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Axogen, Inc.
7/29/2026
Good morning, everyone. Joining me on today's call is Michael Dale, Axygen's President and Chief Executive Officer, and Lindsey Hartley, Chief Financial Officer. Michael will discuss second quarter 2026 financial results and corporate highlights. Lindsey will then provide details on financial performance and overall outlook for the year. This will be followed by a question and answer session. Today's call and presentation is being broadcast live via webcast, which is available on the Investors section of the Axygen's website. Following the end of the live call, a replay will be available on the Investors section of the company's website at www.axogeninc.com. Before we begin, I would like to remind you that during this conference call, management will be making forward-looking statements. Forward-looking statements include statements regarding financial guidance and outlook, clinical development and regulatory efforts, commercial growth initiatives, reimbursement and market access, These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, including without limitation the risks and uncertainties reflected in the company's filings with the Securities and Exchange Commission, including the most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, and other filings made with the Securities and Exchange Commission. forward-looking statements speak only as of the day they are made, and the company undertakes no obligation to update any forward-looking statements except as required by law. In addition, for reconciliation of non-GAAP measures, please refer to today's press release, presentation with highlights from today's call, and the corporate presentation on the investors section of the company's website. Now I'll turn the call over to Michael.
Michael, please go ahead. Thank you, operator, and good morning, everyone. Today, I will walk you through our second quarter performance using the same lens we've used all year, which are the six priorities that comprise our strategic plan. Once I've concluded my commentary, Lindsey will review our financials in detail, after which we'll open the call for questions. As preface to my review of performance for each strategic priority, I want to make clear on behalf of the Axiogen team that we are delighted with our customer creation and market development performance. What you will hear today is that consistent with our plans across extremities, OMF and head and neck, breast and prostate, we are exceeding our goals for growing adoption of nerve care by existing surgeons, increasing the numbers of new surgeons, expanding the number of new accounts, and growing patient awareness overall. Our 23% year-over-year revenue growth this quarter and increased revenue guidance for the remainder of the year reflects this progress and our confidence in the appropriateness of our strategic priorities. While all markets are enjoying strong year-over-year growth, breast growth is particularly strong and accelerating, reflecting the impact of our market development programs, increased patient awareness, improved coverage and payment, and expanded Salesforce coverage. As a result, we will be reporting on the breast business separately in more detail. Starting with our first priority, revenue growth and financial operating leverage. As reported this morning in our earnings release, second quarter revenue was $69.7 million, up 23.1% versus the second quarter of 2025. Reflecting broad base growth across all three target markets. REST led the way, contributing approximately two-thirds of the quarter's growth, with first half 2026 revenue up 47% year-over-year. At the same time, extremities, OMF and head and neck, and other indications combined delivered solid 15% year-over-year growth through the first half. Adjusted net income was $7.3 million for the quarter, adjusted EBITDA was $8.4 million, and we ended the period with $113.4 million in cash, cash equivalents, restricted cash, and investments. Consistent with prior quarters, performance was driven by strong demand for Avance and continued adoption of our broader product algorithm across all target markets. Avance represented 65% of total revenue in the second quarter and 63% year-to-date, up from approximately 60% in 2025. Commercial execution remains strong across the business. Salesforce productivity continued to exceed our expectations and our active surgeon count increased meaningfully during the quarter, an indicator we monitor closely because it reflects broader institutional adoption of nerve care. We are also realizing the benefits of the Salesforce expansion investments we made throughout 2025 and the first half of 2026 as those representatives progress through their ramp and approach full productivity consistent with our market development model. Overall, these results reflect the strength of our commercial organization, the growing adoption of nerve care, and consistency in execution of our long-term growth strategy. Gross margin for the quarter was 72.7% compared to 74.2% for the second quarter of 2025 and less than our plan. The shortfall was driven primarily by product mix as breast growth accelerated faster than planned and relies more heavily on longer advanced grafts, which carry higher production costs. Our manufacturing plans anticipated a growing breast business but not the relative change in revenue mix between our target markets that is now occurring and the resulting impacts on longer graph product mix. We will address these changes in product mix through pricing actions and production efficiency initiatives. However, these measures will take time to implement and as such are unable to affect the remainder of our 2026 forecasted product mix. As a result, We are updating our 2026 gross margin guidance to be at least 73%. Looking forward, our operating bias remains to support growth in all target markets while continuing to improve operating margin, EBITDA, and operating profits. Moving on to our second priority, market development across extremities, oral, maxillofacial, and head and neck and breasts. Consistent with prior quarters, each of our three target markets contributed positively to second quarter results. Extremities and OMF and head and neck both continued the steady progress we've described on prior calls, reflecting ongoing incremental surgeon activation and adoption of the accident nerve repair algorithm and continued account level engagement, reflecting strong execution of our high potential account development strategy. As mentioned earlier in my comments, year to date, breast grew 47% year over year, driven by added commercial capacity, training of new surgeons, expansion of coverage and payment, and increasing surgeon and patient awareness. We believe we're still early in this market's development, even as it becomes a larger part of our overall mix. We now have roughly 215 active breast programs, an increase of over 40 programs year over year, and roughly 560 active surgeons, an increase of over 150 surgeons year over year. As a reminder of how we think about our markets longer term, each one sits at a different stage of development with different referral patterns, different training requirements and different reimbursement dynamics. We outline the size and potential of each prioritized market opportunity at our analyst day in March 2025. and second quarter and year-to-date results continue to reinforce the validity of this opportunity framework. We remain confident these markets can support double-digit growth for a long time as we continue to build the infrastructure, the evidence and the awareness required to make nerve repair an expected standard of care. With regards to priority three, commercial expansion, We ended the second quarter with a total commercial organization of 172 sales representatives, market development managers, and regional directors across all markets consistent with our plan for disciplined, steady expansion of our commercial footprint. Year-to-date, we have added 15, including 9 in extremities and 6 in breasts, bringing those teams to 140 and 29, respectively. along with three dedicated market development managers in OMF and head and neck. We are very encouraged by our return on investment in Salesforce expansion. New representatives, those in their role for less than nine months continue to contribute meaningfully to our growth. We believe these results validate one of our core assumptions that expanding sales coverage is one of the most important levers within our control to affect market development and customer creation. The fourth priority of our strategic plan is commercial excellence, specific to our emphasis on high potential accounts, productivity, and education. High potential accounts continue to be a primary engine for our revenue growth, representing 60% of total revenue and 51% of growth year-to-date. Consistent with overall action growth, productivity in high potential accounts was 20% year-over-year. The number of active high potential accounts increased to 690, up 11 year-to-date. Non-high potential accounts continue to grow as well, representing 40% of oxygen's total revenue year-to-date and driving 24% year-over-year productivity per account. Growth in these accounts reflects growing awareness and adoption of nerve care in general. Active surgeon growth has increased by more than 210 year-to-date. with more than 135 added within high potential accounts year-to-date. We have exceeded our plan for active surgeon growth in 2026. Regarding our professional education programs, year-to-date we have conducted nine programs across all target markets, training 155 surgeons. Next, I'd like to update everyone on our fifth priority, standard of care, evidence and coverage development. As of today, commercial payer coverage for advance is approximately 86% of covered lives in the United States. Aetna remains the largest commercial payer not yet covering advance. Based on historical timing, we expected an update in June. However, Aetna's review is ongoing. If Aetna issues a favorable decision, we will consider that near universal commercial coverage in our existing markets in the United States. with approximately 95% of commercial lives with access to events. At that point, only a few regional payers in Humana will remain. Evidence generation remains a core pillar of our strategy to support development of nerve care guidelines and drive broader adoption of nerve repair and protection. This quarter, we advanced this strategy across multiple fronts. The recently published REPOSE study is an important example Repose provides prospective randomized clinical evidence evaluating axigard nerve cap as an adjunct to standard neurectomy for symptomatic neuroma. The results reinforce the clinical rationale for protecting the nerve end after resection with favorable signals in pain burden, medication reliance, and recovery-related outcomes over follow-up. Importantly, we view Repose as more than a study in one procedure. It strengthens the evidence foundation for our nerve protection portfolio and supports the broader clinical message that nerve management matters when surgeons are addressing pain, function, and quality of life. We are also advancing Nerve Restore, our randomized assessor-blinded study comparing advanced to sural nerve autograft and mixed and motor peripheral nerve reconstructions. This is strategically significant because Autograph has long been viewed as the historical benchmark in complex nerve reconstructions. In second quarter, we activated our first site in the United States and are screening for patients. We are on track for additional site activations in the second half of 2026. Another important evidence generation initiative is Embrace. Our prospective assessor-blinded study evaluating sensory restoration following nipple-sparing mastectomy and implant-based breast reconstruction, comparing advanced supported neurotization to reconstruction without neurotization. As we have discussed previously, generating high-quality clinical evidence in breast reconstruction remains an important strategic priority for Axigen. The program remains on track for initiation later this year, consistent with our strategic operating plan. Taken together, these initiatives demonstrate execution as planned of our strategic evidence generation plan to make restoration of peripheral nerve function standard of care. And finally, our sixth priority, which is about innovation, research and development, and therapeutic reconstruction. Consistent with our strategy to expand oxygen's leadership in peripheral nerve care, We made a strategic investment in Trace Biosciences this quarter, acquiring a minority ownership stake, including a limited right of first refusal. Trace's nerve-specific imaging technology, NerveTrace, is designed to help surgeons visualize nerves in real-time, potentially reducing nerve injury and improving identification of repair opportunities. We view Trace as a highly complementary adjacency to oxygen platforms. Trace helps surgeons find and protect nerves, while Avance supports repair when a nerve cap is identified, serving the same surgeons, patients, and procedural setting. Trace received FDA clearance of its IND in January 2026, and our investment supports advancement through Phase II and III clinical trials toward an NDA. This structure gives oxygen exposure to a differentiated technology with strategic fit while preserving capital discipline and future flexibility as the program progresses. Turning to our prostate program, we continue to make progress and our clinical development work remains on plan. We expect to share more on the next phase of our strategy during our third quarter earnings call. What we continue to hear through our surgical experience program is that there is a meaningful unmet need. Erectile dysfunction and incontinence remain significant quality of life challenges for many patients after radical prostatectomy. We believe nerve reconstruction with Vance may have an important role to play and this work is helping us better understand the urology market, build procedural experience and generate early data. As we look ahead, our decision to move forward will be guided by the market opportunity The ability to standardize and scale the advanced technique, surgeon feedback on clinical impact, and evidence of patient demand that can help shape the care pathway. So far, our assessment is progressing well, and we look forward to providing a detailed update in the fourth quarter. In closing, second quarter performance reflects continued disciplined execution against our strategic plan and commitment to our business purpose to restore health and improve quality of life by making restoration of peripheral nerve function We're encouraged by the momentum across the business and are confident in our ability to overcome the inevitable challenges that come with new market development and building an enduring, profitable business. I'll now turn the call over to Lindsey to walk through the financials in more detail and our updated outlook for the remainder of 2026. Thanks, Mike.
I'm pleased to report our second quarter's 2026 financial results. For the Second quarter, we reported revenue of $69.7 million, reflecting growth of 23.1% year-over-year. Revenue growth continues to be driven by strong demand for advance and adoption of our product algorithm across target markets, with unit volume serving as the primary driver, then price. For the first time, sales from extremities were less than 50% of total sales, as we experienced growth of over 50% year over year in our breast market. Through the first half of 2026, we continue to have double digit year over year growth in all our markets. Gross profit for the second quarter came in at 50.7 million. This represents a gross margin of 72.7%. Gross margin decreased 150 basis points year over year driven by 4.6% higher product costs, partially offset by 2.7% lower write-offs. Sequentially, gross margin declined 250 basis points, driven by 1.8% higher product costs and 0.7% write-offs. Gross margin in the second quarter was less than our internal projections, primarily due to, one, selling more higher costs Biologic Advance starting in April than expected, and two, the demand for certain long-length advance growing faster than the rest of the advance portfolio. These two factors impacted gross margin approximately 1% versus our internal expectations. This demand for long-length advance, largely stemming from the growth of our breast business, exceeded our internal expectations by approximately 14% in the quarter. To better align production with this updated demand profile, we adjusted our production plans beginning in the third quarter, which we expect will increase advanced product cost. As a result, we now expect our full year 2026 gross margin to be at least 73%. As for the cadence of the second half, We expect gross margin to be higher in the third quarter than the fourth quarter. As our non-breast markets continue to grow and demand broadens across a wider range of graft sizes, we expect donor yield efficiency to improve, supporting gross margin expansion over time. We also have multiple initiatives underway focused on increasing graft yields, including long-length advanced grafts. We plan to provide an updated long-term financial framework in the first quarter of 2027. With recent payer coverage wins and VLA approval creating meaningful growth opportunities, we believe additional time is needed to assess their full impact. We have consistently outperformed our long-range revenue growth target of 15% to 20% CAGR and believe we remain well positioned to continue doing so. Operating expenses increased to $52.8 million in the second quarter, up from $40.3 million in the second quarter of 2025, and increased 4.6% as a percentage of revenue. The increase year over year was driven primarily by compensation costs and stock-based compensation expense tied to certain PSUs anticipated to achieve above target on revenue growth components. Sequentially, as a percentage of revenue, operating expenses decreased four percentage points. Sales and marketing expenses as a percentage of total revenue increased 2.2 percentage points to 44.2% in the second quarter compared to 42% in the second quarter of 2025. The increase Year-over-year reflects investments in our commercial strategy to support our market development initiatives and long-term growth plan. Sequentially, as a percentage of revenue, sales and marketing expenses decreased 2.4 percentage points. Research and development expenses increased 25.3% to $8.6 million in the second quarter. compared to 6.9 million in the second quarter of 2025. And as a percentage of total revenue, increased slightly to 12.3% from 12.1%. Our continued investment in research and development is essential to our mission of making peripheral nerve repair a standard of care through the development of clinical evidence and innovation. Sequentially, as a percentage of revenue, Research and Development expenses remained relatively flat. General and administrative expenses increased 38.4% to $13.4 million in the second quarter, compared to $9.7 million in the second quarter of 2025, and as a percentage of total revenue, increased 2.2 percentage points to 19.3% from 17.1%. Sequentially as a percentage of revenue, general and administrative expenses decreased 1.7 percentage points. Net loss for the second quarter was 1.5 million or 3 cents per share compared to net income of 0.6 million or 1 cents per share in the second quarter of 2025. Sequentially, net loss improved $18.1 million. As a reminder, net loss in the first quarter included a one-time loss of $16.8 million, which was incurred upon the extinguishment of our debt facility in January. Adjusted net income was $7.3 million, or $0.12 per share, for the second quarter, compared to an adjusted net income of 5.7 million or 12 cents per share for the second quarter of 2025. Sequentially, adjusted net income improved 3.1 million. Adjusted EBITDA for the second quarter was 8.4 million compared to an adjusted EBITDA of 9.3 million in the same period last year. And as a percentage of revenue decreased, 4.2 percentage points to 12.1% from 16.3%. Sequentially, adjusted EBITDA improved $2.7 million. Adjusted net income and adjusted EBITDA are calculated as net income or EBITDA adjusted for stock-based compensation and the loss on the extinguishment of the debt. The improved bottom-line performance demonstrates our ability to drive both top-line growth and enhanced profitability. As of June 30th, 2026, cash, cash equivalents, restricted cash and investments totaled 113.4 million. Through the first half of 2026, we generated 4.1 million of free cash flow. Based on our year-to-date performance and visibility into the remainder of the year, we're revising our full year 2026 financial guidance. We now expect full year 2026 revenue growth of at least 24% or revenue of at least $279 million. Full year 2026 gross margin is now expected to be at least 73% and we continue to expect to be free cash flow positive for the full year 2026. This guidance reflects continued confidence in commercial execution across all three core markets and the ongoing Salesforce productivity improvement. It does not assume material benefit from payer coverage decisions beyond what is already known. With that, we will now open the line for questions. Operator?
Thank you. We'll now begin the question and answer session. If you'd like to ask a question at this time, you may press star 1 from your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to withdraw your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please for our first question. Thank you, and our first question is from the line of Mike Sarcone with Jefferies. Please proceed with your question.
Hey, good morning, and thanks for taking the question. I guess just to start, I wanted to hone in on 2Q. Nice quarter, but we did see some decel versus the 1Q, and I know you saw some pretty nice acceleration in breadth. I was wondering if you could unpack growth in some of the other markets. Just for the 2Q, I know you gave us kind of an update on the 1H growth, but maybe dig more into 2Q and talk about the moving pieces there if possible. Thank you.
Sure, Mike. We're not going to break out the other segments as we are now breast going forward. However, the other markets are growing consistent with prior comments. So relatively different bases, extremities being largest, OMF, Head and Neck being smaller. But all the markets are growing handsomely.
Okay, great. Thanks, Mike. And then maybe just on the outlook, that's a nice guide raised and baked in there. I was wondering if you could talk about what are the key assumptions as we get into 2H, you know, any color on the end markets there, and then how we should think about sales cadence through the rest of the year. Thanks.
Sure. So what we're, the most significant factor if we had to pull one out that we now have enough time to look back upon is the investments in sales footprint coverage. So for all markets, those individual investments have been very rewarding. So very high double digits. In other words, expand the opportunity to knock on a door and people respond. So we will be working hard to accelerate that activity. Obviously, we have a plan for this year. We're going to look at expanding it further and we'll continue into the future. The caveat, or not caveat, but the constraint in terms of those investments will be that we will not go backwards in profitability, but we will continue to expand as aggressively as we can within that constraint, the Salesforce footprint. The other element that we see direct evidence taking place is that in the planned procedures such as breast, for example, the patient awareness and the surgeon awareness has grown significantly and is becoming a driver of activity and adoption. All the other elements are also very positive just in general from the business coverage and payment, but in terms of picking out two elements, that are major factors that we're gaining more and more confidence in. It would be Salesforce footprint expansion. And then secondly, patient and surgeon awareness.
Awesome. And if I could just squeeze one more in there. Just, you know, you talked about Aetna continuing to review the policy. You know, any cause for concern that they haven't published an update in kind of the timelines you've seen historically or How are you guys thinking about Aetna coverage timing?
I'll let Rick elaborate, but no, I mean, we're disappointed that they haven't made a decision. We thought for sure there'd be one in June, but we know there is activity, but I'll let Rick comment.
Hey, Mike. Thanks for the question. We know they're looking at it, and I would I try to view it through the optimistic lens, which is sometimes these medical policies can just get rubber stamped. Hey, this is the annual update. We're just going to pass it through and approve it. And the fact that they're taking time, I think, means they want to get it right. So we're hopeful. Great. Thanks so much. Thanks, Mike.
The next question is from the line of Larry Beagleson with Wells Fargo. Let's just use your question.
Hi, this is Simran on for Larry. Congrats on the results here. Maybe just to start off on on gross margin might maybe help me understand, you know, I think we generally view breast as a higher ASP opportunity. So just any additional color that you can provide around what exactly is driving the lower margin profile for breast and Can you elaborate on those pricing and manufacturing initiatives that you mentioned? When should we begin to see those offsetting the pressure?
Sure. So with respect to the product mix changes, that's an era in our own internal forecast. So we've always known, as I mentioned in my comments, that these businesses would be growing. But the gross margin plan assumed a relative constant in terms of the product mix between these. That's gotten ahead of us. It's driven by good news, i.e., breast adoption is going faster than we originally planned and assumed. But the result is that product mix reflects a higher relative cost. And specifically for costing, so our cost per millimeter is linear. What is not linear is our actual pricing model. and I've been aware of this for a while and I've held off taking a decision, so that's my bad. And so that's one key element which we will address in the future. The other one is just general efficiency initiatives in terms of production. And as with any supply chain, there's always something you can do more effectively. Given the nature of the supply chain, we won't go into the actual details, We have a number of initiatives that we have very high confidence in. We'll address that. Looking ahead, the bottom line is how to model the business. We still believe 75% gross margin is the appropriate conservative number to look at overall. With regards to this year, however, the things that I've mentioned, there is not a mechanical element or a process that would allow us to implement these such that they would have effect in terms of the product going through and being recognized as sold for the remainder of this year, hence the guide that we made.
Got it. That's very helpful. And maybe just to bounce off of the prior question around guidance, appreciate all the color on kind of how your expectations have changed versus the beginning of the year. but the guidance does imply that growth is around the 23% which is essentially what you delivered here in Q2 for the second half of the year. So how are you thinking about durability of that momentum into the second half and even just beyond as you continue to grow well above the 15 to 20% LRP? Does that reinforce your confidence that You know, you can sustain growth at the high end of that range over that framework.
Yes. So, with regards to customer creation initiatives, virtually every initiative is at plan or exceeding plan. So, and this reflects what we've largely assumed, of course, in terms of the opportunity for oxygen. is that nerve care is dramatically undertreated, but there is interest in doing better in these particular areas, whether it be emergent or planned procedures. And so as long as we keep knocking on doors and providing in a competent, professional way the service and support to do that, we remain very confident.
Great. Thank you.
You bet.
Our next question is in the line of Mike Craig with Learing Partners. Please proceed with your questions.
Hey, everyone. Thanks for taking our questions and congrats on the nice quarter. If you just wanted to start from me, but in terms of the guidance, you know, obviously a healthy raise here. You mentioned that it doesn't necessarily reflect any additional procedure growth from Commercial Winds we haven't seen yet. In terms of what you've started to build in from the ones that we have, can you just talk about the magnitude or help quantify that at all?
If I understand the question, you're asking about how do we quantify coverage and payment. Is that right, Mike?
Yeah, basically just if you've started to build in some additional credit from some of the commercial reimbursement wins that you've seen already for the back half of this year.
We certainly know that there's been effect, and the effect is that the sales cycle gets reduced primarily. You no longer have the objections. You no longer have to go through a process to overcome that kind of obstacle, but the Magnitude of it is at a point yet where it's still difficult for us to actually put a number to or quantify it. And it goes back to prior comments we've made is that we know these events are not light switches. I know people get tired of hearing that, but it really is not one that takes time to take root. And that's what we're in the middle of. It's all getting better everywhere, but it's not fully in place. And it's for the previous reasons that we've described. When one of these events takes place, People need to be – the approval, the extension of coverage needs to be socialized with both physicians as well as the institution. And then the institution, if they haven't already done so, need to negotiate their payment rates. And so that's why generally – and I'm generalizing here. Maybe Rick can add to this. These are typically six months minimum cycles which it takes in order to really enjoy the full benefit of that.
Maybe to add a little color, Mike, we've been tracking this closely. As you can imagine, we get asked this frequently. And I want to give my boss a good answer. What we see is a lot of our growth is driven by same store sales or, you know, believers are adopting more thoroughly. And then there's sort of a long tail distribution of new program starts. And so, you know, I know it was in our script. and prepared remarks on number of surgeons and number of programs. And you see good growth there. I wouldn't say that that's added up to be a significant tailwind yet, but we're hopeful here in the back half and moving forward into 27.
Understood. Yeah, I really appreciate the color there. And then maybe just a separate one on strategy, but, you know, taking the minority ownership stake in trace biosciences, We'd just love to hear your perspective in terms of why now external business development might have been the right fit for you.
Certainly. Timing is one of those elements of life which you need to be ready for. You can't always plan. And as we learn, we've been looking at this space for a while. As core to our long-term strategic plan is that we innovate. as defined by genuinely distinguished advantage based upon benefit versus risk. And one of the biggest challenges in nerve care is, one, seeing the problem, and then secondly, of course, doing something about the problem. Both of those are difficult. It's easy to make that statement. It sounds very simple. But when you get into complexities and you actually look at these wound beds sometimes people are dealing with, It is remarkable how difficult it is to see what it is you're trying to address and understand. So enabling the ability to see a nerve is huge. And so what we have observed with TRACE and have high hopes for is that they will be the technology that will give the first opportunity to genuinely illuminating these wound beds, these situations so that nerve care is simply easier to do and more effective as a result.
Got it. Thanks very much for the call in.
You bet. The next questions are from the line of Caitlin Roberts with Canaccord Genuity. Please proceed with your question.
Great. Hi. Thanks for taking the questions and congrats on the quarter. You know, just to start out, thanks for beginning to break out, you know, breast and advance within your revenue mix. You know, breast is driving about two-thirds of the growth in the Q2, you noted. What was the growth mix in prior quarters since you pointed out that the mix has really grown more to breast relative to the other indications recently? And just given the, you know, the updated guidance, how much of that growth and or mix do you expect to be from breast for the full year?
With regards to Brest, Brest has always had very high double-digit growth, but we're now reaching new levels, is the best way to put it. And so looking forward, while the growth with regards to OMF head and back and extremities continues very nicely on this larger base, Brest is driving the most significant acceleration within the product mix.
Got it. And then just any update on the Elevance gap length restriction and conversations to maybe remove those restrictions or, you know, maybe how any color on how restrictive, you know, this has actually been in practice for the policy.
I'll ask Rick to comment.
Hey, Caitlin. Thanks for the question. What I could tell you is the team at Elevance, we reached out and they were Very willing to meet with us, so we educated them with a couple of world-leading surgeons from well-known institutions, and we're hopeful this gets resolved sometime in the next 6 to 12 months, probably when they do the annual update next year. What I'll tell you is, in practice, we don't hear about a lot of advanced denials, so that's just a little bit of color. Our sales force is trained, if they get a denial, to give our team a call, and we're not hearing a lot of it.
Awesome, thank you so much.
Thanks, Caleb. The next questions are from the line of Anthony Petrone with Mizuho Group. Please proceed with your questions.
Thanks and congratulations on another strong quarter here. One on breast and one on prostate for the team here. Maybe on breast, you know, breaking out numbers here, you know, hitting an inflection point. And I know some of the comments just a few moments ago were, you know, it's mostly same store sales, but to a lesser extent, you're seeing, you know, traction from new accounts as well. But maybe applying those comments to the breast program here. You have 215 active programs and 560 surgeons. That's 150 new surgeons. So how much of that is same store for breast versus new account? And what do you think you can get in terms of total account penetration in breast by the end of the year? I'll have a quick follow up on prostate.
Sure. Maybe I'll ask Jens in terms of the actual breakout, and then I can give some larger color in terms of the future share.
Yeah, I think when you look at the breast growth, we see both existing programs accelerating adoption, and within those programs, that's driven by existing surgeons, but we're also successfully activating new surgeons within these existing programs. We do see a very healthy contribution from new surgeons, also new programs, and then we continue to grow our existing programs as well. So it's really nice growth across the entire customer pool that we see.
A little background to build upon what Jens just shared, Anthony, is we now see a situation where we have people calling us asking for the opportunity to attend our programs. and we also hear from physicians is how often patients now are bringing up presensation as an option for their reconstruction. So it's been a gradual change, but it's definitely a change that's underway. And to say it simply, any program or any physician within a program now feels that they need to know how to do this procedure and need to be able to offer this as an option in order to remain relevant.
That's helpful. And then the quick one on prostate here, just, you know, data coming. Second half of the year, maybe if we can a little bit on some guideposts for what we should be expecting. I know the studies with radical prostatectomies, what should we be expecting in terms of the key endpoints just as some guardrails in terms of success factors? And when you think about prostate, when we look ahead, is it specifically for just radical prostatectomy or all prostatectomy surgeries? Thanks.
The initial data set that we will present on has been done within the constraint of robotic surgical interventions, and these are radical prostatectomies that have been conducted. The patients all had prior function before their diagnosis and the intervention, and so we're looking at the ability to restore the function that they enjoyed before their procedure. and it's done across a little over 100 centers. We have a little more than 100 patients. We have about half of those patients have more than six months of follow-up now. We're looking at both safety, reproducibility and the outcomes as measured by erectile function, time to restoration of function, quality of function and then the same with regards to incontinence. So on third quarter, what we're still in the process of planning is the actual structure of our report. But we will have physicians involved who are key implanters who we will invite so that you can speak to them directly. And they will provide their perspective on the relevance of the procedure and the feedback. All we can say at this stage is what we've been saying is that it's looking good, but It's appropriate that we wait for a little more follow-up on these patients so that there's no surprises. But trends at this point in time are positive. We're doing a lot of go-to-market planning, as you might expect, doing physician, excuse me, patient preference studies. We completed two of those. Remarkable feedback. So it's really driven by what Axiogen has the opportunity to bring to the world in the way of a benefit versus risk proposition. We introduce essentially no risk. The risk is already incurred. And what we offer is the potential of mitigating the consequences of these interventions or these injuries. And we have a lot of experience in terms of the ability to provide a clinically meaningful benefit. And so when you think about the fact that you have to undergo one of these procedures, The ability to incur no risk but to mitigate that, you can probably guess what the patient preference studies are suggesting. So if our data holds up, and we'll certainly have that Q3, I think it will be a very important part of our business in the future.
And just to clarify one point that Mike mentioned was we have over 100 patients across more than 10 sites. He accidentally said 100 sites.
Oh, sorry.
You're good. My bad.
Thank you very much.
The next questions are from the line of Jason Bedford with Raymond James. Please proceed with your questions.
Good morning, guys. Thank you for taking the question. Just two quick ones here. First off, I guess across the coverage, across the sector in health care, there's been some mixed messaging on ACA dynamics. It doesn't seem like it's from your results that you're getting hit too much here, just given the strong growth. I'm just curious. Are you seeing an impact from some of these ACA dynamics and how would you characterize the procedure environment now? And just thinking ahead in the second half, fair to say that procedure demand is strong given the guide?
We have seen no impact of any kind with regards to the ACA dynamics. We're following the news, but it has had no effect on our business to our knowledge.
Okay, that's helpful. Thank you. And then just a quick one, digging in a little deeper on the trace investment there. Is the idea here that it's kind of broadly applicable across your indications? Is this more for trauma and extremities where the wound bed is a little messier, whereas like breast is cleaner given the elective nature? Can you help us think about what this does for you on an indication basis?
Yeah, the simple metaphor I would use is the rising tide. So it's going to help every procedure. It's akin to that of imaging and cardiology. In other words, you just can be able to see what it is you need to see in the first place today, but you can be able to see it more easily and more distinctly. And so this will enable nerve care very, very broadly. Got it. Thank you.
The next question is in the line of Frank Tackett with Lake Street Capital. Let's just use your question.
Great. Thank you for taking the questions. I was going to continue on with some additional questions around the breast business. What I'm really trying to get at is understanding really what inning we are in. I think back to the envelope math implies that we're maybe in the low to mid-teens percent penetrated into the market opportunity layout in breasts. but maybe a few metrics around what do you think the total program opportunity is? How many surgeons are out there that are doing these types of procedures? How many reps might you need to convert this opportunity? And then what are some of the big bottlenecks? And I'll stop that one question given they're multi-part in there. Thanks.
Sure. We're still very early in it. It's just very important to appreciate So the total number of sites of service is about 1,200. Now as to whether all 1,200 someday will be developed, that's difficult to say. But the long and short of it is that the sites that are currently up represent only a small number of the potential market development opportunities that exist. We just had a surgeon visit just the other day, a very active, busy person, and he reminded us that he still has a A huge population comes through and they don't know anything about breastfeed sensation. They don't know about the consequences of their mastectomy. And they certainly don't know anything about oxygen. And so we have, like I said, that's just why I keep repeating that we believe we have years ahead of us in terms of high growth potential as we develop these opportunities.
Okay. Fair enough. Thank you.
Thanks, Frank. Thank you. Ladies and gentlemen, that concludes our question and answer session. I'll turn the floor back to Mr. Dale for any final comments.
Thank you, operator. On behalf of the oxygen team, I want to thank everyone for their time and interest in our work to fulfill the promise and potential for all stakeholders of our business purpose, which is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We look forward to updating you on our continued progress Thank you very much.