David Caraway, Chief Medical Officer at Nevro: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Saul Marquez:
Hey everybody, welcome back to the Outcomes Rocket. Saul Marquez here and today I have the privilege of hosting the outstanding Dr. David Caraway. He joined Nevro in 2014 and serves as Nevro’s’ Chief Medical Officer. Prior to joining Nevro, Dr. Caraway was the CEO of the Center for Pain Relief Tristate LLC in partnership with St. Mary’s Regional Medical Center in Huntington, West Virginia. Dr. Caraway has maintained an active medical practice for over 20 years and has held leadership positions in the North American Neuromodulation and American Society of Interventional Pain Physicians. As a nationally recognized expert in the treatment of chronic pain, he has lectured regionally, nationally, and internationally in the field of interventional pain medicine and authored numerous publications in this field. He received his BS in Chemical Engineering from the University of Virginia School of Engineering and his Medical degree from Virginia School of Medicine and also his Ph.D. in Biophysics from the University of Virginia Graduate School of Arts and Sciences. Just an amazing opportunity to connect with Dr. Carawy on some of the game-changing technologies that they’re up to at Nevro. Such a pleasure to have you here with us, Dr. Caraway. Thanks for joining us.
David Caraway:
Oh, my pleasure. Thanks for having me, Saul.
Saul Marquez:
Absolutely. So before we dive into some of the interesting tech and differences that you guys are making in health care, talk to us a little bit about why you do what you do in health care, what inspires your work.
David Caraway:
Well, really good question. I went into pain management for a very specific reason. I treated patients as an anesthesiologist for their perioperative pain or acute pain. I would run across patients that really suffered miserably with chronic pain, which is a completely different entity. And at the time that I was beginning to contemplate going into the field of treating these patients who suffered so much, the opioid epidemic was beginning to rear its ugly head. And I began to practice in Appalachia, the eastern part of Kentucky, the western part of West Virginia, and southern Ohio. And that was the hotbed of opiate abuse. It’s fueled by inappropriate prescriptions in large part then. And I felt there just has to be better ways to treat chronic pain than doling out pills that really don’t work and then create all the societal consequences that we see now. So I got very interested in this space of neuromodulation and made that sort of the cornerstone of the work that I did in treating chronic pain. It remains that now that I’m transitioned over to industry.
Saul Marquez:
Yeah, it’s a big issue and it seems like we’ve got the COVID epidemic. It’s not going away and neither is the opioid epidemic and just happens to be that a lot of attention has shifted to COVID. But the opioid epidemic is still an issue. Treating pain is still an issue, especially chronic pain. So talk to us a little bit about what you and the team over there at Nevro are doing to add value to the health care ecosystem in this regard.
David Caraway:
Yeah, thanks for that. And you’re absolutely right. Just as a digression, the opioid epidemic actually blew up during COVID. More deaths last year during 2020 than there had been previously. Now, admittedly, some of this is strictly addiction and overdose or largely synthetic opioids like fentanyl. But it’s been a big problem. So I’ll leave it at that. But clearly, for those patients that have chronic pain, the answer is going to be non-pharmacologic approaches to managing that. So if we talk about value-based therapies, what we want is a therapy that has a very high efficacy rate, a very high responder rate, and a large magnitude of effect without significant adverse events or side effects. And that’s reversible. So that’s the kind of therapy that spinal cord stimulation, which is the device that we manufacture provides. So it is a therapy that involves placing a small, flexible wire, basically a little flexible lead that has stimulated electrodes. And we put it into the epidural space. This is the same space that you get when ladies go into labor and get an epidural. That’s the same space. So it’s very common. We put that in there. We do it on a temporary basis at trial. And if the patient gets a very good response over the several days that the trial ensues, then they’re considered a candidate for a permanent implant. I say permanent because there’s a very small pacemaker-like device that gets hooked underneath the skin to this lead to help control pain. Now, what never did is change the game back in twenty fifteen when we came to the US and got FDA approved. While this therapy has been around for some 40 years, it’s all been about masking the pain. It’s been about getting tingling. Paresthesia, as we call them, is this sort of tingling, buzzing, feeling that you stimulate the spinal cord and you get those tingling feelings from stimulation in the same areas where you’re hurt. And then instead of feeling the pain, hopefully, you feel this more pleasant sensation, this tingling and or buzzing sensation never came to the market, threw that all out and said, you don’t need to have the tingling. You don’t need to have paresthesia. With the Nevro device, we operate at a much higher frequency that you don’t feel. So what happens is your pain gets better, but. You don’t have any annoying side effects like the tingling or the buzzing. Never brought that to market based on very high-level evidence and really sort of disrupted the whole space for the good.
Saul Marquez:
Yeah, yeah. So you go from still experiencing some of that paresthesia, dysesthesia to not even experiencing any.
David Caraway:
That’s right.
Saul Marquez:
That’s fantastic. Would you say that’s the key differentiator?
David Caraway:
That certainly is technically one of the key differences. We’re the only one that operates at these very high frequencies of ten thousand hertz that’s certainly around our intellectual property that we carefully protect and make sure that we use. But what I think is the main differentiator overall right now, one of the main differentiators is actually what we do around building evidence. We by far developed the highest level of evidence and multiple studies than any of our very large competitors, in fact. So we’re very proud of that. We came into the market with what’s called a full PMA. That’s the highest level of rigor from the FDA, where the only major device company that came into the market with a full PMA, a pivotal trial, supporting our entry into the market. And we’ve continued to do that. We’ve continued to roll out very high level, we call level one randomized control trials to support our new indications and our new value add, if you will, therapy of it.
Saul Marquez:
Yeah, that’s very clear. And so talk to us a little bit about how you’ve improved outcomes or made business better. Certainly, there’s the payer aspect of it. Is it working? Should we pay for it? Then there’s a patient or whatever, whatever angle you want to take on. This is great.
David Caraway:
Yeah, well, you start off with differentiators then. You asked about how we improve outcomes. We get a differentiated outcomes assessment team that is unlike anything else in this space. Let me just talk to you a little bit about that. We call it our HFX Cloud, and it’s kind of two parts to it. When our device goes into a patient, even for the trial, they have a call center that they can call on the phone. And there we find what we call a coach. And the coach can pull up all of their information and can help them with their therapy and walk them through programming changes remotely, can help them get the best possible outcomes. And they can call them at any time and get a real-time answer. And these are experts. It’s a whole team. And we assign the same person to the same practice so there’s continuity of care. Nobody does that. Now, that’s in addition to our field-based team that manages the operating room and works with the doctors to do the field-based training. Now we hook up that coach to something called Connect. Connect is this cloud-based data collection reservoir where every patient, every time there’s an interaction, either our coaches or our field-based team or the doctor, we push that information up to the cloud it very securely, very privately held. But that gives us the ability to track outcomes. You’re asking for the outcomes of every single patient, about eighty thousand patients tight now we’re in the database. We first interact with them through their whole experience with the Nevro HFX system and we can tell the doctors and the patients what their outcomes are, what kind of benefits they’re getting. We track medication usage, sleep, and all that for every single patient.
Saul Marquez:
That’s fantastic. That granular level data. A lot of folks ask questions and there are big topics around patient-reported data. Is the data device reported or is it input by a patient?
David Caraway:
Yeah, it’s both. When you’re talking pain, it’s almost always subjective data. We don’t have objective biomarkers of pain. I mean, there just aren’t. There are attempts to do that, to look at the electrical output of the core or different types of biomarkers. And none of those mean a thing in terms of what the patient is experiencing as pain. So those are patient-reported outcomes that record. On the other hand, the device also collects information, the programming parameters, the amplitude, how much it’s used, if it needs to be recharged, how often that occurs and how long that occurs. We collect both objective and patient-reported outcomes to synthesize a report.
Saul Marquez:
And that’s a really great point. I mean, this chronic pain, is subjective, and how somebody feels matters.
David Caraway:
That’s right. You know, it’s kind of interesting, Saul. So a lot of the mechanism of action studies that are done in chronic pain, they do them on rats right before they go into humans. So they take a rat, they put them under anesthesia, they cut a nerve, and then they stimulate them, painfully stimulating the rat. And it measures the reactions of the rat, how fast they withdraw their power or whatever. So as an acute what we call no susceptive model, that is to say, painful inducement acutely on these animals. That has no bearing on the complex psychosocial behavior of chronic pain in humans. And so you can learn things from these preclinical animal studies. You can learn some mechanistic issues and some physiology, but it doesn’t translate directly into outcomes in pain management.
Saul Marquez:
Yeah, well said. Well said. A really great point, David. And so as you think about approaches to chronic pain, obviously the techniques that you guys have, what are some of the setbacks that you guys have experienced and key learnings that have made you even better because of that?
David Caraway:
Yeah, you know, when we first came to market, so we had this beautiful new therapy with the best outcome that has ever been seen in the space and actually treating a new indication very effectively, this back pain that had been poorly treated previously? And so we were very protective of how we deployed our therapy. We only went to really skillful doctors. We didn’t use the whole range of therapies that our platform produces. We really did what we studied in our RCT, pivotal RCT and it worked great. We quickly, against these giant companies, garnered a significant share of the market. But, you know, what we realized thereafter is that patients for the same reasons we just said that pain is complex and it’s variable. It’s a psychosocial experience. So not everyone responds to affects our therapy, even though it’s highly effective for most. There are some that don’t. So what we did is we broadened our platform and made it much more versatile. We now can perform essentially all the frequencies that are on the market. We can deliver out of our IPG. Now, we still use our mark therapy HFX at ten thousand hertz, primarily because that’s where the evidence is. That’s where the best outcomes are. That’s where you don’t have to do with that paresthesia, those tingling feelings. But we have this ability to provide all these other waveforms to both so that both the patient and the doctor can have confidence they’re not foreclosing any options.
Saul Marquez:
But that’s great learning. And kudos to you and the team for realizing that and now offering the spectrum of options. Everyone’s different and just never know from a physician and the way they like to treat the patient. What works? What are you most excited about today?
David Caraway:
Oh, I’m really excited about what we call people diabetic neuropathy. We just got this brand new indication approved at the end of last month, the end of July. So this is A phenomenal step forward for these patients who suffer horribly. So diabetic patients, their hypoglycemia, Their high blood sugars lead to nerve damage. And these patients have horrible burning pain in their lower extremities that typically gets worse and it migrates approximately and migrates up the legs. And there are not really any good treatments. I’m sure everyone’s seen on TV, the Lyrica ads, in the burning pain and all that. Well, those don’t work very well. I mean, the best studies on the show you have to treat about eight patients to even have one responder. And then there’s discontinuation rate because the side effects is very high. And spinal cord stimulation had been used on this entity, this disease etiology for a while. But the outcomes weren’t good, you know. Thirty-six percent responder rate for nighttime
David Caraway:
And nighttime pain is the worst for these folks. They walk the floor at night, the reverend, their feet, they can’t even keep their bedclothes on their feet. So we did another of the largest randomized control trial that’s been done in this space. We just completed the twelve-month point on that. We published in JAMA, the six-month data and just a couple of weeks ago got FDA approval to market this. And that’s painful diabetic neuropathy. So I’m really excited about this. There are probably millions of patients that suffer needlessly and we’ve got an answer for them when they go through the medication. We’re not saying you should not try the medications. Sure. But the patients who are refractory to that and who fail appropriate medication management, you don’t have to go on opioids. That won’t work anyhow. We’ve got a therapy that’s FDA approved and really highly successful.
Saul Marquez:
Wow. Congratulations on that approval. I’m sure it was an arduous road to get there. It was never as easy. An indication that, frankly, a lot of people out there could benefit from I don’t remember the number, but I think it was something like fifty million Americans suffer from diabetes.
David Caraway:
Yeah. In certain ethnicities, it’s ranging at fifty percent of people. And it’s a growing problem. It’s not diminishing, even though we’ve got a lot of new drugs and a lot of new approaches. You see him on TV every night, but the problem is still growing. And then, like I say, this diabetic neuropathy occurs, and probably twenty-five percent of those patients with diabetes and at least half of those are refractory. So it’s millions. So we’re excited about it. And not only do we demonstrate that it’s highly effective and I mean, like in 90 percent of cases, we also showed that the majority of patients ready for this had some improvement in sensory and motor. Oh, wow. Now it’s early data and we’ve got a lot more work before. I’m willing to tell you that it’s clear cut that the majority of get better, get some better. But it’s really tantalizing, this early signal of potentially improving the neurological function in some of these patients.
Saul Marquez:
That’s really interesting. So I don’t know if it does or doesn’t, but does it contribute to the halting of degeneration of the nerves or.
David Caraway:
Yeah, TBD, my friend, we’re digging into it. Our next big RCT will look very much like. We’re already doing skin biopsies and things like confocal microscopy and other studies to try to understand what’s going on. And I think probably it’s multiple mechanisms of action. Some of these patients got better right away. I mean, I had some of the study patients tell me, doc, for the first time, I can feel the cold tiles underneath my feet, I mean, in the morning. And that happened within weeks for some patients. Then others it took many weeks or even months. So I think there are different mechanisms of action in place. So we’ll have to sort that all out. But more to follow.
Saul Marquez:
Love it. Love it. Well, congrats on this. milestone and a lot more to come, this has been truly a pleasure to connect with you, David, just to understand the amazing work you guys are up to, how different it is. Before we conclude, I love it if you could just share a closing thought. And where could the listeners get in touch with you, the company, physicians offering these therapies? Let us know more about that and then we can conclude.
David Caraway:
Yeah, well, the name of the company is Nevro. I’m easy to find. But you can just click on the website and you can track me down. My name is Caraway, but we have hundreds of reps throughout the country that service physicians. But on our website at Nevro.com, there’s also a physician finder. So if you’re interested in speaking to your physician, you can click on there. And there is routing towards both our people. We have a call team that is happy to talk to potential patients within the organization. You can click your way through that very easily. You can Google us or you can also go check. If you have a doctor ask if you’ve got peripheral neuropathy. Now’s the time to go to your doctor and say, hey, I want to investigate these effects I hear they’re FDA approved and then you can get a referral to one of our doctors that are trained.
Saul Marquez:
Fantastic. Well, certainly a phenomenal opportunity, folks. Make sure you check them out. Nevro.com. It’s an opportunity to really take care of your patients in a new way. And if you personally are suffering from pain an opportunity for you to take care of your own pain. So, Dr. Carwaroway, really appreciate the chance to chat here today and wish you guys the best here with the release.
David Caraway:
Ok, thanks very much, Saul. Take care. Thanks for having me.
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