webcast in order to view today's presentation slides. With that introduction, let's move to slide four, where it's now my pleasure to turn the call over to Keith Grossman. Keith? Okay. Thank you very much, Julie, welcome, everyone. Thank you for joining us. As Julie said, we're here to cover two main data readouts that came out really just in the last 48 hours, the six-month data release for our NSRBP trial and the 12-month follow-up data for our PDN trial. Our Chief Medical Officer, Dr. David Caraway, is going to do really the heavy lifting on reviewing the slides that were presented by our principal investigators at these two conferences. I want to take a moment just to reframe sort of the business relevance of what we're talking about today. If you'll go with me to slide five. Some of you have seen these numbers before, on the left is what we think is today's market. By today, I really mean 2019 or on a pre-COVID basis. We think it's about a $2.5 billion market, most of which is in the U.S. Importantly, on the right, this is what we think the total addressable market is for a couple of indications for core, lower back, and leg pain for our TAM. On the left, on the light blue portion of this slide, this is where we spend most of our time today. These are the patients who have had prior back surgeries, who have persistent chronic and severe pain, and who require another option post-surgery. This makes up the majority of our business, and it makes up the majority of the spinal cord stimulation business in general among our competitors. On the right side of this graphic in the dark blue, you'll see the total addressable market for those patients who have not had prior surgery, sometimes referred to as virgin back or Non-Surgical Refractory Back patients, or NSRBP. This is, we think, a larger market as you see here on the slide, and a much less well-penetrated market. The reason has historically principally been because of payer pushback. The payers have told us as a therapeutic category, as an industry, that we need to provide a different level of data, and that really gets us to the topic today. That is what we've certainly tried to do with the NSRBP trial. If you'll go with me to slide six. This gives you a little bit of an idea of what we're trying to do. This, unlike PDN, is an on-label indication. The principal reason for conducting the trial that David's going to review with you momentarily has been to drive the decision-making and the acceptance among the commercial and public payer communities. You get an idea from the right, just the leverage in this particular segment. We think that this will become a bit of a tailwind for spinal cord stimulation markets around the world over the next few years. If you'll go with me to slide seven, a little bit just about the relevance of the PDN, or Painful Diabetic Neuropathy market. Starting on the left, the total patients with diabetes that are diagnosed in this country are between, depending on the estimates, between 25 and 30 million. About 20% of those patients suffer from severe and chronic neuropathic pain. Among those, almost half will become, or have become, refractory to the conventional medical management paradigm. The prevalence pool, as you see here, is quite large. All the way on the right here, you see the incidence rate is actually fairly high as well. This patient pool gets added to rather considerably every year in the U.S., to the tune of 140,000-200,000 patients a year, just the incidence therefore being a $3 billion-$5 billion market. On slide eight, this gives you some idea of just the power of, I guess, a market this size. The TAM for this prevalence pool is larger than you're used to hearing about in terms of dollars, and small rates of penetration, we believe, yield interesting results, and it's just the power of large numbers. It gives us really two things. One, the ability to impact the lives of a lot of patients, and a lot of very needy patients who don't have good options, which is our company's mission, and it's what really drives our team. Two, it gives us the ability to access, of course, a very, very large market that we haven't participated in thus far. On slide nine, just a quick reminder of where we are. Our FDA submission for PDN was made in December of this past year. It's been a series of data readouts over the last 6-12 months. Where we are today is deep into our penetration and really ready at this point to launch the indication and waiting for an FDA approval. On the far right, you see here that we think will come in sometime in the third quarter, allowing us to effect a second half of the year launch in the U.S. This is something we're exceptionally excited about. I think it's something we actually get more excited about the closer we get and the more we learn, and the more prepared we become. If you'll move to slide 10, I'll turn things over to David to review both of these data readouts on both of these trials. David? Thanks, Keith, and welcome, everybody. Thank you for taking the time to come out and talk to us today. I'm going to review two of our most important large-scale randomized controlled trials. If you'd move to 11. These are the SENZA Painful Diabetic Neuropathy RCT. I'm going to present the 12-month results and the six-month crossover data. In fact, it was just presented this morning at the American Diabetes Association, so we're very excited. This is fresh data. As you know, the six-month data for this study has been published in JAMA Neurology, and that's available for your use. You can download it anytime. We're really excited about the crossover data I'm going to present today. The SENZA Non-Surgical Refractory Back Pain RCT will be the other topic for conversation. This was presented yesterday at the American Society of Interventional Pain Physicians in New Orleans, which is where I happen to be right now. Again, this will be six-month results that we'll be publishing in the near future. If we move to slide 12. As I've mentioned, this was presented at the ADA. This is the largest diabetes meeting in the world. This is their annual meeting. Dr. Erika Petersen is our PI. She's a Professor of Neurosurgery at the University of Arkansas for Medical Sciences, and we are just so thrilled to get her guidance and her participation in this study. She's one of the largest enrollers as well, but she has been really an advocate of using neuromodulation, in particular 10 kHz spinal cord stimulation, to treat these patients who suffer so much. Moving to slide 13. I mentioned that the audience here for the presentation this morning were diabetologists primarily, who are not overly familiar with spinal cord stimulation, so we needed to explain a little bit to them about the therapy. We had this diagram of what it is. We told them that this is a non-pharmacological, reversible therapy that's been well established, especially in back and leg pain markets. We explained to them that this is a study for refractory patients. As Keith said, these are patients that have been through appropriate conservative therapies, including the gabapentinoids like Lyrica and Neurontin, but other agents as well. We wanted this study to be pragmatic. We wanted them to understand that these are the patients that look like the patients that they see in their clinics on a daily basis. We allowed hemoglobin A1c up to 10. We allowed BMI up to 45. It was a big study. Now, pharma studies you know can have very large numbers, but for a device study, we had 216 randomized, making it the largest study in this space. We informed them of that. It was really well done. We had independent medical monitors, reviewed every patient on their entry into the study and every adverse event. What was it? As I think many of you are aware, this was conventional medical management, guideline best care management, versus medical management with 10 kHz spinal cord stimulation, the Nevro therapy added to that. What I'm excited to present to you today is the design of the study allowed a crossover at six months. I'm going to show that here shortly. Of course, the 12-month data is important, too, and we're going to present and have presented the overall pain reduction, quality of life, and importantly, neurological function through neurological testing. Moving to slide 14, these are the baseline demographics. The important points here is that they were well-matched between the two arms, as you can see by the standardized difference number on the far right column. They were largely type 2 diabetes, so 7% and 3%, just a handful of patients that had type 1 diabetes. That's the patient population. You should also know they're very long-standing disease, 12-13 years, a mean diagnosis of diabetes, and peripheral neuropathy over seven years. This isn't a disease process that simply goes away with time. This is a progressive process where people suffer for many years because the treatments are poor. I mentioned that we allow hemoglobin A1c up to 10. The average hemoglobin A1c, the mean was 7.3% in the treatment arm and 7.4% in the medical management arm. The most important slide I have to show you today is actually the next slide. I wish I could do a drum roll, but that wouldn't be appropriate. Here we go. Moving to slide 15, this is our crossover data. What we see on the blue line is the 10 kHz treatment arm from the beginning. This is the group that we showed the six-month data on previously in our publication, and you can see that to have a very durable effect, at very low pain scores, very low impairment in the quality of life. What is most compelling to me, and I hope to you as well, is what happened at the crossover point. You can see in the orange line that the medical management patients, as you'd expect in the design of the study, did not improve. They stayed the same at six months. Once they were given the 10 kHz treatment, there was a profound, a precipitous drop in their pain scores, all the way to exactly or very close to what the treatment arm had been all along, down near in that two range or lower. You should understand that 93% of those who were eligible did in fact crossover. This is a large addition to this treatment cohort. On the treatment side, on the 12-month data, you can see that it's very durable. Again, probably the most compelling crossover data I've had the pleasure to be involved with in my career. If we go on to the next slide at 16, looking at the upper panel is the treatment on the 10 kHz versus medical management at six months and 12 months. Exactly the same responder rates, 86% at six months, 86% at 12 months. Durable, profound responder rate. If we look then at the medical management arm, the lower panel, as you can see, there were no responders, of course, in the first six months because they were just ongoing treatment. Once they crossed over, became nearly the same responder rate as those that had been ongoing treatment for the previous six months with an 84% responder rate. If we look then at the percent of pain relief, it's not on this chart that was presented to the ADA this morning, but there was a 77% pain reduction at 12 months, same as at six months, which was 76%. Many responders and a profound magnitude of effect beginning as soon as the patients or very shortly after the patients received the 10 kHz therapy. Slide 17. We continued with careful examination of neurological function. You may recall that these were tests that were taught to all the investigators. It was in collaboration with the FDA. Neurologists trained all of our investigators to do these careful exams that involve motor strength, involve reflexes, and importantly, a 10-point foot assessment for sensory. This involved both pinprick and 10-gram monofilament testing. The question we asked the investigators was: Was there significant improvement as compared to baseline in any of these domains, motor, sensory, or reflex function? Once again, look at the crossover. At six months, there was actually a decline from baseline in the crossover group that went all the way up to where the treatment group had been and stayed, at the 60%-62%. In the treatment arm past six months to 12 months, we saw a slight increase in the patients that reported neurological improvement. This is very compelling data, once again, that in this early study, what we're seeing is significant improvement for a majority of patients, also in neurological findings. Slide 18. Some of the other measures we looked at. Sleep impairment is a big problem for people with diabetic neuropathy. These patients have their worst pain at night. They walk the floors. They can't keep the bed covers on, and it's miserable. What we saw when we look at sleep scores, this is what's called PSQ-3. It's very much like the VAS. It's for pain on a 0- 10 point scale. We saw in the treatment arm, the blue line, long-standing durable improvements in sleep disturbance due to pain. What we saw, once again, is a precipitous drop in the rate at which pain interferes with sleep down to near normal levels and certainly consistent with what we saw in the long-term treatment group. In the BPI, which is a measure of mood and interference with daily activity, a similar picture. Really significant rather immediate drop in these scores to near the same levels as normal, to near the same levels as our treatment group had been for the previous 12 months. Slide 19. We have to show that this therapy is safe. The diabetologists are very concerned about that. We wanted to make sure that this group of patients that may have an increased rate of infection, that what we saw in this group. In fact, now with the crossover, we have 154 patients implanted. Key findings. There were no stimulation-induced neurological deficits. There were no explants due to loss of efficacy in either the 12-month treatment arm thus far or in the crossover group. The explantation rate due to infection, which was the cause of infections, was only 3.2%. 3.2% explant rate due to infection. This is very consistent with what we see in the non-diabetic cohorts published in the literature. A safe therapy based on these findings as well as the efficacy that I went through. In summary, we met our primary endpoints on significant reduction in pain. We met our endpoints in all of the secondary measures as well. The crossover data, I hope you agree, was compelling. We now have both pre and post data to examine for things like health economics from that crossover group. We have demonstrated these sensory improvements that continue in a very durable way and after crossover, go directly to where the treatment patients had been for the previous 12 months. Of course, we're going to continue to follow up these patients into the next 24 months. Move to slide 21. This is our Non-Surgical Refractory Back Pain RCT. These are the six-month results from that. Dr. Leo Kapural is the PI on this study, and he presented this yesterday at ASIPP. Moving to slide 22. What do we mean by Non-Surgical Refractory Back Pain? That all has meaning to us. It is patients that not only have not had previous back surgery, but also they are not considered candidates for spine surgery. They were refractory back pain despite good treatments, despite interventional treatments, despite medical management. They were sent with a fresh MRI to spine surgeons, to experts in the field, and deemed as non-candidates for surgery. That's the cohort they were examining there. We looked at not just pain relief, but also a number of secondary measures, disability, quality of life, the patient's perception of change, and also importantly, opioid reduction. This is straightforward, parallel arm, randomized controlled trial, with the patients monitored all the way out to 24 months as it will be in the PDN RCT. We're here today to present the six-month data, where the patients will be allowed to cross over. You see at six months, medical management arm could cross over and have a trial and move on to implant, and likewise in the implant arm, they were allowed to cross over. More to follow on the crossover data. If we look at the number enrolled, there was 159 that were randomized after screening, 76 in the medical management group, 83 in the treatment arm. They were given a trial, and if they had a successful trial, they moved on to implant. The three-month per protocol, that was the primary endpoint for the 75 in the medical management arm, 68 in the treatment arm. At the six-month endpoint, which we're going to discuss today on the per protocol, 65 patients were implanted and available for follow-up at six months. Moving on to slide 24. Basic demographics. A few important points to make here. First of all, we were well-matched. Both groups were quite well-matched in terms of all the baseline demographics. The baseline pain scores were 7.4 in the treatment arm and 7.2 in the medical management arm, were the mean scores. We did allow patients in that also had leg pain. As you know, back pain is often associated with leg pain, and 63% of the patients in the study in the treatment arm did have leg pain as well, and we did follow the impact of 10 kHz stimulation on leg pain as well. You should know, as you understand the study, that we were primarily interested in back pain reduction for this study. We excluded patients that had limb pain that was greater than a 5 for the reasons we did not want to confound our ability to analyze the pain scores for the back. Slide 25. If we look at the pain etiologies, the primary underlying etiologies, again, are disc disease for these patients. Some 72% of the patients in the treatment group had that as one of their diagnoses. We can see that this is also associated with spondylosis. These are the bony changes that often occur with aging or with degenerative disc disease. We see the vertebrae also have degeneration that occurs, and these often go hand-in-hand, the degenerative disc disease and spondylosis. Spondylosis can also have a significant mechanical component with bone-on-bone-style pain and joint pain. There are other diagnoses that were included in this. If we go to the bottom panel, where it says non-surgical candidate reason, 80% of these patients, when seen by an expert surgeon, were deemed not surgical candidates. That is to say, their presentation and underlying pathology was not deemed to be amenable to surgical intervention. Another 20% of patients, 13.3%, were offered surgical intervention, the patient declined. This may be because the ratio of benefit to risk for the patient was not to their liking. They said, "If that's my risk of having a significant improvement, I'm going to decline the surgery after discussion with the surgeon." There were another 7% of patients who were deemed non-surgical because of their comorbidity, their other presenting illnesses, such as heart failure. Maybe they're morbidly obese. That's the breakdown, about an 80/20 breakdown in patients that were enrolled in this study. Slide 26, w e see the actual outcomes that I'm here to present today. Three-month outcomes is 80.9% responder rate. These are patients that had at least a 50% reduction in their back pain. That was a responder. At six months, it stayed very stable, very durable at 80%. You can see that there really was only one known non-improvements, one responder in the medical management arm. A big difference, as you'd expect, given the design of the study. Importantly, sustained 24 months for all of our patients, including the crossover arm. Slide 27, t his is the so-called tornado charts. Important findings include that there are really no significant responders in the medical management arm. There's one patient that's a little bit over 50%. If we look at the 10 kHz arm, really profound responder rate, 80% greater than 50% pain relief, and almost 60% that had greater than 80% pain relief. This means that their pain is essentially gone. Their pain is markedly reduced to the point where it doesn't interfere with their daily activities and cause them to have to limit what they do on a daily basis. We think that this is really one of the most important findings in this study. Slide 28, r eal briefly, we had a lot of secondary endpoints, and I would tell you that 10 kHz was statistically superior for all of our secondary endpoints. Looking at a few individually on to slide 29, this is the percent of pain relief. In the medical management arm, the percent pain relief actually increased by 6%, whereas in the treatment arm, there is an overall reduction of 72% at six months. A marked reduction in the percent of pain relief. Obviously, highly statistically superior. Slide 30, t his is the proportion of Oswestry responders. As you know, the ODI, the Oswestry index, is a measure of function. What we saw here is on the left, there was a marked reduction from 52.9 down to 24.1. A 10-point change is considered a significant reduction. This is multiple times this minimally clinically important difference. In fact, two-thirds of the patients improved by more than one disability category. Really profound, and on the right, you can see that it was durable from three months into six months at around the 80% mark in terms of ODI responders. Slide 31, 70.8% of the patients in the treatment arm reported better or a great deal better. Only 4.6% of the treatment arm reported no change or almost the same, whereas 93% of patients in the medical management arm reported no change or almost the same. Big difference there in the patient's perspective of improvement. Slide 32, quality of life measure. This is the EQ-5D, which is an important measure that looks at five different domains that include mobility, self-care, pain, discomfort, anxiety, all the different measures. Again, in the treatment arm, it's more than twice the MCID, the minimal clinically important difference in the 10 kHz arm with no change in the medical management arm and durable effects from three months to six months for treatment. Slide 33, I'm going to pause just a moment on this slide as we start to finish up. If we look at the change in the daily opioid dose in terms of the morphine equivalents per day, there was a 40% reduction in the treatment arm. This was in a study that was not designed to force patients to get off it. It's not mandatory. 40% had a significant reduction, whereas in the medical management arm, patients on average increased. Overall, 69% of patients decreased or stopped their use of opioids, where in the medical management arm, 50% of the patients increased the daily opioid use. That is a profound difference. In this time of ongoing, during COVID, actually, it worsened opioid abuse. What we've seen is important reason to use non-opioid therapy such as 10 kHz spinal cord stimulation for these patients. Slide 34, AEs. There were no unanticipated adverse events in this study. The adverse events that we're seeing were similar to other studies of this type of design of spinal cord stimulation. The explant rate due to infections was 2.9%. Very low explant rate due to wound complications. I'll point out there were none, zero explants due to loss of efficacy in the first six months of this study. In summary, on slide 35, we met all of the primary and secondary endpoints, verifying that 10 kHz stimulation, when added to medical management as opposed to medical management alone, improves all these different measures, pain relief, function, quality of life, the patient's perception, and importantly, reduction in opioid use. All of the secondary measures that we looked at were multiple times the minimum clinically important difference. These weren't just statistical changes. They were important clinically relevant changes, and they stayed stable from three months to six months. Finally, the last two bullets. These results were very consistent with our pivotal trial in what was primarily a so-called failed back surgery group. Overall, these patients are responding in the same way that 10 kHz stimulation improves the lives of those with so-called failed back surgery. With that, I'll give it back to Keith for closing comments. Slide 36. Okay. Thanks, David. That was terrific. In fact, I'll just take everybody directly to slide 37. As I mentioned today, that I present these readouts, the two words that continue to jump out time and time again are the same words that I've heard from our principal investigators and the rest of our investigative team, and that's profound and durable. We just continue to be very excited about both of these trials and the data that has been generated from these trials, and the impact that we think it will have on the field, our patients, and our company. In the case of PDN, we think that the data that you just saw summarized by David is data that will move regulators, payers, referrers, and patients. It's our job to make all of those things happen, but we think the data will be certainly on our side. In the case of NSRBP, the data is well on its way. This is six-month follow-up, as you heard from David. At 12 months, we think, provided durability continues, we'll then have the data on the NSRBP side that will begin to move payers and the referral patterns as well, which will be early next year. I really want to thank, before we open it up here, our team, our principal investigators, Doctors Kapural and Petersen, for these two trials, all of our investigators, and of course, all the patients who made themselves available. What David just quickly summarized in 20 minutes from these two trials has required tens of thousands of man-hours to really design, execute, and complete. Just really pleased and thankful for the efforts of our team. I think, by the way, the pain community really recognizes that these are very significant investments on the part of Nevro, an expansion of SCS therapy, allowing them to treat more patients, specifically with high-frequency therapy. Despite the struggle that we've had, and frankly, continue to have with the COVID-related recovery of the pain markets generally, the SCS market specifically, and the uncertainty it continues to create in the very near term, our enthusiasm for the mid to long-term growth drivers of both NSRBP and particularly PDN continues to actually grow. The closer we get, the more we see and the more we learn, and we hope that you do as well. With that concludes our formal remarks. Operator, why don't we open it up for questions? Thank you. As a reminder, to ask a question, you will need to press star, then the number one on your telephone. That's star one on your telephone keypad. We have our first question from the line of Chris Pasquale from Guggenheim. Your line is now open. Thanks. Keith, first, congrats on the data. Those studies are very compelling. Payers sometimes ask for a variety of things before they grant coverage, confirmatory studies, real-world evidence, cost-effectiveness data. Based on your preliminary conversations, are you confident that Senza PDN is going to be sufficient to get you where you want to be from a coverage standpoint? Can you just walk through any plans you have to further flesh out the benefit of HF10 in this population? Thanks, Chris. I think we're pretty encouraged by the feedback we've gotten from payers by and large. Payers find these trials to be well-designed, large in size relative to the history of this therapy, and very compelling. That doesn't mean that there won't be some payers that want to see a follow-up trial, that want to see longer-term follow-up. Based on our feedback, we're pretty bullish on the fact that most of these payers will be compelled by the data that reads out from these trials. Having said that, in the case of, and David, you're welcome to pile on here if you like, we are going to be doing more work. There is more data that will be coming out of both of these trials, both published and presented in the coming quarters and probably the coming couple of years. We'll be doing follow-on trials. Certainly in the case of PDN, we already have plans for follow-on trials that you'll hear more about as the year progresses. There were a number of economic outcome endpoints in this trial that we're following as well, and we'll be presenting those over the next quarter or two and then submitting those for publication as well. You'll see a lot more now that we're past the 12-month follow-up endpoint on some of those readouts. That's great. Thank you. Yeah. Go ahead, David. Yeah, if I may. We will be having our 12-month data published in a very high-scale journal, our hope is in the near future. We think that those results will add to this compelling story for the payers. We've met with payers, we've discussed this with them, they're aware of this, and I would just say that the early responses from payers across the board have been pretty interested in the data and compelling. They believe the data are compelling. We've got more work to do. The health economics is a big part of what we're doing, and we've got the framework for that. As we push towards the 12-month results, we'll be also moving on that. We've got some early signals on health economics as well that have been very promising. That's great. Thank you. This is your first time presenting these data to an endocrinology audience. It's obviously a little tough with a virtual format, but I am curious what kind of feedback and reaction to the data you have been able to get from this crowd of physicians? I'll take that if you want, Keith. Yeah, please. The very positive feedback. Very, very positive feedback. I got word from Dr. Erika Petersen that our presentation was their fourth most visited so far at this giant conference. I think there is interest. I just got that a few minutes ago, actually. I think that there is a great deal of interest. The endocrinologists and diabetologists and the diabetes educational nurses that we've spoken to, podiatrists, have all been very impressed with the data. Of course, it would seem to be. Understand these physicians deal with these patients on a daily basis and understand that there are very few good choices. When they look at this and realize that it's a reversible, non-pharmacological responder rates bumping up in the high 80 percentile with profound overall pain reduction and the suggestion of a significant neurological improvement for many of these patients, they're wowed by it overall. Thank you. Our next question comes from the line of Adam Maeder from Piper Sandler. Your line is now open. Hey, guys. Thanks for taking the questions here. Congrats on the data. The first one for me is on PDN and reimbursement specifically. I think on the last earnings call, you talked about having 25% - 30% of payers on board upon U.S. PDN approval. The question is that still the expectation, or has that bogey moved one way or the other? Just how quickly should we think about covered lives scaling here in subsequent quarters? I had one follow-up. Thanks. Okay. Thanks, Adam. Yeah, no, I don't think it's changed. I don't think that estimate has gone either up or down. We didn't expect much movement and much actual decision-making until we had an FDA approval and publication of the data, or at least presentation of the 12-month data as we've had today. I think this meets our expectations. We expect most payers will make decisions in the coming months and quarters. Does that answer your question, Adam? It does. That's helpful, Keith. Thanks for that. Yeah. Just for the follow-up, switching gears to NSRBP, I think you made a comment that you think this patient population could be a tailwind to SCS market growth around the world for the next few years. I guess maybe given some of the commentary towards the end of this call, it sounds like that might be more of a 2022 event. Was hoping you could flesh out those comments a little bit more, Keith. The data that we've seen is obviously compelling using HF10. Do you think you stand to disproportionately benefit, and this kind of further cements your position in the marketplace, or is it something that really just benefits the market more broadly? Thanks so much for taking the questions. We've thought a lot about that, I think that the time will be the test. We'll certainly be doing everything in our power to make sure that both payers, referring, and treating doctors alike all understand that this data set is one generated by specifically high-frequency spinal cord stimulation. I'd like to think if we've done our job, and if we continue to do our job right, that we'll benefit disproportionately from the growth that comes to this market from these virgin back or Non-Surgical Refractory Back patients. That said, all of our competitors, I think, will generate data sets in this patient population. I think that we've always viewed this as a tailwind for really the whole market. Something in which we think all of our competitors will participate and compete. I think in many ways, that's a good thing because it's a very large and very under-penetrated market segment. I think the more data that's in front of payers and referring doctors and patients, the better. Look, I think we're the first ones across the finish line. This is awfully good data. I think it will be difficult to compete with this data set, and so I like to think we'll do better than most, Adam. It's very clear. Thank you. Thank you. Our next question comes from the line of Cecilia Furlong from Morgan Stanley. Your line is now open. Great. Thanks for taking the questions. I guess, just on PDN, I wanted to ask, in terms of different patient cohorts, as you push forward, in terms of patient targeting, but you had splits between HbA1c. I wonder if you're looking at specific patients, who is the ideal patient in your mind, the well-managed patient? Just as you think about too going forward, do you have plans as well to kind of look at different patient populations, either split by HbA1c or other metrics as well? David, why don't you take that one? Sure. Thanks for that question. We did look within this study, and slice the data a number of different ways, including stratifying by hemoglobin A1c within the study. What I would tell you is we did not see a correlation between hemoglobin A1c and either outcomes in terms of responder rates, nor did we see a relationship to adverse events that correlated with hemoglobin A1c. In other words, at least in this study, we've not seen A1c as being a differentiator either in terms of efficacy or safety. Now, as far as other ways of looking at this, who the ideal patient is. What we know is that we do have to manage these patients carefully perioperatively. As to make sure that they don't have problems with surgical site infections. That primarily revolves around glycemic control before the surgery, at the time of surgery, and after the surgery. We've done a great deal of work with our endocrinologists and other folks and really understanding what that looks like. Additionally, we studied lower extremity diabetic neuropathy. We did not include upper extremity in this study. However, as you I'm sure know, this is primarily a disease process of the lower extremities, at least initially. The longer nerves, such as in the legs, are the ones that are affected first, and then progresses sometimes into the upper extremities. We think that the perfect patient are the ones that are just as we studied, this broad group of patients that have refractory disease. That is to say, they're not responding to their medications. They are generally overall under reasonable control, their hemoglobin A1c, but most importantly, their perioperative glucose, and that they have a positive trial. Those are the patients that we looked at, and hemoglobin A1c does not seem to be a predictor. Okay. Thank you. I guess, too, just as you're focused on targeting patients, you talked about directly to consumer, but I'm just curious if you think about this patient population versus some of your traditional pain patients who are more used to the idea of implants, but how do you get PDN patients comfortable with the idea of an implant versus, they've only seen medication really as an option. I guess just nuances as we think about targeting, but really getting these patients comfortable with trialing SCS. I'll take that, I guess. Yeah. One of the things that some of the endocrinologists and podiatrists and the folks that are investigators in the study said, "When I talk to these patients, we mention that it's very much like a pacemaker." They immediately understand that, and it totally relieved them. The idea that there's a device that manages an important characteristic of their life was not foreign to them in the terms of what they know in the cardiac world. That was a way of really getting these patients to understand. The fact that it's reversible, the fact that they could have a test of this, that really did give a lot of comfort among both the enrollees in this study, as well as many of the treating physicians that we've talked to. Okay. Thank you. Thank you. Our next question comes from the line of Matt Taylor from UBS. Your line is now open. Hey, good evening. Thank you for taking the question. Great data. The first thing I wanted to ask you about was the label. Do you have any insight as to whether you're going to get HF10 specifically on the label? You mentioned this could be tough data to follow. Can you talk about how you think using HF10 could be differentiated in the PDN population specifically, or if you think it could be in NSRBP as well? Well, let me take them in turn. In the case of PDN, it's interesting, we've gotten this question a number of times, I appreciate your asking it in this format. To be clear, this is an approval from the FDA when we get it that will be specifically for Nevro. The FDA won't approve a class of therapies here any more than they ever do. If we're approved, we'll have a label indication for our therapy, and it'll be specific to high-frequency therapy. As we approach payers, the payers are waiting for an FDA-approved product along with data, of course. We think that in the case of PDN, this is very clear. It's very specific to high frequency, and it's a very specific label claim and FDA approval to Nevro. Our competitors certainly can and may choose to try to follow, conduct their own trials, try to replicate results, and get approvals of their own. With the exception of patients here and there in the margin, I think we view this as being a Nevro approval, a high-frequency indication, and we think payers will view it that way as well. In the case of NSRBP, I think it's arguably probably a little bit grayer. These patients, we believe, are on label for Nevro and probably on label for most of our competitors. We certainly will press very hard with the payers to recognize the data, but to also differentiate the fact that the data were generated with a high-frequency approach. I think we'll be successful in some cases, probably unsuccessful in others, given that these patients are on label for other devices technically from an FDA standpoint. I think it's a little bit more gray in the NSRBP patients, but I think it's very clear in PDN. Does that help, Matt? Yeah, Keith, that's perfect. Thanks for that. I just had one follow-up I wanted to ask about. You mentioned in the deck here initiating some payer discussions under the pre-approval information exchange guidelines. Now you've got the 12-month data in hand or the six-month NSRBP as well. Do you start to amp that up, and could you give us any feedback on conversations that you've had so far? Yeah. I certainly can give you the general tone, and then I think I'll ask David to weigh in because David has gotten dragged along on actually some of those meetings himself. I think the tone has been very constructive. I think it's been a good reminder for us, and this is mostly for PDN, where we've begun these payer outreach and not so much yet with NSRBP. It's a good reminder of just how difficult these patients are to manage now, and medical directors and decision makers at these plans are very aware of that, very cognizant of the fact that these patients are intensely managed, but not to very good effect and not with very good outcomes. I think there was, as I've synthesized all the reports from these meetings, there's been a pretty receptive approach from these payers to this particular data set. I think that hopefully bodes well for their decision-making following an FDA approval. David, you've been in a handful of these meetings. You want to add anything to that? No, that's right. We've spoken to a number of medical directors of plans as well as within Medicare, and letting them know of our interim data, talking about the study design. They've been really very supportive of both the design of the study and their understanding of the current state of the outcomes. Safety was one of the issues that continues to rise, even as the questions have come up on this call about hemoglobin A1c, about infection rate, and they've been very reassured that we were able to tell them that we have very low infection rates consistent with non-diabetic cohorts, and we showed them that data, and I think that has been another key point. Overall, really good acceptance of the data and the safety of the therapy. Fantastic. Thank you, guys. Thanks for taking the questions. Thank you. Our next question comes from the line of Kaila Krum from Truist Securities. Your line is now open. This is David Rescott in for Kaila. Thanks for taking our questions. The first from me on the PDN trial. You mentioned you had 82% of the patients, sorry, within the CMM arm crossover to SCS treatment therapy. I guess I was wondering what the thoughts are on this metric here. I mean, is this something that was surprising to you? Is it something that you're more bullish around, kind of just indicating a more clear type of interest for patients looking for additional treatment options? I may have missed this in the commentary, I guess could you talk about maybe the reasoning behind the 18% or so of patients who chose not to cross over? Any color there would be helpful. Sure, I can take that. When we look at that data, it's actually 93% of the patients who were eligible did cross over. 93%. Now, eligibility was based on a number of things. One is that they wanted the treatment, that they were still having significant pain, and that the doctors felt that they would be good candidates at that point in time, six months later. That's where that 82% came from. Of those who actually met the eligibility criteria, 93% crossed over. Very high crossover rate overall. The reasons were, as I said, some developed comorbidities during those six months. They declined to go for other reasons, or the physician felt that they weren't a good candidate at that point in time. I would point out, too, just as a follow-up, none of the patients on the 10 kHz side crossed over, decided they'd be implanted and cross over to the medical management. Okay. That makes sense. Keith, I guess one for you, just more on kind of the go-to-market strategy in PDN. I guess, do you have an idea of the number of centers you're looking to initially target here? I guess if we use that 18 trial center kind of as a proxy, do you have a sense for what the number of addressable patients within each of those 18 centers or within a specific center itself could be addressable by PDN for SCS or PDN? Yeah. It's a very large market, and it's reasonably fragmented. While there are large numbers of patients being managed by an addressable number of doctors, it's not terribly concentrated. To give you a little bit of a snapshot, the top 1% of the doctors treating PDN patients by volume is about 2,200 clinicians, and those clinicians treat about 10% of these patients in the U.S. It's about 10% of doctors treat about 20% of these patients. It's reasonably fragmented, and yet the numbers are very large. When you say who we can approach, I think it depends on how we get to them. Because when you look at things like data publications in journals like JAMA and presentations at conferences like ADA, the reach is quite broad. When you talk about digital outreach to referring doctors and, of course, to patients, that reach is also quite broad. When you talk about telephonic or in-person reach on the part of dedicated salespeople, then it becomes very targeted. Of course, we'll be very targeted initially on that top 1%, 2%, 3%, et cetera, that are still managing an awfully large number of patients, but they're reachable. It's a reasonable number of clinicians that we can get to. Does that help? Okay. That makes sense. Yeah. Thanks for taking our questions. Okay. Thank you. Our next question comes from the line of Robbie Marcus from JP Morgan. Your line is now open. Great. Thanks for taking the question and appreciate you putting this together. Really good data and very helpful. Keith, I was hoping maybe to ask one on just trends in the business now. How's COVID recovery progressing? Are you seeing improvements? Are you seeing any uptick in trials and implants throughout the quarter? Yeah. Look, Robbie, let me point out the obvious, and that is that the quarter ends in a number of days. I want to be a little bit cautious here, but I will say in general, that while we continue to see regular improvement, the pace of that improvement is slow. I think we're seeing this in other data sets that you all are seeing in terms of submissions and office visits, procedures, that kind of thing. It gets better and yet it's halting and it's slower, frankly, than we would've predicted. We continue to feel good about the endpoint here, where we think we'll be by in the fall and then by the end of the year. I will tell you that the pathway from here to there thus far, as I look at, say, the second half of the second quarter, it's been a little bit slow and a little bit disappointing, frankly, in the pace of recovery. I appreciate that. Maybe just one for Dr. Caraway on, I think it was slide 33. I noticed that I didn't see this at NANS, but saw that the baseline opioid use in the surgical back pain trial was a lot higher than in the SENZA arm. Is that statistically significant? Is there any reason for that or read-through from it? It just stood out to me and wanted to see what your thoughts were. David, are you still with us? I guess, Keith, if you can answer it. If not, I have another question I could ask also. Yeah. I hope we didn't lose David, or maybe he was on mute. You started the question, and I assumed it was going to David. Robbie, ask it again quickly, if you don't mind. Yeah, no problem. It was slide 33 in the surgical back pain trial. I noticed that there was a much higher opioid starting dose in the SENZA arm versus the medical management arm. I wanted to know if that was significant or if there's anything to read into. Great results in the SENZA arm, but it did stand out as a baseline difference. Okay. I'll just make sure David is not with us. Okay. I'd prefer that he answer this question. This came up in a previous conversation, my recollection, Robbie, is that it was not statistically significant, that the difference between these patient groups, while nominally higher, was not statistically significantly higher. Let me verify that before anybody hangs a hat on it, okay? Great. Maybe I'll just sneak one more in, Keith. The launches, you put in the slides on track for second half. Is there any way to narrow that down in timing, whether it's third quarter or fourth quarter? Just remind us what the back pain approval timeline might look like. Thanks. Well, the dependency for PDN is FDA approval, of course. You've probably heard me, Robbie, talk about this before, and that is that the six-month statutory review time is coming up probably in late July as we do our math. It is a guideline. We're hopeful that the FDA decision will meet that guideline, it could be sooner and, of course, it could be later. The review process is on track. It seems to be a healthy one. Nothing surprising along the entire process thus far, it's hard for us to have exact visibility when that FDA approval comes. I will tell you we're ready to launch when that approval comes. If it comes in July, we'll be launching in July to early August and obviously through the balance of the year. If it comes in August or September, that's when we'll launch. If that helps. With NSRBP, as I mentioned, this is on label now. There may in fact be some label claim changes that we will ask for based on the data, once we get through our 12-month follow-up. I think for us, the real initiative with payers won't begin until we have that 12-month data presented and published. That's really more of a launch on our part that's probably first half of 2022. Great. Thanks a lot, Keith. Appreciate it. Thank you. Our next question comes from the line of Joanne Wuensch from Citi. Your line is now open. Thank you. I hope you can hear me okay. Just a couple of things. Very nice data. Number one, if the majority of the patients in the PDN data were type 2, is this your target population or how did that sort of end up? My second question, this seems to have maybe a more difficult referral pathway with a stop at the endocrinologist first. Can you just make sure I understand, or we understand, what that pathway might be? My last question quickly is healthcare economic data. What particular measurements are you taking a look at? Thank you. Okay. David, I think you're back with us. Do you want to take a pass at this one? Sure. I caught the last part of the question. I apologize, folks. I know it just timed me out and cut me off. The question was about what particular measurements were you looking at for healthcare economic data. We're looking at two things, several things. One is pre and post, right? What happens to the patient after treatment? We look at the longitudinal cost prior to therapy and the longitudinal cost after therapy. That's very important. One of the things we're looking at concurrently are the costs of healthcare utilization during the trial itself. We're collecting that prospectively. How many times are they going to the emergency room? How many times are they getting hospitalized? What's going on with their medications? All of that will go into an analysis. We'll do formal analysis that will include QALYs and ICERs and all the things that we look at to do modeling of the cost of the therapy over time and show adjusted quality of life years and all of those types of measures. It's actually a very formal full HEOR sort of study that we're doing. We have some top experts that are helping us with that as we gather the data. David, the part of the question that you missed initially was a question about the skew in the PDN cohort to type 2s and away from type 1s. Whether or not that was intentional, how it happened, and whether or not that reads on any particular difficulty getting those patients referred from the endos. Joanne, if I'm not asking that right, just step in, please. No, you got it. Thank you. Okay. Yeah. Sorry. Yeah. It's type 2 because that's where most of this disease process is seen. The type 1 diabetics, the ones that come on, what we used to call juvenile diabetes, we don't say that anymore. It's type 1 because certainly you can get it in more mature years. These patients are under active control. Really just that we didn't exclude them. It wasn't intentional to answer that question, but it's just that the bulk of the patients are type 2 diabetics, and that was the nature of the referral pattern that we recruited from various different sources but primarily from the diabetes managing physicians and nurses. Thanks. Keith, the referral pathway and how you think of going from step one to step two to final implantation. Thank you. So the- Go ahead. I'm sorry. If I understood this well, the referral pathway will be part of our work to make sure these patients receive the appropriate treatment. I think I heard Keith talk quite a bit about what we're doing for that outreach. It's an educational purpose, right? We have to make the managing physicians that are out there that have these patients residing within their care for the most part, we have to make them aware of the data, make them aware of the treatments, and get these patients into centers that are centers of excellence that know HF10 therapy quite well. It will be a multistep process. It'll be identifying the patients out in these referring physicians, and then getting them into a center of excellence, getting the trial, and getting implanted. Joanne, now that the 12-month data has been presented, we'll be doing a fair amount of awareness work with the referring community. We may potentially have some data that we can talk about on our Q2 call in early August. Thank you. Our next question comes from the line of Bill Plovanic from Canaccord. Your line is now open. Hey, great. Thanks. Good evening. First, congratulations. That's impressive data. The questions I have, I'm going to drill a little more into the FDA approval processes. You know Keith, you mentioned that your six month is coming up at the end of July. In terms of the discussions, are they asking for any more data, any more clinical studies? Was the 12-month data kind of the final piece of the puzzle they're really waiting for and just review that and kind of move forward? If there anything else is remaining in as you think about just pushing through. Is there anything with the, you've now seen the data that you think is different in either the IFU or the post-approval study that you'd have to go after once you gain approval? Yeah. Bill, I think we'll go into too much detail about some of the interactions we've had with the FDA. We're not being asked for a subsequent study. We're not being asked any questions, frankly, that go beyond what the data that we have and the data that we've submitted to them. They could ask something new tomorrow, but I think we probably would have been asked those questions so far. Our sense is based on the questions we've gotten just along the way, the process in general, the feedback we've gotten, that this is on track. This is really clean data. This was a very well-designed trial. It was a large trial for this therapy. The data and the outcomes speak for themselves. I think our expectation is the FDA will receive it as really everybody else has. From a labeling standpoint, sure. Look, we've yet to get into a lot of detail. We've gotten into a little bit of discussion with the agency on what labeling might look like. I expect there's some of that discussion yet to come. I don't think there's a lot of variables here from a label wording standpoint, but let's come back to that, if you don't mind, once we're at approval from the FDA. Okay. Thank you for that. Just on the commercial, I was wondering if you could remind us, you mentioned you're ready to launch whether that approval comes nearer or farther, remind us again what you're launching with, like how many folks and what that commercial organization will look like on day one? Yeah. I've talked a fair amount about this in the past, so I don't want to belabor too much, but there's a lot that we'll be doing at the time of launch. It's a little bit of an all of the above kind of strategy. The first thing we'll be doing is launching our existing and our new sales organization. By existing, I mean the 400-500 people that we have in the field in the U.S., sales people, managers, clinical people, technical people, marketing people, et cetera, will all be completely trained and ready to go and told where to go and what their messaging is, et cetera. We'll have a similar initiative with telephonic salespeople. We have a new referral sales organization of 30- 40 people that are already completely trained up and ready to go. They know where they'll be going as soon as we have an FDA approval and we're on label. They'll be talking to the referring doctors. We have digital outreach to both patients and referring doctors that will go into high gear once we have approval. Obviously, we have a continued strategy with the societies relative to guidelines, data presentation, and publication influence generally, et cetera. It is a multi-pronged effort that's been in the works for the better part of the last 18 months. All of those things will click into gear once we have approval and we're able to do it. Excellent. Thanks for the recap on that. I appreciate it. Sure. Thank you. Now I will turn it back over to Julie Dewey. Thanks, operator. This concludes the Q&A session. We tried to do our best to get to everybody. We apologize for the couple of you that we weren't able to get to, but appreciate you participating today. Reach out if you have any follow-up questions, and we hope everybody has a great evening. Thank you. Ladies and gentlemen, this concludes today's program. You may all disconnect.