[00:00:00] Kip Theno: Welcome to the Road to Care podcast hosted by SamaCare, where we will talk with key opinion leaders, physicians, administrators, manufacturers, venture capitalists, and legislators to get their insights on the state of health care today and where we see it evolving. SamaCare's prior authorization platform is free to clinics, ensuring patients get on the right therapy at the right time.
[00:00:20] Together, we can simply make things right.
[00:00:25] Hey, everybody, and welcome back to the Road to Care podcast hosted by SamaCare. And I'm pleased with our special guest today joining us in the studio, Dr. Krishnan Chakravarthy, dear friend of mine for a long time. Dr. Chakravarthy is MD andPhD, is an interventional pain and spine physician and CEO of NXTSTIM, which stands for Next Generation Stimulation Technologies. Dr. Chakravarthy is chairman and founder of the Empower YouChronic Pain Foundation, focusing on patient access, advocacy, and knowledge, and an affiliate professor in the Department of Anesthesiology, an affiliate professor in the Department of Nanoengineering at UCSD Health and VA San DiegoHealth Care.
[00:01:07] Chris is a keyopinion leader and worldwide speaker and researcher in medicine with over 10manufacturers and president elect for the AmericanSociety of Pain and Neuroscience, better known as ASPN. Hey doc, how are you today?Thanks for joining the podcast.
[00:01:22] Dr. Chakravarthy: Oh, thanks Kip for having me. It's always an honor to be there with you and to share some of my thoughts.
[00:01:28] Kip Theno: Well, I wouldn't have it any other way. You're a busy guy and it took you forever to get on my podcast, even though we've been friends for years. And I guess my first question is youcouldn't just stop at the MD. You had to get the PhD too? Talk about your journey.
[00:01:39] It's so fascinating in the healthcare doc.
[00:01:41] Dr. Chakravarthy: Yeah, absolutely. So, you know, I always start with this joke. You can tell what part of India somebody is from based on the complexity of their last name. So Chakravarthy is a very strong Tamilian name. Um, and actually grew up in the Southern tip of India and went to my hometown, which was Buffalo, New York, where I pretty much did most of my early education.
[00:02:03] So at university ofChicago, when I first started, I was a big math and physics enthusiast. And I was like, look, that's what I want to spend my life doing. But it's kind of funny. So whenever I bring up, one's own background in history, so you see all theseNetflix movies and it's, it's funny that most Indian parents, even 5, 10 years ago, they would say you're not successful if you aren't a doctor, an engineer in the family.
[00:02:31] So my parents put a lot of pressure on me to be like, "Hey, consider medicine." That was kind of what we did in the community. So it's taking a lot of these pre med classes in undergrad. And I was really into research. And so what happened was around my second and third year of training, National Institute of Health, which is kind of the big research body for the United States government and nationally does some of the great research that we see.
[00:02:59] They had a really interesting program called the Medical Scientist Training Program. And what the concept is that they really wanted to train physicians to be scientists. So you look at the great discoveries that have come through the development of vaccines, Louis Pasteur, I mean, did that in the lab to you hear about, um, peptic ulcer disease.
[00:03:22] I mean, all of those were physicians who thought scientifically. So NIH basically sponsors about 4 to 6 medical students all over the country per medical school. And sometimes the number of medical schools are restricted. But they completely cover the entire cost of the medical education while you take a hiatus between your second and third year to do the PhD part of it.
[00:03:49] So, obviously it was a gluttony for punishment because usually most people are like, ah, it's a lot, but it was such an incredible opportunity to do some very important foundational research. I spent my PhD really working on developing vaccines for the 1918 flu. I spent some portion of that working for the CDC.
[00:04:10] And I got my entrepreneurial bug through the PhD time when really our first startup was in the semiconductor business, looking at using quantum dot technology for labeling a lot of different biological flora for so that the entire experience was so unique and I wouldn't have traded any of it.
[00:04:31] So traditional med school is a four year time frame before residency. I spent 7. 5 years to add on the Phd to that.
[00:04:41] Kip Theno: Wow. Yeah, doc, I've seen you inaction.
[00:04:43] You were an empathetic caring physician, a caregiver. You're a key opinion leader, a thought leader. You work in research, researching for manufacturers, and you're also a teacher of students. And on top of that, as an entrepreneur, you're running medical device companies and specifically NXTSTIM is your latest venture and love to hear about that because when you think of paradigm shifts in medicine or resurrecting, therapies that, that maybe have kind of lost their way, you've done that with this discovery.
[00:05:09] Talk about NXTSTIM.
[00:05:11] Dr. Chakravarthy: Yeah, absolutely. So, you know, it's fascinating. I get this conversation a lot. How does somebody wear so many hats? And what's the driver for discovery? And why are people so passionate about the things that they want to pursue? So, four or five years ago, there was a national sales meeting. And I still remember today, I think we were at that same national sales meeting and I was asked to present. And one of the key topics on the first slide was the importance of "why". And it's a very important concept. When you are thinking about innovation and the time and energy spent in developing and putting your personal time and effort and resources, a lot of times innovators don't ask the question on why, why do you think the thing that you're pursuing has value to society, to your friends, to any of the countless people that may or may not use your product.
[00:06:12] So, I've been a real steward to the neurostimulation space, and I know that we share a common background in that area. Neuromodulation's been around for 70 plus years, and today, if you look at the statistics,there's about 50. 2 million Americans with some form of acute to chronic pain.So the question then becomes, well, how many of these patients are actually getting this therapy?
[00:06:37] It's probably only about 100, 000. So I spent about two, three years ago when I was traveling, I went to a meeting at in India, and it was really fascinating. You know, majority of neuromodulation, which has great data, great science. Why is it that's so few people, not just in the United States, but all over the world have access to these therapies.
[00:07:04] There has to be something that's causing a lack of access to these patients. And, one part of it is cost. So if you go to a place like India, people don't have insurance.How do they afford to pay for something when your insurance isn't there? The second part of it is the complexity of the care delivery model.
[00:07:25] When you think about all of the things, the average cost to the health system today for a single Implantable therapies around $100,000 to $150,000. So if you want to create a technology that has the ability to penetrate and impact countless millions of lives, you have to rethink the entire paradigm and how that model is delivered.
[00:07:51] But the technology has to address that question. Our vision at NXTSTIM and why I'm so passionate about this and I bring this conversation because I grew up in the southern tip of India. That's where all of my extended family is. It's a very poorly resourced area where there are a lot of disparities between people who can afford healthcare and people who can't.
[00:08:12] So the goal and the vision for NXTSTIM is can we take great technology. Where we see the impact of neurostimulation. And in fact, today there's about 44 randomized controlled trials that have been published that have looked at neurostimulation for back pain, shoulder pain, knee pain, any number of different indications.
[00:08:34] And how do we change that paradigm to provide access, community, and a low cost solution that then allows us not just to change the way it provides access to U. S. patients, but to the global patients that may be in very under resource environments. So at the end of 2020 with that vision, I founded NXTSTIM.
[00:08:57] And part of that is understanding how do we accelerate technology to think 20 years ahead? So that it can really change the paradigm in the care delivery. When you look at the most cost prohibitive elements in the neurostimulation space, it's really heavily reliant on personnel. The amount of effort to get multiple salespeople, clinical specialists to the operating room time to the surgeon, we needed to come up with a system that was transcutaneous, noninvasive, but almost reproduce what the biggest challenge is, which is the human element of the therapy delivery. So the genesis of our now FDA approved product, which, just within the last year, we've treated about 3000 patients, is looking at the use of AI to modulate a lot of the therapy paradigms that are heavily reliant on human involvement to try and minimize the cost. So today the average cost of our therapy, which is free to patients and covered by insurance is only at $150 price point versus something that's at$150,000 price point. So when you think about what that could impact in termsof access, in terms of scalable manufacturing, in terms of the digital health platform. I think we are doing something truly groundbreaking in the healthcaresystem. And it's showing in terms of the results that we're getting as we continue to penetrate into the market.
[00:10:40] Kip Theno: Wow. And let me do a full disclosure here. So, Dr. Chakravarthy, to the listeners out there, came to me and we were friends and we had worked together on some projects and he showed me this device. He said, you know, you should give it a try because he knew that I'm a chronic pain patient from the early 90s with a back injury.
[00:10:53] And I had tried everything. I've had I don't know how many epidurals, massive amount of steroids, which by the way are not, that doesn't really work long-term and isn't necessarily great. There's an opposite reaction that happens to those.And I've had almost everything except for the surgery and I'm trying to not go under the knife like that.
[00:11:12] And I have tried probably five or six other what are, what used to be called tens units and none of them worked for me. But this one I literally keep with me in my backpackevery single day and it works. And I've constantly asked you doc about this because what is the mechanism of action? Why is this so different?
[00:11:30] And I know you'vetacked on a lot of value added benefits to it. And we'll talk about remote patient monitoring later, but just in general, why does this device work sowell?
[00:11:40] Dr. Chakravarthy: Great question. So fascinating set of findings. , There was a non industry funded trial. It was called a fast trial. What was so fascinating about that fast trial was they took 200 fibromyalgia patients and they compared placebo stimulation to mixed frequency stimulation in 200 women that were randomized, and there was three very important conclusions that was drawn from that trial.
[00:12:09] Number one, the body inherently, you think about billions of years of evolution, pain is a really important teleological mechanism for why we prevent ourselves from sticking our finger onto a a flame, like it burns, so it makes you it's protective, right?So part of that is what we understand with chronic pain and acute pain is pain in short courses can be very effective in protecting the organism.
[00:12:42] In this case, let'ssay a patient, but when you have chronic pain, the problem that comes is. Paindoesn't necessarily stop. It's constantly ongoing because there are changesthat happen in the brain. But one of the things that people were observing is whenyou take stimulation at a set frequency, like, let's say, a tens unit or anytype of unit, the body's very, very intelligent.
[00:13:09] It's neuroplastic, which means that if I expose the body to the same stimulation pattern, anything after 20 minutes, there's a clear development of what we call tachyphylaxis, which means that the body becomes rapidly resistant to that stimulation. The second unbelievable observation we made was that If you used mixed frequency signals and you were able to change what the body was able to perceive constantly, you were able to retain that improvement in pain control because the neural habituation through transcutaneous stimulation wasn't able to result in that tachyphylaxis.
[00:13:55] In fact, what we found was two things happen. When you mix frequencies, you can actually up-regulate a lot of the endogenous opiates that the body uses as a natural painkilling mechanism. But the second thing that was very profound is, we were actually observing functional MRI changes in the brain that showed that thechanges in central sensitization that happen in a lot of the chronification of pain is being reversed by this type of mixed frequency signal fieldstimulation.
[00:14:30] Now, the challenge is how do I constantly change the program every 20 minutes without human involvement? And that's really what makes this so profound is the AI crowdsources data. Imagine today, AI's most powerful element is the type of data input that it accumulates. So if I have one patient using it for back pain versus a million patients using different programs for back pain, that data then gets assimilated to making the therapy changes when you build that inherent resistance to that therapy.
[00:15:09] So part of it iswhat we have developed is a very sophisticated model. Where we're looking atfield stimulation that's constantly adapting and changing based on patientfeedback, but in a global sense, a closed loop system that's monitoring thatdata through an entire remote monitoring platform. So true remote monitoring isthe ability for a nursing staff to look at that data.
[00:15:39] But, we understandthe human element of that interaction between an individual to a patient hassuch a profound effect on the therapy outcome. So to give you an example: Oneof the big challenges in the neurostimulation space is everybody says "Welleveryone's got great randomized control trial data, but prove it in the realworld outcomes, show me in pure raw data how good this is device isdoing."
[00:16:08] In fact, when we looked at over 500 patients, it's going to be one of the largest data sets that we have. We were able to show that out to 18 months, we had a 92 percent compliance on the device and over 70 percent of patients reported almost greater than 40 percent pain relief. So when you think about the cost to the health system, whether you'd look at drugs, whether you look at $150,000implants, we are proving a model that is groundbreaking.
[00:16:37] It's completely changing the way patients should be treating chronic pain. Why do you need togo to the emergency room? You don't need another prescription for an opiate.This is a front end electroceutical that helps with that. Do you look at the employer model? Amazon, Walgreens, all the big employers now are looking for people to come back to work.
[00:16:58] This device could help with that part of it too. Because you need a low cost, non invasive solution to really permeate the larger ethos of patients. At the end of the day doing a hundred thousand cases a year is not going to solve the bigger issue. I want to remind a lot of the audience before the entire covid pandemic the biggest health crisis in the United States was the opioid epidemic and it still continues to be a major topic. We have to find better solutions and I think we're on to something where we are reframing that healthcare argument by looking at a total different paradigm solution for that.
[00:17:40] Kip Theno: The one word that comes to mind docis compliance, right? And you mentioned clinical trials and clinical studies,and of course those absolutely need to be done. And typically you can look atone and another, and there may be one or two points different. But you havedata from the next dim device that shows, right?
[00:17:56] A different level ofcompliance from what I have seen. Can you talk about that aggregate metadatathat you've collected over the last couple of years and what it means?
[00:18:03] Dr. Chakravarthy: Yeah, absolutely. So we werevery one of the things I wanted to do is to be honest about what data wecollect and presented to our physician colleagues that are still going to makethis a prescriptive model to say, "Look, the things that come out of oursystem is we know what body part is getting stimulated."
[00:18:22] We know what type ofstimulation parameters that patients are using every day whenever they use thedevice in a system that doesn't require any patient input. So by a Bluetoothand cloud, we're constantly collecting that data. We're looking even at the longitudinaluse and compliance of those patients on our device with that program.
[00:18:43] And it also what weknow with field stimulation, which is really unique. Is that we know that theamplitude of stimulation, which means the volume in some sense, how high or howlow that I crank up that stimulation, there's good published evidence that saysthat's correlative to what, how much pain the patient is in.
[00:19:05] So the word biomarker gets thrown around a lot in medical science. And I think what we're trying to say is when we have a system that can aggregate all of that data in real time. We collect that data. We group that data. We have millions of datapoints that we look at for each individual patient's compliance on one individual unit for 18 months, 24 months, and the power in that is, if I were a physician, today, the big challenge in pain medicine is everything that I treat is a subjective input.
[00:19:43] A patient says tome, "I have shoulder pain and doc, this is what I'm dealing with."And we do a physical exam, we collect a history and then we determine, all ofthe different therapy options. But the beauty of this is and I think the best analogy of why this became standardof care was in cardiac and diabetes when they looked at early digital healthinterventions through blood pressure monitoring or continuous glucosemonitoring, the incidences of four vessel coronary artery bypass mortality droppedto 0%.
[00:20:18] And the reason for that was what they foundis if you monitor the right data set. In a digital health platform, not onlyare you looking at significant cost reduction, but you're completely changingthe outcome of these patients downstream by having an intervention that may notnecessarily need a person in there, but can be done through a virtual platform.
[00:20:43] For us, when wecollect this data, what's unique is each individual practice can collect all oftheir patient data onto a unique dashboard that then they can see longitudinal.They can see compliance. They can even see how the usage of EcoAI in differentbody parts allows them to inform the physician on what downstream therapiesthey're going to do.
[00:21:07] So imagine you'recompletely retooling the entire pain space to better understand: why am I doingthese injections? Why am I giving this drug? What am I trying to treat? So weare almost getting to the point of what we think is the concept that I like to coin as Theranostics. It's both atherapy and a diagnostic tool.
[00:21:30] So when we publishall this data, we want, you providers to know how they're doing, but eventuallyinsurance companies to say, look, you don't need to always validate somethingbased on a subjective assessment. We will provide you a low cost theranosticsolution that will help you validate a very, very expensive cost of the healthsystem, which is pain care all over the world.
[00:21:54] Kip Theno: Yeah . And, medicine is reactionary in general, inherently it is, if I'm sick I go to the doctor if I have a myocardial infarction I can go to the doctor, right?
[00:22:01] I have to get treated but, you know, remote patient monitoring, we've seen leads and lags.Like some specialties and markets have adopted it really fast, early adopters.Pain management hasn't really adopted remote patient monitoring. And by the way, it's been around since NASA.
[00:22:17] NASA, I can'tremember if the, if it was the Apollo or Gemini missions, you and I looked thisup a couple of years ago, they would slap a wire on you and you'd be in spaceand they'd be able to have rudimentary EKG readings right down in the bunker.And, I'm curious as how do we make this a first line because there's the oldsaying doc, and you've heard this, the surgery you shouldn't have had is thefirst one, right?
[00:22:37] And yet now you'vegot this maybe first line device and then you've gone through all of theseprocesses and then you've got the last line of therapy. What is that? What doyou need to do from an RPM perspective and what makes NXTSTIM special to makethis a first line thought process for patients and clinics?
[00:22:56] Dr. Chakravarthy: Kip, I love your questionbecause I feel like it tees up all the things I love talking about. So, I thinkthis gets back to me at the heart of what entrepreneurship is all about. Canyou solve a problem that is truly clinically relevant, and those are the typesof things that really become the unicorn businesses that we see leave lastinglegacy.
[00:23:21] So let me give an explanation, right? What I mean by that. One of the challenges in the remote monitoring space for pain management is monitoring is contingent completely on what data you monitor. And whether that data is clinically meaningful. So if the industry prior to NXSTIM looked at what data sets you could monitor weight, blood pressure, glucose, possibly looking at heart rate variability, pulse oximeter.
[00:23:54] The challenge with all of those outputs is, well, what does that mean to an individual pain clinician that's making a decision on what that data should say in terms of the next step for care? If I was a cardiologist, absolutely, blood pressure makes sense. If I was an endocrinologist, sure. I want to understand what glucose levels are so I can better understand that.
[00:24:19] If I'm an astronaut in space, I may be looking at EKG because I want to understand the impact of low oxygen environments on long term or space environments on long term health physiology. So the thing that what we are recognizing is that what makes NXTSTIM unique, and I think part of it is we are tracking data that is extremely important to the pain clinician.
[00:24:43] And that doesn't mean you have to be trained in pain. It can be anybody that's treating pain.And part of that is goes back to the point that things like body location of stimulation, things that included physiologically, amplitude of stimulation.Heart rate variability. All of that put together steps function.
[00:25:04] All of those datapoints when you collated together, there is no platform out there like NXTSTIM.So in some sense, we are trailblazing and pioneering. Remote monitoring for thepain space in an objective manner. Now, why haven't other companies been ableto do it? Because they haven't been able to come to a low cost solution.
[00:25:27] If you look at most of the implantable systems that look at saying they can do RPM, the problem with those systems is that cost of the actual device is $30,000 bucks. Most codes that insurance wants for monitoring, they are paying only $50 a month to absolve the cost of the device. So you cannot have an expensive device to do remote monitoring, you have to have a low cost device that can do preventative medicine. So in some ways we are the ideal, if not the perfect match for what we need to do to bring RPM as a standard of care in pain medicine, because one, we can manufacture these devices at a very, very low cost and at very high volumes.
[00:26:19] And two, we are very bullish on the fact that the data that's coming from the device is actually meaningful to a physician in the care model to make it more effective. So how they take that data and reduce the cost to increasing practice efficiencies is what I think is so meaningful and such an important point of difference to other RPM companies.
[00:26:45] Kip Theno: Well, and what I love about it is I have command and control too. I mean, I get real time feedback and I'm a patient and so I can change it. I can manipulate it. I can save things. I'm getting this constant kind of connectivity and feed. And so I do think to your point, it should be standard of care.
[00:27:00] And that brings me to change gears a little bit, we've had, and I know you keep a watchful eye on SamaCare and what we're doing here. And, it's in prior authorizations for the medical benefits side of what you do, doctor, the injections and infusions as an example. And I've had Christine Mann on, Dr. Scott Howell. And we've talked about legislation and it's interesting that the legislators were kind off fixated on oncology is, well, that's where people get infusions. And you look at neurology, rheumatology, now we're in behavioral health, cardiology is now in infusions.
[00:27:32] So there's this kind of education that has to happen to push this from a legislative perspective.But I think of it in also expanding indications, and why I say that is, we think of chronic pain as back, leg, neck, shoulder, knee, ankle. What about NXTSTIM and moving this even farther out, broadening the horizons of this device for oncology, rheumatology, neurology?
[00:27:54] Dr. Chakravarthy: Oh, fantastic. In fact, our first couple presentations next year is going to be at ASCO, which is one of the big, oncology conferences.Look, pain is a pretty multidisciplinary issue that faces a lot of different subspecialties.And one of the things that we're really excited about is you look at the migraine issues that neurologists are facing, specifically stimulating the trigeminal or the occipital nerve can have a lot of benefits for chronic migraine.
[00:28:26] You look at a lot of chemotherapy induced peripheral neuropathy. A lot of those that are now off label indications for neurostimulation. These can be targeted. Even things like one of the exciting areas we are interested in is overactive bladder (OAB). What's fascinating is people don't realize that a lot of stimulation at the bottom of the foot can affect detrusor activity that may or may not have an improvement in OAB as an indication.
[00:28:53] So part of our strategy is one, we're thinking about where does a peripheral nerve target specifically even like complex regional pain syndrome to things even now, nowadays you see stimulation affecting cardiac indications to angina pain we're trying to think of where can we place our device and given That we can get up to 1200 Hertz compared to traditional field stimulation unit. We can get a lot of depth penetration with our therapy that may be more relevant for us than in the past with other transcutaneous units.
[00:29:31] The second thing is even post stroke rehabilitation. A lot of our devices also have what's called an electromyographic stimulator, so it helps strengthen muscle to help in post recovery. But what's fascinating is, I think part of what next stems product portfolios looking at is we recognize at some level that there are going to be indications that require an implantable solution and part of the trajectory that we're going in is building that low cost ecosystem across not just theEcoAI front device, but an implantable device where we can again bring the cost of production down by affecting the miniaturization of the battery.
[00:30:18] So today if industrystandard is a 14 cc volume battery, we are shrinking that battery down toabout. 0. 5 cc's. So what happens is the entire care delivery model againchanges. In fact, one of our core technologies is being used for stimulatingthe vagus nerve. We've been able to target PTSD Stroke and cord injuries wherewe're able to reproduce the neural networks that a lot of C4 transectionpatients have and get them moving again and rehabbing.
[00:30:53] So we are very bigon being a middleware to software platform. You look at some of the greatdestiny companies like Apple. Why is it so? Attractive to consumers. It'sbecause they've built a strong ecosystem across their devices. So we believethat the indications are just to start. There's so many areas that we're goingto go into, but at the heart of it is the belief on access and a low costsolutions.
[00:31:22] Kip Theno: Well, and you brought up anecosystem, doctor, and I know you just didn't stop with the science and thediscovery and the device. And I'd love for you to talk about your foundation,the Empower You Chronic Pain Foundation. I know this all ties in. Talk to thefolks out there about that.
[00:31:36] Dr. Chakravarthy: Yeah, absolutely.
[00:31:37] Look, I think one ofthe big challenges today is in the pain space, there are about 6, 000clinicians globally, and if not nationally. The challenge is when you look ateducation for pain doctors, it's a one year fellowship post- residencytraining. The challenge with a specialty that is exponentially growing the wayour specialty is, is that the determination of care for an individual patientis highly contingent on which doctor you end up with, because if you look atthe interventional pain space, which is the ability to use differentmodalities, whether it's implantable, minimally invasive spinal procedures,they completely is contingent on the level of training and interest that anindividual physician takes. So the disparity is highly cognizant when you thinkabout if a patient, gets one opinion from a pain doctor to a complete differentopinion, then the value of a second opinion to the importance of patienteducation and driving better care for an individual becomes highly, highlyrelevant.
[00:32:48] And so the ideabehind my foundation was we have on average 55 national societies in painmanagement training doctors, which is great. But the inherent issue is If youare a patient and you can't get the right opinion from a physician, you'regoing to always be shortchanged to what options are there.
[00:33:11] And Kip, you said ityourself, sometimes Is surgery the right answer? Maybe, maybe not, depending onwho the surgeon is, what their level of aptitude is and what their, theindication is versus what about all of the other options that a patient cantake in that care continuum. So part of the foundation at the heart of it iscompletely focused on patient education.
[00:33:36] We really want toget focused on this concept of how do we educate patients to better understandtheir own health, therefore empowering them to better be able to seek the carethat they need. So if I knew about 10 other options for back pain. I'm going tohave a much better approach to talking to a physician and saying, Hey, do youthink that this is the right option for me?
[00:34:03] And that's part ofthe journey. And in fact, when you look at what the foundation is doing, we arecurrently the only patient focused education platform for patients nationallythat has been developing. So part of it is, I think the mission goes back to can we empower patients tobetter understand their health needs so they can become an advocate forthemselves?
[00:34:27] I think it's very,very meaningful and I really enjoy the speakers that have come through. It'sjust been a impressive to see the foundation grow the last couple of years.
[00:34:36] Kip Theno: No, thank you for doing that. Andcongratulations doc. You've always pushed the boundaries. It makes everythingand every company and everybody around you better, including myself.
[00:34:44] And thank you for that. We will support that foundation any way that we can. I do have an Easter egg question. You don't know what it is, but before we get to that, before we get to that, doc, how do people out there contact you or NXTSTIM?
[00:34:56] Dr. Chakravarthy: Yeah, you guys can email me.It's k-r-i-s-h-n-a-n @ nxtstim.com. krishnan@nxtstim.com. Happy to field any number of emails and would love to hear from you. We are on an incredible journey, very blessed to be able to do this for people in general. So, any questions, if you're from the patient, the physician side, I'm happy to field any of those questions.
[00:35:25] Kip Theno: Well, thank you, Doctor, for joining. And here is the Easter egg question. Look, you're a scientist at heartand I love that about you and we've had many a talks on discovery and Iremember telling you the story because I spent the majority lion's share of mycareer in interventional cardiology and Werner Forsman, the first cardiologistto ever do a catheterization, did it actually on himself, snuck into the lab.
[00:35:48] Used a urinarycatheter, 60 cm, put it in there with an assistant and actually took x rays.And that kind of launched the entire interventional cardiology space. And thenyou showed me a sneak peek behind the curtain of what I laughingly called theperpetual motion machine that humans have been trying to figure out for years.
[00:36:06] And you cracked the code and. I know it's bio energy as a fuel. It might be 007 where you could tell me and then you'd have to kill me, but can you give our listeners a sneak peek on that as well?
[00:36:19] Dr. Chakravarthy: Yeah, absolutely. So, I love to be in the lab. I think at the heart of every you find what their passion is.And I'm, I believe I'm at my core of physician scientists and physician scientists are unique because they think about clinical problems and then they bring it to the lab and they have these moments of thoughts that you think, "Oh, this could be really, really profound to me."
[00:36:44] I have invested mylife in looking at use of neurostimulation and I mentioned looking at newfabrication. One of the areas that we are what I believe very interested andwe've all collected a lot of preclinical data is that we are building a selfregenerative catheter that can be implanted.
[00:37:05] Planted that sourcesenergy from the body as a sustainable biofuel. So the industry of biofuel isthis concept of being able to harness the body's energy to be able to createsmall to more complex, types of instrumentation to medical devices that then arebetter able to carry out a specific end result of that.
[00:37:32] Our first sustainable biofuel we're able to develop is thinner than the diameter of a hair. A human hair. Can you imagine?That can self regenerate like an ultra capacitor and actually stimulate to create energy based on what the body produces to better be able to start stimulating into the nervous system.
[00:37:55] The future, I think is groundbreaking. It will be where we will have equipment and technology that are so powerful that you don't need a battery source. It's fascinating. We talk a lot about what 30 to 50 years from today is we're seeing an ever increasing expansion and emphasis on low gravity travel.
[00:38:21] It's going to be the focus of where human civilization is going. So we are invested in, I think, in the longterm building sustainable biofuel devices that can be self perpetuating that don't require an external fuel source. And so part of that is that we've proven that we're able to generate that level of energy that can actually dispense and act like a battery or ultra capacitor.
[00:38:48] So as sciencefiction as it sounds, we are moving light years ahead of where currenttechnology is. I was going to say, did you say flux capacitor?
[00:38:58] Kip Theno: Is that might as well say that. Youknow, I had to do that. And yeah, science fiction made real and that's what you do. So doctor, thank you so much for joining the road to podcast.
[00:39:10] Loved having you on.We got to have you on again. For any VCs out there, manufacturers, clinics,patients, please reach out to Dr. Chakravarthy at NXTSTIM. And a doctor reallyglad to have your voice on the program today. And thank you so much, my friend.
[00:39:24] Dr. Chakravarthy: Thanks Kip. Always a pleasure and really enjoyed being there with you.
[00:39:27] Thank you so much.
[00:39:28] Kip Theno: Thank you for joining the Road toCare podcast hosted by SamaCare, the leader in prior authorization technology and services, where through a script to therapy operating system, we enable connectivity with clinics, peers, and manufacturers focused on optimizing patient care. Tune in next time as together we can make things right.
[00:39:46]Enjoy the music written, produced and recorded by Jam
Podcast produced by JFACTOR, visit https://www.jfactor.com/
Together, we can make healthcare right. Here are some of the outstanding healthcare organizations and associations championing patient health mentioned in this episode:
[00:00:00] Kip Theno: Welcome to the Road to Care podcast hosted by SamaCare, where we will talk with key opinion leaders, physicians, administrators, manufacturers, venture capitalists, and legislators to get their insights on the state of health care today and where we see it evolving. SamaCare's prior authorization platform is free to clinics, ensuring patients get on the right therapy at the right time.
[00:00:20] Together, we can simply make things right.
[00:00:25] Hey, everybody, and welcome back to the Road to Care podcast hosted by SamaCare. And I'm pleased with our special guest today joining us in the studio, Dr. Krishnan Chakravarthy, dear friend of mine for a long time. Dr. Chakravarthy is MD andPhD, is an interventional pain and spine physician and CEO of NXTSTIM, which stands for Next Generation Stimulation Technologies. Dr. Chakravarthy is chairman and founder of the Empower YouChronic Pain Foundation, focusing on patient access, advocacy, and knowledge, and an affiliate professor in the Department of Anesthesiology, an affiliate professor in the Department of Nanoengineering at UCSD Health and VA San DiegoHealth Care.
[00:01:07] Chris is a keyopinion leader and worldwide speaker and researcher in medicine with over 10manufacturers and president elect for the AmericanSociety of Pain and Neuroscience, better known as ASPN. Hey doc, how are you today?Thanks for joining the podcast.
[00:01:22] Dr. Chakravarthy: Oh, thanks Kip for having me. It's always an honor to be there with you and to share some of my thoughts.
[00:01:28] Kip Theno: Well, I wouldn't have it any other way. You're a busy guy and it took you forever to get on my podcast, even though we've been friends for years. And I guess my first question is youcouldn't just stop at the MD. You had to get the PhD too? Talk about your journey.
[00:01:39] It's so fascinating in the healthcare doc.
[00:01:41] Dr. Chakravarthy: Yeah, absolutely. So, you know, I always start with this joke. You can tell what part of India somebody is from based on the complexity of their last name. So Chakravarthy is a very strong Tamilian name. Um, and actually grew up in the Southern tip of India and went to my hometown, which was Buffalo, New York, where I pretty much did most of my early education.
[00:02:03] So at university ofChicago, when I first started, I was a big math and physics enthusiast. And I was like, look, that's what I want to spend my life doing. But it's kind of funny. So whenever I bring up, one's own background in history, so you see all theseNetflix movies and it's, it's funny that most Indian parents, even 5, 10 years ago, they would say you're not successful if you aren't a doctor, an engineer in the family.
[00:02:31] So my parents put a lot of pressure on me to be like, "Hey, consider medicine." That was kind of what we did in the community. So it's taking a lot of these pre med classes in undergrad. And I was really into research. And so what happened was around my second and third year of training, National Institute of Health, which is kind of the big research body for the United States government and nationally does some of the great research that we see.
[00:02:59] They had a really interesting program called the Medical Scientist Training Program. And what the concept is that they really wanted to train physicians to be scientists. So you look at the great discoveries that have come through the development of vaccines, Louis Pasteur, I mean, did that in the lab to you hear about, um, peptic ulcer disease.
[00:03:22] I mean, all of those were physicians who thought scientifically. So NIH basically sponsors about 4 to 6 medical students all over the country per medical school. And sometimes the number of medical schools are restricted. But they completely cover the entire cost of the medical education while you take a hiatus between your second and third year to do the PhD part of it.
[00:03:49] So, obviously it was a gluttony for punishment because usually most people are like, ah, it's a lot, but it was such an incredible opportunity to do some very important foundational research. I spent my PhD really working on developing vaccines for the 1918 flu. I spent some portion of that working for the CDC.
[00:04:10] And I got my entrepreneurial bug through the PhD time when really our first startup was in the semiconductor business, looking at using quantum dot technology for labeling a lot of different biological flora for so that the entire experience was so unique and I wouldn't have traded any of it.
[00:04:31] So traditional med school is a four year time frame before residency. I spent 7. 5 years to add on the Phd to that.
[00:04:41] Kip Theno: Wow. Yeah, doc, I've seen you inaction.
[00:04:43] You were an empathetic caring physician, a caregiver. You're a key opinion leader, a thought leader. You work in research, researching for manufacturers, and you're also a teacher of students. And on top of that, as an entrepreneur, you're running medical device companies and specifically NXTSTIM is your latest venture and love to hear about that because when you think of paradigm shifts in medicine or resurrecting, therapies that, that maybe have kind of lost their way, you've done that with this discovery.
[00:05:09] Talk about NXTSTIM.
[00:05:11] Dr. Chakravarthy: Yeah, absolutely. So, you know, it's fascinating. I get this conversation a lot. How does somebody wear so many hats? And what's the driver for discovery? And why are people so passionate about the things that they want to pursue? So, four or five years ago, there was a national sales meeting. And I still remember today, I think we were at that same national sales meeting and I was asked to present. And one of the key topics on the first slide was the importance of "why". And it's a very important concept. When you are thinking about innovation and the time and energy spent in developing and putting your personal time and effort and resources, a lot of times innovators don't ask the question on why, why do you think the thing that you're pursuing has value to society, to your friends, to any of the countless people that may or may not use your product.
[00:06:12] So, I've been a real steward to the neurostimulation space, and I know that we share a common background in that area. Neuromodulation's been around for 70 plus years, and today, if you look at the statistics,there's about 50. 2 million Americans with some form of acute to chronic pain.So the question then becomes, well, how many of these patients are actually getting this therapy?
[00:06:37] It's probably only about 100, 000. So I spent about two, three years ago when I was traveling, I went to a meeting at in India, and it was really fascinating. You know, majority of neuromodulation, which has great data, great science. Why is it that's so few people, not just in the United States, but all over the world have access to these therapies.
[00:07:04] There has to be something that's causing a lack of access to these patients. And, one part of it is cost. So if you go to a place like India, people don't have insurance.How do they afford to pay for something when your insurance isn't there? The second part of it is the complexity of the care delivery model.
[00:07:25] When you think about all of the things, the average cost to the health system today for a single Implantable therapies around $100,000 to $150,000. So if you want to create a technology that has the ability to penetrate and impact countless millions of lives, you have to rethink the entire paradigm and how that model is delivered.
[00:07:51] But the technology has to address that question. Our vision at NXTSTIM and why I'm so passionate about this and I bring this conversation because I grew up in the southern tip of India. That's where all of my extended family is. It's a very poorly resourced area where there are a lot of disparities between people who can afford healthcare and people who can't.
[00:08:12] So the goal and the vision for NXTSTIM is can we take great technology. Where we see the impact of neurostimulation. And in fact, today there's about 44 randomized controlled trials that have been published that have looked at neurostimulation for back pain, shoulder pain, knee pain, any number of different indications.
[00:08:34] And how do we change that paradigm to provide access, community, and a low cost solution that then allows us not just to change the way it provides access to U. S. patients, but to the global patients that may be in very under resource environments. So at the end of 2020 with that vision, I founded NXTSTIM.
[00:08:57] And part of that is understanding how do we accelerate technology to think 20 years ahead? So that it can really change the paradigm in the care delivery. When you look at the most cost prohibitive elements in the neurostimulation space, it's really heavily reliant on personnel. The amount of effort to get multiple salespeople, clinical specialists to the operating room time to the surgeon, we needed to come up with a system that was transcutaneous, noninvasive, but almost reproduce what the biggest challenge is, which is the human element of the therapy delivery. So the genesis of our now FDA approved product, which, just within the last year, we've treated about 3000 patients, is looking at the use of AI to modulate a lot of the therapy paradigms that are heavily reliant on human involvement to try and minimize the cost. So today the average cost of our therapy, which is free to patients and covered by insurance is only at $150 price point versus something that's at$150,000 price point. So when you think about what that could impact in termsof access, in terms of scalable manufacturing, in terms of the digital health platform. I think we are doing something truly groundbreaking in the healthcaresystem. And it's showing in terms of the results that we're getting as we continue to penetrate into the market.
[00:10:40] Kip Theno: Wow. And let me do a full disclosure here. So, Dr. Chakravarthy, to the listeners out there, came to me and we were friends and we had worked together on some projects and he showed me this device. He said, you know, you should give it a try because he knew that I'm a chronic pain patient from the early 90s with a back injury.
[00:10:53] And I had tried everything. I've had I don't know how many epidurals, massive amount of steroids, which by the way are not, that doesn't really work long-term and isn't necessarily great. There's an opposite reaction that happens to those.And I've had almost everything except for the surgery and I'm trying to not go under the knife like that.
[00:11:12] And I have tried probably five or six other what are, what used to be called tens units and none of them worked for me. But this one I literally keep with me in my backpackevery single day and it works. And I've constantly asked you doc about this because what is the mechanism of action? Why is this so different?
[00:11:30] And I know you'vetacked on a lot of value added benefits to it. And we'll talk about remote patient monitoring later, but just in general, why does this device work sowell?
[00:11:40] Dr. Chakravarthy: Great question. So fascinating set of findings. , There was a non industry funded trial. It was called a fast trial. What was so fascinating about that fast trial was they took 200 fibromyalgia patients and they compared placebo stimulation to mixed frequency stimulation in 200 women that were randomized, and there was three very important conclusions that was drawn from that trial.
[00:12:09] Number one, the body inherently, you think about billions of years of evolution, pain is a really important teleological mechanism for why we prevent ourselves from sticking our finger onto a a flame, like it burns, so it makes you it's protective, right?So part of that is what we understand with chronic pain and acute pain is pain in short courses can be very effective in protecting the organism.
[00:12:42] In this case, let'ssay a patient, but when you have chronic pain, the problem that comes is. Paindoesn't necessarily stop. It's constantly ongoing because there are changesthat happen in the brain. But one of the things that people were observing is whenyou take stimulation at a set frequency, like, let's say, a tens unit or anytype of unit, the body's very, very intelligent.
[00:13:09] It's neuroplastic, which means that if I expose the body to the same stimulation pattern, anything after 20 minutes, there's a clear development of what we call tachyphylaxis, which means that the body becomes rapidly resistant to that stimulation. The second unbelievable observation we made was that If you used mixed frequency signals and you were able to change what the body was able to perceive constantly, you were able to retain that improvement in pain control because the neural habituation through transcutaneous stimulation wasn't able to result in that tachyphylaxis.
[00:13:55] In fact, what we found was two things happen. When you mix frequencies, you can actually up-regulate a lot of the endogenous opiates that the body uses as a natural painkilling mechanism. But the second thing that was very profound is, we were actually observing functional MRI changes in the brain that showed that thechanges in central sensitization that happen in a lot of the chronification of pain is being reversed by this type of mixed frequency signal fieldstimulation.
[00:14:30] Now, the challenge is how do I constantly change the program every 20 minutes without human involvement? And that's really what makes this so profound is the AI crowdsources data. Imagine today, AI's most powerful element is the type of data input that it accumulates. So if I have one patient using it for back pain versus a million patients using different programs for back pain, that data then gets assimilated to making the therapy changes when you build that inherent resistance to that therapy.
[00:15:09] So part of it iswhat we have developed is a very sophisticated model. Where we're looking atfield stimulation that's constantly adapting and changing based on patientfeedback, but in a global sense, a closed loop system that's monitoring thatdata through an entire remote monitoring platform. So true remote monitoring isthe ability for a nursing staff to look at that data.
[00:15:39] But, we understandthe human element of that interaction between an individual to a patient hassuch a profound effect on the therapy outcome. So to give you an example: Oneof the big challenges in the neurostimulation space is everybody says "Welleveryone's got great randomized control trial data, but prove it in the realworld outcomes, show me in pure raw data how good this is device isdoing."
[00:16:08] In fact, when we looked at over 500 patients, it's going to be one of the largest data sets that we have. We were able to show that out to 18 months, we had a 92 percent compliance on the device and over 70 percent of patients reported almost greater than 40 percent pain relief. So when you think about the cost to the health system, whether you'd look at drugs, whether you look at $150,000implants, we are proving a model that is groundbreaking.
[00:16:37] It's completely changing the way patients should be treating chronic pain. Why do you need togo to the emergency room? You don't need another prescription for an opiate.This is a front end electroceutical that helps with that. Do you look at the employer model? Amazon, Walgreens, all the big employers now are looking for people to come back to work.
[00:16:58] This device could help with that part of it too. Because you need a low cost, non invasive solution to really permeate the larger ethos of patients. At the end of the day doing a hundred thousand cases a year is not going to solve the bigger issue. I want to remind a lot of the audience before the entire covid pandemic the biggest health crisis in the United States was the opioid epidemic and it still continues to be a major topic. We have to find better solutions and I think we're on to something where we are reframing that healthcare argument by looking at a total different paradigm solution for that.
[00:17:40] Kip Theno: The one word that comes to mind docis compliance, right? And you mentioned clinical trials and clinical studies,and of course those absolutely need to be done. And typically you can look atone and another, and there may be one or two points different. But you havedata from the next dim device that shows, right?
[00:17:56] A different level ofcompliance from what I have seen. Can you talk about that aggregate metadatathat you've collected over the last couple of years and what it means?
[00:18:03] Dr. Chakravarthy: Yeah, absolutely. So we werevery one of the things I wanted to do is to be honest about what data wecollect and presented to our physician colleagues that are still going to makethis a prescriptive model to say, "Look, the things that come out of oursystem is we know what body part is getting stimulated."
[00:18:22] We know what type ofstimulation parameters that patients are using every day whenever they use thedevice in a system that doesn't require any patient input. So by a Bluetoothand cloud, we're constantly collecting that data. We're looking even at the longitudinaluse and compliance of those patients on our device with that program.
[00:18:43] And it also what weknow with field stimulation, which is really unique. Is that we know that theamplitude of stimulation, which means the volume in some sense, how high or howlow that I crank up that stimulation, there's good published evidence that saysthat's correlative to what, how much pain the patient is in.
[00:19:05] So the word biomarker gets thrown around a lot in medical science. And I think what we're trying to say is when we have a system that can aggregate all of that data in real time. We collect that data. We group that data. We have millions of datapoints that we look at for each individual patient's compliance on one individual unit for 18 months, 24 months, and the power in that is, if I were a physician, today, the big challenge in pain medicine is everything that I treat is a subjective input.
[00:19:43] A patient says tome, "I have shoulder pain and doc, this is what I'm dealing with."And we do a physical exam, we collect a history and then we determine, all ofthe different therapy options. But the beauty of this is and I think the best analogy of why this became standardof care was in cardiac and diabetes when they looked at early digital healthinterventions through blood pressure monitoring or continuous glucosemonitoring, the incidences of four vessel coronary artery bypass mortality droppedto 0%.
[00:20:18] And the reason for that was what they foundis if you monitor the right data set. In a digital health platform, not onlyare you looking at significant cost reduction, but you're completely changingthe outcome of these patients downstream by having an intervention that may notnecessarily need a person in there, but can be done through a virtual platform.
[00:20:43] For us, when wecollect this data, what's unique is each individual practice can collect all oftheir patient data onto a unique dashboard that then they can see longitudinal.They can see compliance. They can even see how the usage of EcoAI in differentbody parts allows them to inform the physician on what downstream therapiesthey're going to do.
[00:21:07] So imagine you'recompletely retooling the entire pain space to better understand: why am I doingthese injections? Why am I giving this drug? What am I trying to treat? So weare almost getting to the point of what we think is the concept that I like to coin as Theranostics. It's both atherapy and a diagnostic tool.
[00:21:30] So when we publishall this data, we want, you providers to know how they're doing, but eventuallyinsurance companies to say, look, you don't need to always validate somethingbased on a subjective assessment. We will provide you a low cost theranosticsolution that will help you validate a very, very expensive cost of the healthsystem, which is pain care all over the world.
[00:21:54] Kip Theno: Yeah . And, medicine is reactionary in general, inherently it is, if I'm sick I go to the doctor if I have a myocardial infarction I can go to the doctor, right?
[00:22:01] I have to get treated but, you know, remote patient monitoring, we've seen leads and lags.Like some specialties and markets have adopted it really fast, early adopters.Pain management hasn't really adopted remote patient monitoring. And by the way, it's been around since NASA.
[00:22:17] NASA, I can'tremember if the, if it was the Apollo or Gemini missions, you and I looked thisup a couple of years ago, they would slap a wire on you and you'd be in spaceand they'd be able to have rudimentary EKG readings right down in the bunker.And, I'm curious as how do we make this a first line because there's the oldsaying doc, and you've heard this, the surgery you shouldn't have had is thefirst one, right?
[00:22:37] And yet now you'vegot this maybe first line device and then you've gone through all of theseprocesses and then you've got the last line of therapy. What is that? What doyou need to do from an RPM perspective and what makes NXTSTIM special to makethis a first line thought process for patients and clinics?
[00:22:56] Dr. Chakravarthy: Kip, I love your questionbecause I feel like it tees up all the things I love talking about. So, I thinkthis gets back to me at the heart of what entrepreneurship is all about. Canyou solve a problem that is truly clinically relevant, and those are the typesof things that really become the unicorn businesses that we see leave lastinglegacy.
[00:23:21] So let me give an explanation, right? What I mean by that. One of the challenges in the remote monitoring space for pain management is monitoring is contingent completely on what data you monitor. And whether that data is clinically meaningful. So if the industry prior to NXSTIM looked at what data sets you could monitor weight, blood pressure, glucose, possibly looking at heart rate variability, pulse oximeter.
[00:23:54] The challenge with all of those outputs is, well, what does that mean to an individual pain clinician that's making a decision on what that data should say in terms of the next step for care? If I was a cardiologist, absolutely, blood pressure makes sense. If I was an endocrinologist, sure. I want to understand what glucose levels are so I can better understand that.
[00:24:19] If I'm an astronaut in space, I may be looking at EKG because I want to understand the impact of low oxygen environments on long term or space environments on long term health physiology. So the thing that what we are recognizing is that what makes NXTSTIM unique, and I think part of it is we are tracking data that is extremely important to the pain clinician.
[00:24:43] And that doesn't mean you have to be trained in pain. It can be anybody that's treating pain.And part of that is goes back to the point that things like body location of stimulation, things that included physiologically, amplitude of stimulation.Heart rate variability. All of that put together steps function.
[00:25:04] All of those datapoints when you collated together, there is no platform out there like NXTSTIM.So in some sense, we are trailblazing and pioneering. Remote monitoring for thepain space in an objective manner. Now, why haven't other companies been ableto do it? Because they haven't been able to come to a low cost solution.
[00:25:27] If you look at most of the implantable systems that look at saying they can do RPM, the problem with those systems is that cost of the actual device is $30,000 bucks. Most codes that insurance wants for monitoring, they are paying only $50 a month to absolve the cost of the device. So you cannot have an expensive device to do remote monitoring, you have to have a low cost device that can do preventative medicine. So in some ways we are the ideal, if not the perfect match for what we need to do to bring RPM as a standard of care in pain medicine, because one, we can manufacture these devices at a very, very low cost and at very high volumes.
[00:26:19] And two, we are very bullish on the fact that the data that's coming from the device is actually meaningful to a physician in the care model to make it more effective. So how they take that data and reduce the cost to increasing practice efficiencies is what I think is so meaningful and such an important point of difference to other RPM companies.
[00:26:45] Kip Theno: Well, and what I love about it is I have command and control too. I mean, I get real time feedback and I'm a patient and so I can change it. I can manipulate it. I can save things. I'm getting this constant kind of connectivity and feed. And so I do think to your point, it should be standard of care.
[00:27:00] And that brings me to change gears a little bit, we've had, and I know you keep a watchful eye on SamaCare and what we're doing here. And, it's in prior authorizations for the medical benefits side of what you do, doctor, the injections and infusions as an example. And I've had Christine Mann on, Dr. Scott Howell. And we've talked about legislation and it's interesting that the legislators were kind off fixated on oncology is, well, that's where people get infusions. And you look at neurology, rheumatology, now we're in behavioral health, cardiology is now in infusions.
[00:27:32] So there's this kind of education that has to happen to push this from a legislative perspective.But I think of it in also expanding indications, and why I say that is, we think of chronic pain as back, leg, neck, shoulder, knee, ankle. What about NXTSTIM and moving this even farther out, broadening the horizons of this device for oncology, rheumatology, neurology?
[00:27:54] Dr. Chakravarthy: Oh, fantastic. In fact, our first couple presentations next year is going to be at ASCO, which is one of the big, oncology conferences.Look, pain is a pretty multidisciplinary issue that faces a lot of different subspecialties.And one of the things that we're really excited about is you look at the migraine issues that neurologists are facing, specifically stimulating the trigeminal or the occipital nerve can have a lot of benefits for chronic migraine.
[00:28:26] You look at a lot of chemotherapy induced peripheral neuropathy. A lot of those that are now off label indications for neurostimulation. These can be targeted. Even things like one of the exciting areas we are interested in is overactive bladder (OAB). What's fascinating is people don't realize that a lot of stimulation at the bottom of the foot can affect detrusor activity that may or may not have an improvement in OAB as an indication.
[00:28:53] So part of our strategy is one, we're thinking about where does a peripheral nerve target specifically even like complex regional pain syndrome to things even now, nowadays you see stimulation affecting cardiac indications to angina pain we're trying to think of where can we place our device and given That we can get up to 1200 Hertz compared to traditional field stimulation unit. We can get a lot of depth penetration with our therapy that may be more relevant for us than in the past with other transcutaneous units.
[00:29:31] The second thing is even post stroke rehabilitation. A lot of our devices also have what's called an electromyographic stimulator, so it helps strengthen muscle to help in post recovery. But what's fascinating is, I think part of what next stems product portfolios looking at is we recognize at some level that there are going to be indications that require an implantable solution and part of the trajectory that we're going in is building that low cost ecosystem across not just theEcoAI front device, but an implantable device where we can again bring the cost of production down by affecting the miniaturization of the battery.
[00:30:18] So today if industrystandard is a 14 cc volume battery, we are shrinking that battery down toabout. 0. 5 cc's. So what happens is the entire care delivery model againchanges. In fact, one of our core technologies is being used for stimulatingthe vagus nerve. We've been able to target PTSD Stroke and cord injuries wherewe're able to reproduce the neural networks that a lot of C4 transectionpatients have and get them moving again and rehabbing.
[00:30:53] So we are very bigon being a middleware to software platform. You look at some of the greatdestiny companies like Apple. Why is it so? Attractive to consumers. It'sbecause they've built a strong ecosystem across their devices. So we believethat the indications are just to start. There's so many areas that we're goingto go into, but at the heart of it is the belief on access and a low costsolutions.
[00:31:22] Kip Theno: Well, and you brought up anecosystem, doctor, and I know you just didn't stop with the science and thediscovery and the device. And I'd love for you to talk about your foundation,the Empower You Chronic Pain Foundation. I know this all ties in. Talk to thefolks out there about that.
[00:31:36] Dr. Chakravarthy: Yeah, absolutely.
[00:31:37] Look, I think one ofthe big challenges today is in the pain space, there are about 6, 000clinicians globally, and if not nationally. The challenge is when you look ateducation for pain doctors, it's a one year fellowship post- residencytraining. The challenge with a specialty that is exponentially growing the wayour specialty is, is that the determination of care for an individual patientis highly contingent on which doctor you end up with, because if you look atthe interventional pain space, which is the ability to use differentmodalities, whether it's implantable, minimally invasive spinal procedures,they completely is contingent on the level of training and interest that anindividual physician takes. So the disparity is highly cognizant when you thinkabout if a patient, gets one opinion from a pain doctor to a complete differentopinion, then the value of a second opinion to the importance of patienteducation and driving better care for an individual becomes highly, highlyrelevant.
[00:32:48] And so the ideabehind my foundation was we have on average 55 national societies in painmanagement training doctors, which is great. But the inherent issue is If youare a patient and you can't get the right opinion from a physician, you'regoing to always be shortchanged to what options are there.
[00:33:11] And Kip, you said ityourself, sometimes Is surgery the right answer? Maybe, maybe not, depending onwho the surgeon is, what their level of aptitude is and what their, theindication is versus what about all of the other options that a patient cantake in that care continuum. So part of the foundation at the heart of it iscompletely focused on patient education.
[00:33:36] We really want toget focused on this concept of how do we educate patients to better understandtheir own health, therefore empowering them to better be able to seek the carethat they need. So if I knew about 10 other options for back pain. I'm going tohave a much better approach to talking to a physician and saying, Hey, do youthink that this is the right option for me?
[00:34:03] And that's part ofthe journey. And in fact, when you look at what the foundation is doing, we arecurrently the only patient focused education platform for patients nationallythat has been developing. So part of it is, I think the mission goes back to can we empower patients tobetter understand their health needs so they can become an advocate forthemselves?
[00:34:27] I think it's very,very meaningful and I really enjoy the speakers that have come through. It'sjust been a impressive to see the foundation grow the last couple of years.
[00:34:36] Kip Theno: No, thank you for doing that. Andcongratulations doc. You've always pushed the boundaries. It makes everythingand every company and everybody around you better, including myself.
[00:34:44] And thank you for that. We will support that foundation any way that we can. I do have an Easter egg question. You don't know what it is, but before we get to that, before we get to that, doc, how do people out there contact you or NXTSTIM?
[00:34:56] Dr. Chakravarthy: Yeah, you guys can email me.It's k-r-i-s-h-n-a-n @ nxtstim.com. krishnan@nxtstim.com. Happy to field any number of emails and would love to hear from you. We are on an incredible journey, very blessed to be able to do this for people in general. So, any questions, if you're from the patient, the physician side, I'm happy to field any of those questions.
[00:35:25] Kip Theno: Well, thank you, Doctor, for joining. And here is the Easter egg question. Look, you're a scientist at heartand I love that about you and we've had many a talks on discovery and Iremember telling you the story because I spent the majority lion's share of mycareer in interventional cardiology and Werner Forsman, the first cardiologistto ever do a catheterization, did it actually on himself, snuck into the lab.
[00:35:48] Used a urinarycatheter, 60 cm, put it in there with an assistant and actually took x rays.And that kind of launched the entire interventional cardiology space. And thenyou showed me a sneak peek behind the curtain of what I laughingly called theperpetual motion machine that humans have been trying to figure out for years.
[00:36:06] And you cracked the code and. I know it's bio energy as a fuel. It might be 007 where you could tell me and then you'd have to kill me, but can you give our listeners a sneak peek on that as well?
[00:36:19] Dr. Chakravarthy: Yeah, absolutely. So, I love to be in the lab. I think at the heart of every you find what their passion is.And I'm, I believe I'm at my core of physician scientists and physician scientists are unique because they think about clinical problems and then they bring it to the lab and they have these moments of thoughts that you think, "Oh, this could be really, really profound to me."
[00:36:44] I have invested mylife in looking at use of neurostimulation and I mentioned looking at newfabrication. One of the areas that we are what I believe very interested andwe've all collected a lot of preclinical data is that we are building a selfregenerative catheter that can be implanted.
[00:37:05] Planted that sourcesenergy from the body as a sustainable biofuel. So the industry of biofuel isthis concept of being able to harness the body's energy to be able to createsmall to more complex, types of instrumentation to medical devices that then arebetter able to carry out a specific end result of that.
[00:37:32] Our first sustainable biofuel we're able to develop is thinner than the diameter of a hair. A human hair. Can you imagine?That can self regenerate like an ultra capacitor and actually stimulate to create energy based on what the body produces to better be able to start stimulating into the nervous system.
[00:37:55] The future, I think is groundbreaking. It will be where we will have equipment and technology that are so powerful that you don't need a battery source. It's fascinating. We talk a lot about what 30 to 50 years from today is we're seeing an ever increasing expansion and emphasis on low gravity travel.
[00:38:21] It's going to be the focus of where human civilization is going. So we are invested in, I think, in the longterm building sustainable biofuel devices that can be self perpetuating that don't require an external fuel source. And so part of that is that we've proven that we're able to generate that level of energy that can actually dispense and act like a battery or ultra capacitor.
[00:38:48] So as sciencefiction as it sounds, we are moving light years ahead of where currenttechnology is. I was going to say, did you say flux capacitor?
[00:38:58] Kip Theno: Is that might as well say that. Youknow, I had to do that. And yeah, science fiction made real and that's what you do. So doctor, thank you so much for joining the road to podcast.
[00:39:10] Loved having you on.We got to have you on again. For any VCs out there, manufacturers, clinics,patients, please reach out to Dr. Chakravarthy at NXTSTIM. And a doctor reallyglad to have your voice on the program today. And thank you so much, my friend.
[00:39:24] Dr. Chakravarthy: Thanks Kip. Always a pleasure and really enjoyed being there with you.
[00:39:27] Thank you so much.
[00:39:28] Kip Theno: Thank you for joining the Road toCare podcast hosted by SamaCare, the leader in prior authorization technology and services, where through a script to therapy operating system, we enable connectivity with clinics, peers, and manufacturers focused on optimizing patient care. Tune in next time as together we can make things right.
[00:39:46]Enjoy the music written, produced and recorded by Jam
Podcast produced by JFACTOR, visit https://www.jfactor.com/
Together, we can make healthcare right. Here are some of the outstanding healthcare organizations and associations championing patient health mentioned in this episode:
[00:00:00] Kip Theno: Welcome to the Road to Care podcast hosted by SamaCare, where we will talk with key opinion leaders, physicians, administrators, manufacturers, venture capitalists, and legislators to get their insights on the state of health care today and where we see it evolving. SamaCare's prior authorization platform is free to clinics, ensuring patients get on the right therapy at the right time.
[00:00:20] Together, we can simply make things right.
[00:00:25] Hey, everybody, and welcome back to the Road to Care podcast hosted by SamaCare. And I'm pleased with our special guest today joining us in the studio, Dr. Krishnan Chakravarthy, dear friend of mine for a long time. Dr. Chakravarthy is MD andPhD, is an interventional pain and spine physician and CEO of NXTSTIM, which stands for Next Generation Stimulation Technologies. Dr. Chakravarthy is chairman and founder of the Empower YouChronic Pain Foundation, focusing on patient access, advocacy, and knowledge, and an affiliate professor in the Department of Anesthesiology, an affiliate professor in the Department of Nanoengineering at UCSD Health and VA San DiegoHealth Care.
[00:01:07] Chris is a keyopinion leader and worldwide speaker and researcher in medicine with over 10manufacturers and president elect for the AmericanSociety of Pain and Neuroscience, better known as ASPN. Hey doc, how are you today?Thanks for joining the podcast.
[00:01:22] Dr. Chakravarthy: Oh, thanks Kip for having me. It's always an honor to be there with you and to share some of my thoughts.
[00:01:28] Kip Theno: Well, I wouldn't have it any other way. You're a busy guy and it took you forever to get on my podcast, even though we've been friends for years. And I guess my first question is youcouldn't just stop at the MD. You had to get the PhD too? Talk about your journey.
[00:01:39] It's so fascinating in the healthcare doc.
[00:01:41] Dr. Chakravarthy: Yeah, absolutely. So, you know, I always start with this joke. You can tell what part of India somebody is from based on the complexity of their last name. So Chakravarthy is a very strong Tamilian name. Um, and actually grew up in the Southern tip of India and went to my hometown, which was Buffalo, New York, where I pretty much did most of my early education.
[00:02:03] So at university ofChicago, when I first started, I was a big math and physics enthusiast. And I was like, look, that's what I want to spend my life doing. But it's kind of funny. So whenever I bring up, one's own background in history, so you see all theseNetflix movies and it's, it's funny that most Indian parents, even 5, 10 years ago, they would say you're not successful if you aren't a doctor, an engineer in the family.
[00:02:31] So my parents put a lot of pressure on me to be like, "Hey, consider medicine." That was kind of what we did in the community. So it's taking a lot of these pre med classes in undergrad. And I was really into research. And so what happened was around my second and third year of training, National Institute of Health, which is kind of the big research body for the United States government and nationally does some of the great research that we see.
[00:02:59] They had a really interesting program called the Medical Scientist Training Program. And what the concept is that they really wanted to train physicians to be scientists. So you look at the great discoveries that have come through the development of vaccines, Louis Pasteur, I mean, did that in the lab to you hear about, um, peptic ulcer disease.
[00:03:22] I mean, all of those were physicians who thought scientifically. So NIH basically sponsors about 4 to 6 medical students all over the country per medical school. And sometimes the number of medical schools are restricted. But they completely cover the entire cost of the medical education while you take a hiatus between your second and third year to do the PhD part of it.
[00:03:49] So, obviously it was a gluttony for punishment because usually most people are like, ah, it's a lot, but it was such an incredible opportunity to do some very important foundational research. I spent my PhD really working on developing vaccines for the 1918 flu. I spent some portion of that working for the CDC.
[00:04:10] And I got my entrepreneurial bug through the PhD time when really our first startup was in the semiconductor business, looking at using quantum dot technology for labeling a lot of different biological flora for so that the entire experience was so unique and I wouldn't have traded any of it.
[00:04:31] So traditional med school is a four year time frame before residency. I spent 7. 5 years to add on the Phd to that.
[00:04:41] Kip Theno: Wow. Yeah, doc, I've seen you inaction.
[00:04:43] You were an empathetic caring physician, a caregiver. You're a key opinion leader, a thought leader. You work in research, researching for manufacturers, and you're also a teacher of students. And on top of that, as an entrepreneur, you're running medical device companies and specifically NXTSTIM is your latest venture and love to hear about that because when you think of paradigm shifts in medicine or resurrecting, therapies that, that maybe have kind of lost their way, you've done that with this discovery.
[00:05:09] Talk about NXTSTIM.
[00:05:11] Dr. Chakravarthy: Yeah, absolutely. So, you know, it's fascinating. I get this conversation a lot. How does somebody wear so many hats? And what's the driver for discovery? And why are people so passionate about the things that they want to pursue? So, four or five years ago, there was a national sales meeting. And I still remember today, I think we were at that same national sales meeting and I was asked to present. And one of the key topics on the first slide was the importance of "why". And it's a very important concept. When you are thinking about innovation and the time and energy spent in developing and putting your personal time and effort and resources, a lot of times innovators don't ask the question on why, why do you think the thing that you're pursuing has value to society, to your friends, to any of the countless people that may or may not use your product.
[00:06:12] So, I've been a real steward to the neurostimulation space, and I know that we share a common background in that area. Neuromodulation's been around for 70 plus years, and today, if you look at the statistics,there's about 50. 2 million Americans with some form of acute to chronic pain.So the question then becomes, well, how many of these patients are actually getting this therapy?
[00:06:37] It's probably only about 100, 000. So I spent about two, three years ago when I was traveling, I went to a meeting at in India, and it was really fascinating. You know, majority of neuromodulation, which has great data, great science. Why is it that's so few people, not just in the United States, but all over the world have access to these therapies.
[00:07:04] There has to be something that's causing a lack of access to these patients. And, one part of it is cost. So if you go to a place like India, people don't have insurance.How do they afford to pay for something when your insurance isn't there? The second part of it is the complexity of the care delivery model.
[00:07:25] When you think about all of the things, the average cost to the health system today for a single Implantable therapies around $100,000 to $150,000. So if you want to create a technology that has the ability to penetrate and impact countless millions of lives, you have to rethink the entire paradigm and how that model is delivered.
[00:07:51] But the technology has to address that question. Our vision at NXTSTIM and why I'm so passionate about this and I bring this conversation because I grew up in the southern tip of India. That's where all of my extended family is. It's a very poorly resourced area where there are a lot of disparities between people who can afford healthcare and people who can't.
[00:08:12] So the goal and the vision for NXTSTIM is can we take great technology. Where we see the impact of neurostimulation. And in fact, today there's about 44 randomized controlled trials that have been published that have looked at neurostimulation for back pain, shoulder pain, knee pain, any number of different indications.
[00:08:34] And how do we change that paradigm to provide access, community, and a low cost solution that then allows us not just to change the way it provides access to U. S. patients, but to the global patients that may be in very under resource environments. So at the end of 2020 with that vision, I founded NXTSTIM.
[00:08:57] And part of that is understanding how do we accelerate technology to think 20 years ahead? So that it can really change the paradigm in the care delivery. When you look at the most cost prohibitive elements in the neurostimulation space, it's really heavily reliant on personnel. The amount of effort to get multiple salespeople, clinical specialists to the operating room time to the surgeon, we needed to come up with a system that was transcutaneous, noninvasive, but almost reproduce what the biggest challenge is, which is the human element of the therapy delivery. So the genesis of our now FDA approved product, which, just within the last year, we've treated about 3000 patients, is looking at the use of AI to modulate a lot of the therapy paradigms that are heavily reliant on human involvement to try and minimize the cost. So today the average cost of our therapy, which is free to patients and covered by insurance is only at $150 price point versus something that's at$150,000 price point. So when you think about what that could impact in termsof access, in terms of scalable manufacturing, in terms of the digital health platform. I think we are doing something truly groundbreaking in the healthcaresystem. And it's showing in terms of the results that we're getting as we continue to penetrate into the market.
[00:10:40] Kip Theno: Wow. And let me do a full disclosure here. So, Dr. Chakravarthy, to the listeners out there, came to me and we were friends and we had worked together on some projects and he showed me this device. He said, you know, you should give it a try because he knew that I'm a chronic pain patient from the early 90s with a back injury.
[00:10:53] And I had tried everything. I've had I don't know how many epidurals, massive amount of steroids, which by the way are not, that doesn't really work long-term and isn't necessarily great. There's an opposite reaction that happens to those.And I've had almost everything except for the surgery and I'm trying to not go under the knife like that.
[00:11:12] And I have tried probably five or six other what are, what used to be called tens units and none of them worked for me. But this one I literally keep with me in my backpackevery single day and it works. And I've constantly asked you doc about this because what is the mechanism of action? Why is this so different?
[00:11:30] And I know you'vetacked on a lot of value added benefits to it. And we'll talk about remote patient monitoring later, but just in general, why does this device work sowell?
[00:11:40] Dr. Chakravarthy: Great question. So fascinating set of findings. , There was a non industry funded trial. It was called a fast trial. What was so fascinating about that fast trial was they took 200 fibromyalgia patients and they compared placebo stimulation to mixed frequency stimulation in 200 women that were randomized, and there was three very important conclusions that was drawn from that trial.
[00:12:09] Number one, the body inherently, you think about billions of years of evolution, pain is a really important teleological mechanism for why we prevent ourselves from sticking our finger onto a a flame, like it burns, so it makes you it's protective, right?So part of that is what we understand with chronic pain and acute pain is pain in short courses can be very effective in protecting the organism.
[00:12:42] In this case, let'ssay a patient, but when you have chronic pain, the problem that comes is. Paindoesn't necessarily stop. It's constantly ongoing because there are changesthat happen in the brain. But one of the things that people were observing is whenyou take stimulation at a set frequency, like, let's say, a tens unit or anytype of unit, the body's very, very intelligent.
[00:13:09] It's neuroplastic, which means that if I expose the body to the same stimulation pattern, anything after 20 minutes, there's a clear development of what we call tachyphylaxis, which means that the body becomes rapidly resistant to that stimulation. The second unbelievable observation we made was that If you used mixed frequency signals and you were able to change what the body was able to perceive constantly, you were able to retain that improvement in pain control because the neural habituation through transcutaneous stimulation wasn't able to result in that tachyphylaxis.
[00:13:55] In fact, what we found was two things happen. When you mix frequencies, you can actually up-regulate a lot of the endogenous opiates that the body uses as a natural painkilling mechanism. But the second thing that was very profound is, we were actually observing functional MRI changes in the brain that showed that thechanges in central sensitization that happen in a lot of the chronification of pain is being reversed by this type of mixed frequency signal fieldstimulation.
[00:14:30] Now, the challenge is how do I constantly change the program every 20 minutes without human involvement? And that's really what makes this so profound is the AI crowdsources data. Imagine today, AI's most powerful element is the type of data input that it accumulates. So if I have one patient using it for back pain versus a million patients using different programs for back pain, that data then gets assimilated to making the therapy changes when you build that inherent resistance to that therapy.
[00:15:09] So part of it iswhat we have developed is a very sophisticated model. Where we're looking atfield stimulation that's constantly adapting and changing based on patientfeedback, but in a global sense, a closed loop system that's monitoring thatdata through an entire remote monitoring platform. So true remote monitoring isthe ability for a nursing staff to look at that data.
[00:15:39] But, we understandthe human element of that interaction between an individual to a patient hassuch a profound effect on the therapy outcome. So to give you an example: Oneof the big challenges in the neurostimulation space is everybody says "Welleveryone's got great randomized control trial data, but prove it in the realworld outcomes, show me in pure raw data how good this is device isdoing."
[00:16:08] In fact, when we looked at over 500 patients, it's going to be one of the largest data sets that we have. We were able to show that out to 18 months, we had a 92 percent compliance on the device and over 70 percent of patients reported almost greater than 40 percent pain relief. So when you think about the cost to the health system, whether you'd look at drugs, whether you look at $150,000implants, we are proving a model that is groundbreaking.
[00:16:37] It's completely changing the way patients should be treating chronic pain. Why do you need togo to the emergency room? You don't need another prescription for an opiate.This is a front end electroceutical that helps with that. Do you look at the employer model? Amazon, Walgreens, all the big employers now are looking for people to come back to work.
[00:16:58] This device could help with that part of it too. Because you need a low cost, non invasive solution to really permeate the larger ethos of patients. At the end of the day doing a hundred thousand cases a year is not going to solve the bigger issue. I want to remind a lot of the audience before the entire covid pandemic the biggest health crisis in the United States was the opioid epidemic and it still continues to be a major topic. We have to find better solutions and I think we're on to something where we are reframing that healthcare argument by looking at a total different paradigm solution for that.
[00:17:40] Kip Theno: The one word that comes to mind docis compliance, right? And you mentioned clinical trials and clinical studies,and of course those absolutely need to be done. And typically you can look atone and another, and there may be one or two points different. But you havedata from the next dim device that shows, right?
[00:17:56] A different level ofcompliance from what I have seen. Can you talk about that aggregate metadatathat you've collected over the last couple of years and what it means?
[00:18:03] Dr. Chakravarthy: Yeah, absolutely. So we werevery one of the things I wanted to do is to be honest about what data wecollect and presented to our physician colleagues that are still going to makethis a prescriptive model to say, "Look, the things that come out of oursystem is we know what body part is getting stimulated."
[00:18:22] We know what type ofstimulation parameters that patients are using every day whenever they use thedevice in a system that doesn't require any patient input. So by a Bluetoothand cloud, we're constantly collecting that data. We're looking even at the longitudinaluse and compliance of those patients on our device with that program.
[00:18:43] And it also what weknow with field stimulation, which is really unique. Is that we know that theamplitude of stimulation, which means the volume in some sense, how high or howlow that I crank up that stimulation, there's good published evidence that saysthat's correlative to what, how much pain the patient is in.
[00:19:05] So the word biomarker gets thrown around a lot in medical science. And I think what we're trying to say is when we have a system that can aggregate all of that data in real time. We collect that data. We group that data. We have millions of datapoints that we look at for each individual patient's compliance on one individual unit for 18 months, 24 months, and the power in that is, if I were a physician, today, the big challenge in pain medicine is everything that I treat is a subjective input.
[00:19:43] A patient says tome, "I have shoulder pain and doc, this is what I'm dealing with."And we do a physical exam, we collect a history and then we determine, all ofthe different therapy options. But the beauty of this is and I think the best analogy of why this became standardof care was in cardiac and diabetes when they looked at early digital healthinterventions through blood pressure monitoring or continuous glucosemonitoring, the incidences of four vessel coronary artery bypass mortality droppedto 0%.
[00:20:18] And the reason for that was what they foundis if you monitor the right data set. In a digital health platform, not onlyare you looking at significant cost reduction, but you're completely changingthe outcome of these patients downstream by having an intervention that may notnecessarily need a person in there, but can be done through a virtual platform.
[00:20:43] For us, when wecollect this data, what's unique is each individual practice can collect all oftheir patient data onto a unique dashboard that then they can see longitudinal.They can see compliance. They can even see how the usage of EcoAI in differentbody parts allows them to inform the physician on what downstream therapiesthey're going to do.
[00:21:07] So imagine you'recompletely retooling the entire pain space to better understand: why am I doingthese injections? Why am I giving this drug? What am I trying to treat? So weare almost getting to the point of what we think is the concept that I like to coin as Theranostics. It's both atherapy and a diagnostic tool.
[00:21:30] So when we publishall this data, we want, you providers to know how they're doing, but eventuallyinsurance companies to say, look, you don't need to always validate somethingbased on a subjective assessment. We will provide you a low cost theranosticsolution that will help you validate a very, very expensive cost of the healthsystem, which is pain care all over the world.
[00:21:54] Kip Theno: Yeah . And, medicine is reactionary in general, inherently it is, if I'm sick I go to the doctor if I have a myocardial infarction I can go to the doctor, right?
[00:22:01] I have to get treated but, you know, remote patient monitoring, we've seen leads and lags.Like some specialties and markets have adopted it really fast, early adopters.Pain management hasn't really adopted remote patient monitoring. And by the way, it's been around since NASA.
[00:22:17] NASA, I can'tremember if the, if it was the Apollo or Gemini missions, you and I looked thisup a couple of years ago, they would slap a wire on you and you'd be in spaceand they'd be able to have rudimentary EKG readings right down in the bunker.And, I'm curious as how do we make this a first line because there's the oldsaying doc, and you've heard this, the surgery you shouldn't have had is thefirst one, right?
[00:22:37] And yet now you'vegot this maybe first line device and then you've gone through all of theseprocesses and then you've got the last line of therapy. What is that? What doyou need to do from an RPM perspective and what makes NXTSTIM special to makethis a first line thought process for patients and clinics?
[00:22:56] Dr. Chakravarthy: Kip, I love your questionbecause I feel like it tees up all the things I love talking about. So, I thinkthis gets back to me at the heart of what entrepreneurship is all about. Canyou solve a problem that is truly clinically relevant, and those are the typesof things that really become the unicorn businesses that we see leave lastinglegacy.
[00:23:21] So let me give an explanation, right? What I mean by that. One of the challenges in the remote monitoring space for pain management is monitoring is contingent completely on what data you monitor. And whether that data is clinically meaningful. So if the industry prior to NXSTIM looked at what data sets you could monitor weight, blood pressure, glucose, possibly looking at heart rate variability, pulse oximeter.
[00:23:54] The challenge with all of those outputs is, well, what does that mean to an individual pain clinician that's making a decision on what that data should say in terms of the next step for care? If I was a cardiologist, absolutely, blood pressure makes sense. If I was an endocrinologist, sure. I want to understand what glucose levels are so I can better understand that.
[00:24:19] If I'm an astronaut in space, I may be looking at EKG because I want to understand the impact of low oxygen environments on long term or space environments on long term health physiology. So the thing that what we are recognizing is that what makes NXTSTIM unique, and I think part of it is we are tracking data that is extremely important to the pain clinician.
[00:24:43] And that doesn't mean you have to be trained in pain. It can be anybody that's treating pain.And part of that is goes back to the point that things like body location of stimulation, things that included physiologically, amplitude of stimulation.Heart rate variability. All of that put together steps function.
[00:25:04] All of those datapoints when you collated together, there is no platform out there like NXTSTIM.So in some sense, we are trailblazing and pioneering. Remote monitoring for thepain space in an objective manner. Now, why haven't other companies been ableto do it? Because they haven't been able to come to a low cost solution.
[00:25:27] If you look at most of the implantable systems that look at saying they can do RPM, the problem with those systems is that cost of the actual device is $30,000 bucks. Most codes that insurance wants for monitoring, they are paying only $50 a month to absolve the cost of the device. So you cannot have an expensive device to do remote monitoring, you have to have a low cost device that can do preventative medicine. So in some ways we are the ideal, if not the perfect match for what we need to do to bring RPM as a standard of care in pain medicine, because one, we can manufacture these devices at a very, very low cost and at very high volumes.
[00:26:19] And two, we are very bullish on the fact that the data that's coming from the device is actually meaningful to a physician in the care model to make it more effective. So how they take that data and reduce the cost to increasing practice efficiencies is what I think is so meaningful and such an important point of difference to other RPM companies.
[00:26:45] Kip Theno: Well, and what I love about it is I have command and control too. I mean, I get real time feedback and I'm a patient and so I can change it. I can manipulate it. I can save things. I'm getting this constant kind of connectivity and feed. And so I do think to your point, it should be standard of care.
[00:27:00] And that brings me to change gears a little bit, we've had, and I know you keep a watchful eye on SamaCare and what we're doing here. And, it's in prior authorizations for the medical benefits side of what you do, doctor, the injections and infusions as an example. And I've had Christine Mann on, Dr. Scott Howell. And we've talked about legislation and it's interesting that the legislators were kind off fixated on oncology is, well, that's where people get infusions. And you look at neurology, rheumatology, now we're in behavioral health, cardiology is now in infusions.
[00:27:32] So there's this kind of education that has to happen to push this from a legislative perspective.But I think of it in also expanding indications, and why I say that is, we think of chronic pain as back, leg, neck, shoulder, knee, ankle. What about NXTSTIM and moving this even farther out, broadening the horizons of this device for oncology, rheumatology, neurology?
[00:27:54] Dr. Chakravarthy: Oh, fantastic. In fact, our first couple presentations next year is going to be at ASCO, which is one of the big, oncology conferences.Look, pain is a pretty multidisciplinary issue that faces a lot of different subspecialties.And one of the things that we're really excited about is you look at the migraine issues that neurologists are facing, specifically stimulating the trigeminal or the occipital nerve can have a lot of benefits for chronic migraine.
[00:28:26] You look at a lot of chemotherapy induced peripheral neuropathy. A lot of those that are now off label indications for neurostimulation. These can be targeted. Even things like one of the exciting areas we are interested in is overactive bladder (OAB). What's fascinating is people don't realize that a lot of stimulation at the bottom of the foot can affect detrusor activity that may or may not have an improvement in OAB as an indication.
[00:28:53] So part of our strategy is one, we're thinking about where does a peripheral nerve target specifically even like complex regional pain syndrome to things even now, nowadays you see stimulation affecting cardiac indications to angina pain we're trying to think of where can we place our device and given That we can get up to 1200 Hertz compared to traditional field stimulation unit. We can get a lot of depth penetration with our therapy that may be more relevant for us than in the past with other transcutaneous units.
[00:29:31] The second thing is even post stroke rehabilitation. A lot of our devices also have what's called an electromyographic stimulator, so it helps strengthen muscle to help in post recovery. But what's fascinating is, I think part of what next stems product portfolios looking at is we recognize at some level that there are going to be indications that require an implantable solution and part of the trajectory that we're going in is building that low cost ecosystem across not just theEcoAI front device, but an implantable device where we can again bring the cost of production down by affecting the miniaturization of the battery.
[00:30:18] So today if industrystandard is a 14 cc volume battery, we are shrinking that battery down toabout. 0. 5 cc's. So what happens is the entire care delivery model againchanges. In fact, one of our core technologies is being used for stimulatingthe vagus nerve. We've been able to target PTSD Stroke and cord injuries wherewe're able to reproduce the neural networks that a lot of C4 transectionpatients have and get them moving again and rehabbing.
[00:30:53] So we are very bigon being a middleware to software platform. You look at some of the greatdestiny companies like Apple. Why is it so? Attractive to consumers. It'sbecause they've built a strong ecosystem across their devices. So we believethat the indications are just to start. There's so many areas that we're goingto go into, but at the heart of it is the belief on access and a low costsolutions.
[00:31:22] Kip Theno: Well, and you brought up anecosystem, doctor, and I know you just didn't stop with the science and thediscovery and the device. And I'd love for you to talk about your foundation,the Empower You Chronic Pain Foundation. I know this all ties in. Talk to thefolks out there about that.
[00:31:36] Dr. Chakravarthy: Yeah, absolutely.
[00:31:37] Look, I think one ofthe big challenges today is in the pain space, there are about 6, 000clinicians globally, and if not nationally. The challenge is when you look ateducation for pain doctors, it's a one year fellowship post- residencytraining. The challenge with a specialty that is exponentially growing the wayour specialty is, is that the determination of care for an individual patientis highly contingent on which doctor you end up with, because if you look atthe interventional pain space, which is the ability to use differentmodalities, whether it's implantable, minimally invasive spinal procedures,they completely is contingent on the level of training and interest that anindividual physician takes. So the disparity is highly cognizant when you thinkabout if a patient, gets one opinion from a pain doctor to a complete differentopinion, then the value of a second opinion to the importance of patienteducation and driving better care for an individual becomes highly, highlyrelevant.
[00:32:48] And so the ideabehind my foundation was we have on average 55 national societies in painmanagement training doctors, which is great. But the inherent issue is If youare a patient and you can't get the right opinion from a physician, you'regoing to always be shortchanged to what options are there.
[00:33:11] And Kip, you said ityourself, sometimes Is surgery the right answer? Maybe, maybe not, depending onwho the surgeon is, what their level of aptitude is and what their, theindication is versus what about all of the other options that a patient cantake in that care continuum. So part of the foundation at the heart of it iscompletely focused on patient education.
[00:33:36] We really want toget focused on this concept of how do we educate patients to better understandtheir own health, therefore empowering them to better be able to seek the carethat they need. So if I knew about 10 other options for back pain. I'm going tohave a much better approach to talking to a physician and saying, Hey, do youthink that this is the right option for me?
[00:34:03] And that's part ofthe journey. And in fact, when you look at what the foundation is doing, we arecurrently the only patient focused education platform for patients nationallythat has been developing. So part of it is, I think the mission goes back to can we empower patients tobetter understand their health needs so they can become an advocate forthemselves?
[00:34:27] I think it's very,very meaningful and I really enjoy the speakers that have come through. It'sjust been a impressive to see the foundation grow the last couple of years.
[00:34:36] Kip Theno: No, thank you for doing that. Andcongratulations doc. You've always pushed the boundaries. It makes everythingand every company and everybody around you better, including myself.
[00:34:44] And thank you for that. We will support that foundation any way that we can. I do have an Easter egg question. You don't know what it is, but before we get to that, before we get to that, doc, how do people out there contact you or NXTSTIM?
[00:34:56] Dr. Chakravarthy: Yeah, you guys can email me.It's k-r-i-s-h-n-a-n @ nxtstim.com. krishnan@nxtstim.com. Happy to field any number of emails and would love to hear from you. We are on an incredible journey, very blessed to be able to do this for people in general. So, any questions, if you're from the patient, the physician side, I'm happy to field any of those questions.
[00:35:25] Kip Theno: Well, thank you, Doctor, for joining. And here is the Easter egg question. Look, you're a scientist at heartand I love that about you and we've had many a talks on discovery and Iremember telling you the story because I spent the majority lion's share of mycareer in interventional cardiology and Werner Forsman, the first cardiologistto ever do a catheterization, did it actually on himself, snuck into the lab.
[00:35:48] Used a urinarycatheter, 60 cm, put it in there with an assistant and actually took x rays.And that kind of launched the entire interventional cardiology space. And thenyou showed me a sneak peek behind the curtain of what I laughingly called theperpetual motion machine that humans have been trying to figure out for years.
[00:36:06] And you cracked the code and. I know it's bio energy as a fuel. It might be 007 where you could tell me and then you'd have to kill me, but can you give our listeners a sneak peek on that as well?
[00:36:19] Dr. Chakravarthy: Yeah, absolutely. So, I love to be in the lab. I think at the heart of every you find what their passion is.And I'm, I believe I'm at my core of physician scientists and physician scientists are unique because they think about clinical problems and then they bring it to the lab and they have these moments of thoughts that you think, "Oh, this could be really, really profound to me."
[00:36:44] I have invested mylife in looking at use of neurostimulation and I mentioned looking at newfabrication. One of the areas that we are what I believe very interested andwe've all collected a lot of preclinical data is that we are building a selfregenerative catheter that can be implanted.
[00:37:05] Planted that sourcesenergy from the body as a sustainable biofuel. So the industry of biofuel isthis concept of being able to harness the body's energy to be able to createsmall to more complex, types of instrumentation to medical devices that then arebetter able to carry out a specific end result of that.
[00:37:32] Our first sustainable biofuel we're able to develop is thinner than the diameter of a hair. A human hair. Can you imagine?That can self regenerate like an ultra capacitor and actually stimulate to create energy based on what the body produces to better be able to start stimulating into the nervous system.
[00:37:55] The future, I think is groundbreaking. It will be where we will have equipment and technology that are so powerful that you don't need a battery source. It's fascinating. We talk a lot about what 30 to 50 years from today is we're seeing an ever increasing expansion and emphasis on low gravity travel.
[00:38:21] It's going to be the focus of where human civilization is going. So we are invested in, I think, in the longterm building sustainable biofuel devices that can be self perpetuating that don't require an external fuel source. And so part of that is that we've proven that we're able to generate that level of energy that can actually dispense and act like a battery or ultra capacitor.
[00:38:48] So as sciencefiction as it sounds, we are moving light years ahead of where currenttechnology is. I was going to say, did you say flux capacitor?
[00:38:58] Kip Theno: Is that might as well say that. Youknow, I had to do that. And yeah, science fiction made real and that's what you do. So doctor, thank you so much for joining the road to podcast.
[00:39:10] Loved having you on.We got to have you on again. For any VCs out there, manufacturers, clinics,patients, please reach out to Dr. Chakravarthy at NXTSTIM. And a doctor reallyglad to have your voice on the program today. And thank you so much, my friend.
[00:39:24] Dr. Chakravarthy: Thanks Kip. Always a pleasure and really enjoyed being there with you.
[00:39:27] Thank you so much.
[00:39:28] Kip Theno: Thank you for joining the Road toCare podcast hosted by SamaCare, the leader in prior authorization technology and services, where through a script to therapy operating system, we enable connectivity with clinics, peers, and manufacturers focused on optimizing patient care. Tune in next time as together we can make things right.
[00:39:46]Enjoy the music written, produced and recorded by Jam
Podcast produced by JFACTOR, visit https://www.jfactor.com/
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[00:00:00] Kip Theno: Welcome to the Road to Care podcast hosted by SamaCare, where we will talk with key opinion leaders, physicians, administrators, manufacturers, venture capitalists, and legislators to get their insights on the state of health care today and where we see it evolving. SamaCare's prior authorization platform is free to clinics, ensuring patients get on the right therapy at the right time.
[00:00:20] Together, we can simply make things right.
[00:00:25] Hey, everybody, and welcome back to the Road to Care podcast hosted by SamaCare. And I'm pleased with our special guest today joining us in the studio, Dr. Krishnan Chakravarthy, dear friend of mine for a long time. Dr. Chakravarthy is MD andPhD, is an interventional pain and spine physician and CEO of NXTSTIM, which stands for Next Generation Stimulation Technologies. Dr. Chakravarthy is chairman and founder of the Empower YouChronic Pain Foundation, focusing on patient access, advocacy, and knowledge, and an affiliate professor in the Department of Anesthesiology, an affiliate professor in the Department of Nanoengineering at UCSD Health and VA San DiegoHealth Care.
[00:01:07] Chris is a keyopinion leader and worldwide speaker and researcher in medicine with over 10manufacturers and president elect for the AmericanSociety of Pain and Neuroscience, better known as ASPN. Hey doc, how are you today?Thanks for joining the podcast.
[00:01:22] Dr. Chakravarthy: Oh, thanks Kip for having me. It's always an honor to be there with you and to share some of my thoughts.
[00:01:28] Kip Theno: Well, I wouldn't have it any other way. You're a busy guy and it took you forever to get on my podcast, even though we've been friends for years. And I guess my first question is youcouldn't just stop at the MD. You had to get the PhD too? Talk about your journey.
[00:01:39] It's so fascinating in the healthcare doc.
[00:01:41] Dr. Chakravarthy: Yeah, absolutely. So, you know, I always start with this joke. You can tell what part of India somebody is from based on the complexity of their last name. So Chakravarthy is a very strong Tamilian name. Um, and actually grew up in the Southern tip of India and went to my hometown, which was Buffalo, New York, where I pretty much did most of my early education.
[00:02:03] So at university ofChicago, when I first started, I was a big math and physics enthusiast. And I was like, look, that's what I want to spend my life doing. But it's kind of funny. So whenever I bring up, one's own background in history, so you see all theseNetflix movies and it's, it's funny that most Indian parents, even 5, 10 years ago, they would say you're not successful if you aren't a doctor, an engineer in the family.
[00:02:31] So my parents put a lot of pressure on me to be like, "Hey, consider medicine." That was kind of what we did in the community. So it's taking a lot of these pre med classes in undergrad. And I was really into research. And so what happened was around my second and third year of training, National Institute of Health, which is kind of the big research body for the United States government and nationally does some of the great research that we see.
[00:02:59] They had a really interesting program called the Medical Scientist Training Program. And what the concept is that they really wanted to train physicians to be scientists. So you look at the great discoveries that have come through the development of vaccines, Louis Pasteur, I mean, did that in the lab to you hear about, um, peptic ulcer disease.
[00:03:22] I mean, all of those were physicians who thought scientifically. So NIH basically sponsors about 4 to 6 medical students all over the country per medical school. And sometimes the number of medical schools are restricted. But they completely cover the entire cost of the medical education while you take a hiatus between your second and third year to do the PhD part of it.
[00:03:49] So, obviously it was a gluttony for punishment because usually most people are like, ah, it's a lot, but it was such an incredible opportunity to do some very important foundational research. I spent my PhD really working on developing vaccines for the 1918 flu. I spent some portion of that working for the CDC.
[00:04:10] And I got my entrepreneurial bug through the PhD time when really our first startup was in the semiconductor business, looking at using quantum dot technology for labeling a lot of different biological flora for so that the entire experience was so unique and I wouldn't have traded any of it.
[00:04:31] So traditional med school is a four year time frame before residency. I spent 7. 5 years to add on the Phd to that.
[00:04:41] Kip Theno: Wow. Yeah, doc, I've seen you inaction.
[00:04:43] You were an empathetic caring physician, a caregiver. You're a key opinion leader, a thought leader. You work in research, researching for manufacturers, and you're also a teacher of students. And on top of that, as an entrepreneur, you're running medical device companies and specifically NXTSTIM is your latest venture and love to hear about that because when you think of paradigm shifts in medicine or resurrecting, therapies that, that maybe have kind of lost their way, you've done that with this discovery.
[00:05:09] Talk about NXTSTIM.
[00:05:11] Dr. Chakravarthy: Yeah, absolutely. So, you know, it's fascinating. I get this conversation a lot. How does somebody wear so many hats? And what's the driver for discovery? And why are people so passionate about the things that they want to pursue? So, four or five years ago, there was a national sales meeting. And I still remember today, I think we were at that same national sales meeting and I was asked to present. And one of the key topics on the first slide was the importance of "why". And it's a very important concept. When you are thinking about innovation and the time and energy spent in developing and putting your personal time and effort and resources, a lot of times innovators don't ask the question on why, why do you think the thing that you're pursuing has value to society, to your friends, to any of the countless people that may or may not use your product.
[00:06:12] So, I've been a real steward to the neurostimulation space, and I know that we share a common background in that area. Neuromodulation's been around for 70 plus years, and today, if you look at the statistics,there's about 50. 2 million Americans with some form of acute to chronic pain.So the question then becomes, well, how many of these patients are actually getting this therapy?
[00:06:37] It's probably only about 100, 000. So I spent about two, three years ago when I was traveling, I went to a meeting at in India, and it was really fascinating. You know, majority of neuromodulation, which has great data, great science. Why is it that's so few people, not just in the United States, but all over the world have access to these therapies.
[00:07:04] There has to be something that's causing a lack of access to these patients. And, one part of it is cost. So if you go to a place like India, people don't have insurance.How do they afford to pay for something when your insurance isn't there? The second part of it is the complexity of the care delivery model.
[00:07:25] When you think about all of the things, the average cost to the health system today for a single Implantable therapies around $100,000 to $150,000. So if you want to create a technology that has the ability to penetrate and impact countless millions of lives, you have to rethink the entire paradigm and how that model is delivered.
[00:07:51] But the technology has to address that question. Our vision at NXTSTIM and why I'm so passionate about this and I bring this conversation because I grew up in the southern tip of India. That's where all of my extended family is. It's a very poorly resourced area where there are a lot of disparities between people who can afford healthcare and people who can't.
[00:08:12] So the goal and the vision for NXTSTIM is can we take great technology. Where we see the impact of neurostimulation. And in fact, today there's about 44 randomized controlled trials that have been published that have looked at neurostimulation for back pain, shoulder pain, knee pain, any number of different indications.
[00:08:34] And how do we change that paradigm to provide access, community, and a low cost solution that then allows us not just to change the way it provides access to U. S. patients, but to the global patients that may be in very under resource environments. So at the end of 2020 with that vision, I founded NXTSTIM.
[00:08:57] And part of that is understanding how do we accelerate technology to think 20 years ahead? So that it can really change the paradigm in the care delivery. When you look at the most cost prohibitive elements in the neurostimulation space, it's really heavily reliant on personnel. The amount of effort to get multiple salespeople, clinical specialists to the operating room time to the surgeon, we needed to come up with a system that was transcutaneous, noninvasive, but almost reproduce what the biggest challenge is, which is the human element of the therapy delivery. So the genesis of our now FDA approved product, which, just within the last year, we've treated about 3000 patients, is looking at the use of AI to modulate a lot of the therapy paradigms that are heavily reliant on human involvement to try and minimize the cost. So today the average cost of our therapy, which is free to patients and covered by insurance is only at $150 price point versus something that's at$150,000 price point. So when you think about what that could impact in termsof access, in terms of scalable manufacturing, in terms of the digital health platform. I think we are doing something truly groundbreaking in the healthcaresystem. And it's showing in terms of the results that we're getting as we continue to penetrate into the market.
[00:10:40] Kip Theno: Wow. And let me do a full disclosure here. So, Dr. Chakravarthy, to the listeners out there, came to me and we were friends and we had worked together on some projects and he showed me this device. He said, you know, you should give it a try because he knew that I'm a chronic pain patient from the early 90s with a back injury.
[00:10:53] And I had tried everything. I've had I don't know how many epidurals, massive amount of steroids, which by the way are not, that doesn't really work long-term and isn't necessarily great. There's an opposite reaction that happens to those.And I've had almost everything except for the surgery and I'm trying to not go under the knife like that.
[00:11:12] And I have tried probably five or six other what are, what used to be called tens units and none of them worked for me. But this one I literally keep with me in my backpackevery single day and it works. And I've constantly asked you doc about this because what is the mechanism of action? Why is this so different?
[00:11:30] And I know you'vetacked on a lot of value added benefits to it. And we'll talk about remote patient monitoring later, but just in general, why does this device work sowell?
[00:11:40] Dr. Chakravarthy: Great question. So fascinating set of findings. , There was a non industry funded trial. It was called a fast trial. What was so fascinating about that fast trial was they took 200 fibromyalgia patients and they compared placebo stimulation to mixed frequency stimulation in 200 women that were randomized, and there was three very important conclusions that was drawn from that trial.
[00:12:09] Number one, the body inherently, you think about billions of years of evolution, pain is a really important teleological mechanism for why we prevent ourselves from sticking our finger onto a a flame, like it burns, so it makes you it's protective, right?So part of that is what we understand with chronic pain and acute pain is pain in short courses can be very effective in protecting the organism.
[00:12:42] In this case, let'ssay a patient, but when you have chronic pain, the problem that comes is. Paindoesn't necessarily stop. It's constantly ongoing because there are changesthat happen in the brain. But one of the things that people were observing is whenyou take stimulation at a set frequency, like, let's say, a tens unit or anytype of unit, the body's very, very intelligent.
[00:13:09] It's neuroplastic, which means that if I expose the body to the same stimulation pattern, anything after 20 minutes, there's a clear development of what we call tachyphylaxis, which means that the body becomes rapidly resistant to that stimulation. The second unbelievable observation we made was that If you used mixed frequency signals and you were able to change what the body was able to perceive constantly, you were able to retain that improvement in pain control because the neural habituation through transcutaneous stimulation wasn't able to result in that tachyphylaxis.
[00:13:55] In fact, what we found was two things happen. When you mix frequencies, you can actually up-regulate a lot of the endogenous opiates that the body uses as a natural painkilling mechanism. But the second thing that was very profound is, we were actually observing functional MRI changes in the brain that showed that thechanges in central sensitization that happen in a lot of the chronification of pain is being reversed by this type of mixed frequency signal fieldstimulation.
[00:14:30] Now, the challenge is how do I constantly change the program every 20 minutes without human involvement? And that's really what makes this so profound is the AI crowdsources data. Imagine today, AI's most powerful element is the type of data input that it accumulates. So if I have one patient using it for back pain versus a million patients using different programs for back pain, that data then gets assimilated to making the therapy changes when you build that inherent resistance to that therapy.
[00:15:09] So part of it iswhat we have developed is a very sophisticated model. Where we're looking atfield stimulation that's constantly adapting and changing based on patientfeedback, but in a global sense, a closed loop system that's monitoring thatdata through an entire remote monitoring platform. So true remote monitoring isthe ability for a nursing staff to look at that data.
[00:15:39] But, we understandthe human element of that interaction between an individual to a patient hassuch a profound effect on the therapy outcome. So to give you an example: Oneof the big challenges in the neurostimulation space is everybody says "Welleveryone's got great randomized control trial data, but prove it in the realworld outcomes, show me in pure raw data how good this is device isdoing."
[00:16:08] In fact, when we looked at over 500 patients, it's going to be one of the largest data sets that we have. We were able to show that out to 18 months, we had a 92 percent compliance on the device and over 70 percent of patients reported almost greater than 40 percent pain relief. So when you think about the cost to the health system, whether you'd look at drugs, whether you look at $150,000implants, we are proving a model that is groundbreaking.
[00:16:37] It's completely changing the way patients should be treating chronic pain. Why do you need togo to the emergency room? You don't need another prescription for an opiate.This is a front end electroceutical that helps with that. Do you look at the employer model? Amazon, Walgreens, all the big employers now are looking for people to come back to work.
[00:16:58] This device could help with that part of it too. Because you need a low cost, non invasive solution to really permeate the larger ethos of patients. At the end of the day doing a hundred thousand cases a year is not going to solve the bigger issue. I want to remind a lot of the audience before the entire covid pandemic the biggest health crisis in the United States was the opioid epidemic and it still continues to be a major topic. We have to find better solutions and I think we're on to something where we are reframing that healthcare argument by looking at a total different paradigm solution for that.
[00:17:40] Kip Theno: The one word that comes to mind docis compliance, right? And you mentioned clinical trials and clinical studies,and of course those absolutely need to be done. And typically you can look atone and another, and there may be one or two points different. But you havedata from the next dim device that shows, right?
[00:17:56] A different level ofcompliance from what I have seen. Can you talk about that aggregate metadatathat you've collected over the last couple of years and what it means?
[00:18:03] Dr. Chakravarthy: Yeah, absolutely. So we werevery one of the things I wanted to do is to be honest about what data wecollect and presented to our physician colleagues that are still going to makethis a prescriptive model to say, "Look, the things that come out of oursystem is we know what body part is getting stimulated."
[00:18:22] We know what type ofstimulation parameters that patients are using every day whenever they use thedevice in a system that doesn't require any patient input. So by a Bluetoothand cloud, we're constantly collecting that data. We're looking even at the longitudinaluse and compliance of those patients on our device with that program.
[00:18:43] And it also what weknow with field stimulation, which is really unique. Is that we know that theamplitude of stimulation, which means the volume in some sense, how high or howlow that I crank up that stimulation, there's good published evidence that saysthat's correlative to what, how much pain the patient is in.
[00:19:05] So the word biomarker gets thrown around a lot in medical science. And I think what we're trying to say is when we have a system that can aggregate all of that data in real time. We collect that data. We group that data. We have millions of datapoints that we look at for each individual patient's compliance on one individual unit for 18 months, 24 months, and the power in that is, if I were a physician, today, the big challenge in pain medicine is everything that I treat is a subjective input.
[00:19:43] A patient says tome, "I have shoulder pain and doc, this is what I'm dealing with."And we do a physical exam, we collect a history and then we determine, all ofthe different therapy options. But the beauty of this is and I think the best analogy of why this became standardof care was in cardiac and diabetes when they looked at early digital healthinterventions through blood pressure monitoring or continuous glucosemonitoring, the incidences of four vessel coronary artery bypass mortality droppedto 0%.
[00:20:18] And the reason for that was what they foundis if you monitor the right data set. In a digital health platform, not onlyare you looking at significant cost reduction, but you're completely changingthe outcome of these patients downstream by having an intervention that may notnecessarily need a person in there, but can be done through a virtual platform.
[00:20:43] For us, when wecollect this data, what's unique is each individual practice can collect all oftheir patient data onto a unique dashboard that then they can see longitudinal.They can see compliance. They can even see how the usage of EcoAI in differentbody parts allows them to inform the physician on what downstream therapiesthey're going to do.
[00:21:07] So imagine you'recompletely retooling the entire pain space to better understand: why am I doingthese injections? Why am I giving this drug? What am I trying to treat? So weare almost getting to the point of what we think is the concept that I like to coin as Theranostics. It's both atherapy and a diagnostic tool.
[00:21:30] So when we publishall this data, we want, you providers to know how they're doing, but eventuallyinsurance companies to say, look, you don't need to always validate somethingbased on a subjective assessment. We will provide you a low cost theranosticsolution that will help you validate a very, very expensive cost of the healthsystem, which is pain care all over the world.
[00:21:54] Kip Theno: Yeah . And, medicine is reactionary in general, inherently it is, if I'm sick I go to the doctor if I have a myocardial infarction I can go to the doctor, right?
[00:22:01] I have to get treated but, you know, remote patient monitoring, we've seen leads and lags.Like some specialties and markets have adopted it really fast, early adopters.Pain management hasn't really adopted remote patient monitoring. And by the way, it's been around since NASA.
[00:22:17] NASA, I can'tremember if the, if it was the Apollo or Gemini missions, you and I looked thisup a couple of years ago, they would slap a wire on you and you'd be in spaceand they'd be able to have rudimentary EKG readings right down in the bunker.And, I'm curious as how do we make this a first line because there's the oldsaying doc, and you've heard this, the surgery you shouldn't have had is thefirst one, right?
[00:22:37] And yet now you'vegot this maybe first line device and then you've gone through all of theseprocesses and then you've got the last line of therapy. What is that? What doyou need to do from an RPM perspective and what makes NXTSTIM special to makethis a first line thought process for patients and clinics?
[00:22:56] Dr. Chakravarthy: Kip, I love your questionbecause I feel like it tees up all the things I love talking about. So, I thinkthis gets back to me at the heart of what entrepreneurship is all about. Canyou solve a problem that is truly clinically relevant, and those are the typesof things that really become the unicorn businesses that we see leave lastinglegacy.
[00:23:21] So let me give an explanation, right? What I mean by that. One of the challenges in the remote monitoring space for pain management is monitoring is contingent completely on what data you monitor. And whether that data is clinically meaningful. So if the industry prior to NXSTIM looked at what data sets you could monitor weight, blood pressure, glucose, possibly looking at heart rate variability, pulse oximeter.
[00:23:54] The challenge with all of those outputs is, well, what does that mean to an individual pain clinician that's making a decision on what that data should say in terms of the next step for care? If I was a cardiologist, absolutely, blood pressure makes sense. If I was an endocrinologist, sure. I want to understand what glucose levels are so I can better understand that.
[00:24:19] If I'm an astronaut in space, I may be looking at EKG because I want to understand the impact of low oxygen environments on long term or space environments on long term health physiology. So the thing that what we are recognizing is that what makes NXTSTIM unique, and I think part of it is we are tracking data that is extremely important to the pain clinician.
[00:24:43] And that doesn't mean you have to be trained in pain. It can be anybody that's treating pain.And part of that is goes back to the point that things like body location of stimulation, things that included physiologically, amplitude of stimulation.Heart rate variability. All of that put together steps function.
[00:25:04] All of those datapoints when you collated together, there is no platform out there like NXTSTIM.So in some sense, we are trailblazing and pioneering. Remote monitoring for thepain space in an objective manner. Now, why haven't other companies been ableto do it? Because they haven't been able to come to a low cost solution.
[00:25:27] If you look at most of the implantable systems that look at saying they can do RPM, the problem with those systems is that cost of the actual device is $30,000 bucks. Most codes that insurance wants for monitoring, they are paying only $50 a month to absolve the cost of the device. So you cannot have an expensive device to do remote monitoring, you have to have a low cost device that can do preventative medicine. So in some ways we are the ideal, if not the perfect match for what we need to do to bring RPM as a standard of care in pain medicine, because one, we can manufacture these devices at a very, very low cost and at very high volumes.
[00:26:19] And two, we are very bullish on the fact that the data that's coming from the device is actually meaningful to a physician in the care model to make it more effective. So how they take that data and reduce the cost to increasing practice efficiencies is what I think is so meaningful and such an important point of difference to other RPM companies.
[00:26:45] Kip Theno: Well, and what I love about it is I have command and control too. I mean, I get real time feedback and I'm a patient and so I can change it. I can manipulate it. I can save things. I'm getting this constant kind of connectivity and feed. And so I do think to your point, it should be standard of care.
[00:27:00] And that brings me to change gears a little bit, we've had, and I know you keep a watchful eye on SamaCare and what we're doing here. And, it's in prior authorizations for the medical benefits side of what you do, doctor, the injections and infusions as an example. And I've had Christine Mann on, Dr. Scott Howell. And we've talked about legislation and it's interesting that the legislators were kind off fixated on oncology is, well, that's where people get infusions. And you look at neurology, rheumatology, now we're in behavioral health, cardiology is now in infusions.
[00:27:32] So there's this kind of education that has to happen to push this from a legislative perspective.But I think of it in also expanding indications, and why I say that is, we think of chronic pain as back, leg, neck, shoulder, knee, ankle. What about NXTSTIM and moving this even farther out, broadening the horizons of this device for oncology, rheumatology, neurology?
[00:27:54] Dr. Chakravarthy: Oh, fantastic. In fact, our first couple presentations next year is going to be at ASCO, which is one of the big, oncology conferences.Look, pain is a pretty multidisciplinary issue that faces a lot of different subspecialties.And one of the things that we're really excited about is you look at the migraine issues that neurologists are facing, specifically stimulating the trigeminal or the occipital nerve can have a lot of benefits for chronic migraine.
[00:28:26] You look at a lot of chemotherapy induced peripheral neuropathy. A lot of those that are now off label indications for neurostimulation. These can be targeted. Even things like one of the exciting areas we are interested in is overactive bladder (OAB). What's fascinating is people don't realize that a lot of stimulation at the bottom of the foot can affect detrusor activity that may or may not have an improvement in OAB as an indication.
[00:28:53] So part of our strategy is one, we're thinking about where does a peripheral nerve target specifically even like complex regional pain syndrome to things even now, nowadays you see stimulation affecting cardiac indications to angina pain we're trying to think of where can we place our device and given That we can get up to 1200 Hertz compared to traditional field stimulation unit. We can get a lot of depth penetration with our therapy that may be more relevant for us than in the past with other transcutaneous units.
[00:29:31] The second thing is even post stroke rehabilitation. A lot of our devices also have what's called an electromyographic stimulator, so it helps strengthen muscle to help in post recovery. But what's fascinating is, I think part of what next stems product portfolios looking at is we recognize at some level that there are going to be indications that require an implantable solution and part of the trajectory that we're going in is building that low cost ecosystem across not just theEcoAI front device, but an implantable device where we can again bring the cost of production down by affecting the miniaturization of the battery.
[00:30:18] So today if industrystandard is a 14 cc volume battery, we are shrinking that battery down toabout. 0. 5 cc's. So what happens is the entire care delivery model againchanges. In fact, one of our core technologies is being used for stimulatingthe vagus nerve. We've been able to target PTSD Stroke and cord injuries wherewe're able to reproduce the neural networks that a lot of C4 transectionpatients have and get them moving again and rehabbing.
[00:30:53] So we are very bigon being a middleware to software platform. You look at some of the greatdestiny companies like Apple. Why is it so? Attractive to consumers. It'sbecause they've built a strong ecosystem across their devices. So we believethat the indications are just to start. There's so many areas that we're goingto go into, but at the heart of it is the belief on access and a low costsolutions.
[00:31:22] Kip Theno: Well, and you brought up anecosystem, doctor, and I know you just didn't stop with the science and thediscovery and the device. And I'd love for you to talk about your foundation,the Empower You Chronic Pain Foundation. I know this all ties in. Talk to thefolks out there about that.
[00:31:36] Dr. Chakravarthy: Yeah, absolutely.
[00:31:37] Look, I think one ofthe big challenges today is in the pain space, there are about 6, 000clinicians globally, and if not nationally. The challenge is when you look ateducation for pain doctors, it's a one year fellowship post- residencytraining. The challenge with a specialty that is exponentially growing the wayour specialty is, is that the determination of care for an individual patientis highly contingent on which doctor you end up with, because if you look atthe interventional pain space, which is the ability to use differentmodalities, whether it's implantable, minimally invasive spinal procedures,they completely is contingent on the level of training and interest that anindividual physician takes. So the disparity is highly cognizant when you thinkabout if a patient, gets one opinion from a pain doctor to a complete differentopinion, then the value of a second opinion to the importance of patienteducation and driving better care for an individual becomes highly, highlyrelevant.
[00:32:48] And so the ideabehind my foundation was we have on average 55 national societies in painmanagement training doctors, which is great. But the inherent issue is If youare a patient and you can't get the right opinion from a physician, you'regoing to always be shortchanged to what options are there.
[00:33:11] And Kip, you said ityourself, sometimes Is surgery the right answer? Maybe, maybe not, depending onwho the surgeon is, what their level of aptitude is and what their, theindication is versus what about all of the other options that a patient cantake in that care continuum. So part of the foundation at the heart of it iscompletely focused on patient education.
[00:33:36] We really want toget focused on this concept of how do we educate patients to better understandtheir own health, therefore empowering them to better be able to seek the carethat they need. So if I knew about 10 other options for back pain. I'm going tohave a much better approach to talking to a physician and saying, Hey, do youthink that this is the right option for me?
[00:34:03] And that's part ofthe journey. And in fact, when you look at what the foundation is doing, we arecurrently the only patient focused education platform for patients nationallythat has been developing. So part of it is, I think the mission goes back to can we empower patients tobetter understand their health needs so they can become an advocate forthemselves?
[00:34:27] I think it's very,very meaningful and I really enjoy the speakers that have come through. It'sjust been a impressive to see the foundation grow the last couple of years.
[00:34:36] Kip Theno: No, thank you for doing that. Andcongratulations doc. You've always pushed the boundaries. It makes everythingand every company and everybody around you better, including myself.
[00:34:44] And thank you for that. We will support that foundation any way that we can. I do have an Easter egg question. You don't know what it is, but before we get to that, before we get to that, doc, how do people out there contact you or NXTSTIM?
[00:34:56] Dr. Chakravarthy: Yeah, you guys can email me.It's k-r-i-s-h-n-a-n @ nxtstim.com. krishnan@nxtstim.com. Happy to field any number of emails and would love to hear from you. We are on an incredible journey, very blessed to be able to do this for people in general. So, any questions, if you're from the patient, the physician side, I'm happy to field any of those questions.
[00:35:25] Kip Theno: Well, thank you, Doctor, for joining. And here is the Easter egg question. Look, you're a scientist at heartand I love that about you and we've had many a talks on discovery and Iremember telling you the story because I spent the majority lion's share of mycareer in interventional cardiology and Werner Forsman, the first cardiologistto ever do a catheterization, did it actually on himself, snuck into the lab.
[00:35:48] Used a urinarycatheter, 60 cm, put it in there with an assistant and actually took x rays.And that kind of launched the entire interventional cardiology space. And thenyou showed me a sneak peek behind the curtain of what I laughingly called theperpetual motion machine that humans have been trying to figure out for years.
[00:36:06] And you cracked the code and. I know it's bio energy as a fuel. It might be 007 where you could tell me and then you'd have to kill me, but can you give our listeners a sneak peek on that as well?
[00:36:19] Dr. Chakravarthy: Yeah, absolutely. So, I love to be in the lab. I think at the heart of every you find what their passion is.And I'm, I believe I'm at my core of physician scientists and physician scientists are unique because they think about clinical problems and then they bring it to the lab and they have these moments of thoughts that you think, "Oh, this could be really, really profound to me."
[00:36:44] I have invested mylife in looking at use of neurostimulation and I mentioned looking at newfabrication. One of the areas that we are what I believe very interested andwe've all collected a lot of preclinical data is that we are building a selfregenerative catheter that can be implanted.
[00:37:05] Planted that sourcesenergy from the body as a sustainable biofuel. So the industry of biofuel isthis concept of being able to harness the body's energy to be able to createsmall to more complex, types of instrumentation to medical devices that then arebetter able to carry out a specific end result of that.
[00:37:32] Our first sustainable biofuel we're able to develop is thinner than the diameter of a hair. A human hair. Can you imagine?That can self regenerate like an ultra capacitor and actually stimulate to create energy based on what the body produces to better be able to start stimulating into the nervous system.
[00:37:55] The future, I think is groundbreaking. It will be where we will have equipment and technology that are so powerful that you don't need a battery source. It's fascinating. We talk a lot about what 30 to 50 years from today is we're seeing an ever increasing expansion and emphasis on low gravity travel.
[00:38:21] It's going to be the focus of where human civilization is going. So we are invested in, I think, in the longterm building sustainable biofuel devices that can be self perpetuating that don't require an external fuel source. And so part of that is that we've proven that we're able to generate that level of energy that can actually dispense and act like a battery or ultra capacitor.
[00:38:48] So as sciencefiction as it sounds, we are moving light years ahead of where currenttechnology is. I was going to say, did you say flux capacitor?
[00:38:58] Kip Theno: Is that might as well say that. Youknow, I had to do that. And yeah, science fiction made real and that's what you do. So doctor, thank you so much for joining the road to podcast.
[00:39:10] Loved having you on.We got to have you on again. For any VCs out there, manufacturers, clinics,patients, please reach out to Dr. Chakravarthy at NXTSTIM. And a doctor reallyglad to have your voice on the program today. And thank you so much, my friend.
[00:39:24] Dr. Chakravarthy: Thanks Kip. Always a pleasure and really enjoyed being there with you.
[00:39:27] Thank you so much.
[00:39:28] Kip Theno: Thank you for joining the Road toCare podcast hosted by SamaCare, the leader in prior authorization technology and services, where through a script to therapy operating system, we enable connectivity with clinics, peers, and manufacturers focused on optimizing patient care. Tune in next time as together we can make things right.
[00:39:46]Enjoy the music written, produced and recorded by Jam
Podcast produced by JFACTOR, visit https://www.jfactor.com/
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