Operator
Good day, and welcome to the Myomo fourth-quarter and full-year 2025 financial results. All participants will be in a listen-only mode.
Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions.
To ask a question, you may press star then one on your touchtone phone, and to withdraw your question, please press star then two. Please note this event is being recorded.
I would now like to turn the conference over to Mr. Tirth Patel with Alliance Advisors IR.
Please go ahead, sir.
Tirth Patel
Thank 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 David 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, target, 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 and uncertainties and other factors that may affect Myomo's business, financial condition, and operating results. These risks and 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
Thanks, Tirth. Good afternoon, and thank you all for joining us today.
During our last quarterly call, I outlined four major objectives for the company: 1, 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 2, increase market access for patients by signing additional payer contracts and engaging with Medicare Advantage and commercial plans for coverage; number 3, manage our cost structure and enhance our manufacturing processes to demonstrate operating leverage as we scale; and number 4, continue to innovate in product development to maintain our market leadership position. I'm pleased to report that we 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 US 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 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 in referring medically qualified patients to Myomo and our O&P partners.
In just the first 6 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 the above revenue initiatives is a revised marketing plan that's raising awareness of our products to healthcare professionals and further optimizing our digital marketing to patients. We believe these initiatives, along with better insurance coverage, will reduce our acquisition costs 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 of 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 China Lead Ventures, a major investor in the JV, to see if the venture can be recapitalized and restructured so that it can address that very large market opportunity in that country.
Our market access strategy here in the US 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 multi-state 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're seeing an increasing number of authorizations from plans 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 a 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.
The app provides enhanced capabilities and data collection for users while 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 control 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. 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 David Henry to provide more of the financials and details.
David Henry
Thank 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 US 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 filled demand from 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 this 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 multi-state 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 and representing 19% of total revenue, primarily from Germany.
The US 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, US O&P, and the VA, represented 42% of 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 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 to 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 one-time write-off of debt issuance cost, cash interest expense under the Avenue term loan, non-cash 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 marked to market to fair value each quarter. Net loss for the fourth quarter of 2025 was $3.8 million, or 9 cents per share.
This compares with a net loss of $300,000, or 1 cent per share, for the fourth quarter of 2024. 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. The 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 Mark II 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 define 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 as a year where we orient our business more towards stroke patients in the incidence population and recurring patient sources through our MyoConnect referral program, increasing engagement with the US 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 to $9.5 million.
With sequentially lower revenue and operating expenses 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
Thanks, David. 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 therapist. With our contract with his Blue Cross Blue Shield plan, he 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. We're now ready to take your questions.
Operator?
Operator
Thank you. We will now begin the question-and-answer session.
To ask a question, you may press star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.
If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we'll pause momentarily to assemble our roster.
Paul Gudonis
While we're waiting for the first question—
Operator
The first question— Go ahead, sir. I'm sorry.
Paul Gudonis
All I 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, and we hope to speak with many of you there. Operator, let's go with the first question.
Operator
The first question will come from Chase Knickerbocker with Craig-Hallum. Please go ahead.
Chase Knickerbocker
Good afternoon. Thanks for taking the questions.
Maybe 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?
Then can you talk about kind of the plan on the direct side of the business to kind of get that acquisition cost down? Thanks.
Paul Gudonis
Thanks, Chase. 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 you're competing with holiday advertising, there may be election cycles in some cases, our pipeline adds, when you divide into the advertising costs, were higher than we like.
What we've done is we've brought on a new head of marketing. She started at the end of last year.
We've 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. We've seen the cost per call go down.
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 cost associated with it.
Chase Knickerbocker
Have you seen any of that improvement so far as we've kind of came into Q1?
Paul Gudonis
We're not really discussing Q1 at this time. I will say, though, it is kind of a little bit early.
The ad agency just really started I would say within the last 6 to 8 weeks, really starting to do their work. 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 first-quarter results.
Chase Knickerbocker
Got it. Maybe just a couple 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?
Thanks.
Paul Gudonis
We've got a couple dozen O&P providers that have been trained, certified, and they are 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
It was about 36 O&P units in the fourth quarter.
Chase Knickerbocker
Got it. Maybe just last one from me, just on 2026 guidance, can you just kind of detail what your assumptions are there for that US O&P business as far as what it'll contribute to that 2026 guidance?
David Henry
We're expecting growth 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. That's because it's just we're too soon into these marketing changes to really have some conviction and to say that direct billing is going to grow.
We're trying to limit the amount of spending on advertising because we've seen the results in the last half of 2025, and the cost per pipeline add is unacceptably high. We need to see that being addressed before we'll decide to spend more money on advertising beyond what we're already spending.
Then the MyoConnect program is kind of really ramping up. There's just some uncertainty 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.
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, and while at the same time growing revenue in 2026.
Chase Knickerbocker
Understood. Thank you.
Operator
The next question will come from Scott Henry with AGP. Please go ahead.
Scott Henry
Thank you, and good afternoon. Starting from the top of the funnel, pipeline adds, 676 is a little lower than it's been in the past couple 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?
Thank you.
David Henry
I think a 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. 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 the last 9 days or so of 2025.
That did have a little bit of an effect on pipeline add generation. We had about 2 less weeks in the fourth quarter compared to the third.
Like I said, I think 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
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 how you calculated it. A little bit higher, not dramatically higher than past quarters, but any comments on that rate?
David Henry
This is the backlog drop rate, correct?
Scott Henry
Yes.
David Henry
By my calculations, was a little over 20%.
Scott Henry
Okay. The trend should be the same.
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
I say you're talking about a pipeline drop rate, then.
Scott Henry
Yes.
David Henry
Okay. I was referring to backlog.
Sorry.
Scott Henry
[laughs] Okay.
David Henry
I haven't calculated the pipeline drop rate, but so I'll take your word for it was around that. There's a
Scott Henry
It's a little bit higher than
David Henry
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, they're making it hard on us to get authorized.
As a result, we're seeing a lot of dropouts as a result of that.
Paul Gudonis
On the other hand, 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 their MyoPro.
Scott Henry
Thank you for the color. 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 pretty good number for the quarter.
David Henry
It will fluctuate with volume, I would expect first-quarter gross margin will be lower than fourth quarter just because of the less units absorbing overhead. As we go through the year, the guidance implies increasing revenues as we go through the quarters of 2026.
That will help gross margin. We're working on as we mentioned actually last analyst day, around 200 basis points of gross margin improvement from various activities.
Paul mentioned the mobile app that 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.
There's other cost reduction projects that we're working on as well. I think that we're trying to get that gross margin back up into the 70% range here by the time we exit 2026.
Scott Henry
Great. Thank you for taking the questions.
David Henry
Mm-hmm.
Operator
The next question will come from Jeremy Pearlman with Maxim Group. Please go ahead.
Anthony Vendetti
Thank you for taking my question. First one is related to the O&P clinics.
I think if I recall correctly, you mentioned in last year's investor day that 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?
David Henry
That is still a goal of ours. We have a number of clinics that they're 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 their regions, piloting it, getting some good results, and then we'll see greater rollout. I think, look, this is the most powerful new product opportunity to address a big unmet need, I'm very bullish about the O&P channel adopting the MyoPro into their clinical treatment plans.
Anthony Vendetti
Great. Then switching maybe to the 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 up more of these payers, are you seeing improvements, or it's still roughly that 6-month timeframe?
David Henry
I think the bigger improvement is coming from the fact that Medicare is now roughly half of our revenues, and Medicare reimburses pretty quickly. We can get paid in 3 weeks, and we're recording revenue on delivery.
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 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 till payment to get revenue. We're starting to see a little bit of that, it's good news that there are a broader base of payers now reimbursing for the device.
Anthony Vendetti
Great. Just last question from us, 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?
Also, do you have a goal percentage of how you want to see that breakdown in the future?
David Henry
The pipeline adds were about 10% of the pipeline adds and about 10% of the orders were from referrals in the fourth quarter. In terms of the way we're thinking about what success might look like here in the near term is we're looking to get the revenues from recurring sources to approach half of our revenues here by the end of 2026.
I think that's the near-term objective that we're focused on.
Anthony Vendetti
Thank you very much for taking my questions. I'll hop back in queue.
Operator
The next question will come from Sean Lee with H.C. Wainwright.
Please go ahead.
Swayampakula Ramakanth
Hey, good afternoon, guys, and thanks for taking our questions. First, on the German market, it's great to see that it grew really well towards 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?
Paul Gudonis
I'm sorry, you cut out a little bit. Which market were you referring to?
The international? Oh, sorry.
David Henry
Germany, I said. Yes.
Swayampakula Ramakanth
Germany 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 gotten very good social court rulings, so many statutory health insurance companies will pay for the MyoPro, we don't face the same reimbursement issues there in Germany as we do in the US.
That's why it's a very good market, grew over 40%, and we're continuing to invest in scaling that operation.
David Henry
Great. Thanks for that.
My second question is on the randomized control study that's going on in the University of Utah. 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?
Swayampakula Ramakanth
The good news is that the IRB was just approved for this trial. It's an RCT, patients with a 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. Our plan is to use that, like we've used 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.
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. Oh,
Swayampakula Ramakanth
fantastic. That's really helpful.
Our last question is on the R&D efforts for MyoPro 3. Could you provide some timeline for the 3.0 model, and what are the primary clinical or manufacturing advantages of the 3.0 versus the 2X?
Paul Gudonis
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.
It's a total redo of the MyoPro to provide more functional benefit for the patients. It'll be customizable like the current one is, but just provide more function, comfort, and hopefully get even greater market adoption because of it.
Swayampakula Ramakanth
Excellent. Thank you again for taking our questions.
That's all we have.
Operator
The next question will come from Edward Woo with Ascendiant Capital. Please go ahead.
Edward Woo
Thanks for taking my question, and congratulations. I was questioning in terms of 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?
Thank you.
Paul Gudonis
I've often said that in terms of the ASPs, the international business has the second-highest ASP compared to the Medicare allowable here in the US. The gross margin will be a little bit lower on international, if we're at about a 68% gross margin in the fourth quarter, international will be a little bit lower than that.
Edward Woo
How much leverage do you have in the model to increase it as your sales grow?
Paul Gudonis
I think all the manufacturing is here in the US, and so as we put more volume into the facility here, the gross margin in Germany will benefit just as the overall company gross margin benefits.
Edward Woo
Great. Thanks for answering my questions, and I wish you guys good luck.
Thank you.
Paul Gudonis
Thank you, Ed.
Operator
Again, if you have a question, please press star then one. 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
Thanks, operator. The actions we've taken over the last 6 and 9 months have already demonstrated progress toward achieving our goals of creating a growing, profitable company addressing this large unmet need of chronic arm paralysis.
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 costs 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 and 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. Thank you all for your questions and your interest in Myomo.
Have a nice evening.
Operator
The conference has now concluded. Thank you for attending today's presentation.
You may now disconnect.