Everyone, this is Myomo. We are a wearable robotics company whose mission is to conquer upper extremity paralysis. Our disclaimer about potential forward-looking statements that might be made today. In terms of our strategic positioning, we have created a new product category with the MyoPro Myoelectric Orthosis. We are the only company in the U.S. with billing codes L8701 and L8702 that can bill Medicare or any other payer, private payer, for this device. That first-mover advantage we have is in a large and growing market, and we have a very strong competitive position. Not only can we bill private payers, but we are also now covered by Medicare, and we are an accredited Medicare provider ourselves.
We're unique in the fact that we are not only the manufacturer of the device, but we also are the direct provider, and we'll bill Medicare for serving that patient. We're also getting new contracts, which I'll explain, in an effort to expand patient access and to make getting insurance authorizations easier. We've instituted a program towards the end of 2025 called MyoConnect, which is the fulcrum for a program where we're trying to increase our revenues from recurring patient sources. We're doing that in order to scale the company easier and to have less reliance on advertising-driven revenues. I'll talk about that more. On top of that, we have a very attractive margin profile. Gross margin is in the high 60%s, approaching 70%, with opportunities to scale. That being a key objective for 2026 to generate operating leverage, which I'll talk about further.
What are the causes of arm and hand paralysis? The major diagnosis is stroke. Other diagnoses include traumatic brain injury, spinal cord injury, or a brachial plexus injury, which is a damage to the nerve that runs down your shoulder. Other diagnoses include cerebral palsy, and MS, ALS as well. This is a large market opportunity, and I'll focus on that larger triangle there on the right. There is a prevalence population of about 1%. 1% of the people in the U.S. have had a stroke. That's roughly 3.8 million people who are suffering from upper extremity paralysis. We narrow that population down by surviving patients that are in assisted living. Those people are not going to be good candidates for the device. You need to be at home and ambulatory, and wanting to be mobile and participate in activities of daily living.
You also need to meet our medical conclusion criteria. You can't have severe spasticity in your arm. We don't want to hurt you if you're putting on the device. You also need to carry appropriate insurance. Some insurance companies just aren't paying for it. It's difficult to get Medicaid coverage, for example, because it's each and every state. When you narrow all that down, there's about 400,000 to 800,000 patients in the U.S. at any one time that may qualify for a MyoPro. You can see that is a large potential market. We're also talking about the incidence population, and something that we're now focusing on. The prevalence population we've been targeting primarily through direct-to-patient advertising. We're now putting resources into trying to serve patients in that incidence population. The incidence population, there are 800,000 people every year that have a stroke.
About one-third will die, about one-third will fully recover, and the remainder will be left with some type of upper extremity impairment. Using the same narrowing criteria I just talked about, that leaves about 40,000 patients-80,000 patients a year that could be potentially served immediately after their stroke and after they've completed therapy, and they're left with upper extremity impairment for the rest of their lives. Just looking at that population alone, forgetting about the prevalence population, at a $50,000 ASP, that's a couple of billion-dollar market opportunity annually. We're one of the only companies in the U.S. that has an orthotic brace that can serve this market. I talked about recurring patient sources and those efforts. Again, to focus on that incidence population, once you have a stroke, then you go into acute and sub-acute care.
That could take up to one week to six months. You're getting inpatient therapy, when you are trying to treat the effects of your stroke. After that, you might go into outpatient therapy. This is where we might run into you in the MyoConnect program. Once you've completed that therapy, and you still are left with upper extremity impairment, our team of clinicians that are out there in the field, also some clinical salespeople that we've hired at the beginning of this year, out there trying to generate referrals, and not spend advertising dollars in order to generate revenues.
Our primary source of revenues has been that prevalence population, which are people that are 12 months or more post-stroke. One good thing about focusing on that incidence population and looking to generate referrals is that the people in that incidence population, they're closer to their pre-stroke life. They remember what it's like to be able to use their arm. They might be more motivated, and they also should have fewer contraindications than we see in that chronic population who could be years post their stroke and have had the opportunity to develop some of these contraindications that could prohibit them from using a MyoPro. There's a multiple of good reasons why we are trying to move into and start to target people in that incidence population. I mentioned reimbursement earlier.
We have two HCPCS codes that we are the only company in the U.S. right now that can bill under those two codes, L8701 and L8702. Those codes were issued in 2019, we were initially coded as a rental. It took five years to get that corrected by CMS, beginning January 1st, 2024, we got lump sum reimbursement. We were classified as a brace, I should say, and then in April 2024, a fee was posted for lump sum reimbursement. That fee, as of right now, January 1st, 2026, is $68,800 for the Motion G and $34,970 for the Motion W. The Motion G allows you to also bend your arm at the elbow and to grasp objects. That is our highest-selling device, probably 95% of our revenues. I mentioned that we have Medicare coverage. That means Medicare Advantage plans.
They're required to follow Medicare coverage guidelines, but because there's no local or national coverage determinations, they're allowed to apply their own policies, their own coverage policies, which is what they use to deny. We apply all the pressure that we can to try to increase their authorization rates, but this is something that is not just a Myomo issue. This is everybody in the healthcare industry dealing with Medicare Advantage plans. We have entered into contracts with commercial payers. I'll talk about that a little bit more in just a second. Those commercial payers cover 80 million lives, and then more than 100 VA medical centers have ordered MyoPros. Talking about market access and covered lives, I mentioned just recently that we entered into a contract with Elevance in the first quarter. Elevance is actually a multi-state arrangement.
Elevance operates the Anthem Blue Cross and Blue Shield plans in about two dozen states, about 45 million covered lives. We're working right now to enter into these state-by-state contracts, which we expect to complete by the end of the second quarter. When you add that to other contracts that we have entered, plus the Medicare population, we are in network with about 158 million covered lives, which makes reimbursement a bit easier, and I'll talk about that in just a bit. I'm going to show a couple of videos here of what it's like for patients to be able to move their arm again with the MyoPro.
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You can see that's some of the things you can do with a MyoPro. It's an assistive device that allows people to perform activities of daily living. Try doing some of those things with just one arm. Here's another example of someone who's using the MyoPro just to work in his garden. These are things that you take for granted. For these people, these represent meaningful improvements in their lives.
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Let's talk about the device and sort of how it does what it does. Think of this as sort of a brain-computer interface. The brain emits what's called an electromyogram signal that goes from your brain, and it moves through your muscles. That's what tells you to move your arm, move your leg, what have you. We have developed through MIT in conjunction with also Harvard Business School or Harvard Medical School. We have non-invasive sensors that sit on the surface of the skin. These sensors sit on the bicep, the tricep, and both opposite ends of the wrist. Those sensors will pick up that electromyogram signal going through your arm, amplify that signal up to 100,000 times, and through amplifying that signal, it will activate motors and allow you of your own volition to move your arm or to grasp objects.
This is very empowering for patients. This technology is covered by 35 patents in the U.S. and internationally. The longest of those patents goes out to 2042. We are currently selling the MyoPro 2x that we launched in 2025. That was an updated version of our prior product, the MyoPro 2, which enables improved donning and user experience overall. In addition, just this year, we introduced what's called the Myomo Mobile App. You can go onto the App Store, download the app.
What that app does, though, is it allows the patient to be able to view our myConfig software, and it allows a therapist to help a patient get the best use of the device, and they can do it over their phone, and we no longer have to provide a laptop computer, and we're saving about $400-$500 a device by doing that. The MyoPro is supported by a growing body of clinical research. We had an outcome registry, and we reported on some of the results from that, and also did a retrospective study looking back at Medicare-aged patients specifically. Both of those studies showed a statistically significant and clinically meaningful improvements in upper extremity function from the MyoPro.
These were studies that were done prior to CMS deciding to change our classification to a brace, and then to reimburse and post fees for the MyoPro. We think that these studies helped in that process. Later in 2025, there was a retrospective study that was conducted, a systematic review, looking at, in general, the use of a myoelectric orthosis after stroke, with similar results to what I just mentioned. Right now, we're also conducting the highest level of research, a randomized controlled trial that's underway at the University of Utah. That trial will include 50 subjects, 25 of which will have a MyoPro, and 25 will receive therapy only. We will be testing against validated outcome measures, measuring the ability to perform activities of daily living.
The purpose of that study will be to use that to go to CMS and to the Medicare Advantage players, and to convince them that their coverage policies are wrong and maybe improve the reimbursement rates for the MyoPro. Let me talk about our go-to-market approach. This represents our direct billing channel, which is about 70% of our revenues. It starts with generating a lead that will come either from TV or social media or increasingly now through referrals from places like Spaulding Rehabilitation or Shirley Ryan AbilityLab. Those patients will be first met by someone in our customer experience department.
In that department, they'll talk to you on the phone, they will check to see what insurance you have, and if you have the appropriate insurance, you pass the first screen, and they will ask you if you want to move to a Doxy waiting room where a telehealth screen will be conducted by one of our patient eligibility specialists. During that telehealth screening, which will take about 30 minutes, we'll check what you're able to do moving your arm, what you're able to do with your hand, also check your cognitive abilities and see if you could be a potential candidate for a MyoPro. If you pass that screening, then we'll move you along into the reimbursement process. You've now become part of our pipeline.
One of our patient navigators will then be in contact with you, where we will encourage you to get a face-to-face visit with your physician, and then to collect your medical records and receive a prescription from that physician. Once we have those things, if you're a Medicare patient, we can go ahead to proceed to provide you the device. No prior authorization is required. If you have a Medicare Advantage or other commercial insurance, we will need to get pre-authorization in order to provide you the device. Once we receive that, we'll go ahead and custom fabricate the MyoPro. Each MyoPro is customized for each patient. Once we have that authorization approval and the ability to deliver you a device, we'll take measurements of your arm. We'll do that either remotely or in person.
Those measurements, you can see those purple orthotic pieces there, those are 3D-printed through a third-party contractor we use, though we are going to be insourcing that activity in 2026 as a further cost reduction measure. This device is custom fabricated for each patient. Once that device is then fabricated, completed, we then provide it to one of our licensed certified prosthetist orthotists out in the field, there's about 12 of them or so, who are licensed to provide the MyoPro to patients. That's then fitted. You would then be sent to a therapist, and that therapist will help you learn how to use the device.
That therapist has been trained by one of our, what we call our MyoCare coaches, that are out there, and then we'll also support you after delivery as well, just to make sure that you're getting the best possible outcome from the device. That 70% of our revenue I mentioned starts with lead generation. Here's an example of one of our television ads.
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That's just an example of one of our television ads. We're seeing good success with some of those ads that we're now showing. We primarily show those ads on places where our patients are most likely to be watching TV, comfort TV, Bonanza reruns, I Love Lucy reruns, for example. That and advertising on social media, those are the ways that we bring in patients, in addition to referrals, into our direct billing channel. Talking more about some of the other channels, we're also working closely with O&P providers around the country, including Hanger Clinic, which is the largest. Others like Limb Lab and others. We'll provide them the device as well. We like being just the manufacturer. We're not taking on reimbursement risk. It's good contribution margin when doing so.
Through our MyoConnect program, we can either handle that patient ourselves through our direct billing channel, or send them along through to one of our O&Ps, our centers of excellence, who we spent a lot of time training. There's hundreds of them now that are trained around the country, and we're starting to see growth in our O&P revenues, which I'll talk about in just a second. Our strategy direction and four success pillars for 2026. We're shifting to recurring revenue sources, including our MyoConnect program. We define those recurring sources as referrals from stroke centers or other therapy clinics. The O&P channel in the U.S. and in Germany, and then VA hospitals in the U.S. Those aggregate to our recurring patient sources. We're also looking to increase market access and add additional payer contracts. I mentioned the ones earlier, particularly the most recent one with Elevance.
We're trying to demonstrate operating leverage. We want to grow revenue at 1/2, or grow operating expenses at 1/2 the rate of growth of revenue for 2026. That is our guidance. Also cut the cash burn in 1/2. Finally, while we're demonstrating that leverage, continue to invest in product development and research. I talked about the RCT that we're funding through the University of Utah. We're also in development with the MyoPro 3, which we will be looking to introduce maybe sometime late in 2027 or maybe sometime shortly thereafter. Looking at our revenues, we've had good, solid revenue growth since our IPO in 2017. We had $40.9 million of revenue in 2025. Our full year guidance for 2026 is a range of $43 million-$46 million. When you look at our P&L, $10.1 million of revenue in the first quarter.
As I mentioned, that was up 3% year-over-year. Gross margin, 68.2%. That was up 100 basis points year-over-year. The operating loss was $3.2 million. That was down compared to same quarter a year ago. I also mentioned earlier that operating expenses, you can see that they were down slightly year-over-year. The net loss was $3 million compared to $3.5 million in first quarter of last year. In terms of the balance sheet, $15.7 million of cash on hand at the end of the first quarter. We burned about $2.7 million. We have $12.5 million of debt. That's 11.75% debt through Avenue Capital. It's interest-only until May of 2027, where we start to begin to pay principal in 24 equal monthly installments. We also have the ability to access another $5 million that has already been committed.
The ability to access that additional $5 million, which is at our discretion, begins in November of 2026. I mentioned recurring patient sources. Those sources in the first quarter represented 49% of revenue. Direct billing referrals were 20%, international was 20%, the U.S. O&P channel was 8% of revenue, with the VA being remainder. Our goal for the full year was to get to 50% by the end of Q4 2026. It looks like that we might get there earlier than that. Key metrics to keep focused on are pipeline and authorizations and orders. The pipeline stood at 1,680 patients, with 250 Medicare patients. That's up from 1,482 patients at this time a year ago. Medicare patients were about flat. They moved through the pipeline more quickly because there is no reauthorization required.
First quarter of 2026, we had 239 authorizations and orders, and a backlog of 226 patients, which was up over fourth quarter. You can see that the backlog, our book-to-bill ratio, which is backlog divided by revenue units, and people that drop out of the backlog, was above one for the first time in several quarters, which I think is a good sign of the health of the business here going forward. Now, going back to those pillars really quickly, updating on where we were on our success. First quarter, we had 49% of our revenues coming from these recurring sources, up from 25% a year ago. Talking about market access, we're entering into these new state-by-state contracts with Elevance. I just talked about the operating leverage, 3% revenue growth versus the prior year. OpEx was 1% lower. Gross margin was up 100 basis points.
Net of all that, adjusted EBITDA was improved by 20% compared to the prior year. The RCT is in process and moving along nicely. 18 subjects have been enrolled so far. Out of the 50 total, we expect to have everybody enrolled by the end of the year. Here is our management team and board of directors. I'll just mention, Paul is our CEO. He's out in Germany this week at the largest O&P conference in Europe at OTWorld. Two new board members have been added, Will Febbo, who is CEO of a privately held Performance Health Systems. Prior to that, he was CEO of OptimizeRx. Joe Manco, who is a Senior Principal at Horton Capital Management, one of our largest shareholders. With that, I will stop the presentation.
I think there's a few minutes left where Joe or Jim can ask me some questions.
Great. Thank you, Dave. It seems like getting that Medicare reimbursement had a pretty significant impact, especially on revenue. Has it also helped you get reimbursed from some of the private payers?
Well, it's supposed to work that way for Medicare Advantage, but Medicare Advantage can use their coverage policies to deny coverage. The way that that stops is through either a local or national coverage determinations. Because of that, we do everything that we can in our direct-to-patient advertising and also through our referral activities to try to find as many Medicare patients as we can. Medicare patients represented 51% of revenue in the first quarter, and we would like to see that percentage go higher.
A couple of times in the presentation, you mentioned your goal to increase the percentage of revenue from the recurring patient sources.
Yeah.
Why is that such a key for you?
It's a key because the contribution margin in those channels that are those recurring sources is higher. That will enable us to scale more easily than relying on advertising driven revenues, because you have to spend advertising dollars six months-nine months in advance of getting the revenue. You have all the other associated clinical costs with it. If we can generate referrals, that will assist our direct billing channel because we are not spending the advertising dollars for those patients. Getting referrals, when you take the advertising driven direct billing revenues compared with direct billing revenues through generating referrals are higher contribution margin. The O&P channels in the U.S. and Germany are also higher contribution margin because we're not spending those advertising dollars.
Those recurring patient sources, those are your most profitable patients, it sounds like.
Yeah. That's the reason we're doing this, to improve the operating leverage, enable the company to scale faster, and to get to cash flow break-even faster.
What revenue level do you need to achieve for that cash flow?
I think, yeah, assuming that we're not making major changes to our cost structure, as long as we're on the same trajectory we're on, about $60 million of annual revenue, maybe $15 million a quarter, is that cash flow break-even point.
You're approaching that level pretty quickly.
Yeah. Our guidance would suggest that we're going to have higher than $10 million quarters here in the coming quarters to get to $43 million-$46 million for the year. Making progress towards that objective.
I guess brand awareness of the product is really a key. If I were to go to an O&P center or talk to a rehab therapist, how likely is it that they know about Myomo at this point?
I think certainly much more likely than they were a year ago. We're making great strides. There are maybe 150 now clinics that we have conducted screenings for, trying to generate referrals. We've trained hundreds of O&P practitioners around the country. I think the knowledge level of the MyoPro has greatly increased.
All right. Well, we're just about at time. Actually, we are at time. Are there any final comments you want to make before we?
No, I think in the short time, you asked some good questions, and I think clarified the fact that our focus is on both growing revenue and getting to cash flow break even as quickly as we can.
All right. Well, I know we kept you busy yesterday and today with meetings. We appreciate that. Appreciate everybody for tuning in today as well. Thank you, Dave, and hope to hear from you soon to get an update.
All right. Thank you. Bye-bye.
Bye-bye.