Capital Markets Day Transcript - MYO 2025-06-18

Terth Battelle, Head of Investor Relations

All right, good morning, everyone, and welcome to my OMO's Investor and Analyst Day event. I'm Terth Battelle with Alliance Advisors IR. We're delighted to have you join us today in person and via the webcast, and we have a lot to share with you over the next few hours. We'll spend a lot of the morning going into the direct provider business, lead gen, field ops, reimbursement, post-delivery support, and then we'll go for the manufacturing tour, and after which we'll have lunch served, and we'll spend the afternoon discussing international business, the OMP channel, product development, finance, and we'll wrap up with a Q&A. But before we begin, I'd like to caution that statements made during today's event by management other than historical facts are forward-looking statements that are covered by the safe harbor provision of federal securities laws. These forward-looking statements are not guarantees of future performance and may involve and are subject to risks uncertainties and other factors that may affect my almost business financial condition and operating results these risks uncertainties and other factors are discussed in my almost filings with the securities and exchange commission actual outcomes and results may differ materially from what's expressed in or implied by these forward-looking statements furthermore except as required by law, MIOMO undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this event, June 18th, 2025. It's now my pleasure to turn the podium over to MIOMO's Chairman and Chief Executive Foster, Paul Godonis.

Paul R. Gudonis, Chairman

Well, thank you, Turf, and thank you, everyone, for attending here in person to our first-ever Investor and Analyst Day and for all those of you that are watching online. So just a little bit of background on myself, and I also asked all of our senior executives who you'll meet today to give you a little bio themselves. I've got 40 years plus experience in bringing new technologies to market. From the first cell phone network in the country that was spun out of AT&T, a couple of smaller enterprise software companies. One was acquired by EDS and then took and built that into a quarter billion dollar business in 20 countries around the world. Then when the Internet was being commercialized in the mid-'90s, I joined the company BBN that really did invent the Internet. We took a little $5 million regional network and turned that into a billion-dollar global supplier of Internet services, about 5,000 staff. I ran with inventor Dean Kamen the global robotics competition with a quarter million students, 100,000 volunteers, corporate sponsors like NASA, Google, Medtronic, Boston Scientific, IBM, and others. And then through that, I met the team from MIT that had this really big idea to conquer paralysis, a big unmet need, some key patents from MIT, but they really needed a CEO to come in and commercialize it. So I joined the company initially as an investor. I figured out, okay, how do we build a team here to get the right product market fit, totally redesigning the product, targeting all these individuals with paralysis, raised capital, and you can see today is the team that we've got here at MIOMO, as well as this new facility to continue to expand the business. I've got an MBA from Harvard Business School, got my engineering degree at Northwestern University, where I serve on the dean's advisory board for the engineering school, the biomedical engineering council. I've been an advisor to the Northwestern medical device development course, and also for Design for America. So what we want to accomplish today is I really want to give you a deeper dive into MyOMO's operations, meet members of our senior leadership team, tour our new headquarters here, especially those of you who might have been at the old Portland Street office, we've got the space now to really grow this company, you'll have a chance to test your EMG signal with one of our MyoPro demo units, we'll provide details regarding our long-term business plan, which is really the focus of today is how are we going to scale this business from where we are today. We won't be updating Q2 or 2025 guidance today because we're really focused on how we're going to build a business and your questions on that. And then also, one of my goals is to listen to you and learn from our guests today. So over the last several years, the strategic context here is we are so well positioned in this marketplace. We've created a new product category with the MyoPro of myologic orthosis. We have the first mover advantage in meeting a large, unmet need of people with chronic arm paralysis, and one that grows every year. Last year, we finally received CMS reimbursement, which opens up the market to all the Medicare age population here in the U.S. We established a direct provider business, which Micah Mitchell, our chief commercial officer, will present to you today to basically bring this product directly to the patients, and now we're developing the new orthotics and prosthetics clinical channel, and we've got an attractive margin profile, 70% gross margins, and opportunities to improve that with scale. Our go-to-market model in our channels, and if you look at just Q1 results here, our direct billing channel with our own certified process orthotist, our own reimbursement operations, 79% of our revenue in Q1. The VA, about 3%. And we've served many veterans across the country with the VA medical centers. Our international business, which you'll hear from John Freuters, who heads up international from Germany today, was about 13% of revenue, and that sets growth year after year. And there they sell through in-country orthotics and prosthetics clinics that are in network with these insurance companies that are licensed in Germany. And then with the U.S. O&P clinics, just 5% of our revenue in the first quarter, but we see that as an important increasing part of our business going forward here. And the next big milestone, and I've talked to some of you about this, is we've been growing the company now 10 years of revenue growth year after year, and our aspiration is to get to a $100 million company and do that within the next three years by 2028. And so that's what we have set our sights on as a milestone to pass through and can keep going from there. But you're going to hear our plans about how do we get to that position here in the next several years. The team of people you'll meet today. I report as chairman and CEO to the board of directors. Our commercial operations team is headed up by Micah Mitchell. And we've got marketing, Joe Tchaikovsky. Fueled operations is headed up by Peter Young. Unfortunately, Peter had a family medical issue to deal with today. So Peter isn't here with us today, but Micah will fill in for him. And then Kathy Sawyers heads up our clinical services team. Then we've got medical affairs, Dr. Harry Coleman heads up that operation, which is really around our research as well as all of our reimbursement operations. Our engineering and product strategy head is Malcolm Bach. Our manufacturing operations, and you'll get a tour from Colin personally this afternoon. So Colin heads up manufacturing, John Freuters International, and then our CFO is Dave Henry. So with that, let me turn it over to Micah, and then, of course, we'll be out looking for your questions all along the day and then a more extensive Q&A session at the end of the day. So thanks again, and Micah, it's all yours.

Micah J. Mitchell, Other

Okay, thanks, Paul, and thanks to all of you for being here, those that are in here in person, as well as those that are streaming the event. So my name is Micah Mitchell. I'm the chief commercial officer. I've been with my MO for about eight years. A little bit about me. So I've spent my whole career working in home medical equipment space. Some small companies and medium companies that were rapidly growing, some large companies as well, have worked on the provider side where we're helping the patient individually as well as on the manufacturing side. And interestingly enough, my M.O. is not my only stop for a company that has done both. I'll kind of rewind 30 years. My capstone economics project at Baylor University, we were trying to determine if there was a correlation between the time spent in inpatient rehab and long-term health for those that had spinal cord. injuries. I personally talked to several hundred patients who had spinal cord injuries where they took me through their journey from what their life looked like before the injury, what it looked like right after the injury, and then what it looked like long term. And I immediately learned that I wanted to dedicate my career to helping disabled people. Many things have changed in the past 30 years, so for example back then patients would have inpatient rehab for months, two, three months inpatient to learn how to live with your disability. Unfortunately, today, for a lot of reasons, that's measured in weeks and sometimes even Shortly after finishing undergrad, I got straight into the home medical equipment. I personally went into thousands of patients' homes to learn how they survive being physically disabled. Our whole job, all along the way, has been to come up with assistive technology devices and products to help them do more with the physical limitations that they were facing. So, how to get from point A to point B, how to get in and out of bed, how to breathe easier in your own home, how to adjust yourself in bed, all of these assistive devices have always been designed to accept someone's ability that day and to give them devices to help them improve. I never would have believed back then had somebody told me that soon there will be a product that helps people move more than they're able to at the time. And here we are today with the MyoPro, which you'll learn much more about later today, that helps someone with a paralyzed arm to immediately move the arm and grasp things and gain movement. What we're doing to me is meaningful, it's exciting. I think you guys will appreciate the business that you will learn about today but I hope you also appreciate the humans that we are helping each day to improve their quality of life. So I'm going to briefly right now take you through the patient journey. So about 80% of our revenue is the direct billing business so we're going to spend about an hour talking about that. So right now all kind of briefly take you through the journey then we'll have other leaders come up and get into some of the more specific details of each step of the way. As you can see we kind of think about it starting with lead gen and that's not only sort of getting leads it's also educating the community I'm getting awareness among patients therapists physicians as well but it all starts with that our marketing efforts to generate some demand and then we have to do some things to make sure that clinically they're a good patient and to get funding in place it's an expensive product and so there is a health insurance component and you'll learn quite a bit about that as well it's a custom fabricated device we don't stock these things in the field and take them off and put them on so there's quite a bit of work required to make this perfectly fit each patient's arm the distance from the pivot on the elbow to the hand every hand is different and we'll kind of take you through the fulfillment process and you'll get a sneak peek of how we do it here once we deliver the product many home medical equipment orthotics and prosthetics it's You can deliver the product, and not a lot of training is involved. Our product is different. If you haven't moved your arm in a while, there's a process to learn how to move the arm again. It requires therapy and post-delivery protocols, and you'll hear a little bit more about that as well. So briefly on the lead gen, we're educating through a few different methods. We lean heavily on TV advertisements, social media, because they work very well for our demographic. What we've learned is not only are we reaching out to and educating patients, we're also educating family members others in the circle of care such as physicians and therapists as well once we've kind of generated the awareness and interest and have someone to talk to they go into the the intake and telehealth screening intake is really the first time we talked to someone on the phone and a lot of times folks have done quite a bit of research other times they've done no research so the phone calls can vary once we sort of check that first phone call box then the next step for efficiency and a lot of reasons is a telehealth screening a lot different than a zoom call we use a platform where the patient is able to see a clinician face-to-face through a video call to make sure that we're all moving in the right direction a few of the metrics that we publish so but one is obviously pipeline ads once a patient has completed a telehealth screening with a clinician so that we validated that they are a clinical candidate and that they have a payer that might pay for the device it graduates from the telehealth screening to the next stage and that's a pipeline ad, which is one of the metrics that we publish. At that point, we need to get funding in place and make sure the physician understands the product and wants their patient to have it and then orders the product. While we are doing these things, the patient sits in the pipeline. Once we have funding in place and a physician's order in place and it's ready for us to move forward into the fulfillment, that's when it exits the pipeline and enters the backlog. where it sits in the backlog where we do the heavy clinical lifting, fabricating the product, finding therapists, training therapists, delivering, and then usually at delivery is where the patient exits the backlog and turns into revenue. So kind of high level and just brief reminder, generate demand, talk to the patient, do sometimes a telehealth screening, sometimes a in-home eval during that telehealth screening middle phase. Once we have confirmed they're a good clinical candidate and they have an insurance that might cover the product, they enter the pipeline. While we're trying to get funding in place and talking to their physicians, they're sitting in the pipeline. Once funding's in place, they exit the pipeline and enter the backlog where they sit until we deliver the product. And again, in most cases, revenue is recognized at the time of delivery. So as we get into a little more detail, I'd like to bring Joe Chikosky, our director of marketing, up who will take us through the marketing legion aspect.

Joe Tchaikovsky, Other

Good morning. My name is Joe Tchaikovsky. I'm the director of marketing here at NIOMO. Originally from Pittsburgh, PA. Currently I live in Dallas, Texas. So diehard black and gold living behind enemy lines. So I started my career at the JCPenney corporate office in Plano, Texas. Great opportunity. A few years later, I went across the street to EDS. Oh, there we go. Sorry about that um went across eds it also across the street of plano texas uh great experience right out of the gate two world-class corporate organizations from there i went on to vertus communication which is a 1.2 billion dollar marketing communication company jc penny was a client of vertus that's how i got over there um five years prior to coming to my omo i was working for a boutique agency in dallas and i was focused on my clients directing consumer for a medical device. So when I saw this opportunity as a really good fit and why I've been here at Mioma, we've been working to refine our marketing efforts and I'm responsible for lead gen and I'm focused on getting the cost per pipeline acquisition down. Here's looking at, we primarily get leads from three sources. The first one is TV, next one is digital advertising and social media, and then the third is clinical referrals and organic. With our TV advertising, we do utilize an agency for consulting, for ad placement, and for pricing. Additionally, as part of the Q1 meta situation, we have also partnered with a digital agency that has proven to be effective. With TV, we tracked our performance using about 50 tfn toll-free numbers which each station you know with tv we have a call center in fort worth texas if somebody calls during the day they could talk to the cxd team if we have availability in the telehealth we call it a walk-in and it can go right in with digital advertising and social media we get instant results on a daily basis and we're looking at the campaigns in real time tv is good because it makes the phone rings and we have an excellent call center. With social, a lot of leads come in in the evening. Patients are, you know, 1 a.m., seeing our ad on TV. They go to our website. They fill out the form. And then those are outbound calls made by our call center during the day. And then for clinical referrals, which are increasing, you know, we tend to get better clinical patients, particularly if the referring source is knowledgeable and has been trained by Cathy's RCS team. We are constantly working to increase referrals. It's a priority for the company. And then lastly organic. You guys may familiar with the AOPA coming up in September. We're really excited about having two speaking opportunities this year there. We're going to be at the PM&R later this year. So we're acting engaging the O&P community. Also we are at AODA in Philadelphia engaging therapists, OTs and PTs and then we're also looking into local events all right the next two slides we're just going to look at quickly some Facebook creative you know patients users appreciate a brand that appears dynamic and relevant this is the Myo Pro 2x so this is all new photography that we recently taken so you know fresh campaigns applies you know active engaging you're also doing a lot of attention-grabbing videos which have been highly effective and we're We're also using AI to scale, so go to the next slide, you can see we have very different ad copy, very different images. Each morning I can see which got the most clicks, which needs to be optimized, and we can also see ad fatigue in real time. So if the cost per lead is increasing, increasing, increasing, we'll switch to creative out. here's taking a look at advertising spend and advertising spend is pretty much digital primarily Facebook and on TV and we're looking at this on a weekly basis you know for example with TV we can test multiple stations and then on the digital side we have Instagram we have Facebook so we're determining our specific strategy on the creative and placement on a weekly basis you know for example you can see on this slide you know we did have a hiccup I would call it with Meta in Q1 and you can see in April so you can see in Q1 that we really spent more on TV which historically we spend more on digital advertising in April we brought on an ad agency earlier in the year we rebounded in April, and you can see cost per lead coming up next. Our cost per lead is better than it has been in 2024, in April, and this is increasing our budget, drastically increasing our budget. So we're really in a good position, and I get the question all the time, is there a saturation point for our digital advertising and direct consumer for stroke patients?

Micah J. Mitchell, Other

Based upon this data you know we're not experiencing saturation at this time okay now we'll kind of talk about our advertising cost per pipeline ad and i'll even kind of go back to the previous slide we're spending so much more spent so much more on advertising in april than we did any quarter in 2024 and as you spend more even when you're well below a saturation point you still can we have rapid increases in your spend you can see some increases in your calls per lead even when you're below a saturation point. Part of that is timing with social media spend and TV spend and whatnot. What we're experiencing is our cost per lead in April, even with the more significant spend with leads two and a half plus times what we were getting in just a few months before, not only is our cost per lead not rising, but it's getting better. So I would kind of say if there is a saturation point for advertising, we're nowhere near it at this point. That said, so advertising cost per pipeline ad, which is a metric that we publish, is a function of two things, our cost per lead and our lead conversion. Each of those are a function of some other things. So when I think about cost per lead, is there competition? So, for example, at the end of the year, Medicare Advantage plans tend to advertise in the same space that we're advertising, which on the good news is that that kind of confirms that we are advertising in the right places. Also, end of year, we're competing with other advertisers for sort of end of year holiday shopping and those things. So we, competition is a factor, and we try to account for that when we're planning our spend throughout the year. Also, it's performance, and it's how well are our teams doing converting those things. So when I think about lead conversion, some of the things that we're doing today, so for example, the telehealth screening was a good guy for us because it became much more efficient. We could take a patient from the phone directly into a telehealth screening, and that was a good guy for our ratios. some of these sort of factors we control some we don't control but we do the best that we can to control all of those things and then that kind of leads to an advertising cost for pipeline ad which as you guys know we do publish the patient decision-making process is not always straightforward probably similar to many of us when we have a significant purchase sometimes you you sort of go through the process quickly and other times it can take a lot of time you begin to get interested in something, so you begin to seek information. In our case, sometimes it's a patient maybe seeking information from family friends, from therapists, from physician, from the internet. So sometimes they want to go through that process. Also with our patient population, things happen. It's not straightforward for a disabled person or someone with hemiparesis to get out of bed. They're generally not going to work to make their lunch to kind of get through the day there are other comorbidities and health issues so we do see a lot of those things sort of pause the patient's journey where they need to take a break focus on other things and or learn about the product only to come back and re-engage with us later so there's sort of a cycle time aspect of our pipeline ads as well from you know generating leads to getting them into the pipeline to navigating the process of that of that timeline some things we control some things we partially control and there are other things that we don't control what I want to demonstrate here is kind of how long that actually takes so what we've known or what I'll share is of the pipeline ads each month so the patients who pass the clinical telehealth screening generally about half of those pipeline ads are from sort of new leads that we got within the last month and about half of those pipeline ads were older leads so patients who engaged with this needed to pause and take some time and figure some things out, and then came back to us. You can see we're very strong the first week, so we generally, when a lead comes in, they're contacted immediately, and so we have a pretty good search those first two days from the lead date until the date that they become a pipeline at. Then due to our messaging, we have plenty of success sort of that first ten days, and then we see a drop off where patients need time, they want to be put on hold, they're thinking they're talking to the circle of care and then we reactivate leads through direct campaigns and a lot of different efforts and in some cases separate from our efforts patients just come back to us so some patients are ready to move immediately other patients need time which is not really measured in weeks it's in years from the time that they first engage with us until they're ready to proceed with the process so marketing efficiency there's some good news in here and some some old news in here as well but so our cost per lead is the orange bar, and obviously January, February, we had a hiccup there where the cost per lead increased on us for a short period of time. That was due to some meta changes. We have that situated, so that's way behind us, and the April cost per lead is as good, if not slightly better, than what we were experiencing a year ago. The white line is our ad spend per pipeline ad. These are two different axes, by the way, and clearly as As we were spending more for leads, our advertising cost per pipeline ad increased through Q1 and we're beginning to see that decrease. That said, due to the long cycle times, if we're getting two and a half, three times more leads today than we were getting Q4 in months at the beginning of the year, we would expect our cost per lead to decrease at a more rapid rate than our cost per pipeline ad because so many of our leads are new. Many of these new leads will convert to pipeline ads in a short period of time. Other of these new leads, of which we're getting many more than we did in the past, will need time to mature. Okay, so now I'm going to go into field operations and dig into a little bit more. So Peter Young is our Senior Director of Field Operations. He has 20 years of experience in home medical equipment. He's been a great addition to the team, and he has three departments that he handles that take us from the intake to the telehealth screening, and then all the clinical work that our CPOs do so the intake we have a intake center in Fort Worth Texas it's about a 20 seat call center we really do more than your typical call center but there you it's a wonderful team that we that we've grown from I guess two or three folks seven years ago up to about 20 today when when I first joined the company I was actually living in Ohio and Paul and I began talking about sort of what the future of the company may look like and we we really knew that we would need a strong robust call center well as it turns out Cambridge which is where we were based at the time in Boston are not ideal locations for a rapidly growing call center partly just to the due to the cost of labor so we went through a process that many similar companies go through to determine what is the best place for a call center that could grow to a hundred heads in a in a short period of time there's a handful of locations. So Cleveland, Ohio is a popular spot. Nashville was more popular, I think, than it is today. And then you have a couple cities in Texas, kind of Austin and the Dallas-Fort Worth area. So we chose the Dallas-Fort Worth area. We've really zoned in on the profile of the intake coordinators. We would love to have some home medical equipment experience, maybe some insurance experience, doctor's office experience. But what we've learned is even more important than that is someone who's a good listener, who they want to help and talk to disabled people. And sometimes even the conversations can take some time with slight cognitive deficits, with speech issues. And so we want a good team of intake coordinators that are patient, kind, and caring, but also smart enough to do the job and handle the sort of unique complexities that we have that not all call centers do have. We are able to, with this particular department and where it is, we're able to rapidly scale it up and down, which is a huge benefit to us. Today we handle about 25,000 inbound, outbound phone calls with this team, and when we think about the phone calls, there's inbound and outbound. So one great thing about a TV ad, a lot of patients will see a TV ad, go do some research, fill out a form. If a form is filled out, then we are an outbound call center, trying to call the phone number to get the patient on the phone. On the other hand, if it's a TV ad and our phone number is on the screen and they call us directly we love those because it's an inbound call we say hello the patient on the other end is already mentally ready to have the conversation with an outbound call we don't know what we're catching them doing are they trying to get out of bed are they about to you know go to the bathroom so we have to help the patient mentally you know get into the state for the conversation that we're about to have so we are always looking at incoming and out outgoing calls and our success rates on those as well so once we've talked to the patient and we've clarified that they have a paralyzed arm and that they have an insurance that might cover the product, then we flip them to the next clinical screening stage. We began testing centralizing telehealth screenings about a year ago. So before we centralized telehealth screenings, our CPOs, who are the licensed clinicians out in the field that I'll elaborate on in a minute, where they would travel, they would go to a patient's home, they may go to a therapy clinic, they may go do a shape capture, and then maybe they're home a day or so a week. And when they're home, they would go into our waiting room and handle pre-scheduled telehealth screenings. Well, we wanted to be more efficient as a company. That's one of our, it's one of our, the CPOs are a unique resource and a limited resource for us and an expensive resource for us. So we thought, can we centralize this function so that our field CPOs can do more patient contact product things for which they're trained to do? And can we also allow them to not have to worry about going into this waiting room with a side benefit for the patient and the side benefit is the patient doesn't have to schedule the appointment they would have that option but if they want to have their telehealth screening now they could immediately hop into the waiting room so we tested this about a year ago it was successful and so we built a team we have a handful of patient eligibility specialists these are also clinicians but they're like a physical therapist assistant or a COTA occupational therapy assistant so they understand how a stroke patient presents, they've been trained on our product, so that through a telehealth screening they can quickly determine green light, yellow light, red light, and the yellow light band is fairly narrow. So some patients clinically cannot use our product, some can, and we'll talk about more ratios as we go along, but we've learned just to be more efficient let's do that through a quick telehealth screening, and then to even be more efficient let's centralize the telehealth screenings so that anytime someone wants to come into the waiting room they can immediately hop in, and one of our clinicians is there to see them on demand. So I'll kind of rewind one step to our intake coordinators in the call center. Now as they're talking to patients, again, they don't have to schedule you for next Monday or Tuesday. If the patient's ready, willing, and able, they send them a link and they hop right into the waiting room immediately, and we'll see a brief telehealth screening here shortly. So we are always trying to make sure we have the right number of people doing the right things at the right time and so we're kind of managing the process flow all the way through so among other metrics where we want to make sure that the telehealth screens that are completed sort of match the increase in leads so the the gray bar here is kind of the increase in leads you see that the term workable leads so for example there are some insurances that don't cover the myo pro yet like state Medicaid plans and things like that that's not a workable lead for us okay so of the leads that have a chance to get a myo Pro, that's sort of a workable lead, and as the telehealth screens are completed, you can see we're generally following the same path, so that's good news. You can probably visually also tell that the percent of telehealth screens completed, so the blue bar, that are good, which is the orange bar, which are pipeline ads, the percent that are good has decreased over time. And what we found is as our clinicians get more experience and know better clinically and better outcomes, as we've narrowed the yellow band, we've generally narrowed it to more or sort of red light than green light because we want to maximize clinical outcomes. Today when we complete the telehealth screening with a patient with a paralyzed arm with an insurance that might cover the Myopro, about 40 percent of the time we move to the next step and that's a pipeline add, and about 60 percent of the time it's either, sometimes it's not yet, if they have some clinical conditions that they can work on through therapy. And sometimes they're overqualified, and sometimes it's just not going to work for them. Okay, so kind of a few of our hold reasons. The most common, there's kind of two big buckets of why patients don't get the product. One is they're too bad off clinically. So we have tone and spasticity, which tend to get worse over time with a stroke patient. Those are kind of the primary reasons someone won't get it due to tone, which Kathy will speak to in a little bit. The other reason is some patients are overqualified. So you do have some patients who just have a deficit in the hand, but not in the elbow. And a hand-only device might benefit them. Kind of tricky. And then we have some patients who can move better than they think they can. And our product would not help them do more activities of daily living. So of the 60% of the time that we say no, most of the time it's either they're clinically too bad or clinically too good. And then this is a telehealth screening.

Megan, Analyst — Patient Eligibility Specialist

Okay, I think we're ready. So, so I'm Megan with my OMO. I'm going to ask you some questions, get some medical history from you, take a look at your arm, kind of see what you can do with it. And based on that, we'll determine if we think the Myopro will be a good fit for you. Okay. Okay. All right. And just to confirm your James Ford. Perfect. Okay. So tell me what's going on with your arm. What happened? And was that Christmas Eve of this past year of 24?

Speaker 15

Yes, ma'am.

Megan, Analyst — Patient Eligibility Specialist

Any pain in that left arm? So when you lift it up high. And when you do lift it up kind of high, how high does the pain get on a scale of 1 to 10? A 7. But no pain otherwise. And then what's your dominant side, the right or the left? So we're going to do some stretches just to see how flexible that arm is. So you can use the right to help you. We're going to kind of start at the shoulder and work our way down. so let's put both hands together and let's start with a nice big shoulder stretch so let's pull that left arm up about to there we don't want to go too high if we've got a subluxation any pain when you go that high okay let's go back down and then what about pulling your arm out to the side like you're trying to show me your armpit can you lift it up good any pain there good all right You can relax. Let's move down to the elbow. Go ahead and grab onto that left wrist and I want you to reach towards the camera. Good. And then get that elbow as straight as you can. Great. Good. And then can you bring your hand to your mouth? Very good. Let's move down to the wrist and hand. Can you pull your fingers open and give that wrist a good stretch? Good. And then can you push your wrist down?

Speaker 1

Very good.

Megan, Analyst — Patient Eligibility Specialist

And then what about your thumb? Can you pull your thumb away from the palm of your hand? I can actually move my thumb a little bit. Oh, okay. And then can we move the camera down just a little bit so I can see that thumb? Okay, so pull the thumb away. Very good.

Micah J. Mitchell, Other

So it's interesting. We began testing telehealth screenings in Q4 of 2019. Kind of tested it. It began to work. And so we sort of began to roll it out to all of our CPOs at the time. and again we weren't centralizing it and there were some technological challenges that our patients mostly faced because they don't work on zoom all day like the rest of us when covid happened that really helped us with the technical issues because patients were doing telehealth with a whole lot of health care providers and so that was definitely a good guide for us about 85 percent of our digital leads come in through a smartphone and so it appears with this person they actually used a smartphone so it's in their hand they talk to us intake coordinator we do get some on laptops and other things but then they're able to on the same phone click it in this case he had a family member helping him with the phone which is always helpful. Okay so once we're through the telehealth screening and they're in the pipeline then we need to get funding in place for the backlog so Dr. Kovelman will speak to that in a minute but then once we have it off and it's time to for our certified prosthetist orthist to do their work we call that kind of the fulfillment stages for us. Today I think there's 13 on the screen we have 14 full-time CPOs. So obviously with healthcare everything is regulated. For a custom fabricated orthosis for the most part you need to be a certified orthotist CO, certified prosthetist CP, or certified prosthetist orthotist CPO. And this kind of depends on what you get is what you thought you wanted to do when you went to grad school. So it's two years of graduate school followed by sort of a yearish of internship and then an exam and then you become certified and then of course every year a certain number of continuing education units to maintain your certification. I mean the way I think about it the CPOs is they're they're almost a therapist and they're almost an engineer and they're really good with their hands. What I've also found I'm working in this space is that it will just kind of lump CP, CP, CP, CO, CPO we just kind of call them all CPOs but what I found my opinion is that the CPOs care more about their patients than anyone else I've been around in healthcare, more so than physicians. They really care about helping their patient and improving the quality of life. And working for us is unique because our patients are able to focus on one product that's cool and exciting and they get to travel and see a whole lot of different patients. A typical CPO job is you drive to a clinic or office, you're there from 8 to 5, you have a few referral sources built in, physicians that are doing amputations or refer for braces and orthotics, patients come to you, you do your work, the patients go home. So the CPOs that work for us, it's a little bit different. They're home-based, they travel a lot as we cover the country with with 14 of them. As we're growing, we believe a lot of efficiency gains and interesting things will happen when we get to 30 CPOs and particularly when we get to 40. 40 is kind of a magic number with sales territories where you're kind of done with airplanes and hotels, which so helps with the expenses, but it also allows the CPOs to see more patients and be more efficient and sort of increase their annual revenue number per clinician. The fulfillment process, so once we have an off and we know this patient, funding is in place and this patient is going to get a myoprobe. For us, that's a heck of a lot of work to get to this point. In most cases with a lot of healthcare, so if my son, for example, if this happened, we thought he broke his arm, we called the pediatrician who has an x-ray machine there and he said, come on in, I'll do an exam. He immediately behind the scenes went to our insurance and received a prior off for an x-ray now He couldn't do the x-ray unless he did a physical exam first But the prior off was sort of automatic because an x-ray for a broken arm is standard of care We do a heck of a lot of work to get to that point because we're not quite standard of care yet But once that once we show up at the doctor's office, that's kind of the fulfillment stage He's going to do his physical exam do an x-ray and treat the patient That's where we finally get into this fulfillment stage. We get to do the heavy clinical lifting that everyone wants to happen. That starts with getting a perfect shape capture of the arm. Similar during COVID, we felt that it would be much more efficient to have a sort of a digital shape capture kit where, if needed, we can do it remotely. So this kit can be mailed to a patient where they can get help maybe from their therapist or a family. In the kit, as you open it up, you can see the kit on the left side. There's a screen where we can pipe in with a telehealth right there, help them take pictures, help them place things on the arm, so we get that perfect shape of their arm. Once we have the perfect shape of the arm, that's where the magic happens over here, which you'll get a walkthrough later, where we fabricate that custom device to specifically fit the patient's measurements. I will say upper arm and lower arm, all fairly similar, but the pivot from the elbow to the wrist within a millimeter, the shape of each hand is so different, and we have to get it just perfect, and it takes time to get those measurements, and then it takes time to build the product, and then after the product has been fabricated, we show up for the delivery. Occasionally, a delivery can take an hour. More common is a three-hour delivery, which is a lot of time to be face-to-face with a patient, doing the tweaking on the product, doing the initial training, and then after to the delivery is where additional heavy lifting from a clinical standpoint takes place, which Kathy will speak to that later as well. So I talked a little bit about territory management. All the creaning sales territories is not unique to us. It's a little more complicated on our end because not only are we looking at where do the stroke patients live, where are our leads coming from, but there is a state licensure aspect as well that each state can do their own way. Most states have it, some states do not. And so when we hire a clinician, we need to make sure that they are licensed in the state or states that make sense for MIOMO. In addition, CPOs are a limited resource, and as the O&P industry grows, we're all competing for the limited resources. And we believe as we grow and kind of get to that magic 30 number and then up to 40, we will see significant efficiency gains for our clinicians in the field. Okay, so do we want to pause for Q&A, Dave? Okay, so before I pass over to Dr. Kovelman, And we've kind of gone through the way that we sort of generate awareness and interest in our lead generation and marketing, kind of a little bit of the process flow. So we'll open it up for any questions about that part.

Scott Henry, Analyst — Alliance Global Partners

Thank you. Scott Henry with Alliance Global Partners. There was a lot of talk about cost per lead and how that's changing. How do you measure quality of the lead? I mean, we can add more patients to the top of the funnel, but we want to make sure they're equally as strong of candidates as the one before. How does one measure that?

Micah J. Mitchell, Other

So great question. We look at every metric that we can. So for example, a patient with Medicare is a much higher quality lead than a patient that has a state Medicaid plan that won't cover the product. So for things such as payer, even geography, we can think about quality of lead. We've been asked a lot about clinical quality of lead. Is there a way or can we determine if there's a difference in the clinical quality of lead? Our belief is that we cannot. So if someone's contacting us with a paralyzed arm from a stroke a certain number of months or years ago, it's hard for, we don't believe that that changes over time. So if you give me a bucket of 100 stroke patients that contacted us six months ago or a bucket of a hundred stroke patients that contacted us today, we believe that because of the way that we advertise and what we know clinically, that a clinical quality, those would be the same.

Scott Henry, Analyst — Alliance Global Partners

Okay, fair enough. And I assume you verify that over time to track it.

Micah J. Mitchell, Other

We do, yes.

Scott Henry, Analyst — Alliance Global Partners

Perfect. And the second question, I just had a final question. You know, you mentioned cost per lead gets higher during periods of rapid growth. I guess, is there a reason why you can't have the benefits of scale? Meaning a lot of times when business goes up, costs go down, is it just a trailing issue?

Micah J. Mitchell, Other

Yeah, I think over long periods of time we will. Yeah, it's a great question. So I'll use TV as an example. When we first began using TV ads, it was local advertising. So we go into certain MSAs and we would advertise that way. We quickly got to where we could handle the country nationwide. it had enough cpos and when we went from local advertising to national advertising there was a huge cost per lead gain because we were at scale and the reason it goes up over short periods of time has to do with our money doesn't get us as far so if i triple my tv budget next week i'm not going to get as many ads run per dollar as i would this week and so like with tv we're doing sort of a remnant reverse bidding so which really works well for our demographic and the companies that we're competing with, we're very zoned in, but if I want to triple my budget and clear that money, I have to be a little more aggressive on the amount that I'm willing to spend for that 30, 60, or 120 second ad. So the ad still performs just as well, I just have to spend a little bit more money for the same air time if I increase the budget significantly over short periods of time. So it's not really the quality of lead, it's that my advertising dollars don't quite go as far during times of rapid growth. It also seems that some of the social media platforms, Facebook, for example, they're paying attention. And if a company likes what they're getting from Facebook and is rapidly increasing their spend, we believe that Facebook, understandably so, takes advantage of that a little bit and sort of charges us a little bit more per lead. We think we can correct that over long periods of time or with slow growth, but over rapid growth, it's a little bit less efficient.

Ari A. Colligan, Analyst

This is Ari A. Colligan. Thank you for hosting us today. Regarding lead generation on Facebook, can you just kind of specify how many different creatives you have on Facebook, i.e. is it one sort of banner ad, video ad that you're showing to everyone? Are there five different ones? And what sort of efforts you're making if you, let's say, have a best performing control to constantly be experimenting and trying to find new, even better performing creative?

Micah J. Mitchell, Other

Sure, great question. And I'll speak to that at a high level, and I may need Joe to help me. I don't know exactly how many. You saw a couple slides of ads. I don't know exactly how many are running today. Let me even back up before I talk about performance and how we measure it. With strokes, we have incidence and prevalence. Incidence is you just had your stroke. You're going through the stroke journey from the beginning. That's the new incidences. And then you have prevalence, right? So your stroke was in the past, and you're dealing with life as a stroke patient. Whether your stroke was last week or 10 years ago, other than the few patients who are receiving a Myopro, your arm's still paralyzed, you can still benefit from our product. So as we think about advertising, to get in front of the incidence population, which we do some and we'll do more in the future, it's costly because it doesn't magically happen. To go to trade shows and talk to physicians and do lunch and learns and all of those things, there's a cost associated with those things. That said, stroke patients who had the stroke a long time in the past, they're they begin to do similar things they watch similar things on TV their digital footprint starts to look similar and frankly it's not an appealing demographic for most companies so we're not competing with Apple or GM to get in front of that demographic so as we focused on the prevalence that's where we've really gone heavy with the social media and the TV another benefit of social media and TV is we get almost instant results TV I'm kind of delayed about a week or so but you know I run an ad I don't know how much money is going to clear this week, but by Friday I know what cleared and what ads ran, by Friday I know how many times the phone rang, and we can see exactly how each TV show is performing with TV, and we can tweak it weekly. Facebook digital is the same. Digital though, our budget, the amount we want to spend, we're more likely to hit that on the target, and then we're able to look at the results in real time as well. I personally review it every week, and the agencies are going through all the things you would expect them to go through. Okay, this station's performing well, let's spend more money on this station. This 92nd is outperforming the 122nd ad, let's focus on the 92nd ad. And with Facebook, kind of what happens behind the scenes is what our agency does, where he's constantly looking at what does that picture like? Is it the blue background or the green background? Is it the new creative or the old creative? So that we're looking at dollars per views and dollars per clicks.

Joe Tchaikovsky, Other

Joe, how many different Facebook ads are we running at any point in time? anywhere from 30 to 50 we're looking at this every yes we're going into a lot of short video on Facebook and both Instagram we're also partnering with YouTube and we're going to have some more ads on YouTube so dynamic engaging you know everyone's our demographics not on TikTok but they do you know look at their phone they're engaging with the grandchildren on Facebook and we are going to go with more video ads but when it's a static ad we can make changes more quickly We don't rely on assets to, you know, edit the ad or have a different, you know, 15 seconds or 20 or 25 or 30, but we're doing both.

Ari A. Colligan, Analyst

What portion of your advertising?

Joe Tchaikovsky, Other

Yes, I would say on Facebook, 80-20, 80 static, 20% is in video, and we'll gradually see that increase.

Micah J. Mitchell, Other

And if you're looking at Facebook and you're seeing some of our ads, the distribution you see should, you know, fairly match up with what everyone else is seeing as well. i had a few related questions you mentioned two and a half to three times increase in was that pipe leads there were you yes a number on that that's correct so what's the time frame of that so when i think about april i'll use april as an example um versus um january and before um like february and before so april you kind of look at it weekly or monthly even now two and a half to three times as many leads as we were receiving a few months before and six months before and nine months before. To 2024, we were fairly flat on advertising spend and leads.

Speaker 18

Okay. So the April number was two and a half to three X on leads versus the 4Q24 normalized.

Micah J. Mitchell, Other

Correct. With the lower calls per lead.

Speaker 18

Without this Facebook HIPAA issue, right?

Micah J. Mitchell, Other

That's not in the- Once we got beyond the issue in April.

Speaker 18

I was a little confused on the comment that Scott asked about. You said ROI, you're not saturated, ROI is good. Why would there be this drop-off in cost per lead then?

Micah J. Mitchell, Other

Great question. What I'm trying to demonstrate is the hiccup that we experienced in January, February is behind us at this point. So, you know, if we did not have a hiccup and everything was steady and then we tripled sort of our spend, you would expect that immediately your cost per lead goes up a little bit. Like I said, it costs me more to run a TV ad if I increase it really, really sharply. So a little hiccup January, February, recovery in March, April. I'll kind of compare April to before the hiccup. I'm spending a lot more money and my cost per lead is lower. So that indicates to me that we're not near a saturation point. Among other things that indicate that to me, but yes.

Speaker 18

Okay, and just to finish the thought, I mean, if you, the ads are supposed to translate to leads and then at pipeline ads, right? Do you believe you are at least same ROI or better now as compared to what you were before?

Micah J. Mitchell, Other

Sure, I think over long periods of time, the same cost per lead is going to result in the same revenue. Due to the patient, the patient's personal process, right, where a whole lot of them are ready to act right now, and others want to wait. So today, I have a higher percent of new leads, because we're spending so much more and getting a lot more leads, than I did six months ago, right? Six months ago, my percent of new leads and percent of old leads were remaining kind of steady, and so we kind of, you know, saw the pipeline ads. So as I'm getting a whole lot of new leads, the percent of pipeline ads that are new leads would expect to be greater, because I have more new leads. The ROI on all the new leads, long term, I would expect to be the same. But over short periods of time, the advertising cost per pipeline ad, I would expect to be a little higher because some of these leads will need time to mature.

Speaker 18

Okay. That's just a measurement issue, though? Last question. What is a lead? What's the definition of a lead? And what's the conversion to an ad?

Micah J. Mitchell, Other

So I'll answer the lead part, and I might need you to clarify the conversion to an ad. So a lead is a name and phone number of someone who has a paralyzed arm or a family member or friend with a paralyzed arm. So if it's a form fill, so one line, they fill out the name, phone number, email address, that's a lead. If it's TV, if we say hello and talk to a human long enough to get a name, you know, then that's a lead. In time or in ratios?

Dave Henry, CFO

In ratios.

Micah J. Mitchell, Other

Yeah, so we don't share the specific conversion pieces. We see nothing short-term that can't be explained from rapid increases or decreases in spending or leads.

Chase Knickerbocker, Analyst — Craig-Hallum Capital Group

Chase Knickerbocker, Craig Gallen. Just kind of to build on that, if we think about kind of post-algo change at Facebook, and now it's clear the cost per lead has stabilized, even gotten a little bit better. Or is there anything different about the quality of these leads? And I would imagine at this point you've had a couple months to kind of see that. Should we think of there being any difference in quality? And is it still kind of that 40% is progressing to pipeline that you kind of shared earlier in the presentation?

Micah J. Mitchell, Other

Yeah. So quality of leads are the same. So for example, of the workable leads, 45% of them have historically been Medicare and are still Medicare. And it can be 44, 46. but we're not seeing any difference in sort of the quality of leads that we can measure. Now, clinical quality, what we are seeing is fewer patients clinically go through our screening. We believe that has to do with our clinicians' learning, and the patients' learn as well. The product is exciting, and we had a patient come visit with us last week, and she even stated, in spite of everything that you told me and prepared me for, I had a hard time listening because I was viewing getting my full arm back. And if you are a guitar player before your stroke, you are not going to be a guitar player with our product. And even when we say that, they don't always hear it. It was the same for me when I joined the company. I thought everyone with a paralyzed arm, we were going to cure them all and off we would And our clinicians are the same. It's exciting. It's fun. And when they first start, they have a hard time saying no to a patient who really wants the product. Over time, they learn, as they're doing the follow-up and the deliveries, that, gosh, the cognitive ability, or they were in a wheelchair and they just ended up not being able to use it as much as we would want to, or not using it at all. So our clinicians, we believe, with experience become more clinically deliberate. Not significant, but over time that's the trend that we're seeing. And we don't believe that's a quality of lead. We think that's just a clinician learning our product and being more clinically deliberate.

Chase Knickerbocker, Analyst — Craig-Hallum Capital Group

And that kind of timeline, from a standpoint of the kind of percentage of patients that convert to the pipeline, that do convert to the pipeline, kind of 50% being within 30 So during times of no growth, about half of our pipeline ads are leads from the same month, and about half of the pipeline ads are older, older leads, call them reactivated And so is it fair for us to think about kind of currently that's still remaining Or since the growth has happened?

Micah J. Mitchell, Other

Great question. So here's how we try to explain this. If I were to stop advertising today and spend zero dollars on advertising for all of July, I would continue to have pipeline ads. They would all be old leads. So then it's not 50-50 anymore. It's very low percent new leads and a very high percent old leads if I'm not advertising at all. Similarly, if I crank up the volume on advertising, which we recently did and leads increased two and a half, three percent, then the percent of my pipeline ads that are new leads goes up above 50% a little bit because I have all these new leads to work with. So during times of rapid growth or even steady growth, the 50-50 will change a little bit. If we were to keep advertising spend the same for the next two years, then it would revert back to 50-50 pretty soon. Did I answer your question?

Speaker 13

I'm curious, Micah. You had the graph that showed the percent of total workable leads and the pipeline ads. which is decreasing over time as a total percentage if there's no fewer good leads or no for example more bad quality leads what would explain the discrepancy there so you say that again i'm sorry yes there's a graph you prior showed that had the percent of total screening leads and what percent of those were pipeline ads yeah that one yeah so this is the number of screens that were completed a telehealth screening in our telehealth waiting room charted against leads so we're trying to make sure these are generally going in the same direction to make sure that we're getting patients

Micah J. Mitchell, Other

through the phone call and into the telehealth screening the the Delta between the orange and the blue slowly growing over time so over here about 60 percent of patients pass the telehealth screening today about 40 percent pass the telehealth screening and one explanation for that could be that there's lower quality leads coming in but you just argue that that's not the case so what explains why the Delta is increasing? So I don't believe that that fewer patients pass the telehealth screening because there's a change in clinical quality. What we believe is that our clinicians get more clinically deliberate or clinically strict as they have more experience with patients using our product which is appropriate we believe and it's probably the same with lots of med device and even surgical interventions and pharmaceuticals as well over time, you are trying to better zone in on who's going to get the appropriate and best clinical outcome.

Speaker 13

So putting payers aside on the pipelines, is it fair to assume that you think the percent of pipeline ads that will result in total sales will increase because they're higher quality pipeline ads?

Micah J. Mitchell, Other

So I think a couple things could happen. One is fewer patients who get the product are going to use it more minutes or more hours a day and more days a week. So I think that patients will drop out of the backlog because there have been times where we get to the shape capture and we really see the patient and do a full clinical evaluation and learn then that they're not a good candidate, so I would expect both of those things to happen.

Micah J. Mitchell, Other

Hi. Just a clarification on something you just said about patients and even doctors sometimes being overexcited and coming in with the expectation that they're going to maybe get full recovery of their capabilities and reality hitting so in terms of making it from a lead to a pipeline ad is that a binary process where it's either will benefit or will not benefit obviously will benefit makes it or is this a great or is there a big gray area of marginal benefit you know medium benefit good benefit high benefit and in that gray area is there a decision process that that patients and doctors make as to whether they opt to move on or not? Great question.

Micah J. Mitchell, Other

Yeah, great question. So instead of using the word gray area, I'm going to use the word yellow light. So we talk about green light, yellow light, red light. And then we also talk about where the yellow light needs to shift. And this is for the telehealth screening. We have green light. We know they will benefit from it, no question. We have red light. We know that they won't. And then we have yellow light. What we kind of do is we've expanded the yellow light into the red light to say, hey, let's, we're not sure, the telehealth screening clinician thinks that they're not a good candidate, and then the yellow light, we send a clinician into the home to put a mark kit, which you guys will see, to put a demo kit on them. At that time, we kind of narrow, there's still a yellow band, right? So sometimes we know green, sometimes we know red, we still know yellow. At that point, if it's yellow, then we want to get the circle of care involved in the patient to let them know, okay, this will move your arm. if you don't have shoulder movement for example you may not be able to get to your mouth to feed yourself or you know your arms too big you may only be able to go here to try to explain clearly to everyone clinically what we believe is going to happen in addition we explained the work they're going to have to do to even get to that to that point therapy multiple times a week right for multiple weeks and then we and then we try to allow the circle of care to decide as it turns out interestingly enough when I've been around these conversations generally the circle of care wants to do anything and everything they can to help this patient get better at all and usually the one who doesn't want to move forward is the patient after thinking about it. That's at least been my experience. I would be speculating do they you know is the juice worth the squeeze you know is all the work gonna benefit them and sometimes is the I think the patient is thinking is all the work that I'm about to ask my spouse and family to do to help me, is it worth it for everybody as well?

Terth Battelle, Head of Investor Relations

We have one last question from somebody on the webcast.

Dave Henry, CFO

Are there major differences between cost per lead for TV versus social media advertising?

Terth Battelle, Head of Investor Relations

And do you see differences between conversion rates of patients who come from these two channels?

Micah J. Mitchell, Other

So the cost per lead is a little bit different. I will say with TV there's an overall lift across the board so if I stop doing TV ads my social media calls per lead with our experience has been it would increase. So TV is beyond the how much I paid for the ad and how many times the phone rang. TV does convert a little better just for the simple fact that we get them on the phone so they're making that outbound call we say hello there's no phone tag right when someone fills out a form they don't answer the first time we call them and when we get them on the phone as mentioned they're not ready for the conversation. So sometimes it's, I'm on the way out the door, can you call me back later? So we do like TV for the overall lift, and because when we're an inbound call center, it's just a lot quicker and easier through the front of the process. Good question.

Dave Henry, CFO

Okay, Harry.

Harry Kovelman, Other

Okay, now over to the exciting stuff. All right, my name is Harry Klovelman. I am an MD. I am the chief medical officer of MIOMO. I have about 25 years of experience in the rehab and orthopedic world. Been at different companies, as you can see on the slide. And I've been at MIMO almost about almost five years. The hockey picture. There is a message here. So that was a picture of me when I was about 14 playing in Canada, junior hockey. How many people are familiar with the 1980 Olympic hockey team that won the gold medal? Raise your hand. Okay. So their journey was really nice, right? Herb Brooks coaching them, college kids. The journey was really nice. But if they didn't win the gold medal, we probably wouldn't be talking about them. My journey here at MIMO, our journey has been really fantastic. We got operating efficiencies. We got CMS approval. We're getting some in-network provider agreements. But to get to the pinnacle, to the milestone of $100 million, okay, it's all about the win. It's about I need to make sure that every one of the patients that walk in the door, that qualify for everything Micah said, we can facilitate getting a pre-author or an authorization from the payer. That's my goal, and I'm here until we achieve that. Okay. So I'm going to talk about my department. My department works on after they come over the wall. Okay. They've been screened successfully. They come over the wall. My department is really responsible for collecting the medical records and the physician's order proceeding, submitting all the documentation to the payer. Okay. That's what my department does. So it's been really good in some aspects when I look at it in my 25 years. And in other aspects, there's been a lot of face wins. The tailwinds is we got Medicare Part B. We're doing really well on our appeals at the ALJ. We're getting some in-network provider contracts. But what's heading us off, right, what's causing us to be a little stagnant, is we are working with these MAOs or Medicare Advantage organizations that are providing an obstacle for us. And I'm going to go into why it's an obstacle and why I think we're going to overcome the obstacle. And I'll show you some reasons. So how big is my department? What goes on here? So we have 15 patient navigators. These navigators have one director and two leads. so it's very hierarchical, and everybody's managed to the best of their ability. They guide patients through the MIMO journey. They call the patient, they help them set up the doctor's appointment, they communicate with the doctor, they get all the documentation, and they really provide and facilitate the journey. But the journey doesn't end there. There is specific documentation that needs to be collected in order for us to submit the pre-authorization request. There is a checklist by CMS, by traditional Medicare, and by me, okay? Because at the end of the day, we need to document medical necessity. Once all that paperwork comes in, once all the paperwork comes in, it goes down the hallway and it goes to the clinical appeal specialist. They write the pre-auth and or the appeal, depending on if it's a first-time submission or we got denied. Now, they have been trained excessively on the documentation of medical necessity by Medicare guidelines, by the Medicare program integrity manual. I cannot review 150 submissions every month or 130 submissions, so I have to have a team that's responsible. They're mostly OTs. They know what the rules are, and they follow it. Not only do they review it, they have to sign a document to show that they reviewed it, and they agree that it is medically necessary to submit. Once they get that done, it goes back over a wall, and it goes to the insurance coordinators. The insurance coordinators submit the documents to the payer. Not in the case of Medicare. We don't need to do that. We don't need a pre-auth. And they work with the payers to obtain either the authorization or the denial. And they continue to verify, calculate out-of-pocket costs, and obtain single-case agreements if we need it. Okay? Okay. Last but not least is research. We have three people in the research department. I'll talk about that in general as we go on. But this is my department as a whole. So, where are we today versus where we were prior to receiving Medicare approval, okay, or CMS reimbursement? If you look at Q1 2023, you'll see that most of what was coming in from the revenue side, I'm doing this for our CFO, I usually don't talk about this, okay, the revenue side was Medicare Advantage plans. Okay. Medicare Advantage wins. 47%, 47% was the VA. Okay. Excuse me. Was our, our channels, our OMP channels, right? And then others. Okay. So now what happened in 2025, a huge difference, a huge difference. 59% is Medicare. 18%, 18%, 18 is now Medicare Advantage. And 23% is other. So it's been a huge shift in the business and there's reasons for that. So why? What's happened, right? What is the headwind to us? The headwind is really the Medicare Advantage organizations. It's not just us that experience it. I speak to colleagues. I speak to people in medical device, CMOs. Everybody's experience, and I'm sure as investors, you see it in the news, okay? The MAOs, their profitability is on a decline. They've really tightened up what they're approving. And even when we appeal it, they're tightening up. The preauthorization rates are low. the denial rates are high. It really is costly to take these people all the way down and do the appeals. So as you can see here, oh, sorry, sorry, let me go back. As you can see here, the MAO, the Medicare Advantage Organization, off rate in 2023 was about 37%. So out of every hundred, thirty-seven where we were getting off. Now it's about fifteen percent. Huge difference. Absolutely really tough headwinds. So what are we doing? What can we do about it? So here's how we overcome the denials. They're usually in three groups. I see this all the time. They come on the denials, and here are the three reasons. The first bucket is experimental and investigational. So what is an investigational device or a drug? An investigational device or a drug is one that's waiting for an authoritative regulatory body to approve it. Well, can't check that box, we've already been, we have 510K exempt, we're in the EU, so we really can't be considered investigational. Well, what about experimental? You see that all the time. Yes, we do. But the classic definition of an experimental device or a drug is one that's awaiting to be to show its safety efficacy or effectiveness can't check that box for us we have over 25 peer-reviewed publications with impact factors ranging from 1.4 to 5.7 does everybody know what an impact factor is or okay an impact factor is like the strength of the journal right ten is really high like New England Journal of Medicine is up there one is average in medicine we're ranging anywhere from 1.4 1.4 to 5.7 so very very well established peer-reviewed journals I already went over the definition of E&I and again we are 510k exempt FDA knows about us and we have a device listing. So we really don't fit that definition of experimental and investigational. So Harry, what's the next bucket? What are you seeing? Not medically necessary. My God, I spend every day going over medically, the patient being, fitting the criteria. So when you look at medical, being medically necessary, there are certain programs, manuals, guidelines out there that give us this guidance number one is the Medicare program integrity manual so this is specific rules that give you the guidance are you fitting the definition in the section 13.5.4 there are seven foundational statements I'm not going to go each and every one of each and every one of them if you want to know them please send me an email be more than happy to go over it with you. But we make sure when our writers get the information that we fit that criteria. So if I go to an administrative law judge hearing, I can say, hey, Your Honor, we fit this, and they can't consider us medically necessary. We make sure the chart notes from the physician have every detail point about when they had the stroke, what is their range of motion, documentation of spasticity and or tone, prior treatment, have they failed it, they need to improve their ADLs. So it's a very, very thorough process. And that really takes a lot of time. The last bucket that we really don't see anymore, occasionally somebody will try to fit it in, and this is where I know they're just templating it, they're really not looking at it, is they'll put in there, you're not covered by Original Medicare. That's an easy one to overcome. We are covered by Original Medicare. You all know that. So I get all this information. We submit. How long does the process take from getting the information to getting an approval or a denial and taking it all the way to what we call an administrative law judge hearing, which is specifically for Medicare Advantage enrollees. So on average, on average, it can take anywhere from five to 10 months in the process. Remember, they got to be screened. They got to get to the physician. Physician has to write the notes. We got to submit. We've got to wait for the first denial or the auth. Then we've got to submit for the second denial. Then it goes up to Maximus, which is the qualified independent contractor for CMS that reviews it. Maximus, 97% of the time, it's actually 96.9%, but 97% of the time, they agree with the lower court decision, so to speak. and that I have to wait for that denial to take it to an administrative law judge hearing. So it's a very, very long, complicated process, and it takes, patients can get frustrated, but that's why we have the patient navigators. They're constantly calling these people and communicating with them. Okay, so what is an administrative law judge hearing? An administrative law judge hearing is the Office of Medicare Hearing and Appeals. I get all the documentation together, and we go to this administrative law judge hearing. It's telephonic. I appear with outside legal counsel who's representing the patient. I give the medical testimony. I give the medical testimony. I'm going to go into the legal argument in a minute, okay? All those notes that I told you about are somehow given to the judge, and I have a summation of it that I give to the judge. Basically, we want to stay on the phone for no longer than 20 minutes, okay? Also, when you go to these administrative law judge hearings, a lot of it is the luck of the draw, right? There's X amount of ALJ judges, some more favorable than others, as is in with any court system. What are we doing to date? As of yesterday, as of yesterday, we are winning 58% of our cases that go to ALJ. So, Harry, is that good? Is that bad? Where does that sit in? When I speak to peers, legal counsel, and others attending, even John Naft, who's in the audience, they will tell you, in the absence of an NCD or an LCD, which we do not have, their win rate is about 30%. 30%. We're almost doubling that. So is the process and the demand of gathering the paperwork and everything we need working? My answer is, it is. It is working. And we're going to continue to take all these MAOs to ALJs as long as the documentation is correct and as long as they continue to deny us. So, you remember, I said I present the medical testimony. Here's where outside counsel, we work with an individual who I've learned so much from, I can't give enough kudos to, but they present the legal part of it. And remember I told you there's codes, okay, and there's the Medicare program integrity manual. This is what our position is. And obviously, it's working. There are three rules, laws, statutes, whatever you want to call them, that we make a point of to the administrative law judge. Number one, number one is CFR 422-101A. It's the Code of Federal Regulation. It specifically states, specifically states, that MAOs must cover everything, everything that is reasonably and medically necessary for Medicare beneficiaries and must cover all services and devices covered by original Medicare. So original Medicare doesn't pay for investigational experimental devices. End of conversation. So they have to pay for our device. Our device is reasonably and medically necessary. We get the paperwork to document that. So we have a very strong argument. The second reason, experimental or investigational devices are excluded from Medicare coverage. CFR 411.15. Like I said, we're not an experimental or investigational device, or else Medicare won't be covering it. So check that box. The last one is a unique one. So what we believe, per 422-101-B, plans do have the right to come up with a policy. Plans do have the right to come up with a policy. But it can't be an exclusional policy. It has to be an inclusional policy, or else they're denying access to care for the Medicare Advantage beneficiaries, which Medicare would give them. So they can't take a commercial policy and say, that's it, we're not covering. What they should be doing is say, hey, here's our inclusional coverage criteria for the Maya Pro. If you meet A, B, C, and D, we will authorize it. So there's, again, I just want to emphasize, there's a medical portion, and then there's the legal portion. So what's the plan? How do we move forward? Where are we going from here? We're going to continue to write our appeals. We're going to increase the number of ALJ hearings. We're going to continue to take them. We're going to review, and we're going to keep on going. I was averaging five to six a month last year. I'm doing about 12 a month now, okay? Even with the legal fees, our outside counsel, it's still a good contribution margin activity. You can tell I'm the medical guy. I really don't understand all that stuff, but that's okay. We're going to publish an MEO review paper and submit a one-year outcome follow-up manuscript. Again, adding to the publications. We're going to continue our research efforts. And last but not least, we're going to enter into network contracts to become an in-network provider. So, Harry, what is that and what is it doing for us? So here's what I want to show you. So as of yesterday, as of yesterday, this is where we sit with in-network provider contracts. We have access to about 27.2 million lives. as an in-network provider, okay, that can lead to a policy change. Remember, you have to have a contract, and then you have to have a policy on it, okay? Not always do both entities talk to each other. But when I submit that pre-auth, the first thing they look at, They look at the submission, MyAmo, MyApro, in-network provider, yes or no. That determines whether it even moves to the next step. So while we've signed all these, okay, and we're working on geofencing to these areas, right now, most of these were signed in the last half of last year and the beginning of this year. I suspect we will, we will see some return on this. Okay. So that's where we are as of today. Okay. With that, with that, I think I'm going to entertain questions. So any, any, any questions? Yes.

Ari A. Colligan, Analyst

Yes. and you divide that by the number of cases you handle over the course of the year. What are the actual costs? That's included in cases where you get final approval.

Harry Kovelman, Other

So I'm going to defer to our CFO for that. I kind of keep the blinders on from the medical perspective. Try to keep a separation of church and state. I hope you can appreciate it.

Dave Henry, CFO

Perry mentioned the contribution margin. The real variable activity is the legal cost, and so if you take the appeals legal cost and you spread it out over all of the appeals that we undertake, it's only about a few thousand dollars of incremental legal costs. So if you get an authorization at, you know, $50,000, it's a good activity to continue to do. And, you know, he's going to bring on, he talked about increasing the number of appeals. He's going to have one additional person to help him with that. But that original person was already here. So it's not even really an incremental cost. So it's a good activity for us to continue to pursue.

Harry Kovelman, Other

Yeah. Just a final question. So I would love to do that, right? each each administrative law judge hearing is in a de novo hearing so we submit prior off from if we got that pair and we're taking to them but it's a de novo we also have the ability to submit to the portal showing them without showing a video without the device and with the device I believe you're not allowed to contact them in person in this process I see anywhere I rarely see the same judge twice in a year. Sometimes I do. Again, a lot of it has to do on the submission, right? There are some judges that are more favorable than others, but we don't, we can't touch them in person as of today. Yes? Hi.

Scott Henry, Analyst — Alliance Global Partners

Thank you. Scott Henry, AGP. With regards to the MAO authorization rate, as you mentioned, it went from 37% to I think around 15%. And you're doing all of these different things to improve that. Where do you see the end game? Is it to get it back to 37%? Is it to stop the decline or maybe even get it higher than 37%?

Harry Kovelman, Other

So the end game is win, right? I think it's incremental. I think what you're seeing now There's an association called MDMA, Medical Device Manufacturer Association. They're working a lot with CMS to kind of send a message to all these MAOs that, hey, you have to follow the rules and regulations. We are part of that. As we win more ALJs, it's costly for them to come. Sometimes they'll submit a positional statement. And then there's other times where I've been on the administrative law judge hearing, and there's four people from the payer there, which could include the CMO, the vice president of compliance, their Medicare Advantage person, their contract person. It can really go an hour and 20 minutes. Right. I I suspect that as these these other plans who are, I guess, willing to work with us more. As the tide rolls and we start to change, I would expect to go from 15 back to where it was with an end game, an end game that, hey, we are a network, we are a provider, and we have a change on the policy. That, to me, would be the end game.

Scott Henry, Analyst — Alliance Global Partners

Thank you. And then just one final question. Obviously, Medicare has been a big boom for the business. not trying to predict the future, but if you think out just one, two years out from today, do you think that environment, which has become more favorable, is likely to continue to improve, to stay the same, or could it pull back? How should we think about that category if we can think about it at all?

Harry Kovelman, Other

I don't know if I can, I don't know if I'm the right person to answer that question right because when remember when they they come over the wall to me so to speak right i am uh looking at papers and documentation are they an appropriate candidate that that's what i look at every day according to our fitting criteria according to tone specificity are they appropriate if more appropriate patients come in more appropriate patients will be fit right So do I hope it increases over the time? I do, but I don't know if I'm really the right person to answer that. I'm sorry. I'm not trying to get around it. I hope that happens. Yes, I want it to happen. I'm sorry. Okay. I think there was one more. Oh, Chase.

Chase Knickerbocker, Analyst — Craig-Hallum Capital Group

Harry, how has the ALJ win rate kind of progressed over time?

Harry Kovelman, Other

Yeah, great question. I didn't even think anybody was going to ask that. So three years ago, three years ago, when we really started to get into it, we were at about 28%. It progressed to 34% to 42%, and now it's upwards of 56% to 58%. So it has progressed. But you know what? We've gotten smarter, right? We have the right people working with us. we're using the right tactics now and it's been really a learning process for me as well in the case of the alj denials do they give you kind of rationale as to why and then to go back to like the initial denial what the percentages are the different reasons what that the medicare advantage players give you yeah so i want to laugh but it's really not funny okay because when we go to the hearings we are basically saying we are basically it's the same dialogue every time, right? Because we get the same denials every time. We could have one judge rules in our favor, and the other one doesn't. It's like, or he or she doesn't. Did they even, your question is, when I look at it, did they even read it? Because what they'll say is, no, your device is still experimental and investigational, right? I'm like, okay, no, per CFR, whatever, you don't fit into that criteria i find i find it it motivates me to get better right how do we overcome these it still goes back to remember when they send the denial not medically necessary and investigational experimental the judge either finds for it or they find against it over the last three months the CFR those ones that I put up there you know every judge recently has been quoting that no if you know you you have to do this okay and yes it's medically necessary so I you know John is here in the audience I know John goes to a lot of ALJ hearings he could comment on that as well but that's what I'm seeing what percentage of patients are dropping out kind of through the process right after the initial denial to not get it kind of all the way to the ALJ hearings oh is Micah here or yeah no Micah what percentage are dropping out what percentage as they come in and go through our go through the process drop out before all the way through so they get we submit the pre-auth maybe we get a denial and then they're dropping out from that point on sorry so the question

Dave Henry, CFO

is is how many you know when you get to the point of having an authorization how many ultimately drop out and don't continue with the process they enter the backlog at that point you know at the point where we have an authorization they enter the backlog and about 20% of the backlog will drop generally each quarter that I get the question there's even a step before that because we you know, even before we get the final denial from Maximus, they will, you know, Harry's team will actually triage and see which of those patients might be appropriate to move forward to the ALJ hearing. Some will even drop out and even go to the ALJ hearing. Yeah, so, and that can be a good number of them. I mean, I don't have a metric off the top of my head of exactly how many that is. But, you know, Harry, he talked about his, his objectives. I think, I think last year we took about, was it 50 patients to?

Harry Kovelman, Other

50, we won.

Dave Henry, CFO

So we took 50 patients to ALJ hearings. So there is a weeding out process and we're looking to then increase that. And he's looking that, you know, we're adding more resources because we're seeing more success and we're going to be taking more people to ALJ hearings, try to get more Medicare Advantage authorizations. So I'm going to turn this off, I think, to keep things on schedule. We'll go ahead and introduce Kathy Sawyers.

Kathy Sawyers, Other

Hi, everyone. I'm Kathy Sawyers. I'm the Senior Director of Clinical Outcomes here at MIOMO, and I'm a physical therapist and also an assistive technology professional. I've been with MIOMO about five years, and before I came to MIOMO, I spent many years in the clinic doing multiple things. I was a director of skilled nursing, I was a director of clinical operations for Heart Institute, and I've done many things in healthcare leadership. I have a lot of clinical experience. Throughout that time, I've kind of kept my hands in patient care. My primary focus at MIOMO is to enhance our clinical outcomes, and I also manage our training team, and I manage our MyoCare team, which is the team I'm going to tell you about here in just a little bit. I also collaborate, myself and my team, we collaborate with the engineering team and the product management team to ensure that our products are usable for our clients. And I also collaborate with the business development team so that we get the MyoPro name out there so that therapists know about the Myopro. So what problem are we trying to solve with the Myopro? Basically, we are trying to give those patients with neurological deficits from stroke, brain injury of some sort, brachial plexus injury, or spinal cord injury, we're trying to give them their own motion, and we're trying to give them more function. So, 800,000 people have a stroke per year, approximately, but out of those 800,000, only 250,000 of those people have a chronic arm weakness. And again, I mentioned some other diagnoses that are appropriate for the MyoPro, again, traumatic brain injury, brachial plexus injury, and spinal cord injury. So what is the MyoPro and what does it do? The MyoPro is a myoelectric brace, or orthosis, that uses myoelectric prosthetics, robotics, and neural rehab, and it wraps it all into one device. And the difference between using a prosthesis myoelectrically and using a brace myoelectrically is a big difference. when you have a prosthesis, you don't have a limb to put it on, right? You're using a robot, basically. When you use a brace, you have an arm. You have a weak arm, a heavy arm, an arm that may have neurological effects. Like, does anyone know what spasticity is here? Okay, so spasticity is that resistance to motion and it's abnormal tone, people don't control it well. So we are using the MyoPro to help, again, control that. We use our sensors that listen to the EMG signal. We use our software that magnifies the signal so that it allows the arm to move and power the motors for that. Also the MyoPro teaches that brain and muscle connection so that we get muscle memory back and neuroplasticity. So Michael was saying that not everyone is a MyoPro candidate, which is absolutely true. So what do we do to ensure that we have the right people? We do a full medical history. We do a cognitive screen because cognition is extremely important for the MyoPro. We also do a range of motion, like passive range of motion, active range of motion. We check their spasticity and tone level. We check to see if they have caregiver support, and we also use our MARC unit. What is a MARC unit? Well, we use the MARC unit to test the EMG signal, and I have one right here. So the MARC unit is basically our test unit. Our clinicians use this in the field to test the MyoPro on the patient. So you can get the EMG level that the patient can create, and then we use, again, our software to magnify that signal. It's an adjustable brace, so it fits most everyone that can fit into a MyoPro. And then the patient gets to put it on their arm. They get a feel for it. They get to see how it's going to feel, how it's going to look. Although, I will say that the MARC unit isn't a great depiction of what the MyoPro really looks like, but it gives the patient an idea. By the way, when someone puts this MARC unit on, most of the time, it's the first time they've moved their arm in years, so it's pretty impressive. So we have two different MyoPro devices. One is the MyoPro Motion W, stands for wrist, so we have the wrist is, it's supported, and then the elbow motor functions in the Myo, in the Motion W. The MyoPro2X Motion G is the device that we just released in April, at the end of April, and this is a version of that. It comes in pretty colors, too, like the purple one you see on the screen. So the motion G is for grasp, stands for grasp. And you have the elbow motion and the open and close of the grasp. The clinical team really has a finger on the pulse of what's going on with our patients. And in doing so, we want to share that information, collaborate with our product management team and our engineers to make sure that we, again, are getting a product that's usable for our clients. So the MyoPro2X was one of the goals was to simplify the donning experience and promote greater independence of donning for the patient. So if you take a look at the screen here, on your left, we have a dorsal hand strap. strap. Patients who present with their forearm and their palm down usually are able to use this dorsal strap for donning. So they place their hand in the MyoPro on the handshell and they secure the strap over the top of their hand. Some patients present with their palm up, okay? And so that spasticity doesn't allow them really to get their palm down well. So, we created a hand strap that allows patients to put their hand in neutral to get into the MyoPro. This is a way that we can serve more patients with the MyoPro. We, again, we understand their presentation and we know that it's not a one-size-fits-all. We know it is not the same, everybody, not everyone is the same. So what is MyoCare? So MyoCare is our post delivery program that Micah talked about and we have several therapists, OTs and PTs alike, who we have recruited that have a heavy neurological background and they've been out in the field, out in the clinic, and their expertise is in stroke management or neurological disease management. So basically we've kind of set them up into different groups of people. The clinical coordinator is the role that starts the process after the myopro has been ordered. The clinical coordinator contacts patient, they give them call, they talk to them about their baseline goals, they talk to them about going to therapy, and they gather information about do they have a therapist locally available to them. If they do, we try and train that local therapist on the MyoPro if they're not trained already. If they don't, then we go look for a therapist in their area. So we have to be particular about this. A, it needs to be a neuro therapist. They need to be able to take the patient's insurance. And it has to be within distance The patient couldn't get there. So this is a fair amount of work. We have two people doing this job, and they split the United States into north and south. So this person is not on this screen, but there is a clinical trainer, and you're going to meet Stephanie here in just a minute. So she's kind of our sole clinical trainer. She, once we get the therapist information, she goes to work, and she offers them a 90-minute live webinar, or she offers our Myelmo Academy, which is our clinical modules that are online, and then she can follow up with them thereafter as needed. Once the RMO or the regional manager, sorry, we just changed their name, regional myopro orthotist delivers the device, then they pass it off to the regional clinical specialist. The regional clinical specialists are PTs and OTs. There are boots on the ground that go and help train the therapist and spend time in the clinic with the therapist doing that hands-on training with the patient as well. They follow the patient for about six months, and then they hand off to the myocare coach. The myocare coach carries on sort of like a telephonic case manager, if you will, but they can also do telehealth. Just to back up for a second, we have 12 regional clinical specialists and a couple of managers in that role, and then we have two myocare coaches. So here's the layout of our region map, and you can see that they cover a fair amount territory. There's a lot of travel to get to in-person visits and so we supplement that. To improve our efficiency, we supplement that with telehealth. In the future, we prefer to shrink these territories so that they are a drivable distance. We also want to continue to get But the MyoPros socialized out to those therapists who are neurotherapists, and we want to create a certification program for therapists. Right now, we have a certification program for CPOs and our internal therapists, but we don't have a certification for therapists. Therapists like to have certifications behind their name. So we want to roll that program out, and in addition to that, we'd like to be part of the core curriculum of the OT programs in the U.S. So this is a map showing our 1,600 or more trained therapists that we have. You can see we have a fair amount of trained therapists in the east side of the country, but these therapists have been trained, but just like everybody else, they change jobs, they retire they go home and have a baby and never come back to work so we're constantly training people I would say that 70% of the myopros we deliver every month we train new therapists for so we're trying diligently to make these therapists experts on the myopro and when you train people new new new it's it's a challenge. So Stephanie Dunaway is going to come in here in just a little bit and talk to you, show you a demo of the MyoPro, but she is kind of the sole OT that has been leading the charge for training. So we have a PEARL program, which is a protocol that we share with therapists, and this is a protocol that we share that we try and get the MyoPro integrated into the regular therapy sessions. We recommend 10 to 12 weeks of therapy at twice a week, and then one-on-one therapy sessions 45 to 60 minutes. That's a lot of therapy, folks. And that's just the minimum. So I told you we have a certification program for our CPOs. We do. And we have a certification program for our internal regional clinical specialist or therapist. So this is just a little snippet of what they learn for the MyoPro2X. We have an online version so that they can do some prerequisites. Then we train them hands-on in all the MyoPro devices, and we have a hands-on lab test as well as certification test that's written. And we ask, why do we put all this effort into our patients and our clinical outcomes? So you need to meet Sandra. She's kind of a superstar. She's 62 years old. She had a stroke at age 37. She had right arm weakness. so for 25 years she has not been able to use her right arm and she's one of those people had minimal tone and spasticity and so she's done very very well let's see what she has to say her dog looks nervous doesn't you can hear the RCS in the background there with the patient mommy didn't drop you in the floor like I usually do so Sandra has gotten her life back with the MyoPro I spoke with her just recently and she is doing really well she's so happy that she can move her arm and use her arm for function She actually works at Chick-fil-A, and she was able to wear her Myopro to work the other day. I'd like to introduce you to Stephanie Dunaway. She is our clinical services manager. She has created all this content for our training, and she does a phenomenal job. And Stephanie is going to demo the Myopro. Do we have anybody here on a short-sleeve shirt? anyone? Oh, do I have, oh, sir. Excuse me. Yeah. Would you mind being our demo person for the MyoPro, please? Yeah. So we're not going to put, the MyoPro is custom fabricated for particularly for patients. Yeah, if you can stand right here, that's great. The MyoPro, as you know is custom fabricated for patients so we don't have one your size and we're not going to take the time to put the mark unit on you but Stephanie is going to use a tethered device to kind of show you how the mile pro works okay so we for demonstrations like this as well as in services and training purposes so what I'll be doing instead of putting your whole arm into this I'll just be wrapping these bands around your arm.

Stephanie Dunaway, Other

So we've got four sensors, and we'll start, since you've got short sleeves, we'll start with the upper arm. So these two sensors are going to wrap around your bicep and tricep. They are color-coded. So blue sensor will go over your bicep, red sensor will go over your tricep, and the information from these muscle groups will drive the the motor at the elbow. You can shimmy these around if you need to. And then to the other cuff. This will go on your forearm. Slide that in. So we've got two additional sensors here, ones that will be listening to your wrist and finger muscles that close, and another group will listen to the muscles that open. So if you had your own MyoPro, the sensors would be embedded inside and we would just be teaching you to put the whole thing on. Okay, so I will power this on. Nothing's going to happen. I'm going to connect to our software, so you can just relax your arm. Just take a minute. Okay, so when we turn it on, it's in standby mode, so this gives us a chance to assess sensor position and make sure everything is comfortable for the patient. There are different modes that we can access depending on on what muscles are working well for the patient, what we want to work on in therapy. So we'll go through a couple of those here. So I can control the modes by using the power buttons here, or if a clinician is using the software, they can control it via the software. So we'll start with the hand. I'm going to put you in the first mode. This is called close mode. So this is going to be working on the muscles that you use to close your fingers. So for this motion, you're going to bend your wrist towards your body and then the hand motor closes the fingers. As soon as you relax the motor will reset into an open position. So the hand bigger pardon the hand design is a three jaw chuck so we're using the thumb index and middle finger so if you bend your wrist and again that closes the fingers as he rests or relaxes the motor opens the fingers back up. So we can focus on this single muscle group to get grasp and release, or we can focus on your extensors. So for this movement, you're going to move your wrist away from your body. Let me adjust it. So I can change the sensitivity of the sensor. Let me try again. So that opens the fingers. As he relaxes, it closes it again. So it's the same movement, the same grasp and release pattern, but we can focus on different muscle groups. Eventually, as part of our training, the goal would be for someone to use both muscle groups together. So that's what we would be looking at to progress to over time.

Micah J. Mitchell, Other

Can I ask a question? Of course. So this is the G?

Stephanie Dunaway, Other

This is the motion grasp, yes.

Micah J. Mitchell, Other

So the other one, you wouldn't have this?

Stephanie Dunaway, Other

You wouldn't. You would have everything here up to the hand shell. You would not have the hand motor or the finger or thumb supports, but everything else is included. Yep. Okay, so that's the hand. So I'll put the hand back in standby. We'll look the elbow. So this is set up the same way. So we can do one muscle at a time or both. So for this one, this is biceps mode. So we're going to bend. So whenever you're ready, bend up. The elbow motor responds. As you relax, it resets into extension. So it will only move when it detects a signal from you. It's not going to move your arm for you. It's not going to stimulate him with electrical stimulation or anything like that. So the sensors will pick up that intent to move. Even if it's really weak, we can magnify his muscle activity with the software and make sure that we're getting the desired response.

Micah J. Mitchell, Other

So if I'm wanting to move and thinking about moving... Sorry. That was me. That was me. Even if the transmission of the signal is not really there because the arm is paralyzed, you amplify it.

Stephanie Dunaway, Other

So we can work with patients who don't have any visible motion at all, and that's part of the evaluation process is to do an evaluation with our sensors and make sure that they've got a usable signal that can power it, yeah. And then this last mode here is tricep mode. So for this one, this starts with the elbow bent, and for this one, you're going to engage your tricep. So you're just going to push down to the floor.

Speaker 23

Start up here.

Stephanie Dunaway, Other

So that moves into extension. When you rest, it moves back into flexion. So just like with the hand, we can work on individual muscle groups, but the goal is to reach a point where you can use both muscles together for different functional tasks. But that's how it works. Thank you very much.

Dave Henry, CFO

All right. Well, thank you. So we've come up on noon. So for those that are on the webcast, we're going to break here for a tour, and Colin is standing up. He'll raise your hand, Colin. He will take you over to the next building at 45 and do a tour for you. For those of you that are on the webcast, we have a video of that same tour that we will launch here momentarily. And then after that, we'll be on break until around, I would say, 12.35 p.m., maybe 12.40 at the latest, and we'll start back up again. So we'll see you in about a half hour or so.

Colin Anderson, Other

Welcome to MyOMO headquarters in Burlington, Massachusetts. This is where engineering, craftsmanship, and patient-first care converge to create the MyoPro, our powered orthotic brace that restores upper limb movement. Step inside and follow the journey every device takes from first measurement to final shipment. This is our office space on the second floor of our new headquarters. As we briefly move through, you will notice that we have plenty of new workstations and collaboration spaces for our various growing teams. quality, IT, human resources. As we round the corner we have space for our operations teams including fulfillment and supply chain. We then come to finance, product and project management and engineering. We start with the shape capture because every patient's arm is unique. In the past that meant mixing plaster, wrapping the limb and thermoforming braces around a heavy cast, a very manual and labor-intensive process.

Colin Anderson, Other

Today we've replaced the casting process with a remote shape capture kit we overnight the kit to the patient's home then guide the patient and a family helper over a secure video call high resolution photos and a quick hand scan capture every critical landmark here at miomo we're working to bring ourselves up to the future and state of the art bringing in 3d scanning technologies to perform shape captures of our patients utilizing 3d scanners we're able to now this is a big step forward to cast the arms so

Colin Anderson, Other

Today, we are piloting handheld 3D scanning systems that will allow our O and P channel partners to utilize the equipment that they already have on site. Back at headquarters, our fulfillment team opens those images, draws digital reference lines and extracts the exact dimensions. By reducing the need for a clinician to travel to each user's home, this is a cost-effective and accurate way to collect the necessary measurements. With dimensions in hand, the manufacturing team runs an automated script that generates custom orthotic shells in seconds the files go to our additive manufacturing partner who 3d prints each shell in medical grade pa12 nylon those parts arrive at myalmo in just three to five business days after the order is released production begins at first station laser cutters process custom liners padding and other components sewing machines stitch liners and straps and our technicians cut tubing extruded bars and rivet various sub assemblies together each step is guided by a device history record tailored to that single user finished sub assemblies move to in process inspection our inspectors verify every dimension and bench test the motor assembly supplied by our third-party contract manufacturer they also inspect the shells quality is built into our processes the recently verified sub assemblies arrive at final assembly where technicians integrate the motor sensors and electronics transforming a bin of parts into a functioning myo pro we kit together the myo pro a pre-configured laptop manuals and accessories then at final inspection we run a full functional test we check sensor response motor performance and verify that the myo games and my config software launch flawlessly so the user can begin using their device on day one finally the kit is sealed labeled and scheduled for shipment whether it travels across town or across the world every mile pro leaves this dock ready to give its new owner the power to move again. We are currently expanding our manufacturing footprint at our Burlington headquarters. We will be adding new offices and space for additional manufacturing coming soon in July 2025. From remote shape capture to rigorous inspection, every step you've seen is engineered for safety, comfort, and speed. Thank you for touring Myomo Manufacturing. All right, we're back on. All right, so I'll go through our manufacturing and operations processes. I'm Colin Anderson, I'm our Director of Global Operations. My background is a little over 15 years in the medical device industry, primarily in orthopedic implant manufacturing, and then kind of moved over to MIOMO, been in a lot of different operations and engineering roles, streamlining production, reducing costs, kind of scaling with small and large companies, depending on what we were doing. And then my educational background is I have a Master's in Mechanical Engineering and also an MBA from Darden so I'll go through again I know we just did a tour but we'll go through high level what that process was again with a little bit more detail and for those of you online you'll get a little bit more information than maybe the video had but we'll go through making a mile pro so you can see there's a lot of different components these are high level the various things that are on our 2x device you can see humoral cuff finger saddles things like that. Those are the orthotic shells, and then motors, and various sub-assemblies that we put together as well. So this is what our manufacturing process map looks like. So you can see starting on the left, we start with the shape capture, which we've talked about a few times. Then we go all the way to shipping to the user on the right side. So we go through shape capture, model generation, we saw that. That's where we're customizing the design. Then we go to first station, where we're making the sub-assemblies. At model generation, we sent the file over to our 3D printing supplier out near Worcester. And then we're also receiving in our motor kit assemblies. Sorry, motor kit assemblies come from near Worcester, and then 3D print suppliers in the Boston area. But all that stuff gets united at first station. We move through our in-process inspection steps, final assembly. We kit all the various ancillary goods that the users will need, go through a final inspection, we ship it out to the user. And then, like I mentioned before, we have a three-year warranty on the device so if there's any issues users can contact tactical customer support we can bring the device back if we need to for service and repair and then we can go back through our outgoing inspection process and ship the device back to the user so as you saw we have our remote shape capture kits we have a whole bunch of them on the shelf they go through a process of their own so they go through a sanitization process and a maintenance and calibration process after they come back from the user then they get ready to go out on the shelf and then once we ship them out the user engages in that shape capture process with our clinician then they come back to us so they're in an ever-going cycle we have probably like 35 50 of them just kind of going in and out of the building after we get all the measurements we go through generation where we create those shelves like I mentioned we also create all of the user specific dimensions we move to first station a lot of tabletop equipment so low capital investment a lot of labor in this process. We have laser cutters, which I didn't show on the tour, but they were in the video. And then we also have the shells that come in from an outside supplier. We go through in-process inspection. So we benchtop test the motors, verify dimensionally everything. We make sure our liners are the right size, sewn properly, everything fits okay. And then we move to final assembly where we build the finished device. So right now we have four different workstation setup. Like I mentioned, we have a capacity of about 120 units per month on one shift. So as we build the device, we route the cables, we glue things together, we put different pins in, we rivet different things. Then we kit the device, so they get spare batteries, a charger, manuals, laptop, carrier bag. That's all put together and it moves to final inspection. At final inspection, we go through a full functional test so we didn't get to see it on the tour but they'll do exactly what we did in the demo today and they'll actually actuate the sensors and make the arm move make sure the motors are responding properly they make sure it connects to the laptop that goes out with it and they make sure everything's on the laptop that we need we then pack it up into a box and it goes on the shelf waiting for shipment for when the user needs the device so now kind of shifting gears a little bit recap on the manufacturing process so what have we done over the past year? So one of our main things is we've been scaling our capacity proportionately with demand. So as you can see this is the total number of shipments that we've had over the past 12 months ending at the end of Q1. We have a capacity right now of about 120 and and the main way of increasing capacity is through hiring additional labor. So we've increased headcount on the assembly floor. We moved here in January of 2025. So that was a an interesting process as you can see you know volume was a little bit higher than it had been previously in the year so moving with a higher volume coming over here that was a good exercise and we were able to lay the floor out really nicely here to get much better process flow and then as I've mentioned a couple times the quickest way to increase capacity on the manufacturing side is really just adding a second shift and bringing in more labor we have all the equipment we need we have the floor space so that's quickest way to grow. So what did we do when we moved here? Well we outgrew our headquarters in Boston and for those of you who have seen it, it was a very small space. We have much more space here and what we did was we we laid out our floor and we're only occupying half of the first floor in a much more efficient way for the material to flow. So as you can see we kind of have a little loop that everything runs through. It comes in our dock on the bottom part there and then it comes through. Raw materials get inspected. They then work their way over to first station we make all our sub assemblies we process everything through just the way that I showed you on the tour and it goes back out the door we're continuing to expand so we're growing into the second half of the building we're expecting to be in there in July so we're about a month away from having that space open to us there's three main things we were doing we're increasing office space so some of our operational folks are up on the second floor we want to move them down closer to manufacturing we're increasing our production capacity. So we're increasing floor space. And we're also increasing our engineering development space. So we're building out a larger model shop, kind of prototyping area. The overall goal here is that three-year objective. We need to get to 250 units a month. That'll help us hit that $100 million a year goal. Streamline the product and process flow, as I mentioned. Make more space for product transfer. So we don't want to introduce new products into our cramped existing area. We want a new spot to put MyoPro3 into. continuing our insourcing and continuous improvement projects. So those are focused on cost reductions and efficiency. And then also mitigate supply chain risk with increased safety stock. So how do we do that? That means that we need to have a larger area for our stock room. So right now it occupies about half the space that you see here. So we occupy the top half right now and we're taking over the bottom half. So we'll increase the size of our stock room. That'll help mitigate issues where you have a sudden supplier closure or something like that And we need to make sure we have enough materials on hand to mitigate that risk and keep production flowing. We'll enable ourselves to insource some of our core sub-assemblies, which I'll go into a little bit more on the next slide. And then, like I mentioned, give us flex production space to introduce new products, increase our R&D area, and then also, again, increase that stock room capacity. So cost reductions and risk mitigation. So we're targeting about 200 basis points of gross margin improvement on a quarterly basis by the end of 2026 so q4 to q4 how are we doing that here's three kind of primary examples so with our new space we'll have room to insource some things so we're really good at assembly as you saw we do a lot of assembly operations one of the components that we don't assemble in-house right now is is that elbow motor and that grass motor so we can bring the assembly operations of those in-house reduce costs approximately about 15 is what we have right now as our target. The FE and SP joints as well, they're parts that are on the wrist area of the device, insourcing those, assembly operations. One further thing is eliminating the laptop that goes out with the device. So that's a large piece of cogs, and we're doing that through the introduction of a companion app, which Malcolm will talk about when he comes up here. And then labor optimization. So we're really focused on implementing lean manufacturing on the manufacturing floor. So that's going through a lot of different training, teaching people the various tools, how to streamline things and eliminate waste in our various processes. One of the big things here that we've noticed recently was we spend about an hour cutting Velcro to put the liners on the device. So how can we automate that process? It's a custom device that's kind of difficult. So we did figure out we could use our laser cutter, we could write some code, and we could generate these patterns that we need to have for each device. And we can cut that Velcro out and basically reduce manufacturing time by an hour. So we're working on projects like that. And like I said, about 2% gross margin improvement is what we're looking for. And with that, I think any questions? All right, then I'll hand it off to John Freiders, and he'll go through international operations.

Ari A. Colligan, Analyst

Oh, sure.

Colin Anderson, Other

Yeah, so we're five days a week, roughly 40 hours working a little overtime with the fluctuations in demand. But it's one shift varying people from the manufacturing side, fulfillment side, and then all the inspectors as well. We have done that in the past. So we have a really good workforce here. They're pretty dedicated to the mission. They like the products They do come in over time. We work on weekends if necessary depending on demand fluctuations So we have that core team already. Yes So our overall manufacturing lead time varies a little bit but on average we're around 10 business days So if we get the order in we need the measurements we'll ship it within 10 business days. We can expedite on occasion Typically the turnaround time can be a little bit longer than that But we'll finish the device and then I showed that picture where there was a bunch of devices on the shelf So like I said, we finish typically before we need to ship it So it'll sit there and go out once the patient's ready to receive the device Just broadly speaking, it's a very high margin business But any impact from the tariff environment?

Scott Henry, Analyst — Alliance Global Partners

How do you think about that? How could that impact you guys?

Colin Anderson, Other

Yeah, so obviously, constantly monitoring that. It changes daily, weekly. We really haven't seen much of an effect. We think maybe up to about 1% gross margin impact on that one. I think we published guidance on that in April. It's really not much of an effect. We have a lot of local suppliers. So I mentioned the motors come from here. Their suppliers, obviously, if it's an electronic, come from overseas. But we have dual sources in there. Things are pretty efficient on that side of it textiles are really the only thing that's that's affected so the bag or or maybe the liner materials they come from overseas may be affected by tariffs and that's not a very large cost in the product so not a big impact from an R&D perspective what is the competitive landscape out there and do you have IP protection to ensure that this device does not get jumped in the market so I'm gonna pass that question to Malcolm and he's gonna present on it later so maybe hold your question and then you can ask again when he's up here. Any other questions?

Speaker 2

Where do you see yourself getting to like a year or two from now from a manufacturing standpoint on a monthly basis? In terms of volume?

Scott Henry, Analyst — Alliance Global Partners

Yeah.

Colin Anderson, Other

So like I mentioned before, we're shooting for that 250 units a month target in about three years. So we'll be scaling proportionately as demand comes in. Pretty, I mean, you saw kind of some of the projections of how we're getting there. It's kind of linear, a little bit more than linear.

Speaker 2

Okay, thank you.

Colin Anderson, Other

All right, so I'll pass it off to John Freuters, and he'll go through our international operations.

John Freuters, Other

So it's good afternoon from Germany. It's almost 7 o'clock in the afternoon, and we had a very nice and hot day, 90 degrees Celsius plus, which is without climate, obviously a warm day in Germany. My name is John Freiters. I'm signing responsible for international operations, which is basically the business we have in Europe, a little bit in Australia, and I'll show you around it. So, the first slide you're going to see is slide number 86, I believe. I joined MyOMO in 2020. Before that, I did some consulting work as in-between jobs and then joined MyOMO as managing director for my home europe gmbh gmbh is uh is equivalent to uh ink so we're a wholly owned subsidiary of myomo inc based here in germany the city we're based in is guttingen and gutting is actually in in the bullseye of germany so we got the north south east west the autobahn connections here uh pretty decent drives for all direction berlin is as far away as munich as it is as it is the rural area. So from a sales and business development position, well-established to do business in Germany. I've always been more or less the last 30 years of my career in this like environment. So orthotics, prosthetics, DME equipment, wheelchairs, mobility solution, neurological rehab, and also most of my career with Autobach, but also some startup experience with the previous company, Rewalk, that actually made exoskeletons for bar-plegic individuals. and join that do. From education, I have a biomechanical engineering background and an MBA from Caltech in Northwestern. And with all we do, next slide, please, that shows 87 to me, our focus has been on international, but specifically on Germany. So the slide you should see in front of you shows 4.7 million in revenue in 2024. that kind of 96% of that is revenue in Germany we do have some business in the UK we have some incidental business in Australia we're trying to grow that too so there's a there's a lot of opportunity in other markets but our focus really has been on Germany and building a team and a business here that is sustainable and can grow accelerated in the years to come next slide please and that has to do with the reimbursement environment in Germany which is favorable for Myopro. We have about 82 million people living here in Germany and everyone without exception has health insurance. That means that if you qualify and you're insured by a German health insurance, specifically statutory health insurance, your odds are close to 100% that you will be legible for a Myopro device. And if you consider that there's 150,000 stroke survivors in Germany and that those stroke survivors have likely statutory health insurance and those are legible for a Myopro fitting, we were well advised to focus the builder business in Germany first. And so far, we've been successfully with launching Myopro here in Germany and had over 50 statutory health insurances covering for a Myopro. That means those patients that had a stroke, had a brachial plexus injury, a traumatic brain injury, that actually went through the funding process got approved of Myopro. And that's 50 out of the 96. So we're close to over 50% of insurance companies that actually have had a funding experience and helped us to build the process. We've had insurance companies that said this is new and innovative. We've never funded it before. for, and we don't know if we have to or can pay for it. So they decided to reject the application and go to what we call the social court appeal process. You have a round of appeals where you do it in a dialogue with your insurance company. If they continue to denial, not open for your argument, you can then actually take it to social court. And the social courts actually look at what you're entitled to under the rules of the statutory insurance rules, so the lawmakers. And we've had 100% success rate so far, actually, that we filed claims on behalf or in cooperation with insured people that actually then eventually, or at the end of the process, got approved for the Myopro. So that means that not only can we get paid for it, but then they can do it voluntarily, following the rules, or we'll be forced and arm twisted by the social courts to actually pay for a Myopro. So that means that if we go out and talk to patients, qualify those, we can give the statement that if you are technically, physically, cognitively qualified, you have the EMG, there's no contraindications, you're eligible for a myoprope, you stick to the process, you will end up with receiving your myoprope, which is a good statement we can make. Next slide, please. It means that the patient journey in Germany is that we have to reach out to the percentage of the 150,000 stroke survivors that we see in Germany that have insurance. And a lot of those actually find us through social media, Facebook, Instagram, but also through Google search. We've been feeding with artificial intelligence lookup guides like ChatGPT or other AI channels that write about Myopro, and more and more people show up online. Also, through prescriptions, therapists, the OMP industry, the orthotics and the prosthetics industry, the CPOs that we see actually start providing us patients. Once we are in contact with a candidate, so a potential MyerPo user, we'll see them in a live in vivo testing. That means our clinical team and also our business development managers go out and meet with the patients either in a clinic at their physiotherapist or occupational therapist or at their CPO's office or at the doctor's office, and actually we do a screening with the patient. That means we want to make sure that we're really certain that it's an illegible patient, that there's no contraindication, that they're physically capable, that they can actually do something, get the best functionality out of a myoprope. And that screening is also used to produce the evidence that we need to actually get the funding process started. So once these patients are tested and screened, considered suitable, then they actually step up to the next step, and that means they get a prescription. And I'm looking at slide 89 right now that shows the patient journey, as I don't see the slides just checking. So you get a prescription for your doctor that's bullet number three, a letter of medical necessity. And the doctor has also seen videos of the screening that they do. So it's an informed decision by a medical professional to prescribe a Myopro. And they also then actually learn about the Myopro, so they're aware of the product that is out there, and they can start considering to stop Botoxing and start prescribing Myopro in the future. That package goes out to the insurance company. That insurance company has to review it. Eventually, it leads to an approval, as we just learned. And once the approval is there, the scanning is done, the measurement is done, the device is fabricated. It goes to the OMP clinic, and the OMP clinic, by law, fits the patient. So in Germany, we haven't touched on that, we are not allowed to fit the patients directly. We're kind of a licensor state. We have to work through the CPO's office, who also hold the contracts with the insurance company. They'll eventually fit the patient, and they get funded for that. once the patient is fitted with a MyoPro, it actually comes to a very important stage. This is where the user or the candidate with the MyoPro has to learn to use the device to eventually be able to use it in everyday situations by themselves, become independent, and restore functionality, can be able to use both hands again. So that means that in some cases in 0.4 though, and that's the next slide, we do not always get a direct fitting from a funding application. Only 10% of our applications go directly from the funding process into a direct approval. And a direct fitting does not mean that we fit the patient direct as myomo. It means that we get a definitive fitting without the trial, without a longer period test session. So as the application goes out to the insurance, the insurance said there's no evidence, we fund for for a bespoke device. In 65% of the funding application, though, the insurance companies have reasons to believe it might not be a suitable product because it's new to them. They're not aware of it. They might think it's not something that the patient is actually willing or capable of using. So, they go through a trial period. And the trial period is a six-month window where the user has to show progress. So, without capabilities of doing anything without the Myopro, So at the end of that six-month trial course, education, training, they have to shoot progress, but they also have to show that they can actually do activities of daily living with a myoprope. Now, to ensure that in that relatively short period, and it maybe sounds long to you, but most of the patients we see are six or eight years after their stroke, after their incident, and have shown a track record that everything else has failed. So we get a kind of a difficult patient population to fit with a myoprope. And we have to show an acceptable and positive outcome in the six months. And that's why we've installed MyoCare. And MyoCare is in our program in Germany where we work with the therapist, we work with the end user, we see the person on a screen, on a video, but also in live sessions. Every three or four weeks, we'll go out there, reach out to the therapist, educate them, support them, and help them to actually get the results that we need in that six-month window. So then actually from that, we get the definitive fitting. and we get the approval by the insurance company that the user can continue. It is not as easy. It's a lot of touching and work time with the user, but it also gives us a competitive advantage. It's unique in the industry. It's unique to this product. And as this product is new, we're kind of setting the stage. We're kind of raising the bar because we're making something that is difficult very possible. And we also show to the insurance companies that once we do it with the price tag that we have, We actually prove the evidence and we produce the outcomes that they see that they get money for their investment, and it's worth spending time. We're also building trust. That means that this is unique and gives us also a competitive advantage. When you go to the next slide, it shows the revenue distribution in Germany. We've currently talked about the direct fitting of 10%. This is where between the application that goes out to the statutory health insurance is an average of 200 days. then we get the approval user receives their myopro that will not be taken away from them it's not a test it's something they can keep for life and we still support it with a myoclare program so to get the the results and the adl outcomes that they're expecting the 65 goes to a trial and out of the 65 of trial patients we get currently a 35 conversion rate that means 70 of our revenue currently relies on the combination of trials and conversions and that's something that we have to actually work on, improve on, and continue to grow. That also shows that on the next slide, what we're going to do to make sure that that number continues to grow, our total revenue, but also the importance of our trials and our conversions. And the next slide, the slide number 92 on my sheet, is we're going to enhance or enlarge the team. This is still a country where people buy from people. People want to be having a positive experience to actually expand and invest in the activity that we see, the PTs, the OTs, the CPOs, the insurance company, they're following results. And to make sure that we're doing these hand-helding with the patients, with the new therapists, with the CPOs, with the new partners we sign up in this market, we have to cover some open areas. So we have to hire more people, specifically CDMs. We have to cover more areas. We have to make sure that we can keep up with the growing number of inquiries, that we can keep up with the number of trials, that we can keep up and secure and even improve our conversion rates by being there more often. And also at the same time, building our pipeline for 2026, as well as the years to come. So scaling the team, managing the user connection, training new therapists, reaching out to medical professionals. That's where we probably actually are investing time and effort to hire more people. When you look at the next slide, our development and growth initiatives are really starting with scaling the team. We need to qualify and skill people. We need to find them, recruit them, hire them, and train them. The majority of our team members have not had a field travel experience. So they're clinicians from a clinic, and actually we put them in the cars, put them on the road, and have to work them in a sales-style, business development-style organization, which is a bit different than patient care. So that's where you need a specific type of person, and you also need a specific training program to make sure we can do that exceptionally well. And our past years have shown that we're on the right track to find the talent that we need, recruit them, hire them, and also keep them. Once we have a larger team, our areas get smaller, our frequency of contact can increase, our downtime of driving, Germany is a large country, goes down. We believe we can do more contacts and produce more results. That also means we can reach out more to the medical professional direct. We're doing a lot about social media, which is digital advertising, which has been successful. But we also want to be in the doctor's office, spend more time with the therapists, build our pool of key opinion leaders, go out to the neurologist that has prescribed the Myopro in the past and ask them to do more in the future. And that means that we want to work on Myopro becoming a standard of care for stroke patients where traditional therapies and medication have not shown the results in the outcome that restores functionality of the affected site. Once we have a larger team, we can intake more inquiries. We can up our marketing, advertising, congresses, symposia, and actually do more. We're currently on hold because our team size is the bottleneck to grow. When we have more people, actually, we can spend more money and grow and scale faster. And a part that we're doing is we'd like to keep the company lean as digital. Everything is field-based. It's digital. It's remote office-based, but also our processes. We want to make sure that they're smooth and slick and lean. The part that we've done last year is we've done and installed an online screening. So we don't have to do a lot of phone calls up front to find out that the user is not suitable. The user goes to a website. They go to a self-screening process. And only when they actually are qualified on a certain level, they can sign up to be contacted. That means that our hit rate of the inquiries that we get has improved. And we don't have a lot of downtime. we're not spending a lot of time for everybody's time on contacting calling and follow-up of candidates that actually eventually show up that they're not a suitable my appropriate candidate and then the last slide if we continue to do what we did in the past we really believe that by 2028 we can do 15 million dollars in revenue or more in in the future so if we're on the momentum as we are continue to scale and grow the team and be as successful as we were in the past we think that's a bright future for Germany and beyond. That's it in a nutshell from International.

Dave Henry, CFO

We're going to take some questions from the audience if they have any, and we'll hand you the mic if you have some. Just a second. There is a question, John, so we'll get that for you.

Ari A. Colligan, Analyst

Okay. John, thank you. I hope you're able to get dinner and we haven't interrupted you too much.

John Freuters, Other

Actually, you did.

Ari A. Colligan, Analyst

That's okay. So one question about patient follow-up after the Myopro is delivered. In Germany, do patients get therapists on a weekly basis to help support and train them on how to use the Myopro? because I was surprised that the conversion rate after the trial is only about 35%, which would suggest that many of the German recipients have not learned how to use the device properly.

John Freuters, Other

That's a fair question. So what do we do, and why do we have the results? That's your question, correct? Correct. We do follow up with each individual, and it's independent if they get a definitive fitting, where there's no risk of the device being taken away, or if it's a six-month trial. In reality, it means that within a frequency of every three to four weeks, our clinical trainers see the user, because in most cases, it's new to the user. they've not done this before. It's very often, also almost in every case, it's new to the therapist. So they haven't worked with a myoprop. So we got a combination of two people who've not done this before. We've also seen that for some patients, it's difficult to learn. In Germany, most of our users are at the end of their therapy options. So they've really come a long way of trying everything else to restore functionality of their hand and of their arm so we really get the difficult ones that means we're on top of things here as good as we can train them educate them coat them and coach them and in between the three and four weeks there's always a follow-up by phone a video call people can always contact us either the cdm direct the bdm direct there's always somebody in the team available to support that and give them the coaching and the guidance. That means that there's reasons why it's 35% for now. One reason is some patients are good on paper. They're good in the screening. They're good in the submission. When it comes to actually doing something, it fails. Reasons are they get a second stroke. Reasons are some circumstances in private life made the myopro less of a priority. It was harder than they thought it was. The therapist wasn't as good. And sometimes it's us. We were a small team last year. We did not have enough people, so we couldn't do the quality of training or be there more often as we should have been or could have been. So our results of 4.5 million could and should have been better if we had more people. Unfortunately, we also had people from a second or third stroke and also dying during the program. So we lose those two. fortune that's only a small size is we also have candidates that get so well and get so good that we've seen that they kind of don't need the myopro after six months anymore so they walk out with a restore of function without the myopro and curing and healing is actually the myopro has helped them to recover and gave them a lot of less bit of shove in the direction of where it needed to be. So, the 35% has upside potential for us in outcomes if we can do it better, more with a higher frequency. But you'll still have a patient population that will stop using the Myopro as it is, as they've learned it's too difficult, too hard, too fatiguing, or secondary circumstances prevent them to continue to use the Myopro.

Dave Henry, CFO

Does that answer your question? it does thank you uh there is a question that came from um online uh the question was and i'll go ahead and answer it um is international profitable and so um it's a it's a question that uh there's a business answer and then there's a statutory answer uh when you're doing business in a foreign country the objective is is that they want you to be profitable because they want you to pay taxes and there's only so much that you can of headquarters type of costs that you're allowed to allocate to a different country before they say time out we're going to audit you and so yes international is profitable from on a statutory basis today which is why you know when you look at the income tax line at our of our pnl you see that there's income tax expense and that comes from Germany, and that is because they are generating a statutory profit, but if we were to allocate, you know, headquarters costs and other costs, you know, to Germany as we do, you know, the direct billing business here, you know, we lose, you know, we're in a lost position in the U.S., and Germany would be in a lost position if we did that, but we're physically unable to allocate a lot of those costs because of transfer pricing And there's another question, and just a second, John.

Speaker 21

Oh, thank you. When the 35 or 37 percent are returned, when the, sorry, the ones that do not continue after the six-month trial, is myocompensated in any way for those devices? Is there, like, rental or leasing or?

John Freuters, Other

Oh, absolutely. So what happens with the ones that don't convert out of the 65% that we do? Some of those users are not counted as conversion because some of those go into an appeal stage. They have a functional outcome, they've shown progress, the insurance company denies or doesn't recognize that, and they say, no, it's not good enough, it's not enough of what we see. So we appeal for those. So they may come into the bucket of a conversion at a much later stage. It can take two years until you actually get a court approval. So they'll be later on added to revenue, but they're not recognized as conversion. Second of all, we're using a fleet of inventory, which consists out of motors and parts that are refurbished. So it's refurbishing of – it's ecological and economical. In our trial sessions, we don't use new equipment all the time. We're using the custom-made parts that are new and individual, but we're still using the motors and the parts to refurbish those that's returned to the U.S., then they're actually brought back into the fleet, and they're used to the next trial. And, yes, we do get paid for our trials. Our trials consist out of paying for the device, but also the insurance pays for the training, and the device costs are costs of our MyoCare support are included. So that is covered by insurance. It's not something we do for free.

Dave Henry, CFO

Yeah, so just to elaborate a little bit about that a little bit more, generally a trial will be around $20,000 depending on the exchange rate for that six months, and that fee is non-refundable. So that allows us to take revenue when that trial commences. And then if there is a conversion after that, as John mentioned, that device is returned to the U.S., we're not going to have them keep a device that has used motors on it. We will ship them a brand-new device, and then there will be another charge for the final cost for that conversion. Right. Are there any other questions? All right. John, thank you very much. Go have dinner and a beer, and appreciate your time.

John Freuters, Other

You're very welcome. Enjoy the rest of the day, everybody. Bye-bye.

Micah J. Mitchell, Other

I want to talk about the O&P channel now. And for many of you may not know, but we had an experience with the O&P channel in the past. So I'm going to first rewind to talk about what happened in the past, so about eight years ago. And then we'll talk about what is an O&P provider and what do they look like today. And then we'll go into the things that we're doing and what the future may look like. So, when we first had the MyoPro to dispense, had to choose a channel common for manufacturers. The first thought is generally not to go direct to the end user with a custom fabricated orthotic. There was no decision making process. If we wanted a channel to sell through, it was going to be the orthotic and prosthetic providers who employ the CPOs who are required to dispense a custom fabricated orthotic. So, we had a team of about 10 clinical sales reps. These were fantastic professional sales reps that were really good at cold calling, outbound calls, having conversations. They came to us with many relationships within the O&P community, and the idea was to meet with an O&P provider, help them understand our product, the reimbursement, the technology, the patient, how to generate referrals, and then sign them up to be a center of excellence. On the one hand, we had great success signing up centers of excellence. On the other hand, sales were not following. And so at that time, as a one product company, to help the centers of excellence that had chosen to carry our product, to help them actually sell more units, we began to help So we began to do some social media advertising and some other things like that so that they could generate some patient flow so that they could sell myopros. That worked well. And so then we would have screening days. We would schedule them at the OMP clinic or at a local hospital or rehab facility, have multiple patients show up. We would be there along with the CPOs that work for the COEs, and we would help them evaluate the patients so they could build their pipeline, and sales did not follow. We heard things like, I'm getting denials, the funding is a challenge, so we brought on our previous chief medical officer, and we built kind of a team of funding experts so that then we could also help the O&P channel with some of the funding challenges. We were doing a good job supporting them, and while they were trying to navigate the MyoPro journey, they had another business to tend to as well. They had other patients coming in the door, and ultimately, we didn't feel like we could control our growth as much as we wanted to at this point as a one-product publicly traded company, so we made the decision to also start our direct billing channel. We didn't totally put the OMP channel on pause. We continued supporting those that we were working with, but we were not out recruiting new centers of excellence OMP providers to dispense our product. As it turns out, we learned so much from our direct billing channel. We learned a heck of a lot about the product, a lot about how patient, a lot about how stroke patients present, so clinical protocols. We learned a lot about the funding process, process, and we learned so much more than we even thought we could, while at the same time we controlled our own destiny and were able to grow sales and all of those things. So now that we've had Medicare has begun to cover the product, and with all of the things that we've learned, we have recently relaunched heavily into the O&P space to sign up more centers of excellence. So now let's kind of talk about what does an O&P provider look like? so it wasn't that many decades ago when health care was all centralized so you go downtown you'd have the medical district with all the hospitals and rehab facilities all in one location a patient could leave a facility after a stroke or spinal cord injury go across the street to a company that probably was a full DemiPost provider durable medical equipment prosthetic orthotic supplies they could get a cane or a walker or a hospital bed or diapers or a wheelchair or a scooter or a respiratory oxygen machine, prosthetic, orthotic and oftentimes there was even a pharmacy in the back. Mom-and-pop shop where a patient could sort of go across the street from the hospital and receive everything they needed. Again that's not very many decades ago. A lot of things have changed over the years. One is how you know there's generally not just a hospital district right so we have hospitals all could sort of spread out at this point. Due to sort of clinical expertise required for new products, due to reimbursement, where some products are profitable and many are not, due to private equity, roll-ups, a lot of other reasons, the industry looks a little different today. So you tend to have sort of, for example, a respiratory or oxygen provider. That's 90-plus percent of their business. They may do a few other things here and there to please a referral source or a patient. Home medical equipment and orthotic and prosthetics, for the most part, sort of split. The expertise to know all of the orthotics and prosthetics is it's hard to do a whole lot of other things as well as before referral sources and whatnot so today the providers that we deal with almost across the board focus on prosthetics and orthotics and their prosthetics part of their business has has grown quite a bit lately so those are the folks that we sell through whether they are part of a national company or a local mom-and-pop shop usually each individual clinic looks about the same these are not not as large as our facility that you just toured. They may have anywhere from three to thirteen employees at the facility. They have patient rooms where patients are coming in. They do have a fab shop in the back where they are fabricating some of their own prosthetics and other devices right there. We think that about half of the industry are sort of national companies and there's a handful of them. And then the rest is kind of split between your regionals, maybe twenty or fewer locations, and then your locals as well. A few key things for them is one One is they tend to have in-network contracts, which is something, as Harry mentioned, we've begun working on with our direct channel as well. They have that in place. If they're a local provider, it's probably state-specific. If they're a national, it could be a national contract as well. So we have recently restarted going into the O&P market.

Micah J. Mitchell, Other

With Medicare begin last April, we hired a handful of people, a couple sales reps and a few clinical trainers and then began to engage with the O&P community last here I would sorry let me get a few videos here hi my name is Aaron Sorenson and I'm the owner of restorative health services group we have locations in middle and East Tennessee as well as in Northwest Georgia over the next year we We have some expansion, kind of some lofty goals to continue our growth throughout Georgia, as well as continued growth through Tennessee. And we were looking to also expand into Alabama and Louisiana. We have practices currently in the pipeline for those acquisitions. And we think by the end of the year, we should be well over 20 offices, probably more in the mid to upper 20 area. One of the things we're looking to do in 2025 is to have some initiatives where we are looking to expand some of our technology offerings, both in prosthetics and orthotics. And obviously, the MyoPro fits right into that initiative.

Micah J. Mitchell, Other

So Aaron is a good example. Family-owned business, although he's growing quite rapidly. He was exposed to the MyoPro with our first iteration eight, nine years ago, and he chose not to pursue it at that time. We've re-engaged with him, and he is very excited, and he's early in the certification process, and we'll kind of go through that process here in a minute. So initially, we did a soft launch last year. There were a few things that were happening. Medicare had begun to approve the product. The MyoPro 2X, which we just launched a couple months ago, we knew was right around the corner. The certification training is intensive. It's multiple days. I'll elaborate on that shortly. but we felt like it wasn't appropriate to go through a full certification process sort of at the end of last year when we began to launch this and then have to do it again. So we did create an opportunity for O&Ps to get the first part of training, which is a couple hours of remote training to learn indications, contraindications, and basically learn how to evaluate a patient to know if it's green light, yellow light, red light, and then so they could sort of build their pipeline. However, we were required to come do the clinical work with them. So if they had a patient where they got a prior off and were ready to move forward, we would be involved with that. We had great success with that in that we learned that we could recruit COEs. They were even more interested this time than they were eight years ago in the MyoPro, the funding situation, the reimbursement. And so as we've relaunched it in full force, we've immediately gone to those that did the sort of initial training last year so they could start the formal certification process and i'll show the details with that we're still very early but there's a few questions that that we've been trying to answer along the way so the first is can we get a commitment from these o and p owners managers decision makers to carry our product and it's more than just a yes ship it to me we'll put it on a patient it's a full commitment to first of all have their clinicians come out of the clinic for multiple days to train. Out of the clinic means no revenue for the local clinic, so there's a commitment there. Our post-delivery protocols are extensive. A lot of orthotic and prosthetics you can sort of deliver, and then you don't have to put as much time into it after you've sort of been paid. For our product, we're requiring them to commit to a myocare-type program where they will continue to provide clinical services and not get reimbursed for them for each myo-pro patient that has been delivered. So we've had success getting the commitment from a sales standpoint where, I don't want to say we're batting a thousand, but almost. They really are interested in our product and doing what we want them to do. Committing to the clinical aspects, yes, they are all making that commitment. We're very, very happy. What we have learned is our funding is not the same as all of the products. So kind of all the things that we've learned that Dr. Kovulman mentioned, we are teaching them as well. They are learning that. So we've proven that we can teach them the funding aspects. Kind of the bottom two things on the screen are those that were, you know, the jury is sort of still out on those. So for example, we have some small orthotic and prosthetic providers, I think a million, a couple million dollars a year in revenue, who then have to get to a point to commit to purchase our product for around $30,000, and sometimes that's a big financial risk to a mom and pop shop, and in some cases they are hesitant to do that, which we understand. Even for some of the well-funded larger OMPs, there is a sort of a financial risk aspect that we are having to help them navigate. And then finally, as we think long-term, where every stroke patient, early in the stroke journey, obviously the first week or so you're trying to stabilize and figure things out. If you end up with hemiparesis, the next few months is fairly intensive therapy regime. It's kind of the beginning of the stroke journey. As we look into the future, and we want every stroke patient to be introduced to the MyoPro very early in the stroke journey, that's a big step to take. Can the COEs take that on their own? Do they have sort of the marketing ability, willingness, and salesmanship to help us get to that point? We don't know. We will get there. The question is, along that path to get there, how much of the lifting are we doing? How much are we doing with the COEs, and how much are they able to do on their own? And again, we're so early in this that we don't know exactly what that's going to look like yet. So high level for an O&P to get certified on our product. It starts with several meetings and them needing to commit. In almost all cases they do, although we have had a handful of O&Ps who have chosen not to proceed even after the initial conversations. After that, they do an initial remote eval training, same thing we began offering last year where they kind of begin to understand a little bit more about how a stroke patient presents and what it would involve working with our product. After that when we kind of get to the the top row far far right and that's when the really their time commitment really you know we when we come to their site we're going to be there for a couple days we require that they have multiple patients with good payers so it might get funded ready for us before we get to their facility. We also ask, since we're going to be there, line up some in-services, so something like a room like this, but full of therapists, so that while we are there, we can also do an in-service for their current referring therapists to help them. So that's our eval certification day one. The idea is we let a lot of therapists know about this local clinic that's carrying the MyoPro, but we are with them there by the way, so that they can continue getting referrals from those therapists, build their pipeline even above the few patients that we're seeing together when we're with them. Then we leave, they go back to their regular work, and once they have authorizations and they're ready to deliver the myopros, then we come back for fitting day one. Fitting day one, there's training before, training during the fitting, training after. Fitting day one, we kind of do most of the work. Fitting day two, we sort of share the work. Fitting day three, they do most of the work while we are observing, followed by a test. It is likely that in most cases fitting day one is a month before fitting day two, a month before fitting day three. So sort of this journey from a COE committing to us going with them, each patient, and again we're investing to make sure that their clinical care is appropriate for the myoprobe. This journey is going to take some time. Fitting day one, we're selling them a product, and they're getting reimbursed. Fitting day two and three, they are also buying the product from us, but once they're fully certified that's when we're hands-off and they're placing orders and we're shipping product and that's when it starts to get exciting for us when we have more and more certified COEs. We began this process just when we launched the 2x end of April early May and we found that most weeks we are initiating the certification process for multiple O&Ps each week as our clinical team has grown as well.