RESOLVING BACK PAIN AND NIH FDA CHANGES featuring AMY BAXTER

Hi, Amy, I'm Sean. I'm on hold with my bank right now, because somebody is making a fraudulent transaction on my account. So I'm you're on mute. I'm having to dispute that. So I'm sort of multitasking at the moment, so I apologize for that. But I am here.

That sucks. Sorry about that for you.

Yeah, I tried calling the merchant. And it just they're like, Give us, tell us your account number. And I'm like, Yeah, that's not gonna happen

Right.

Like. Oh, well, we can't find it by your email or by your name. I'm like, okay. Well, then, you have no business charging my card

And we've got this weird thing where somebody's trying to. They're charged there they've got. They keep invoicing us for $45,000 from this company in in Italy for consulting. And it's but it's also this stuff like Paul, we haven't gotten an invoice from Amy Baxter. Can you please send this, you know, and it's like, somehow they know our names and they know my Cfo's name. But but they made an entire fraudulent email trail that didn't exist where I said, oh, I'm so sorry about that. Let me forward it, and we'll take care of it as soon as possible. Kind regards. And the thing is, I'm never like that on emails. I'm succinct and bitchy. So it's like this is not me. I would never have said those things. And and I always copy my Cfo on stuff like that. So it's just like it's it's totally made up

I hear you

So how do you want to handle this? I mean, how much? How many live people do you have that tune tune in, if any? Or is it all recorded and not live

It is live. They are tuning in and they're already 2 on the call. Promote panelists. Probably about 20 ish and since Joe recruited you, he's probably gonna be doing most of the talking. But you know, in the event that he doesn't, I will. And we will. Hi! Arlen!

Hi! Thanks for inviting me

Thanks for coming. There's Joe. I'm promoting him making co-host

Good to see you again, Joe. It's been a long time you're muted. I've I've made the same math

With that

I'm on hold with my bank because of a fraudulent charge. So I'll be with you guys in a moment. I'm just waiting

Did I charge on it?

Just 59, 99, but it's enough to irritate me and close the card

Principle of the thing

It's more than the it's more than the principle. It's also that risk that the 6 months a year later they start hitting your card

I thought you were, yeah interested bees

I got an issue, got one of the

Yeah, I don't think I've seen you since. Maybe we met at at the Daniel Crafts event. I don't know. Maybe a decade ago

Is it really that long? You know it's it's again this weekend, is it? Yeah, I I just agreed to go 2 days ago, and and I need to change as soon as we get off. I need to change my ticket to to not go for the whole time. Yeah, I want to see Rick hurts, while you know, while we still can

Hmm! He's going to be there in person.

He's he's given a talk on Wednesday morning, and then Larry Brilliance talking a couple of times, and Dean Kamen's gonna be there so

Nice

Yeah.

The few times I went ray always phoned it in

I met Ray I met Ray because I'm a friend of Peter Diamandis, and there was a he was doing a keynote at a thing that I was getting some I and a bunch of other people were getting a very minor award at, and I walked up to introduce myself to him because he's friends of a friend. And he looked at me, and he said, Where's my goddamn coffee? I was like, you know what? Perhaps we should meet a different time. So so I have met him in person, but that was the extent of our interaction.

That was your interaction with ready

Yeah.

Hmm.

I guess I was dressed as a server. I don't know I had the gender of one. So yeah.

Joke in there somewhere, but it wouldn't be very funny

I'm looking forward to to reuniting with him

Yes, make sure you wear something bright

I'll make sure I wear. Don't wear black and white

Right. That's what I'm saying.

I'll avoid carrying a towel, although that would make it funnier if I did

Yeah, I'm very eager to hear from you. I watch your stuff and and see what you're saying. And you have a lot to say, not only about the state of the regulatory world. but interested to hear what you're doing on your personal work. And well, folks are rolling in a bit slowly today. And I typically go around and I make a comment about Andre's tie, or, you know, ask someone where they got that bad haircut. I'd love to just jump in, because I'm sure we have at least an hour's worth of conversation. ahead Dr. Myers, how are you today? Thanks for coming 2 weeks in a row. It's good to see you.

and as we look for the mute button

Yeah, thanks. Yeah. It's nice. Thanks for inviting me.

Yeah, oh, every week we're here, Internet in person.

I don't know but Hi, Amy, I'm Arlen Myers

I I have seen your name many times, and never seen never seen you in quasi person. So it's nice to meet you

Here I am. It's not a deep fake

Again.

Or a dolly, whatever the chat is putting out these days. But

Apparently the oxytocin of a zoom is about 80% of being really face to face. So I'll take that

Is that true

Yeah. And texting is 0. Even mothers texting daughters, no oxytocin at all.

Wow! I've got

That's the next thing I want to research I'm really interested in. If I think that's why we have. Our global anxiety is a lack of the safety hormone oxytocin that comes from face to face interactions. But I don't want to start by digressing, so I'll I'll wait

Where are you located, Amy?

I'm a bit of an oxytocin whore so I guess I'm not on zoom nearly enough

I am. I'm currently in my cousin's apartment in Brooklyn, but

Oh, yeah, we're in Brooklyn. I grew up there

Oh, you were the kids live in Bushwick.

I. I grew up in Bay Ridge, Brooklyn.

What area are we in in Brooklyn? You're being quiet for me because I have a very important zoom. So but I'm based in Atlanta. Harlan

I see? Good. Yeah. I think

Atlanta and and part-time Portugal, as of this year

Yeah, nice.

And why is that? Why Portugal?

Because my husband's a Sephardic Jew, and a lot of his family got killed by fascist regimes. So you know, it could happen so, Portugal. He got Sephardic citizenship. We've been working on it since 2020

Hmm.

Actually, there's a fair number of people that are doing that. I have a friend that's in Portugal.

Yeah, we're in we're in Gaia, which is just south of Porto

Oh, yeah, actually, there was an article in the newspaper about buyer's remorse in Portugal. because all these folks were going. Not all these, but I mean more than you'd expect. We're going to Portugal. And then, once they got there. it wasn't quite what they expected. but I understand why they went there

Oh, I really, I know we're digressing before we start. But, Arlen, tell me about that.

Well, you know you heard the story about the Sephardic Jews and Spain and Portugal, and all that, and migration and diaspora, and all that business. And now a lot of these countries are allowing you to be citizens in that country. partly motivated by what's going on in the United States. So people want a safe exit. So they're applying to these various places. For example, my myheritage is from Poland. and my wife is from Hungary and my friends. So just for grins, you go on the website and you go to the Hungarian Embassy, and they all have these, these things where you can apply and all you have just have to demonstrate lineage

and then you get into the EU. You you know all the stuff in case you wanna an exit. And actually, because of what's going on politically, a lot of people are moving so at least part time. and some of it has to do with entrepreneurship visas. It has to do with just living there at a certain period of time before you have to come back that kind of thing. So anyway, these people go to these places. This particular place was Portugal and the healthcare situation. So, for example, if you're older, health care obviously is a big deal, so they thought they were able to get the healthcare they wanted. They couldn't.

There's a lot of blowback in some of these places with Americans buying up the real estate and raising the prices of the locals. So there's a lot of pushback about rising costs of housing, particularly in Mexico and then and in this local community. So you know, you're not as they weren't as welcomed as they thought they would be. And then they got into some issues with healthcare. It was complicated about bank accounts, it was complicated about tax returns, etc. Etc. Etc. So in this particular article they were. They left they came back to the United States

When we're not talking about Nih FDA and back pain, I'd be happy to give give our personal experience, which is very much the opposite of that. But but actually, I don't want to, because I don't want that many more people to come, because it's pretty great right now. So but yeah, their health care depending on which. What you look at is 6th in the world, on places where us is a 16.th But we don't. The people we know that are expats. There have had a great time with healthcare. But again, let us not digress and

We're all about

Let's regress back to the mean

We will in just a second. I just want to say I'm really happy, just like a whole bunch of of dear associates join the call I haven't seen lease sign, even with little what oxytocin he's giving me right now in perhaps 2 years, Lee. Just say, Hi! And let the folks at home know what you do

Hi! Hi! My name is Lee Stein, and I live in Portugal. No, you don't. The healthcare system in Portugal is pretty solid, especially for aging populations, and while the U. Us. Healthcare is cutting back the Portuguese health care I doubt will ever be cut back. And it's it's it's it's quite interesting

Alright well, as a credential. Tell them what your Gmail email address is.

It's my name Lee, Stein, LEES. TEIN at Gmail, or you can use your phone and grab that QR. Code give you a that'll give you. I'll give you enough information. It even has my venmo. If you want to send me money

That's good to know. It's the original lease sign on Gmail. Before there were thousands of these signs on Gmail

Do that

So thank you for joining us today. Okay.

Thank you very much for the great work that you do

Dr. Baxter is here today, and she has a lot to share Would you like to start with FDA Nih, or what you're doing with your work in pain.

I I think there.

Or are they both the same? Really

Yeah. Well, I think there's a story arc to be had here. And so, of course, a lot of the the stats or things I was gonna discuss got turned upside down and shaken out yesterday. So I will talk a little bit about where what I'm doing and my interactions with both of them. And then some of the implications that I see some of the numbers, and I'd love to to discuss, or whatever format you like to have. So my background was pediatric emergency medicine. Did fellowships in child abuse in emergency pediatrics did ut Southwestern a clinical research certificate and then came back to practice in Atlanta, Georgia, because

when you want an academic faculty position, but you also need help with 3 children, then you go back to where your parents are. So when I came back to Atlanta, the database I wanted to work with was at a private practice, and so, in order to get access. I had to actually leave Academia for the research that I wanted to be doing, which was on procedural sedation, propofol fentanyl, ketamine. Penabarb, all that kind of stuff. So I did about 10 years of work in procedural sedation with a lot of pain, drugs and sedation drugs. And at the time I didn't have a a faculty appointment because of of internecine politics with Emory and and private practice groups. And so my faculty appointment is in Augusta University.

where I am now a full professor, as of when they change over in July. So that's exciting. But because of that, I had to get an sbir when I started wanting to research pain. So instead of getting a normal ro one to look at pain management for vaccines, I had to form a company to get an sbir. So that was back in 2,008 and worked with nichd. Then people started using the device I made to block using opioids after total knee replacement. So quit practice in 2016 to work on a device for whatever the biggest opioid problem was. And it turns out that's low back pain. So at this point I began working with Nida versus ninds. Both of them had just gotten the money to do heal grants. So what the lure is is that trump went to Francis Collins and said, How much is it going to cost you to solve the opioid crisis? And he said, A 1 billion dollars and trump said, I'll give you a billion dollars. You solve the opioid crisis.

So from that came the heal grants and help end addiction long term. I think they're not using that acronym so much anymore. But I was one of the 1st heal grants, and we got it through Nida to develop a device that would reduce low back pain and prevent opioid initiation. For those with low back pain turns out 25% of people who go for ambulatory care with moderate to severe low back pain are given opioid prescriptions. Even now it was up to 37%. But it's the number one cause for writing outpatient non-cancer, opioid prescriptions. And and the reason I'm giving you all this detail is because I think that it's important to we all realize it. But the timeframe of politics is very different from the timeframe of science. And so I began

doing the background research in 2016 to apply for and get the Grant in 2019 there was a a 5 Year Plan that the Nih, a bold plan that the Nih put out in 2020, and one of their predictions was prediction 31 was that by 2025 they'd be able to reduce the amount of pharmaceutical pain, relief with devices. and other interventions. So. So what I started working on 2016 was part of a bold plan in 2020, and now in 2025. This is the year that hopefully within the next 2 months the opioid. the opioid avoidance paper, will be published, and not only that, the paper demonstrating that low back pain can actually be reversed when it's chronic, mechanical, low back pain can be reversed with a bunch of different specific vibration frequencies. So it's taken a decade to get to the point. We'll probably get de novo by the end of the year. So it's taken a decade to have this idea and need translated into

something that can be FDA cleared and approved, and it'll probably take another 2 years for that to translate into into disseminated use. So the the low back pain part of what we're doing. I can. Now I'll let you. I'll let you go, Joe, and tell me. And actually one more thing, though, so so from a regulatory standpoint, when we started with the device to block needle pain. there's another paper that is submitted now that demonstrates that it really is with a particular frequency of vibration. What you're doing is neuromodulation. So there is a big difference placing the same frequency. If you're trying to block needle pain for vaccine, if you. The normal pain for 13 year olds was 5 out of 10.

Putting a vibration device proximal to where the where it's going. That was 1.8 8 out of 10. But if you put the same vibration device here. the pain was 0 point 3 5 out of 10 with 93% pain reduction and with 84% having 0 pain 13 year olds getting a tdap. So it says, a couple things, says that this is not distraction, that when you're putting something in multiple dermatomes as opposed to a single dermatome, you get different outcomes which supports the notion that this is neuromodulatory, that you've got a neurotransmitter which is released in the dorsal horn that's blocking pain. So that start when we began using it for sharp pain to reduce opioids, and we got FDA clearance for that.

It doesn't make any difference in the marketplace, because Medicaid and Medicare won't acknowledge that the mechanism is is neuromodulatory. They say it's distraction. So it's a comfort item. So it's excluded from any kind of coverage. So I think that some of the slicing and dicing and blending of all of the different healthcare services. Make a lot of sense in that. There are certainly barriers between what the Nih believes is good science what the FDA is willing to consider safe and effective, and then what Cms. Will pay for. So these things there are barriers that are intrinsically antithetical to inexpensive health care.

We made the device the 200 Hertz device for the neuromodulation, for acute pain. We made that into devices for for post-OP pain reduction at 65 bucks a pop, and because they wouldn't be paid for by Cms. Because they refuse to acknowledge it. That's part of why the strategy became. Let's go for a a high priced, very highest possible hanging fruit. Let's go for low back pain, and let's go against the $27,000 implantable electrical stem for low back pain. And it was really the regulatory barriers were what caused us to have to go to a very high priced model to get something to patients, when we would have been perfectly happy if the data had been accepted for lower priced things

One of my favorite people on earth happens to be on this call, and my go to expert for anything having to do with Cms and reimbursement. I of course I'm talking about Andre domino. No, I'm joking, Nikki. Will you come off mute? And what are your thoughts on that

I think that was mean to Andre. That's what I think

Yeah, a little bit, but we love him. He's our punching bag

But I am Sicilian, so be careful.

And I'm on the other coast, so I should be good for now

I'm only half listening as I'm juggling so many things. But, Amy, I picked up on something you said here at the end. about because of these regulatory things. We had to go high priced. you know, and it's funny how sometimes like reimbursement or the regulatory pathway, because we had to do, Pma. We had to do 30 million dollars worth of clinical trials, which means we now have to recuperate that which means we have to charge more. So now we're going to try to get into this higher paying Apc. Or Drg. whether you're inpatient or outpatient, and it's like what a goofy market that is that because of this regulatory thing that the Government came up with, I now have to charge more or and it's like it frustrates people that aren't in the Med tech world like, why is something so expensive? Why is this pedicle screw? For you know a spine surgery so much money? And it's like. Well, let's walk you through

now. Maybe after a certain period of time, that pedicle screw could be 5 bucks. But certainly when it begins. what Amy just described, and what I deal with on a daily basis. It's like, if I want this product to work. I have to follow this odd game with Cms. In order to get put into this payment classification instead of this payment classification. Otherwise my investors won't get a return, and we're dead, you know.

You're not goofing off on this call. What's your full time job?

I'm a health economist for Boston Scientific

And one of the other things that that I, you know as a practicing physician, was unaware of was just how much orthopedics wags the dog for all medical pricing, because the orthopedic devices and practicing orthopedists and some spine surgeons and some pain docs. But when they're dispensing a device that Medicaid has agreed to pay for at $1,200. They charge a storage fee. so they bill Medicaid for $1,200. The device costs 38, the person that's dispensing the device and fitting it charges $200, and so the orthopedist bills $1,200 and pockets the remainder of that

238 as as a storage fee, and not all do this. And it's it's sort of a as one of my friends, said Cms. Is comfortable with the minor fraud they know, and they don't want to open the doors to greater fraud. But that's the kind of fraud that because of that. when I finished my 1st well, because of that, the private practice orthopedist doing this, it doesn't happen in academia, to my knowledge. And so the academic docs for anybody who's doing a medical device. They're like, Okay, well, I'm going to charge half a million dollars, because that's I was noble and went into research. And I was smart, and I went into research. And so I'm going to charge a half 1 million dollars for a study.

So when I, when we 1st studied the vibracol device, which is, you know, the same 200 hertz device but strapped around with a very specific timed ice pack that I calculated the thermal energy. So you can't get any kind of frostbite. So when we 1st did this, the orthopedic surgeon who did the pilot and discovered there was 35% opioid reduction wouldn't publish it unless I gave him 200,000, and he thought he was giving me a deal, because it's usually almost across the board. A half a million and it's not price fixing. It's just that's what everybody in orthopedics will charge. I've talked about 12 different docs who were very excited when they thought it was for equity or half 1 million, but not interested in just doing

independent investigator initiated research, anyway. So the 200,000 he thought it was lowball. I thought it was abhorrent and and unethical. And it turns out it's probably both. but that then causes orthopedic surgeons to be much more expensive to hire, and so that that kind of trickles down to cost of hospitals cost of a lot of things just because of where where prices have been pegged by Medicaid and Medicare for reimbursement. I don't know if any of the changes that happened yesterday are gonna change, that I doubt it. But that would be a a place where it would make sense. Arlen would love to know what your thoughts are

Actually, I have a question given the the mandatory reduction of indirect costs given Kennedy where he is given blah! Blah! What what's Gonna happen or what is happening

Very big in different questions, and I'm sure many of the people on the call have a better line of sight than I do. As an investigator talking to other investigators. I know that many times you have people in academics who are married to other people in academics. So we just got a as part of developing the low back pain device. And I am answering your question. It's just circuitous. And it really depends on people. So as part of developing the low back pain device because our primary outcome was opioid use. I didn't want to do it in a place where there were prescribers on site to risk bias. So we did it at a chiropractor office.

and in order to find and to get the data on these wild type opioids. Anybody who was using opioids from any source. I had to make an algorithm for data collection. So we made that. And then the Nih wanted to put that into the FDA toolkit for further device investigation. We got another device. We got another grant for 900,000 to validate the the dose opioid source tool that we used for our 1st study. So the person who is I was busy. So I got somebody at at Hopkins to to be Co. Pay. I with me. And her husband was with Usaid looking at malaria, so he's gotten laid off, and so she is supposed to be executing the study with me at the Nia. At Hopkins, looking at post-OP pain, relief with the device to reduce duration of hospitalization and use the dose tool as part of that. And so her part is delayed

because of that. So what I'm saying is what I see and what I hear from a lot of different investigators is that there are reasons, because of the milieu beyond their own personal grants or their own personal indirects. But there are reasons why their research has stopped or slowed. We are fortunate in that. Apart from from the issues with with our clinical site. our funding was stopped for 8 days, and then it got back up and running. But I know a number of people who now are having to look at moving because of their spouse, or they just don't feel like they can trust the system to hire grad students. So and of course, obviously, there's there's a ton of studies which are just being truncated and stopped. So everything that's already put into it is lost.

So what's happening is there's there's a a visceral deer in the headlights freeze, you know there's there's a lot of fight or flight that is in freeze right now for the people I know in the Nih you know, there was a lot. There was a stop in recruiting for the studies, and I'm sure all of you know this and have heard it. But if you're going to be on an Srg. If you're going to be on a scientific review group, you get asked about 4 months beforehand, you're gonna review for free about 6 to 8 applications that each take about 8 h, and then you're going to meet. Usually, virtually, they started in person again recently. But you're going to meet, and you're going to discuss this. So everybody has. There's 20 people around a table. All of you are experts in your field. You're all recruited for specific expertise for these specific grants.

and and that got stopped because there is a a law that you couldn't have these meetings without having the announcement of the meeting. So the initial Kennedy Hhs. Put a freeze on the meetings that were already scheduled, and then put a freeze on the announcements. So the announcements are back up again. But what this means is you can't just get 20 experts to all. Be able to convene again for 2 days in with short notice. So what I understand is that the the granting has been delayed. 90% of the granting has been or they're at 9. They're at 10% of the speed of Grant decision making that they were before January

Is this is, yeah, is this a percutaneous device? Or is it just on this

You have something you could show us for us visual types about your prototype, what you're working on anything

It would have been a great idea if I brought

Screenshot

Yeah. So basically, so so no, what are no? Alright, I'm gonna I'm gonna back up. Then if we're gonna go, if we're gonna talk about the device. Let's talk about back pain first.st

I should do. Mark. You've been patient. You've written 2 things now specifically about vibrations. Maybe you want to ask that. Come off mute

Yeah, just just, I'm just curious on on how the device works and what it does. It's vibrational, so sound

Yeah, no, it's actually just mechanical. So it turns out that just as I was alluding to the neuromodulation, while in 1965, with Melzac and Wall, people started thinking, oh, well, it's electrical. And actually, I could probably pull up a Powerpoint or 2 to show you. But but really the initial pain. Blocking neuromodulation was done with vibration, and it was found that you had to put it in the same dermatome, but not at the site, and 200 Hertz was discovered. This was stuff that was done both in 1960 by Wall and in the late eighties by a guy named Michael Salter. who's still alive, is at University of Toronto. Great great work on why vibration specifically blocks nociceptive pain, turns into adenosine in the dorsal horn, and then it is a presynaptic blocker, so it inhibits the glutamate. That is the pain, the pain neurotransmitter from getting onto the receptor that's going to take it to the brain.

So when we started with this in the early eighties, there's a guy named Lunderberg in Sweden, who made a metal plate that was about 6 by 8 inches. And I will put the link of our website. It's harmonicscientific.com. And that's got pictures of the device. And it's got stuff about how it works. So when I started with this because of the opioid reduction of the 200 hertz for musculoskeletal pain, I put a couple on Lundeberg's back pain here that had worked better than tens and was not blocked by Naloxone, whereas tens is blocked by Naloxone. So I put a couple of the 200 Hertz vibration units so that it could then be. Oh, they're very nice, so that it could then go against the low back.

and it could transmit the amplitude directly into the low back, and it turns out that the amplitude of 200 Hertz was only really helpful for people who had just had an injury, but not as great for chronic. So what we did was, there are a couple things that do work for low back pain. There's heat, there's cold, there's there's pressure acupressure. And there are 3 new discoveries about low back pain in the past 5 to 10 years that that explain why what we're doing now probably is working what was effective was slower vibrations. So when we used higher amplitudes and slower vibrations.

we got different effects, and particularly when we had them on one plate, and they had harmonic interactions. If you've ever seen. If you saw if you saw the Lord of the Rings TV series, there's something called a calody plate, which has a whole bunch of vibration that causes with different frequencies. It causes different niduses of intensity, of amplitude. So if you can. You can. You know, different frequencies. You can see different patterns start to move around. And so what we did was, we just made 8 different. We started with 12 in the pilot got it down to 8 different patterns that were giving a full solid metal plate worth of amplitude that covers the whole low back. It's discrete. You can wear it under your clothes. But the

but the thing that is really interesting is that there are piezoelectric. There are piezoion channels in the muscles and in the cells that respond to pressure. So mechanical force is actually a direct anabolic stimulator. It stimulates growth by having the pressure opens up the Channel ion channel, and most of these ion channels that are force mediated are dealing with growth and repair. So by having a force with vibration these piezoelectric channel. They are not electric, but these Piezo ion channels are on or off, and so if you press them and then press them faster you can get the effects more quickly.

So one of the things. So that's 1 thing. So one thing that's new is that there are mechanical force related ion channels that are that are directly related to muscle, repair, and muscle stimulation. The second thing that's new. This is mostly from a guy named Peter Hodges, who's in New Zealand, Australia. I think he's in Australia. And so what he started finding was that when people have chronic low back pain that you can't see anything on either. A. You're not. Gonna there's nothing. There's nothing in the Ted. Talk about the Duotherm It's a good Ted Talk, but there's nothing in it except at the very end about the about the duotherm. So so the other thing that that Paul Hodge has found, and

mainstay medical has done a really good job of using this information. So most 90% of chronic low back pain is you can't see it on an MRI or a Ct scan. It's not bony, it's not nerve. And what it is is that there are changes in the muscles that stabilize the spine. So those changes, then cause the muscles stabilizing the spine to grow, they outgrow their blood supply. There are fatty changes that cause pain from the the Ceramides that the fat releases, and then it because it doesn't have enough blood supply. It ends up getting sticky, and the fascia adheres to it. So thing number 2 is that the main cause of acute low back pain is actually these multifidus and erector spinae muscles. So what Maine stated was, they put electrical stimuli into the multifidus muscles, and over about 2 years they were able to reduce disability from an oswester disability index of about 65 down to about 55,

so well, crosswalk to a promise group anyway. So they were able to reduce that what we have found in our studies is that by using a whole bunch of these different anabolic frequencies. It's taking about 2 months to get people down to that same disability which is actually normal. And the 3rd thing that is a new discovery, 1st published in 2011 by Helene Longavan, who's now running the the complementary and alternative Nih Institute, if it still exists. But what she found was that if you look at the shear of the muscles moving, if you've got low back, pain. the muscles all move as one, and if you don't have low back pain, and you do the same muscle. They all slide. I've got again beautiful videos of this. And so so the 3rd thing is that fascia pain is probably the biggest part of this mechanical chronic low back pain because it doesn't have enough blood supply, because the the fascia gets stuck.

Turns out there are little nubs of acute pain, nerves that are stuck in between the fascia and the muscle. So if it's not sliding, every tiny move is tugging on these pain nerves. So one of the other things that makes it move is heat. So by combining heat, which you put behind the metal plate and these different vibrational frequencies. We're making over time. We're using the ion channels to to rehabilitate and to cause growth of the muscles. It turns out 92 Hertz inhibits fatty changes, and there's a whole specific range that increases blood flow, and there are some really slower other frequencies that are very narrow, but they inhibit the

and the pro-inflammatory Cgrp in the dorsal horn of the spinal cord, anyway. So there's there's probably 8 different potential ways that these different frequencies are interacting. But what we're seeing is people all of a sudden start moving the same way that people in the multifidus trials do they go? Oh, wow! I feel so loose. So all right, I've spoken a lot, and I apologize about for the jargon for people who are not in medicine. I'm going to put on my readers, so I can see if there's comments that I need to respond

No, I'll I'll read them a lot. Most of them are are links and such. I'd like to know. Where are you in in commercialization. Are you on the market? Because I want one

Yeah, well, so here's the thing. Back to all of the regulatory part. So the workers. Comp is where most people are going to start. Once you get your 510 k. Or once you get your de novo or 510 k. Then you can start selling into workers. Comp, and that's where a lot of low back pain issues. Cost a lot. So they pay an average of 19,000 for a low back strain, and so we pegged the price at 4,900. We started this with an Indiegogo campaign, so we have about 200 of them that have been in circulation for 3 or 4 years now. So we have longitudinal anecdotal evidence on how long you know that once you once you fix the back. It's maintained.

we have been selling them as a compassionate use program for 1,500, but I don't want to mess up the FDA, and so I haven't made any claims at all. So the website has 0 claims and the company that's doing our our De novo. I just asked them yesterday I was like, you know. given everything that's going on, should I just say, forget it, and and say, Go ahead and just let people buy them at lib. But we have. We had to buy an Moq of a thousand for our clinical trials, and so we have about 600 left. So. and that. That's a nebulous answer for your question and talk to me offline because I still don't know the right answer. Maybe you guys in the group do, can I? Can I go ahead? We're Sgs cleared is A is a type. Bf, medical device. So we can be on the market as a medical device

and people are buying them. But but I I don't know. I don't want to jeopardize the fact that we're going up against I you know we did an integrated analysis compared to the common criteria with the multifidus studies with this implanted electrical probe, and and those are the results that I have been writing up, but it's it's enough. That's the $27,000 procedure. And this is definitely going faster and and being a lower end, disability

I'm very, very intrigued by somewhat of a glib comment that you threw in there, and that was, should we just forget about it in light of everything that's going on, and just talk to me about that

I I think that the system for orthopedic and medical device reimbursement is, is. if not fraught with corruption. It's gotten so, Byzantine, that it is no longer productive for the goal of helping people

God bless you! Can I tell you, as a New Yorker, I thought you were just gonna say it's so fucked up. But you said corruption, and Byzantine and other big words. God bless you, Dr. Amy Baxter.

The only problem with Byzantine is you can't play it for Scrabble, because it's too long. But otherwise it'd be a really high high point word, but for low point words. The system is broken, and I agree with that. And so the thing is so I can't. You know Medicaid Medicare are already operating with such a tiny overhead. and they have responsibility without authority for appropriations. So I don't see how that system is going to be maintained, and it seems like the rumblings are that Medicaid will be severely truncated, and if it is, then truncal devices like ours are not going to be covered for anybody

who's who's under 65, or whatever the age is. So if if that seems like it's a, it would be a logical thing. So it seems like it's a writing on the wall which makes you know, I think, that the huge debate we have in neurotech is, do you go direct to consumer? Or do you go through what I've been doing and trying to go through all the medical parts 1st and get your science out there and then get clinical adoption. I just think that it's too soon to tell. But what's going on now may upend the construct of trying to work through the clinical channels. If you have a device that's class one that has a demand for it.

One of our 10 X alumni is the president of Alpha Stem. You must be familiar with their work, and I'm

Stats, or which is

You know what I'm of a certain age now that his name is just left my head, I'll tell you what it is. He's relatively new, or he joined the company 2 years ago. But I'm wondering if if all of those devices, Tms and the like are all going to not get the regulatory support that they need to be able to make the types of claims where they can go ahead and and market themselves as aggressively as perhaps a younger Amy Baxter once imagined her device would be. Yeah, let's let's take Victoria's question, and then I'll I'll kind of talk a little bit about my experience with the FDA.

Hi! So my question was, just, how is this different? Or how does it add to somebody that is under chiropractic care, such as my sister. My sister has had back issues. For probably 30 years she worked on the line at Detroit, Diesel, which injured her back. And so I you know you're explaining it to me, and how it replaces tissue. How long does that take in the severity of injuries, as far as because hers has also led to neuropathy and a little bit of Ms. Over the years

Alright with the caveat that none of this is published. So this is not peer reviewed. We do have a there is a there's a pilot. We reduced paying 57%, whether it was chronic or acute. But there was no, there was no no control. And so these the studies we did. The FDA wanted us to do it against an active intervention. So I used a 4 lead prescription, 8 channel tens as my placebo. and the and we did it in a chiropractor's office. So everybody there was was a chiropractic patient. It takes about 2 months to get down to a promise score of 55. So that if you look at pain, interference as disability, pain, interference, all of those promise scores that are used by the Nih patient reported outcome measurement system.

They're normed on a 50 point scale. So it's called a T score. But 50 is average for the Us. Or whatever population you're norming against so 55 is considered to be mild. Pain. 57.7 is moderate, and 65.7 is is severe. So if the people who were at severe. It took them 2 months to get down to a level of 55 on average. and the ones who were more likely, interestingly, the ones who are more likely to to get there. Some of we're making a neural network now to try to evaluate who it's really going to work for and who? It's not car accidents. Mvcs people who had a traumatic incident. Those are the ones. And usually it's it's

2010, 15 years ago those ones were they had an extra 5 points of reduction, so I can't. I can't answer your question. Very. You know I can't answer it well yet, because we're because the data is only a hundred 60 people

Right.

Stuff, but it's certainly not going to work if there's something surgical. The type of people, though that work for us are the same ones that Multifidus has. So if you, the mainstay medical, do so, if it's like, if there's if they have, if the worst pain is when they start moving after sitting, you know, getting up, you know. Initiating movement is the hardest. I think those are usually ones where it's a it's a an underperfused fascia. holding on to all these pain nerves. So the 1st movement is Yanks, all the pain nerves, and that's where the pain is excruciating. And then standing for a long time, and then there's actually a test you can do pushing on the low back. I'm so grateful for what mainstay has done, because they've really made it easy for me to say, Okay, well, here's here's how you distinguish who should be using this device

Given that. How many years? Now, pardon, you've been working on this device for how many years now

I've been working on the technology for 20. And the device itself, I guess. 1026. Well, 9, 2016

I would be curious if I may ask a question. So I had a 14 year old Labrador retriever, and she had chronic arthritis, and our vet suggested acupuncture, and she started doing acupuncture, and the results were miraculous. She would run out of that office like you know, she was fine, and you know, over the next week or 2 or 3, it would, you know, slowly, you know. Does this have anything to do with that kind of Chinese medicine based either acupressure acupuncture, or that same kind of mechanism for pain blocking

Yeah, that. So I don't think so. I think that acupuncture is going to be an adjunct. I think so. One of the things that acupuncture does do is it has. It's highly associated with increased oxytocin. Oxytocin is the regulatory systems, the parasympathetic calming safety neurotransmitter There are specific frequencies of vibration that enhance oxytocin release. So I think that the final common pathway would be similar. But I think that they're different. I think that they're adjunctive. But it's not what's happening. I think that the thing is, I mean multimodal is multimodal. I think that having multiple different frequencies. I think we're decreasing. Fatty changes. I think we're having a huge impact on fascia.

which is one of the interesting things, is some of the people who've got acute and chronic. They've had pain issues in the past. They've gotten epidurals, and then they have a new injury. One of my buddies I was doing a talk for her at the pediatric Sedation Conference, and she's a picu sedationist. She had just torqued her back, pulling this 100 kilo kid off of a Ct. Scanner because she needed to breathe for him for a little bit. And so she was just just in such pain. She put the device on, and in about 20 min, with the device, with heat, she went. Oh, something changed! Wait a minute! And she did the movement. They all did this movement, she said. It's oh, something just changed. So that's clearly something mechanical.

And and this was about 3 years ago, as I was starting to hypothesize and try to figure out what? Why this was working. So I think that that particular part of it is is fascia is when the fascia is stuck, that you know. If you, if you fascia is called what gums fascia onto muscle is hyaluronic acid. Hyaluronic acid is a thiopectic substance which means that it's a solid until you jiggle it enough, and then it becomes a liquid kind of like cornstarch. So I think that part of this is is the right frequency that we now know. But I'm not telling anymore, because everybody started using my 200 hertz thing. But I think that we got the right frequency to jiggle that hyaluronic acid. And then the heat also does something. So for a certain percentage of people in our study, it was about 20%. They did have something happen within the 1st 30 min. Also Lundeberg, Lunderberg.

you know, when he was doing just the single motor against tens, he had a certain percentage that that something happened immediately. And then they had. They were pain free for a couple of weeks. So so I think that there are multiple things happening

Eddie.

Hi, Amy, yeah, actually, you just touched on my question, which was, A. What is the duration? Is this something that somebody has to do sort of, you know, daily, or or you know, how long does the effect last? And then the other question is again much to where one of the earlier questions about the the frequency. Is it one size fits all, for everyone has the same magic response at at 200 Hertz? Or is there a range of frequencies that might work for some and not for others?

Yeah. 2, 200. Hertz is really just acute. Sharp nociceptive pain. 200. Hertz is post, OP. 200. Hertz is needle procedures. 200 Hertz. Was not that great, for for the low back pain it was. It was the lower frequencies, and it's also the harmonic interaction. The, you know, and we're trying to. We're trying to codify this, because, you know, I really I don't want to make the mistakes that a lot of devices do, going out saying it works for everybody, and then it's like, Well, you've got to select your patients better. The the people who it's worked best, for are those who had an injury. It's been in the data, the people who are Bmi over 30 and duration of pain greater than a year.

And I will add to that the the Mvc. Or a trauma. It didn't stay in the model, but it's it's it seems like it's more consistent the people who have had the the really quick. Oh, my gosh! I can move thing. They last between 2 weeks and 2 months, not doing it anymore. But they're again, they're like the 15 to 20% minority. For most of the people. The average time for getting down to normal. But normal disability was 2 weeks sorry, 2 months, and and they would use it to start with like when in the in the data, they were using it 2 or 3 times a day. and they were usually using it with heat. And then by about a month most people were not using any temperature at all, and they were using it about twice a day. And what we what we hear from the people who are in the Indiegogo campaign that use it. They say that once they got it under control they only need it. If something happens. You know, if they if they torque it again, or they'll some of them are using it 1st thing in the morning, every day, most of them. They were using it about once or twice a week, or less.

Have you? Have you thought about sports, sports, injuries.

We've we've got an Nfl person. I've certainly thought about sports injuries with the with the single motor, 200 hertz devices. That's Vibracol. They're 65 bucks. It's a it's an issue of weight ratios. We can't get the amplitude to penetrate deep enough for most big beefy people. But for the low back it doesn't seem to matter again. We had. We had statistically better outcomes with greater than a year, Bmi over 30

I'd like to. I don't know how many folks have to drop at the top of the hour, and I I see there are questions. I suspect they're about your device. I'm very interested because we we talked about this in in the title of today's Talk for your perspective on Nih FDA, and where things are going. I I'd love to touch on that, and if time allows, we'll come back to Arlen and Andre's questions

Yeah. So my big concern. And what I have seen happening already, I think that the one change in the Nih that's a good idea is to have the Srgs be central rather than under each institute. I think that makes a lot of sense, and that's a good change. I think that the repercussions of very naturally risk averse academics not wanting to risk not wanting to put the time in to get grants. I think that's going to be something that is an unforeseen consequence that will be more profound than I think. Probably any of the restructuring and reorganization. I think there are a number of different organizations like Ahrq Pcori.

Not so much. I I think, that Samhsa almost should go under that, and not niosh and and and OS. H. But I think that some of the ways these groups are being pumped together are strange bedfellows, and that's going to make them more inefficient. But the thing about the FDA is that they are so heavily bound to old rules and to precedent that is creaky and not responsive to new science. For example. when we started talking about getting our 510 K for the post-OP pain. They were very, you know, really focused on. Well, we need to have the testing on your hot packs. And I was like, these are commercially available. And like, yeah, but they're they're going to be, you know, we have an instant hot pack because it has to go through solid. You can't transmit vibration through liquid or gel. It diffuses the amplitude. It doesn't work. So we spent so many hours

fighting about that and and you know there's no established therapeutic that actually works. They have a range 40 to 43°C. But it's not based on real physiology and science. It's just kind of precedent. And on the other side, I was like, look, you've got people that are using devices with an amplitude over 0 point 3, you know, like the theragun or hyper ice, you need to be regulating things that are actually going to cause danger with the new understanding of tissue mechanics that we have. And instead, you're stuck on. Well, can you prove that it's between 40 and 43 degrees, which is arbitrary and and

and not relevant. So I think that with the FDA I'm just saying, I think, that there is some there is shuffling and work that can be done. The problem is that the way their system is now this is going to break it. This will crack them open. They cannot right now they have to get things done by certain days. And so the people who are assigned to like our breakthrough application, for example, they have to get a response in 60 days. Okay, well, if they only look at it 3 days before, and they realize they need something else, and we're not available to talk to them. Then they've flagged their account, and they freak out. And and so that's what I have seen happening. So they said the whole thing about oh, well, you know, we're not going to have inspectors or reviewers for drugs or medical devices removed with the 3,500 people that they're they're getting rid of.

Yeah, you are, you know they already have the person who was on my on our breakthrough lives in New Jersey. So I'm I can't imagine that the process of either moving or finding a new job is not going to slow down everything with that. But my point is, I also think that that very new systems need to be implemented there. So I think that that losing 3,500 in the FDA is going to absolutely break and and delay by easily a year every approval that goes through just because of the way their system works. It's it's they're already so stressed and so so under manned for the way they're doing the task so hopefully, this will mean that the task, the way they do the task has to change

I saw something today in in my Linkedin feed about how the speaker was projecting that maybe half of medical device. Vcs will close down soon, because even as it was the rightfully low percentage that ever make it to Ipo or M, and a like 70%, just close type of thing, and I can't imagine that I have to imagine that there's that entrepreneurs like you like you 1020 years ago, who are just starting now, are going to be so discouraged about the likelihood of getting through this morass that it's like what just like you said before, should we? Just, you know.

What the the one bright point would be. If after this. after a lot of these systems get dismantled. And mind you, I think that the Nih works really beautifully, and I wish that the dedication to science that they have went through the other Institutes and through the FDA and Cms, I mean, it's just. It's ludicrous to have the best and the brightest in our country rule on science by deciding to give it a grant. Having spent all this time reviewing it with battling it out with 20 other people around a table, and then having it through the filter of the scientists who are doing it, and then not use that information anymore. Not no longer accept that. We've already looked at the safety. And we've looked at so many of these things. Now you're replicating this with the FDA. Then saying, we're not sure this temperature is safe and or just prove it, we think it is. But you have to. You have to

test it to prove it. And then, having Cms say, Well, we don't even think it's really science. We think it's distraction when you've already got a whole, the best minds evaluating it. So I think that trying to move that more linearly, so that they're not housed in different places. I think that would be one benefit, and the other thing is truly, if the Administration wants to move more toward non drug. Certainly non opioid and and more physiologic health based solutions. Then that's devices. you know. That's that's going to be devices all day long. So if we're really moving to physics, medicine instead of chemistry medicine.

then then it will be then devices and young people getting into devices are going to have a benefit. If money follows those mandates. and that's the part that remains to be seen. Are they going to break it down first, st and then put money in just like the heal? Grant that Francis Collins took the money and put it into a grant. Now we're seeing 10 years later. Now we're seeing the results of what the money does to promote devices to reduce opioids

Thank you. I'm wondering at a place I wouldn't ask you to comment on behalf of Boston Scientific, but perhaps in the conversations that you have. What are you hearing in terms of changes being brought by the new administration, and how it relates to either big businesses like yours, or perhaps some startups and smaller companies that you talk to on the side

On the big side on on the Boston side. I've heard surprisingly little. You know a big company like Boston Scientific. We get little newsletters and things from corporate, and you know

Little newsletters? Yeah, a little. Yeah. Think whatever

But you know it's a 50,000 person company, and there's people that are looking at

60,000 foot level things, and all the way down

And for us, generally speaking, I think it's business as usual. We just keep going. There's a change in the administration. Rfk, Jr. Is going to let go whatever the news was yesterday. 10,000 people, or whatever. We'll see what Dr. Oz does with the with the agency. But, generally speaking, we just keep going. and you know I don't mean to sound flippant when I say it's business as usual. You know. We are aware, of course, that Washington, DC. Has been turned on its head, and things like that. But, generally speaking, we just keep going. I'm booking a meeting any day now with Cms. I have some things I need to talk to them about, and we just keep going.

That's not to say that behind the scenes there's not upheaval and things like that, but And and to to Amy's point, it's different in orthopedics, you know, that might be a different upheaval from where I am in vasculature. But yeah, we we've just we just keep going

And the smaller ones

Nothing. I haven't heard anything from consulting clients or anything like that where they're upset. I get asked questions. But to that point again, Joe. It's like, just keep going. Submit your 5, 10 K. Submit this Cms recommendation. Sorry, Joe.

I said, that's that's more encouraging than what what I thought you were going to say.

Yeah.

I think, Marty Macri, I really I respect him. We're on different sides of Covid vaccination, but otherwise I really think he is super smart and has looked at these issues for a long time. So I'm actually happy that he is going to be heading up. FDA. I think if anybody's going to be able to look at reforming systems to be more efficient. I think he will. I thought. My husband just brought me. This is what the vibrical ice packs look like. And so the thermal energy cannot cause frostbite even in a baby. But it's it's it will melt in 20 min. So it's a good icing time. This is the knee device. And so it's got the 200 hertz device in it.

and the motor is right there. So sorry for interrupting, but just I meant to have props, and I I didn't

No, no, it's all good. And I showed some things on the website. So if folks on the call, I I read a comment or 2 one to potentially buy one of your devices. They can do so on the website, or they cannot

They need to talk to. They need to talk to me to get I think I think the code is Ama. 2024. If you want to get it at 1,500, then you need to put the code in, because otherwise we have it on the. We have it on the price that we. We're going at it for Cms, which is 4,900, because we are up against the $27,000, multifidus surgery. So that said, though I mean pain. Doctors get $10,000 for putting their little doodles in, and it takes 15 min. So pain doctors are probably not going to be super stoked to change their practice. But yeah, I yeah, again, I it's you know I'm not. I'm I just I don't know. Arlen probably knows I should talk to him, or I'm waiting to hear what our people say in terms of whether or not I should just go ahead and and, you know, put put the claims that we've got supported in the literature that's already published, and then add this stuff. Once these new ones get published

Maybe we can invite you back in a year and see how you navigated it and what you decided

Sure it's just a 6. It's a 5 h time difference to Portugal most of the time.

Will you be living there by then?

Yeah should be. I'm actually speaking at. There's a Harvard, Pm. And R. Conference in June June 5.th They have a research day, and so they have 3 speakers talking about new physiology, of recuperation. So I'm talking about the force, gated proteins and repair. And I'm talking about Multifidus. I'm talking about fascia. I'm talking about different frequencies for inflammation, for blood flow, and vasodilation. So you know I can. I I can give you that to to share Joe with. But but if anybody's around Boston I I'm that's where I'm gonna spill the tea on a lot of this. And I also did a brain mind talk June first, st

that we that I put a lot of what the what the physiology of what we're doing is so so yes, I'm so glad, I persisted, and and got you to join us today. What a treat

Thank you so much

You've just helped all of us when we're, you know, back before we were self-sustaining. It was. It was such a blessing to to know that you had answers that I didn't have to pay somebody at $1,200 an hour to to find out, and you were willing to talk, and you're willing to share. So I appreciate what you've done for the entire industry

That's very, very kind. Thank you, Shawn. Who do we have next week? George is gonna talk to us about

Yeah, George is. Gonna talk to us. George is incredible. He's like 24 years old, and figures he's an oldest child, and he has a startup that is. taking all sorts of data from the FDA. Particularly around warning letters. And he's going to talk to us about warning letters, and he's done this amazing analysis of the warning letters, and what can be learned from warning letters in both in the aggregate and in the, you know, the specific. And so he's developing a platform with a a startup partner on like, what do we do with with all this data? And so there are really interesting things happening with data,

and real world evidence and that sort of thing that people, people are any. I've I met him. I was just like, Wow, this is like 24 years old, like what I was doing at 24 years old was

We should not talk about that on this call. It's for

I should not talk about it on this call right? It did not look anything like, you know.

I mean he's not going to be an Amy Baxter. But you can't, Amy Baxter every week, or else where do you go from? There

You. You underestimate he's got 31 years to get where I am. So. But he

Is it portable?

Well, no, just to be 55,

Okay. Well, we'll stop there. Thanks, friends, for joining Amy. Great to see you, and we'll keep in touch. God bless

Can you leave it open for one second for me to answer a question from Arlen?

Has left the call, but it's recorded. If you want. Okay, we'll say goodbye.

Okay. Alright!

Bye, everybody see you next week

Bye.

Hey! Carrie!

Bye.

Thank you.

Thanks so much. I hope that you're I hope you're not being frauded upon

Oh, I was. Yeah, did you did, did you? That card is canceled or bad, I mean, it's a pain in the butt, but at least to handle

Get a new card. Yeah. Can you leave it on for a second? Just so I can see what people were asking

Actually, I can send you the text file

Oh, perfect! That'd be great!

Let me just figure out how I can. Webinar chat. Let's see. I think when I end the call I get the webinar chat sent to me. And then what happened is, I will copy that into an email and send it to you. So if you just give me your email, and I will. You can just put that in the chat. And I will forward the

Alright. There you go!

The chat file to you, and you'll have everything

Thank you very much.

Thank you.

Afternoon. Bye-bye

2,