Myomo, Inc. ($MYO)
Earnings Call Transcript · March 9, 2026
Earnings Call Speaker Segments
Operator
OperatorGood day, and welcome to the Myomo Fourth Quarter and Full Year 2025 Financial Results. [Operator Instructions] Please note, this event is being recorded. I will now turn the conference over to Mr. Tirth Patel with Alliance Advisors IR. Please go ahead, sir.
Tirth Patel
AttendeesThank you, operator, and good afternoon, everyone. This is Tirth Patel with Alliance Advisors IR. Welcome to the Myomo fourth quarter and full year 2025 financial results conference call. With me on today's call are Myomo's Chief Executive Officer, Paul Gudonis, and Chief Financial Officer, Dave Henry. Before we begin, I'd like to caution listeners that statements made during this call by management, other than historical facts, are forward-looking statements. The words anticipate, believe, estimate, expect, intend, guidance, outlook, confidence, targets, project and other similar expressions are typically used to identify such forward-looking statements. 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 Myomo's business, financial condition and operating results. These risks, uncertainties and other factors are discussed in Myomo's 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, Myomo undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call today, March 9, 2026. It's now my pleasure to turn the call over to Myomo's CEO, Paul Gudonis. Paul, please go ahead.
Paul Gudonis
ExecutivesThanks, Tirth. Good afternoon, and thank you all for joining us today. During our last quarterly call, I outlined four major objectives for the company: One, continue to grow revenue through our direct-to-patient marketing as well expand the number of orders from recurring sources, namely the orthotics and prosthetics channel and the MyoConnect referral program. Number two, increased market access for patients by signing additional payer contracts and engaging with Medicare Advantage and commercial plans for coverage. Number three, manage our cost structure and enhance our manufacturing processes to demonstrate operating leverage as we scale; and number four, continue to innovate in product development to maintain our market leadership position. I'm pleased to report that we've made progress on all four of these objectives. Fourth quarter of 2025 was our strongest revenue quarter of the year with $11.4 million in revenue. This brought our full year revenue to $40.9 million, representing 26% growth over 2024. We also recorded the highest number of orders in the company's history with 241 MyoPros ordered during the quarter, up 5% sequentially from the third quarter. This growth was driven by expanded penetration of the O&P channel, the early success of our MyoConnect clinical referral program and stronger international revenues. Over the past year, we launched the MyoPro Center of Excellence program to educate domestic O&P practices on the new MyoPro 2X product and the improved reimbursement environment. O&P providers from national and regional chains to local independent practices ordered approximately 100 MyoPros last year. In addition, quarterly revenue from the U.S. O&P channel exceeded $1 million for the first time and our revenue from the O&P channel was up 81% for the quarter, and it doubled for the year. To capitalize on the clinical relationships we've developed with therapists at rehab hospitals across the country, we established the MyoConnect program to engage therapists and physicians and referring medically qualified patients to Myomo and our O&P partners. In just the first six months of this program, we've had over 100 qualified candidates enter our patient pipeline and referrals were nearly 10% of total pipeline adds in the fourth quarter. We'll continue to lean into the MyoConnect program in 2026 as we focus on growing revenues from recurring patient sources. MyoConnect makes sense for clinicians since they want better outcomes for their patients, and these rehab hospitals will continue to provide therapy and training support based on the MyoPro protocol. This strategic pivot to recurring patient sources is already evident in our results. Back in the fourth quarter of 2024, 26% of our revenue came from recurring sources. By the fourth quarter of 2025, that figure had increased to 42%, representing 52% year-over-year growth. Supporting above revenue initiatives is a revised marketing plan that's raising awareness of our products to health care professionals and further optimizing our digital marketing to patients. We believe these initiatives, along with better insurance coverage will reduce our acquisition cost per customer. Our international operations delivered quarterly revenues in excess of $2 million for the first time, growing 46% for the quarter and 48% for the year. The increase was due to growth in the patient pipeline, more O&P clinics and medical professionals sourcing patients for MyoPro, favorable reimbursement policies from statutory health insurers and some foreign exchange tailwinds. We're adding more business development and clinical staff to our team in Germany, and we expect continued growth in that market in 2026. However, Over in China, we became aware toward the end of the year that the majority shareholder in the joint venture, Ryzur Medical, ran into financial problems in its core rehab hospital business and declared bankruptcy. As a result, operations in the JV company are on hold at this time. As you may recall, we received $2.7 million in upfront license payments a few years ago, and we're now working with Chinaleaf Ventures, a major investor in the JV to see if the venture can be recapitalized and restructured, so they can address that very large market opportunity in that country. Our market access strategy here in the U.S. continues to gain traction, and we've signed in-network contracts with additional Medicare Advantage and commercial payers in the past several months. Most notably, we recently reached a multistate agreement with Elevance Health, which allows us to begin executing state-by-state in-network contracts across their network, which covers 45 million lives. This represents our first such extensive payer arrangement, which provides for case-by-case authorization. This is significant since we are seeing an increasing number of authorizations from plants where we have a contract. Since we have these agreements on pricing, we don't have to go through a lengthy single-case agreement process, and that speeds up the patient's access to MyoPro and our revenue cycle. Our third major initiative is to manage our cost structure, and we've taken steps to increase our organizational efficiency, reduce the cost of outside services and continue to drive down material costs for manufacturing MyoPro units. We're becoming more efficient while investing in critical R&D projects to build on our market leadership. In Q2 of this year, we plan to activate the Myomo mobile app for patients and clinicians which is now available as a free download in the Apple and Google app stores. That provides enhanced capabilities and data collection for users, allowing us to reduce the cost of goods sold by eliminating the need to ship a laptop, including our proprietary software to each MyoPro user. Meanwhile, we expect to roll out other enhancements this year, while developing the next-generation MyoPro 3. Another R&D investment we're making is in a randomized controlled trial that's being conducted by the University of Utah Rehabilitation Hospital, and this is expected to add to the growing body of research publications, including the two that were released last year. So in summary, we're making significant progress in our strategic pivot to recurring patient sources, an increased number of insurance authorizations and O&P channel orders and a lower cost structure as we intend to cut the cash burn in half in 2026. With that overview of our results and actions, I'll turn the call over to our CFO, Dave Henry, to provide more of the financials and details.
David Henry
ExecutivesThank you, Paul, and good afternoon, everyone. As Paul mentioned, we saw full year revenue growth of 26%, driven by growth across all of our sales channels, led by the U.S. O&P channel and international, which both had record quarters. Revenue for the fourth quarter of 2025 was $11.4 million, which was our highest revenue quarter this year, up 13% from the third quarter of 2025, but down slightly versus the prior year period. The year-over-year decrease was driven by a lower number of revenue units and a slightly lower average selling price or ASP. In addition, in the fourth quarter of 2024, we experienced stronger Medicare Advantage revenue and fill demand for Medicare patients after beginning to cover the MyoPro earlier that year. We delivered 208 MyoPro revenue units during the quarter, down 5% year-over-year, but up 12% sequentially. 62% of fourth quarter revenue units were generated from authorizations received during the quarter. In addition, our ASP decreased less than 1% versus the prior year to approximately $54,600 due primarily to channel mix. Medicare Part B patients represented 49% of revenue in the fourth quarter. Medicare Advantage patients represented 20% of fourth quarter revenue and in dollar terms was down 11% compared to the prior year quarter. As I'm sure you have seen with other companies, it's been a challenging year dealing with Medicare Advantage payers, who have constrained us by issuing a high number of pre-authorization denials, necessitating an appeals process in order to serve these patients. We have and will continue to fight these denials to make our product available to patients who are in need. As we enter into more payer contracts, we are seeing more authorizations under those agreements, but not enough so far to replace the volume from payers that previously authorized more routinely. We continue to work to secure more payer contracts and are encouraged by our first multistate payer arrangement with Elevance. 69% of revenue in the fourth quarter came from the direct billing channel compared with 81% in the prior year quarter. Direct billing revenue was down 20% year-over-year due to lower Medicare and Medicare Advantage authorizations and challenges with social media lead generation we faced in the first half of 2025. Partially offsetting lower direct billing revenue were solid results in our other sales channels. International revenue was a record $2.2 million, up 46% year-over-year, representing 19% of total revenue primarily from Germany. The U.S. O&P channel also achieved a milestone, reaching a record $1 million in quarterly revenue, up 81% year-over-year and representing 9% of total revenue. Recurring patient sources, including referrals under our MyoConnect program, International, U.S. O&P and the VA represented 42% fourth quarter revenue. As of December 31, 2025, the pipeline stood at 1,528 patients, an increase of 10% year-over-year. During the fourth quarter, we added 676 patients to the pipeline which is up 3% from the prior year quarter. We exited the quarter with a backlog of 199 patients, a record 241 orders in the quarter, combined with the smooth running operations, resulted in a record 62% of fourth quarter revenue units coming from intra-quarter fill units, up 35 -- up from 35% of revenue units a year ago. Gross margin for the fourth quarter of 2025 was 68.6%, down from 71.4% a year ago and up from 63.8% in the third quarter. The year-over-year decrease was due to a lower amount of overhead capitalized inventory compared to the prior year period and higher warranty expenses. Operating expenses for the fourth quarter of 2025 were $10.6 million, up 19% over the prior year quarter. This increase was driven primarily by higher sales, clinical and marketing expenses, particularly advertising expense, which was up approximately $1.2 million year-over-year. Advertising spending in the fourth quarter was down 4% sequentially. Operating loss for the fourth quarter of 2025 was $2.8 million compared with an operating loss of about $200,000 in the prior year quarter. Fourth quarter non-operating expenses include a onetime write-off of debt issuance costs, cash interest expense under the Avenue term loan, noncash interest expense for the amortization of discounts on the debt and a loss on the change in fair value of derivative liabilities bifurcated from the debt on the issuance date and recorded as separate liabilities, which must be mark-to-market at fair value each quarter. Net loss for the fourth quarter of 2025 was $3.8 million or $0.09 per share. This compares with a net loss of $300,000 or $0.01 per share for the fourth quarter of 2025. Adjusted EBITDA for the fourth quarter of 2025 was a negative $1.9 million compared with a positive $200,000 for the fourth quarter of 2024. Before I move to the balance sheet, let me give you a quick summary of some selected full year results. As I mentioned, revenue was $40.9 million, up 26%. Gross margin for the year was 65.7%, compared with 71.2% for 2024. Decrease was due to higher overhead costs primarily due to our facility move earlier this year. Investments in R&D, which resulted in the launch of the MyoPro 2X, our marked 2 unit and progress on the MyoPro 3 in 2025 as well as higher sales and marketing expense, drove the increase in operating expenses to $41.3 million in 2025 compared with $29.4 million in 2024. Turning now to our balance sheet and cash flow. As of December 31, 2025, cash, cash equivalents and short-term investments were $18.4 million. Cash burn, which we defined as free cash flow was $1.5 million in the fourth quarter, excluding the net proceeds from the Avenue term loan, repayment of the debt to Silicon Valley Bank and issuance fees and expenses. Operating cash flow was a negative $1.1 million in the quarter compared to a positive $3.4 million in the fourth quarter a year ago. Let me conclude my remarks with financial guidance. As Paul mentioned, we are approaching 2026 a year, where we orient our business more towards strong patients in the incidence population and recurring patient sources through our MyoConnect referral program, increasing engagement with the U.S. O&P channel as well as continued international growth. Our near-term objective to generate a majority of revenue from recurring sources is expected to make the business easier to scale. To fund this transition, we will continue to advertise direct to patients, but limit the growth in advertising spending, while building out our MyoConnect program and adding direct sales resources to support the O&P and international channels. As a reminder, first quarter revenue tends to be seasonally lower and expenses higher with payroll taxes and employee benefits resetting. In line with this historical seasonality, first quarter revenue is expected to be in the range of $9 million to $9.5 million, with sequentially lower revenue and operating expense is expected to be slightly higher sequentially, we expect first quarter operating loss to be higher than fourth quarter 2025. For 2026, we expect revenue to be in the range of $43 million to $46 million. We expect gross margin to benefit from higher volume and lower cost of goods sold per unit as well as a 2% Medicare price increase effective January 1, 2026. In addition, we expect to generate operating leverage and limit the growth of other operating expenses. We expect to limit the growth of OpEx to half the growth of revenue in 2026. With gross margin expected to increase in 2026 and operating cost management, we expect a lower operating loss in 2026 and that cash burn or free cash flow will be reduced by roughly half in 2026 compared with 2025, driven by the higher revenue and gross margin, partially offset by investment in R&D and sales and marketing as well as interest expense on our debt. We are committed to growing the top line, while prudently investing in the business. With that overview, I'll turn the call back to Paul.
Paul Gudonis
ExecutivesThanks, Dave. To summarize, in 2025, we saw a 26% revenue growth. We launched the MyoPro 2X. We invested in developing the next-gen MyoPro 3. We generated several million dollars in orders from the new O&P channel, and we grew the recurring revenue portion of our business by over 50%. We also expanded our addressable market by engaging patients right after their stroke, while they're still in the rehab centers in addition to the large prevalence population with chronic arm paralysis. For example, we just provided a MyoPro to a 36-year-old male, who had a stroke last year and was referred to us by his therapists. With our contract with his Blue Cross Blue Shield plan, it was quickly approved for the device and received it within a year of the incidence of his stroke. As we look ahead to this year, we plan to continue this go-to-market transition, reduce our customer acquisition costs and demonstrate that operating leverage with a lower cost structure. While the untapped market for our product remains vast with hundreds of thousands of potential patient candidates representing a large long-term opportunity given our sales and marketing transition and the uncertainty around the behavior of the Medicare Advantage payers, we believe it's prudent to be conservative and guide to approximately 10% revenue growth with improvement in adjusted EBITDA. We're looking forward to updating you on our progress as the year unfolds.
Operator
OperatorWe're now ready to take your questions. Operator?
Operator
Operator[Operator Instructions]
Paul Gudonis
ExecutivesI was going to say while we're waiting for the first question, I do want to mention that we're planning to host another Investor Analyst Day for an update on the business, and we'll provide details on this event at a later date. We hope to speak with many of you there. Okay. Operator, let's go with the first question.
Operator
OperatorThe first question will come from Chase Knickerbocker with Craig Hallum.
Chase Knickerbocker
AnalystsMaybe just first, you noted progress on MyoConnect, though cost per pipeline add increased in the quarter. Can you just detail what maybe drove that up in the quarter? And then can you talk about kind of the plan on the direct side of the business to kind of get that acquisition cost down?
Paul Gudonis
ExecutivesThanks, Chase. So the MyoConnect program is gaining traction. We're getting these referrals, and there's no advertising cost around that. Fourth quarter, as we've mentioned in the past, tends to have a higher advertising cost because they were competing with holiday advertising, there may be election cycles in some cases. So our pipeline adds when you divide it by -- into the advertising costs were higher than we like. And so what we've done is we brought on a new head of marketing. She started at the end of last year. We brought on a new digital marketing agency in January. They've gotten started revamping our digital marketing approach and social media. We've introduced new TV creative for that advertising, and we've seen the cost per call go down. So we expect that all these different actions should take down that cost per pipeline add over time, especially with more referrals where there's zero advertising costs associated with it.
Chase Knickerbocker
AnalystsHave you seen any of that improvement so far as we kind of came into Q1?
David Henry
ExecutivesWell, we're not really discussing Q1 at this time. I will say, though, it is kind of a little bit early. I mean the ad agency just really started, I would say, within the last 6 to 8 weeks, really starting to do their work. So it's a little bit too early to talk about results at this time. I think we'll give you a better update when we report in May our first quarter results.
Chase Knickerbocker
AnalystsGot it. Maybe just a couple of more details on the O&P channel, if you would. Can you give any sort of kind of KPIs around kind of ordering number -- like number of clinics that ordered in the quarter, some sort of active account number? And then can you just give us the number of units through the O&P channel in Q4? Was ASP kind of solid there Q3 to Q4?
Paul Gudonis
ExecutivesWell, we've got a couple of dozen O&P providers that have been trained, certified and ordering the MyoPros, and we had over $1 million of revenue in the quarter. And so on an average price there, some 30-some units, Dave?
David Henry
ExecutivesThat was about 36 O&P units in the fourth quarter.
Chase Knickerbocker
AnalystsGot it. And then maybe just the last one for me. Just on 2026 guidance. Can you just kind of detail what your assumptions are there for that U.S. O&P business as far as what it will contribute to that 2026 guidance?
David Henry
ExecutivesWell, we're expecting growth in the in the O&P channel and in international, that's what's going to drive the growth this year. I think direct billing is going to be relatively flat if you look at it. And that's because it's just we're too soon into these marketing changes to really have some conviction that -- and to say that direct billing is going to grow, we're trying to limit the amount of spending on advertising because we are trying to -- we've seen the results in the last half of 2025. And the cost per pipeline adds is unacceptably high. And so we have to -- we need to see that being addressed before we'll decide to spend more money on advertising beyond what we're already spending. So -- and then the MyoConnect program is kind of really ramping up. And so there's some just uncertainties -- some uncertainty as we see -- as we wait to see how these marketing changes will flow through and to get some better visibility on what that channel might look like for 2026. But we're working really hard to grow those recurring patient sources because, as Paul mentioned, the cost per pipeline add there is minimal, and we're all about trying to increase operating leverage, reduce cash burn, while at the same time, growing revenue in 2026.
Operator
OperatorThe next question will come from Scott Henry with AGP.
Scott Henry
AnalystsStarting from the top of the funnel pipeline adds, 676 is a little lower than it's been in the past couple of quarters. Do you see that as an aberration? Are you getting higher quality adds? Or alternatively, should we see that bounce back towards some of the higher levels we saw in the middle of the year.
David Henry
ExecutivesYes. I think the key will be the success of MyoConnect to generate some pipeline adds. We're not going to spend more on advertising. We're going to try to keep that spending relatively flat year-over-year. So that's where the sources are going to come from. We did have, you're right, 676, it was a little bit lower. I will say, though, that we did shut down for about -- in the last 9 days or so of 2025. So that did have a little bit of effect on pipeline add generation. We had about two less weeks in the fourth quarter compared to the third. So like I said, I think it's -- we're really looking to see the MyoConnect program gain some traction and try to bring more pipeline adds at a much reduced cost per pipeline add here in 2026.
Scott Henry
AnalystsOkay. We'll continue to track that. Also, the dropout rate, I think by my calculations, was around 40%. I guess that could change a little bit depending on how you calculated it. A little bit higher, not dramatically higher than past quarters, but any comments on that rate?
David Henry
ExecutivesThis is the backlog drop rate, correct?
Scott Henry
AnalystsYes.
David Henry
ExecutivesYes. It was about -- my calculations is a little over 20%.
Scott Henry
AnalystsOkay. The trend should be the same depending -- I'm just backing it out of the reimbursement pipeline. If you add all the adds and you subtract the units placed, you come up with a number...
David Henry
ExecutivesI guess you're talking about a pipeline drop, right, then?
Scott Henry
AnalystsYes.
David Henry
ExecutivesOkay. Yes, I was referring to backlog, sorry.
Scott Henry
AnalystsNo.
David Henry
ExecutivesAnd I haven't calculated the pipeline drop rate. So I'll take your word orders around that. I mean there's...
Scott Henry
AnalystsIt's a little bit higher than...
David Henry
ExecutivesYes, the overall pipeline is -- the pipeline did decrease and a lot of that was probably because of drops. There's been a lot of Medicare Advantage patients that have been accumulating in the pipeline that we're having. They're making it hard on us to get authorized. And as a result, a lot of them -- we're seeing a lot of dropout as a result of that.
Paul Gudonis
ExecutivesOn the other thing, Scott, what we are seeing is, especially from the referring therapists because we've encouraged them to check insurance and so on, we're seeing more Medicare qualified patients coming to us from their referral channel, which means there's a higher probability that they will get approved for the MyoPro.
Scott Henry
AnalystsOkay. And the final question. Gross margins were very strong in the quarter, and you mentioned they could get even stronger, at least in the press release, from that kind of 68%, 69% level, do you think that could be a new baseline and kind of how high can that go? Because it's obviously a pretty good number for the quarter.
David Henry
ExecutivesYes, it will fluctuate with volume. So I would expect first quarter gross margin will be lower than fourth quarter just because of less units absorbing overhead. But as we go through the year, the guidance implies increasing revenues as we go through the quarters of 2026. That will help gross margin. In addition to -- we're working on about -- as we mentioned actually last Analyst Day around 200 basis points of gross margin improvement from various activities. Paul mentioned the mobile app that will be -- we expect that to be released here in the coming weeks. That will help take out about $400 to $500 of cost out of the MyoPro because we're not providing a laptop anymore. And there's other cost reduction projects that we're working on as well. So I think that we're trying to get that gross margin back up into the 70% range here by the time we exit 2026.
Operator
OperatorNext question will come from Jeremy Pearlman with Maxim Group.
Jeremy Pearlman
AnalystsFirst one is related to the O&P clinics. I think if I recall correctly, you mentioned in last year's Investor Day that you have -- you were planning on having roughly 200 clinics trained certified and to be able to deliver the MyoPros in 2028. Is that still a goal that's on track. How fast is this O&P network expanding?
Paul Gudonis
ExecutivesThat is still a goal of ours. We have a number of clinics that they are earlier stage, where they're just getting trained. They're building their patient pipelines. They're getting the reimbursement and so then they will turn into orders. We also have a very robust national account programs because there's been consolidation in the industry where there's been a number of players that own 40 to 50, 80 or so clinics. And we've been doing national account planning with these entities, where they're starting out with a couple of other regions piloting it, getting some good results, and then we'll see greater rollout. So I think, look, this is the most profitable new product opportunity to address a big unmet need. So I'm very bullish about the O&P channel adopting the MyoPro into their clinical treatment plans.
Jeremy Pearlman
AnalystsOkay. Great. And then switching maybe to reimbursement cycle times. I think, again, in the past, you've mentioned numerous times, it's roughly 6 months, I think, from when a patient reaches out until you actually get payment. Now that you're signing out more of these payers, does that reimbursement cycle time -- are you seeing improvements, or it's still roughly that 6-month time frame?
David Henry
ExecutivesWell, I think the bigger improvement is coming from the fact that we're -- Medicare is now roughly half of our revenues, and Medicare reimburses pretty quickly. We can generally get -- we can get paid in three weeks, and we're recording revenue on delivery. The most -- I would say the majority of our revenues are occurring at delivery, though I will say that one of the things that we see with the backlog here is that as the -- as we have more contracts and the payer base broadens, not only are we seeing contracted payers authorized, but also non-contracted payers. And we're actually seeing a bit of an increase in the non-contracted payers authorizing the MyoPro, which means we're waiting for payment to get revenue. So we're starting to see a little bit of that. So it's sort of a -- it's good news that there are a broader base of payers now reimbursing for the device.
Jeremy Pearlman
AnalystsOkay. Great. And just last question from us. What -- I might have missed this earlier in the call, but what percentage of the pipeline add was from this new recurring referral sources as opposed to maybe some of the direct in the past? And also, do you have a target goal percentage of how you want to see that breakdown in the future?
David Henry
ExecutivesThe pipeline adds about 10% of the pipeline adds on about 10% of the orders were from referrals in the first -- in the fourth quarter. In terms of the way we're thinking about what that -- what success might look like here in the near term is we're looking to get the revenues from recurring sources to get -- to approach half of our revenues here by the end of 2026. So I think that's the near-term objective that we're focused on.
Operator
OperatorThe next question will come from Sean Lee with H.C. Wainwright.
Xun Lee
AnalystsFirst, on the German market. It's great to see that it grew really well since the end of last year. I was just wondering if you could provide some color on what were the main drivers behind this growth? And how do you expect that market to go in 2026?
David Henry
ExecutivesWhich -- I'm sorry, you cut out a little bit. Which market were you referring to, international?
Xun Lee
AnalystsGermany, yes.
Paul Gudonis
ExecutivesGermany is a large market with over 80 million population, 1% prevalence, you're talking about 800,000 prevalence population plus, again, all these incidences. Our team has done a good job recruiting a number of O&P practices around the country there. And we've got very good social court ruling. So many statutory health insurance companies will pay for the MyoPro. So we don't face the same reimbursement issues, they're in Germany as we do in the U.S. So that's why it's a very good market, grew over 40%, and we're continuing to invest in scaling that operation.
Xun Lee
AnalystsGreat. My second question is on the randomized controlled study that's going on in the University of Utah. So if this study is successful, how will you use this data in your commercial efforts? And where do you think it will help the most?
Paul Gudonis
ExecutivesWell, the good news is that the IRB was just approved for this trial. It's an RCT, patients with the MyoPro versus those that don't get a MyoPro as a control group. We should start seeing the first readouts by the end of this year. And our plan is to use that like we use the other research to basically convince more payers that they should be covering the cost of the MyoPro because it's not experimental, it's not investigational, and it is medically reasonable and necessary. So that's -- our plan is that will just reinforce the research that's already been published, that's been accepted by CMS and many other payers just like this new Elevance agreement we entered into and announced today.
Xun Lee
AnalystsThat's very helpful. Our last question is on the R&D efforts for MyoPro 3. So could you provide some time line for the 3.0 model? And what are the primary clinical manufacturing advantages of the 3.0 versus the 2X?
Paul Gudonis
ExecutivesWell, this will be a next-generation platform. We are revamping everything about the MyoPro from the chip that's in the device, the software that's there, the sensing systems, the orthotic materials, the hand grasp capability, elbow motor harness. So it's a total redo of the MyoPro to provide more functional benefit for the patients. It will be customizable like the current one is, but just provide more function comfort and hopefully get even greater market adoption because of it.
Operator
OperatorThe next question will come from Edward Woo with Ascendiant Capital.
Edward Woo
AnalystsCongratulations. A question in terms of the -- as you guys continue to grow international, what's the gross margin percentage in international compared to domestic? And what is your operating leverage opportunity?
David Henry
ExecutivesYes. So the -- I've often said that in terms of the ASPs, the international business is -- has the second highest ASP compared to the Medicare allowable here in the U.S. And so the gross margin will be a little bit lower on international. So if we're at about 68% gross margin in the fourth quarter, international will be a little bit lower than that.
Edward Woo
AnalystsAnd how much leverage do you have in the model to increase it as your sales grow?
David Henry
ExecutivesI think all the manufacturing is here in the U.S. And so as the -- as we put more volume into the facility here, the gross margin in Germany will benefit just as the overall company gross margin benefits.
Operator
Operator[Operator Instructions] And this will conclude our question-and-answer session. I would like to turn the conference back over to Mr. Paul Gudonis for any closing remarks. Please go ahead.
Paul Gudonis
ExecutivesWell, thanks, operator. One of the actions we've taken over the last 6 to 9 months have already demonstrated progress for achieving our goals of creating a growing profitable company, addressing this large unmet need of chronic arm paralysis. And we're planning for a record number of MyoPro orders this year with a growing contribution from these recurring patient sources. We expect to lower our customer acquisition cost with a new approach to digital and TV advertising and the shift to the new O&P and rehab hospital channels. Our lower cost structure on these projects to reduce our manufacturing costs should result in improvements in our gross margin, and we continue to innovate in product development to maintain our market leadership position. We thank you all for your questions and your interest in Myomo. Have a nice evening.
Operator
OperatorThe conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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