BoneChat call #8 - Lisa Voronkova - ComeBack Mobility startup discussion

Uh, so anyway, we're live with Lisa Voronkova, uh, co-founder of Comeback Mobility, and she's going to walk us through kind of the origin story of Comeback Mobility and the technology. And, um, raise your hand if you have a question. You can physically raise your hand or use the little icon. Uh, you can also drop questions in the chat and, uh, Well, just handing the mic over to Lisa.

Welcome.

Hi, so happy new year, and, um, I'll try to make it as casual as possible today. And we also had a brief discussion with Tiger before that I would try to make it as useful as possible, uh, like sharing our experience with this project. So if you have any specific questions, just feel free to interrupt me. I don't want it to be like a lecture or something. Tiger, you mentioned that we are pretty young. In my opinion, we're not really because we already work for 3 years and it's first medical device for us. So if I knew about how long it takes to take medical device to market before, probably I would not start this business and I would not commit to this project after all.

But you and everybody else.

Okay, don't feel bad. So yes, um, yes, thank you. So this is our website. Let me tell you the story. Like, we have an official story which we tell at every pitch just because it sounds great. So our founder, my co-founder and CEO Ilya, is a— was a professional fighter, and also he had a couple of projects. He sold his project and decided to go after his dream to become a professional boxer in Thailand. So he went to Thailand and he got injured and went through the rehabilitation process. And that's how we came up with the idea. It's an official version. Now the truth is that he managed to find an investor And he said, like, okay, I have a couple of ideas and we have to test them. So he contacted me because I had previous experience in hardware devices, but wellness devices, and we tried to figure out what would work and what would not. So our first idea was to create a tool to measure way of walking for kids with cerebral palsy. Sorry, I'm not good in pronunciation. So we tried to produce a couple of prototypes and they were working. However, I understood that it would be really hard to scale this device. And meanwhile, in the same time, we were trying to test another hypothesis, which was the measurement of the gait after the leg injury. How we got with this idea is we just talked to a couple of doctors. And also this was something relatable because Ilya was going through the rehabilitation. It took like half a year for him to recover after the injury. And for professional boxer, it's like way too long because half a year without training, it's just like end of his career as a boxer, maybe for better. So when we try to dig into this topic, we realized that starting like 50 years ago, like starting in 1970, um, people were trying to figure out how to measure, uh, the gait, how to measure the partial loading on the injured leg. So there were a couple of suggestions, like, um, try to step on the egg without cracking it, or try to step on a bathroom scale and memorize the feeling, then walk like this. However, like, should I mention that based on how tired you are, based on which medicine you're taking, your perception of how painful it is, right, can change. So you cannot follow the rehabilitation correctly. You cannot walk with like 20% of your body weight put on the injured leg, like for a week. Also, another thing that we also discovered in the process is that our body is not trained to do this type of activity. So the moment you sit, you forget how to walk again. So we try to understand how to solve this issue. And our first guess was to put sensors on the leg. And we noticed that a lot of people try to do the same. But after all, it's not that scalable because you cannot reuse it. Like, you cannot use it after someone else. It's not comfortable. It's not fitting any option. So like if you're, for example, in Norway, the weather in summer and the weather in winter are completely different and your solution should match with every shoe. So we decided to put the sensors in the crutches because there is a moment when you walk where you distribute your weight between crutches and assisted leg. So this solution happened to be way more scalable and way more easier to execute. And we also noticed when we were applying for patents, that a lot of people thought the same initially, that they put sensors on the leg, but we made our research and we never found someone who succeeded with this solution to the market. So all these solutions with the sensors in the insole, specifically for the purpose I'm sharing right now, specifically for measurement of partial weight-bearing process, were not scaled to the market. They were just designed, um, so for practical reasons. So we were working on this project starting in 2020. We executed with the first batch fairly fast. So by the end of 2020, by the end of the year, we already had a couple of patients. We had the solution. So how it looks, there's an application for the patient and application for the doctor or physical therapist. It depends on the medical system in the country you are trying to address. So one patient, like after the surgery or after the injury, comes to the doctor. Doctor says, okay, Um, you should put like, let's say, 20% of your body weight for the first week, then 30% for the next week, then 50%, and then maximum weight. And the patient would receive the entire program in the app. He would attach these devices— like, we have the SmartCrutch Tips, SmartCrutch Adjustment— to the bottom of the crutches they use, and we comply with all the crutches, because this upper part of the device is adjustable, so it can be bought for cane or for crutches, doesn't matter, any crutches, not for walkers though yet. And then the patient would receive visual indication, so in simple words, the devices are blinking, and so the person would understand if they're stepping too hard or tool. We made a satisfaction study and validation study, and in validation study we proved that we can provide 80% compliance with the partial weight bearing with our devices with indication versus 20% usual compliance without indication, because when patient is not observed by PT specialist, they are like forgetting how to walk. Another important moment we noticed is that when patients are using our devices, they're feeling more confident because they know after all, are they doing well while walking or not? Like, can they walk as it was prescribed?

So, so Lisa, so just to clarify, so there's a light on the sensor And the patient can, the patient can look down and see the lights either red or green or something like that.

Yes, usually they're looking down anyway because again, they're trying to be very careful. So when you're walking with crutches, you look down, you're not walking normally looking straight because you're trying to be very careful. You're not used to this process. Uh, yes, we also tried the sound indication. We tried vibration. Vibration was not working at all. I mean, for the purposes we were expecting and sound indication we're using sometimes during the training of the patients inside the hospital. So you hear sound from your phone, which says like basically step harder, step softer or silent when you're doing great. And so that's how PTs are proceeding with the training now in the hospitals we are working with. So it's also actually good result. Because our competitors in this field are, as I said, scales. Sometimes it's like squishy toys, like dog toy. So they are trying to understand the sound of the step or sometimes doctor is just like putting the hand under the leg of the patient and saying like, okay, oh, it's too hard. Don't do that. So this training of the patient usually takes 40 minutes versus 6 minutes with our device because it's easier for people to understand how to walk. Now, fun part. Now let's talk about business because this was like just the lyric. I also want to mention that we are obviously from Ukraine, so we started in Ukraine, but then war started. I actually have a couple of pictures to show here that when the war started, our engineers were in the shelter and were working from shelter. So that was like insane experience, I would say. Um, here, so there are like our 3 engineers who went to serve, and that's— that was our office by the time of the war. And also here is like some pictures, like there was our office in normal times. If you can see a bit better. Yeah. That was me working with my dog. And so, yes, as I said, we executed with the device pretty fast. We had a really good engineering team. So as for like, you know, usual risk with the hardware startup is that you cannot execute. Well, we managed, it was fast. We already have contacts with the production. Like we all had the team and engineers all settled. So we had the devices, we had the application. It was not buggy, it was working. We were solving this issue. And now we face the question, who's going to pay for us? So yeah, let's discard this part when we were all stressed because of the war. So it took about half a year for all of us to adjust to this new reality. And luckily enough, before the war started, just a couple of days before me and Ilya left the country. So we're now based in New York. It was just honestly good luck for us. But also like Ilya is very into this, you know, karma approach or destiny approach. So he said, okay, maybe we were meant to be. So the universe is just, you know, not letting us to shut down the project. So the question was, who is going to pay? And that is something that we are trying to sort out by now because we tried a couple of guesses and just now we understood how much money are we saving for the insurance companies after all. And I think that is something that we should have focused way before. Again, if we knew, so if I would start my next project and it would be also related to healthcare. I will start from here. Thus, for me, it was not obvious in the beginning. So I was working with the wellness devices, and it was pretty obvious how to sell. Like, you can sell to the corporate, you can sell B2B— not, sorry, B2C, not a big deal. Uh, so how we sorted out how much money I was saving, um, as you mentioned, Tiger, during the previous call Mark told me about the workers' compensation. So we're trying to understand how much you can save if we would speed up the return to activity from the patients. And what we started out is that if they're following the prescribed protocols with our devices correctly, then we can speed up the recovery up to 6 to 10 weeks depending on the diagnosis. However, what we also notice is that, um, there is a couple of other parameters who are also affecting the outcomes in the money, which are quality of life, which can be like measured quality of sleep, amount of medication which is used by the patient, um, pain level, which is similar to quality of life but Not exactly. Um, as I mentioned, return to duty, return to work, but the most important is the secondary operation, like reoperation in general, or infection, or any complication that can be a result of, from rehabilitation process. So what we noticed is that, uh, there are a lot of studies once we started to work in this direction that proven that are proving that. Okay, my favorite article about, about rats. So they took 40 rats, they distributed them into 3 groups and broke their legs. A lot of fun. I think it's an amazing article. So look, now they took first group and made them run every day with the broken legs. Second group, they made them swim. And third group were just like hanging there. Without any activity. And then they tried to see what was the best result in the rehabilitation for them. So depending on the focus, like there were like a couple of parameters, there were either swimming or running, but never the, like, never resting stage. So the more activity you put, the better the bones would get together. And so in a couple of traumas, if bone is not— how to say it— like it's non-union, right? So when you experience non-union, the bone should be broken again and operated again, and it means like second surgery for the patient. But now let's, let's talk about money. What we also noticed while talking to insurance companies is that a lot of them are moving to bundle packages. And so it means that if you're getting paid for one diagnosis, then reoperation would not be covered. So it would be more beneficial to hospital to have proper rehabilitation for the patient. So where we are now, luckily enough, we were selected to Techstars. We went through this acceleration program and we started conversation with a couple of insurance companies. As you, Tiger, mentioned that what kills you is a lack of focus, we believe that the best focus for us would be on the insurance companies and trying to very precisely calculate how much money we can spend Given all this, what I, what I mentioned.

So what, let me, let me try to figure this out. So what, what other products do insurance companies pay for that reduce a return to surgery or improve quality of life or less pain meds? What, what are some corollary products?

So, uh, that's another issue we're facing. Uh, what I believe is very best for us— you mentioned that we are the only solution on the market, and that is true, because if you were talking about, let's say, X-ray, right? You have an X-ray machine and you have a HCPCS code for this machine, so you're getting reimbursed for every use of this. We have to obtain our own HICPIX code because we don't have similar equipment. Now they're using just scales, or as I mentioned, toys, you know, as like, as a competition to us. There's no similar device. So to prove that, we're trying to launch a study with a couple of universities and hospitals whom we like, we just walked in and tried to persuade them that that would be like really fun to make this research with us to show that we actually can bring some better outcomes for the patient by using our device. Once it would be done, probably we would obtain our HCPCS code and then get paid per use. Because for now, what we can do is just a revenue share model. Which is not scalable enough, in my opinion.

And so one of your early customers is HSS. So HSS, they can't do anything without doing a clinical study. So everything's a clinical study. So what are they asking you to do, Lisa?

We have an ongoing study with them. So we have a list of diagnoses. And for each of these diagnoses, we have a list of outcomes. And we cannot have a study with multiple outcomes. So we have to have one prior outcome and then secondary ones. We're trying to distribute the diagnosis between a couple of hospitals. So HSS is taking one specific diagnosis. Then Kaiser Permanente, who is also our partner, using another diagnosis, and so on. So we are trying to complete this study in 2 years because we honestly started with this specific study just 3 months ago. Before that, we were doing satisfaction study, FDA, all other certification, HIPAA compliance, and all the regulation you have to do before you get to humans. So yes, so you— sorry, Mark, you have a question?

Yeah, Mark, go ahead.

Yes, first of all, Slava Ukraini.

Pyroslava, Yakut.

Are you using RPM codes to pay for the treatment?

Yes, we tried. So we have 3 codes that can be applicable for us. But we still didn't sort it out how to make it, uh, like scalable enough so we can use this code as a revenue share model only because we cannot charge for the equipment yet, right? Well, we obtained one HIPAA Xcode, but we failed so bad because it just had like zero reimbursement. So we got the paper where it says, okay, you know, have this code with zero reimbursement.

Good luck.

The RPM codes, uh, reimburse pretty well, um, so that would be a good revenue stream, it would seem to me. Are you familiar— there's a Canadian company, uh, out of Montreal called EQ Balance. They are a neurological company, and they're— yeah, and they use RPM codes for their application for patient stability because the number 2 reason for readmission after total joint replacement is they fell down, you know. And so it seems to me like the RPM codes would be a pretty good revenue stream. You say you are using them? At this time? The remote patient monitoring codes?

Yes. Yeah, okay.

And, uh, are you familiar with another Canadian company called Emovi? E-M-O-V-I?

Yes, yes.

Yeah, their work with, uh, biomechanical parameters for stability and movement and for function, uh, seems to go very well with I mean, I guess I'm bringing these up to tell you that there's certainly a great awareness in the market that this postoperative regimen of recovery is more important than people give it credit for.

That is true. What we noticed also is that when we get into the conversation with the insurance, They're asking, but did you guys have a research with your device? I don't know, maybe we are doing something wrong. So what we are trying to show, like, if you go to our website, you can see that we have a couple of articles published to prove the point we're making. However, when we are in the conversation with the insurance, they are all asking for our own research. So lately, I, I have a feeling that we are not a business but, you know, research company working with all this, like, numbers and research procedures. And I'm not sure if it's, like, mandatory. And are we making some mistake here after all? Or, like, easier way?

Yeah, I mean, you're— this is a classic thing where you, you— startup focuses on the technology first, and, and they figure that out, and then they figure out, uh, product-market fit and business model later on. So this is just, this is classic. John's got a comment or a question.

Yes. Thank you, Tiger. Lisa, this is great. Very interesting to hear. I wondered if, yeah, I wondered if this is just kind of a general question, a little bit off of reimbursement, but I wonder if you find in the marketplace that there are some adversaries to your technology such as like maybe physical therapists, because your device will reduce their billable hours. It will reduce that part of the process of injury recovery. One, I wonder if you experience that or you suspect that. And then two, you know, how do you, how do you plan to work around that and find the right stakeholders within the insurance companies or others that will see the value and be willing to pay for it? Just, I wondered if you were running into unexpected hesitancy in the market.

Yeah, so it was pretty unexpected for us because our idea was to go to PT clinics and say, hey, we have a solution for you and it would be very beneficial because we are gonna reduce the amount of money that you can receive from this very patient. So they said, okay, yeah, very good, thank you very much. So the couple of people who agreed to use it first, and start prescribing it. And then they figured out that actually they're not happy with this because they would reduce the amount of visits for the patient to this specific clinic. I don't want to sound evil. It's just, it wasn't unexpected for me in the sense that's like, um, we should have focused on this money aspect first. That's why talking about the insurance, um, I believe that it would be easier to prove that we are a good solution for this because for this, I mean, for humanity, for recovery, because we already figured out that we can save a significant amount of money for combination of these complications that can occur after wrong rehabilitation. And so insurance would likely care more of that. Also patients care more. Like care about their own rehabilitation. What we noticed is that, like, I was again talking to Tiger about it. Oh, thanks, Mark. I was talking to Tiger about it, like, where we are, who we're focusing on, and we focused on Medicare specifically now, because what we noticed is that if seniors are using walkers and not rehabilitation fast enough, then they're getting addicted to using walkers. And so we want them to use crutches and rehabilitate faster and stay active faster. And that's another point we're trying to prove. But once we distribute all our 10 diagnoses that we choose between the hospitals who are willing to partner with us, then we would go into the second research, which would prove, um, competitive— like, comparison of walkers and crutches for seniors.

Got it.

Go ahead, Ted.

Yeah, Lisa, have you looked— are you familiar with a company called TrackPatch? There's a wearable for total joints, or they even have a spine division. I'm curious if you kind of looked at their, you know, model. They're collecting data attached straight to the joint to kind of measure mobility and things like that. And how— I don't know how that business is going. I just kind of became familiar with it a couple years ago. But, but is there a corollary to what you're doing, uh, with your, you know, support mechanism and what they're doing as a wearable? Is that totally different?

So we— like, first of all, Tiger Buford introduced me to, um, to a team member of the startup, and we had a conversation. I was here, and it was super useful for us. It's something that we haven't considered But we started thinking of that we can actually measure every assisted step and understand this data. And it was exciting to know. So they're doing pretty well. They had exit in August and also they're team member of this BoneChat.

If I'm not mistaken. Yeah, Colleen Gray, who used to run TrackPatch Health, is a BoneChat member.

Yeah, no, she was super nice to us. She took her time to talk to us a couple of months ago and, um, told about her experience. It was like very interesting to hear. Um, so yes, we also were a bit unmotivated by amount of time every medical device is taking to the exit. So in their case, it was like significant amount of time, in my opinion. And so probably we would have the same or longer. So this is also kind of longer commitments that both of us were expecting for this project, but we're going to execute anyway because it's really fun to see how patients are excited about the project. They— I've never seen such reactions before when I'm doing satisfaction interviews with the patients whose opinion, to be very honest, not truly matters in our business model because unless we're selling to them directly, Well, you understand, they were so excited. They were so happy about the product. They were saying, okay, I was unable to walk without it. And I also cannot imagine how I would be walking and going through this rehabilitation without this product.

So my other thought for you is, is, um, you know, military applications for rehabilitation of military soldiers and people in the military and maybe partnering with a service-disabled veteran organization that can kind of give you an inside track on potential innovation grant opportunities through DARPA, other places to help fund, but also getting their name associated with your research would be— I think would be helpful. Have you looked at that or have any contacts in that space?

So thanks to Techstars, we have a contact with a couple of companies who are introducing startups to Department of Defense. We have a tiny issue is that we are Ukrainians, we are not US citizens. So majority of the grants are available for US citizens only, or companies are owned by US citizens. However, there are a couple of grants that are offered to friends of the US. Which is Ukraine also. So we're trying to apply to these grants and we received a big commitment from Ukraine. Now, I mean, because of war, we have a lot of injuries who would benefit from our solution. So we're trying to get into this program and prove that it would be beneficial, not only in our opinion. But yeah, yeah, but thank you. I would love to, to proceed.

I have a friend who runs a service-disabled veteran organization that's very connected on the innovation cycle and taking new technology that's going to be— his whole company is, you know, soldiers that have been injured and are now, you know, applying themselves into the med tech industry. So it might be good contact for you. I can send his information to you.

Thank you.

Yeah, I got a question for you, Lisa. Um, are you using RPM codes or RTM codes, remote therapeutic monitoring or the remote patient monitoring codes with it?

Uh, let me, let me look specifically which codes we are using. And because I have them listed, we're using 3 codes now, so It's, um, remote patient monitoring. Uh, it's the initial device setup. And, uh, third one, I don't remember the name. It's like training. Okay, the code that we use during the training of the patient.

Okay, um, you're probably using RTM codes. I would look into that because RPM codes were more for, uh, oxygen, heart, you know. Those type of things. When they came out with the RTM code, that was specific for remote therapeutic monitoring for musculoskeletal devices, and you should qualify for that. If I get your email, I can, I could send you a kind of thing on that if you wanna see it just to make sure you're, you're using the right thing. I can tell you in the world, I, I'm in spinal bracing now. I used to be in orthopedics and spine for 20 years. The guys I know that do trauma and ACLs and all of that stuff, if you can use the RTM codes and they can bill for it, you'll be amazed at how much traction and how much support they will give you to try and get this on crutches that they're giving patients because then they can monitor it and they can have their PAs, their PAs and nurses bill for it. So I don't know if HSS is doing that or any of the other ones that you're looking at. But there's kind of a, the, the, the orthopedic doctors love to add on billing if they can and it, and depending on in the state, it's like $75 to $150 a month that they can bill for it.

So the trick here is that you can actually extend the amount of codes you're using really much without insurance questioning it.

That's another—

we noticed. So the only thing that they're trying to add on here is that, um, this remote patient monitoring— I shared this, I shared it in the shared chat— there's these 3 codes we're using. However, I still believe that if and when we obtain HiggsPix code, reimbursable this time, uh, then it would be a bit easier for us.

Oh, it, it definitely is where your money is going to be, is in the HiggsPix code, but it's tough.

I'm just so, um, interesting. Lisa, what are your— what are the— may I— may have missed it. What are the— what's the labeling or the claims that you are presenting? I assume there is a Class 1 device and you've been through all that, but what, what can you claim to the hospital or physical therapy center or Oh, it was actually a Class 2 device.

And we got an FDA approval, which we decided not to extend for next year, starting January, starting this January, because it's like too hard for us to keep these payments. And we don't see a point for the following year to keep up with an FDA. But we started as a Class 2 device, probably it was wrong. So now we consider maybe changing to Class 1. What exactly do you want me like to—

yeah, so the, so the FDA, uh, you know, lets you claim certain language about your product and, uh, it's very specific. You can't kind of go out of the box. You can't say it cures cancer, but you can say You know, it gives, I don't know, it gives a numerical number about the weight bearing on each step. So I'm not sure what, like, at HSS, what can you say? What, when you present to HSS, what do you say that the product actually does?

So we're saying that it's, first of all, reduce the time for the physical therapists to explain how to, like, to train the patients so they can increase the volume of the patients coming to the physical therapy, uh, with the same amount of money per patient. And then we're claiming that we can speed up the recovery.

And you'll prove that with, with, uh, enough clinical trials?

So, uh, yes, there's our, like, our partner is Dr. Piszczuń. Uh, he's from the Netherlands, but he made a couple of research all over the world who is showing that, uh, when the patients are following the protocols precisely, then, um, the rehabilitation can be speeding up. Significantly, but only for a couple of diagnoses.

And what diagnoses are, are, is it trauma? Is it post-traumatic mostly?

Uh, so, um, we have ankle fracture and gluteus maximus fracture that are proven, and the rest is just a hypothesis we have. But our main claim to the hospital is that your doctors would work less. Your PT specialist would work less with our device.

Well, that's really, that's really valuable. It's the whole reducing friction for the customer theme that we've been talking about for weeks.

Yeah.

Andrea's got a comment or a question.

Yeah, I did a little quick patent search to see, because you said there's not much on the market, and it is surprisingly, you know, just a few minutes. So it's not, not a full search, but there are very few patents as well, US patents. There's a lot more, a lot more foreign patents out there. But interestingly, a lot of stuff that came up was exoskeletons and other kind of like walking assistance that, that had sensors and stuff in it. So that might be an alternative way of figuring out who's paying for those, you know, if, if they are out on the market. So maybe not crutches, but if some— it's It sounds like it would be the same kind of potential benefit and potential challenge with, with payment. So you might want to look into that. And I saw you guys have a PCT patent application.

Oh, we have 5 of them. Yeah, we have 2 patents issued already. So actually, there are a lot of patents also about this assisted devices. So for example, there's also pedal for smart cane and so on. But all this were designed inside some university, probably for someone to get a PhD or something because they were never executed. And the businesses that we found were using just smart insoles. And later on they decided to go for, I don't know, gait research or gait analysis, which is different area of application because actually the sensors we are using are bulky, like it's not comfortable to walk with them all day. And you have to— sorry, there was a question from Ted. Not really. Okay. Thank you. Yes. We have a couple of friends, also like startups who are doing skeletons, like exoskeletons and also devices for rehabilitation when just like, like the Icarus, right? I think it's kind of similar products to ours even though the shape is different. But how to say, like they have a code for exoskeleton, they already have a Quick Picks code and we still are about to get ours. So that's the main issue we're having now.

Yeah, so we— so Lisa's got something that works. It obviously, it gives instant feedback, it helps with compliance, it helps with better clinical results. It's just got to figure out how to— the business model and the incentives and how to, you know, who does, who's the primary customer and what code is needed to reach that customer. We got a lot of smart people here.

I, I tell you what, that, you know, whoever was tapped on the military, they, you don't even need full approval if it's less than $3,000. They can pay by credit card in the military, and you could get a lot of commercial traction if you get an advocate in a couple of bases that could lead to, you know, other adoption in that. But that's something I would look at.

And research. Go, go to Walter Reed. You know, they, they are driven to, you know, kind of put the latest innovations, you know, into on the veterans to the show and collect data on that stuff.

Yep, absolutely.

Good, good suggestions. Go ahead, John.

Um, thank you. Uh, and maybe this is just a statement of the obvious, so forgive me. But I know that, you know, it seems to me on the first pass is that the companies that are the payers, the insurance companies that are going to be motivated to reduce physical therapy costs and reoperation costs, all those things, and Kaiser, knowing that Kaiser self-insures, right? So they're paying for everything out of the Kaiser finances. Right. They would be very, uh, should be very interested in this. And I guess maybe my question, if there is an answer, is I'm sure you're looking at what type of research that you could do quickly and effectively that you could then go to them and say, look, here's a 30% reduction in physical therapy time in calcaneus fractures or things like that. And, and I'm assuming that, that you guys are pursuing that, but is that Um, is that seeming to work, or is the, the research too expensive and timely? What was the, what was the hurdle there?

Oh, there's a hurdle, it's just time in general. So we have a mentor, Dr. Feng, from Kaiser Hospital in California, and so he's an angel investor and also he's a surgeon. It was really easy to pitch him because he was facing this problem before, and he understood the product instantly. So he came to this meeting and he was like, okay, okay, I got it. I think it's cool. So we're trying to test one diagnosis there. His specialization is ankle fractures. So we're trying to make this research, but as I mentioned, we're trying to target the percent of complications, which would appear as a result of wrong rehabilitation process, right? So for that, we need at least 1 year per patient because the standard of measurement is that like after 1 month, after 3 months, half a year, and then 1 year, because a couple of injuries, um, sorry, a couple of complications may appear way later. So if it's not like, let's say infection or something that you can notice right away, um, it would be noticeable after some time. So probably the biggest issue I have is just time. And also, like, you have to spend some time to gather these patients, like, to collect them and to start working with them.

Yeah. And I don't know how, uh, financially painful that extended physical therapy and rehabilitation is to the insurance companies or to people like Kaiser, but I would assume that that might be a quicker path, like if you targeted reduction in physical therapy or rehab time, you might be able to show something there. But again, I'm speaking kind of uneducated in that space. So, but anyway, thank you.

We don't know either. What we heard, again, I'm trying to talk to as many directors of the plants as possible to understand what is, you know, significant difference. What is that? How much is that? So the results we heard, like the answer we heard and we would have in mind, is that saving $2 per person per month for the plan. So this is the number we're trying to address and see if we're actually able to save that much or more.

Lisa, I'm sorry, what was the number you said?

$2 per person per month inside the plan. Wow, not much.

Yeah, I was like, I thought you were gonna say $200. I was like, well, I still think you could do it, but it's only $2 per person per month.

No, no, per every person, not per injured person.

Yeah, right, it's the global amount for the global. So, so it has to affect the global patient population, not just the people undergoing the treatment, correct?

Okay.

And, um, also another number we heard is like, save at least $5 million per year per plan, but it was like from the open source, not from the private conversation. We were watching some conferences online and we're just listening to what they're discussing between each other.

We ran into a similar problem where, where we were looking at partnering with the University of Colorado and they bring in UnitedHealthcare. And so our brace is working great. We're keeping all these kids out of surgery, which is $150,000 to $200,000 savings. And they said, you know, the savings per patient is massive. But the amount of total savings isn't as much as kidneys or, you know, diabetes, you know, cancer, whatever, those type of things. So, and, and from what they're looking at it was, okay, we've only got so many people that we can dedicate to partnering with these companies and trying to implement it and save money. They're going to go for the biggest bang for the buck for each of those people is what it comes down to, regardless of, of what you're saving per patient. It's the total amount.

That's really interesting.

Yeah, it was very disappointing, I can tell you that.

I would say a little frustrating as a potential patient, right? Right.

Yeah, yeah, you get— you're like, you know, we've had a bunch of success with Blue Cross Blue Shield. You got to test the different insurance companies because United's a pain to deal with actually on our commercial side. Blue Cross Blue Shield, we've had luck in 20 different states, so just depends on the insurance too.

So let me share, um, how we're approaching this really quick. So, um, sorry, half of this would be in Russian or Ukrainian. I mean, it's for our internal use, but here's the amount of diagnosis we're trying to target here. And here we have like cases per year, percent of complication where, which results in non-union, percent in delayed healing. And also we have a link for every number. So we're trying to sort out which would be the best, like the most interesting for us. Mechanical complications, pain, infection. And so, by the way, it was surprising to me to hear that we can affect infection also. But the trick is that if you have, um, stimulus to walk enough, and when you're not scared to walk and you walk as prescribed, um, the blood goes faster, to say so, and sorry, into the pores. Um, and so the percent of infection goes down. Um, so, and here we're trying to understand, um, which research would be also doable for us because for a couple of diagnoses, we need just too many patients. Like here is almost 1,000, which is impossible to reach. So we're just trying to see what we can actually do and where do we start.

Seems, seems to me, I'm no study expert, but it's more of, you need an economics outcome study, not a clinical outcome study. You need to collect dollars and cents.

You know, this also have, let me show you here. So good. So here we cost for like readmission in total and risk per patient. So for example, some things are pricey per case is what you mentioned right before., prices per keys, but it's not affecting the entire population as much. So of course we're trying to understand where we can save the most.

Interesting.

Really interesting.

Oh, and here's like another one specifically for Kaiser. I just put it, that's Maybe it would be also helpful for someone, so like feel free to reach out. I'm not sure if we're doing it right because we're doing it for the first time, but here we are calculating the cost and also for different plans for commercial and Medicare, trying to use the open sources. So not every number here has a link, and also from different resources we have. Different numbers, but that's pretty much it.

Yeah, Kaiser would be a great partner because they can mandate the use of this.

Absolutely.

And they love the remote monitoring. They do it for, uh, glucose delivery and that, and because it's tied into your phone, and if you're not taking your insulin properly or whatever, they'll actually reach out to you and say, hey, we need to get you in and have a little chat 'cause we don't want you showing up into the ER. So they are proactive on that type of stuff, but you have to have a surgeon be an advocate. It's tough just to knock on the front door at Kaiser. If you can get a surgeon that'll take it to their innovation committee and say, hey, I wanna study this and I wanna do this, you can really go some places. And if it gets some traction, Kaiser Ventures also supports companies too. So it's a good thing. We're early on that path for going through Kaiser, but that's where we're trying to go.

What, Lisa, what are you specifically doing with Kaiser right now? I know you have an investor and a—

No, they're not investing yet. Yep.

Oh, but you have a physician. You have a physician investor who works for Kaiser.

Uh, so again, he didn't invest in us, he's just our mentor by now. Got it. Um, again, we hope we would establish enough relationship with him because we would love to have him on board because of his expertise, and seems like it's a really good fit. Uh, but his focus is on ankle fracture.

Got it.

Well, any other comments, questions? Do you have a— do you— can you give a really short picture or video of how the device works, Lisa?

Oh sure, but yeah, it's on the website, uh, like the first, the first video you see when you open the website. I can share the screen actually and, um, and show it.

Give me a second. Oh, I'm not sure if I can—

you may not be able to share the screen.

Yeah, but here, here's the link. Here's the link to the video. It has like just 60 seconds. Okay, perfect. It just explains everything. Oh, the only thing is that in the video we say that we also have a web interface and we decided to cut off this functionality because of some recent restrictions in the hospitals. So we're using just the mobile applications by now. Okay, so the device talks to the patient's cell phone through cell phone and also like physically. We tried to build some sound indication, but what we noticed is that if you use it outside of the hospital, um, it's not very helpful. So we build the second version of the device without it because this like beeping or dynamics are not helping you enough.

Are you issuing any reports to physicians? Like, okay, this patient is doing this much for— okay, just automated email, or how are those going out?

Uh, you can download it from the application. Okay, then you can see it for each patient. So we have application for doctor and application for patient, and doctor can see all his patients, so they can download the statistic from each of them.

Okay.

I saw you had, Lisa, an indication for chondral defect under meniscal repair. So, you know, I've got a little bit of experience in that and I'm on a board of a company that is, you know, attacking that problem. But it'll take an FDA PMA study. But their solution, their claim they want to claim is immediate, post-op weight-bearing capability. But what I've asked, you know, the management team is, how are you going to measure that? And maybe, maybe this is— I can connect you with them, and this is a way, you know, to incorporate this into their study to kind of show that their solution allows immediate weight-bearing versus, um, you know, other solutions that don't. And, you know, let that be a value proposition for them. And it's a big, you know, I think there's quite a few numbers of chondral defect repair and they're expensive. They're expensive procedures today.

So that's true. That's actually another thing that we noticed. So can you imagine that protocols for the post-operation care were not changed for like 50 years? Why? Because there is just no biofeedback device, no tool to understand how a person would walk. So doctors are just prioritizing the construction safety over the speeding up the recovery, right? Because you don't want a person to overload the leg without even knowing that. Um, that's something else that we noticed while working with our mentor, Dr. Klisiewicz, who's trying to design new protocols of rehabilitation. But again, um, it's still hard to implement in the industry right now because We don't have the tool. I mean, we have the tool, but we are still going to prove that this tool is working right in the study. Yeah.

I'll connect you with the management team, the clinical team. They're a Scandinavian company and, you know, this is a big deal to them to prove that they can—

If it's a Scandinavian company, maybe we are working with them already. That's okay.

Yeah. It's Askel Healthcare out of Helsinki in Finland.

Okay. No. Okay.

Maybe with their competitors.

I'll, I'll send you, I'll send you the info.

That's a great point, Ted. I mean, that's another angle where just to get off the ground, Comeback Mobility could be a clinical trial company for a while, you know, because, because yeah, everybody says partial weight-bearing and nobody's measuring it. And for clinical studies, you need to actually measure weight-bearing. Go ahead, John.

Hey, thanks, Tiger. We, uh, I wanted to reinforce one thing that you said is the, uh, an important factor is the entire econometrics model. So, uh, creating a model that shows maybe in ankle fractures the entire, uh, time savings, you know, all of those econometrics that will add up. So you'll have a, it won't just be the reoperation savings, it'll be that whole model that you can build out. The, the reason I bring that up is it was very, very helpful for the startup I just, um, got off the ground, Endeavor Orthopedics, uh, is because the implant itself was much more expensive, uh, than wires and pins. We had to really demonstrate, and we were in the process of proving that there were other metrics that would apply to the cost savings for some, not all of the stakeholders, but some. And then, uh, and I just think that that will be a— that will be an important factor, um, in, in terms of that. The other piece is what I wanted to say is what Tiger just said, was that we were, we were we wanted to make the claim that one of the reasons that the implant that we had manufactured deserved a premium price was our hypothesis was that patients' early mobilization, right? It's an AO founding principle, and that if they were— if they put a plate on the patella and tied the extensor mechanism all together, patients would be able to mobilize sooner. And do— and so we knew that some of our doctors were doing that, but we had no real data. So I think to Tiger's point, there might be other fracture or products that would really like to be able to demonstrate using your product that, look, we can show that they— these patients mobilize earlier and more readily. So I— it's an interesting comment that Tiger said that that might be a clinical trial tool that other startups or even beyond startups might want to use because we couldn't officially really make that claim. It was, we had to always say our hypothesis is that your patients will mobilize sooner.

Anyway, thank you. That's a great point.

Thank you.

Interesting. Well, any more comments or should we wrap? We're hitting, we're basically hitting an hour.

That's great. Wish you all the best. Let me know, you know, if I can help you with my service-disabled veteran friend and I'll connect you with the folks in Helsinki as well.

Thank you so much.

Beautiful.

Good luck, Lisa.

Good luck.

Thank you. Thanks, guys. I, I guess it's a wrap. So next, next week we're gonna go back to Thursdays. And so January 11th, uh, Alyssa's gonna talk about her porous pedicle screw for basically drug delivery or anything you wanna deliver through a pedicle screw, antibiotics. So that'll be really interesting. All right. Thanks, guys. Happy New Year.

I've gotta be at the I'll catch you later. I'll be at the Consumer Electronics Show, and Lisa, you ought to think about that for the following year. There's a whole med device section for connected devices, and there's a lot of fun. There's a lot— where is that?

Where is that, Jamie?

Vegas.

Vegas. So it's like JP Morgan right into CES.

Yeah, where else would it be?

But it's amazing how much money is in that for connected devices. It's something you ought to look at.

Anyway, excellent. All right, happy New Year.

Thanks for the invite, Tiger. Take care.

See you next week.

All right, bye-bye.

Bye.