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spk04: Ladies and gentlemen, thank you for your patience. Please remain on the line. Your conference call will begin momentarily. Again, we do appreciate your patience. Please remain on the line. Your conference call will begin momentarily. Thank you. Good day, ladies and gentlemen, and welcome to the Accident, Inc. Report's first quarter earnings call. All lines have been placed on a listen-only mode. If you should require assistance throughout the conference, please press star zero on your telephone keypad to reach a live operator. At this time, it is my pleasure to turn the floor over to your host, Ed Joyce. Sir, the floor is yours.
spk06: Thank you, Dagma, and good afternoon, everyone. Joining me on today's call is Karen Zadare, Accident's Chairman, Chief Executive Officer and President, Eric Deviney, Vice President of Peripheral Nerve Science and Clinical Innovation, and Pete Mariani, Executive Vice President and Chief Financial Officer. Karen will discuss the quarter and our outlook for the year. Eric will discuss the recon study and top-line results, and Pete will provide an analysis of our financial performance, followed by closing remarks from Karen and a question-and-answer session. Today's call is being broadcast live via webcast, which is available on the investor section of the Axigen website. Within an hour following the end of the live call, a replay will be available in the investor sections of the company's website at www.axigeninc.com. Before we get started, I'd like to remind you that during this conference call, the company will make projections and forward-looking statements regarding future events. We encourage you to review the company's past and future filings with the SEC, including, without limitation, The company's forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, statements related to the expected impact of COVID-19 and hospital staffing on our business, statements regarding our growth, our financial guidance, product development, product potential, expected clinical enrollment timing and outcomes, regulatory processes and approval, APC renovation timing and expense, financial performance, sales growth, product adoption, market awareness of our products, data validation, our assessment of internal controls over financial reporting, our visibility at and sponsorship of conferences and educational events, global business disruptions caused by Russia's invasion of Ukraine and related sanctions, and other matters not within our control. And with that, I'd like to turn the call over to Karen. Karen?
spk03: Thank you, Ed, and good afternoon, everyone. It's a pleasure to be talking to you today. I'm pleased with our first quarter revenue of $31 million, matching last year's first quarter, and an increase of 6%, excluding the impact of revenue from a five soft tissue membrane. We're also thrilled to have announced today that our RECON study successfully achieved its primary endpoint, which is a critical milestone towards transitioning advanced nerve graft to a licensed biologic and further supports the expanded adoption of AVANCE. Before providing comments on our operational results, we'd like to discuss the RECOM Topline Data Readout. The study achieved its primary endpoint of non-inferiority as compared to conduits. The safety profile of the study was consistent with previously published data, and we remain on track to complete the work necessary to submit our BLA in the second half of 2023. I would like to remind you that this study was the culmination of many years of effort and one of the most significant undertakings in our company's history. We're extremely pleased with today's outcome, which is consistent with the results we have seen in our registry data collected over the last decade. Achieving RECON's top-line endpoint provides clinical confirmation of the performance of advanced nerve grafts. The results of this study provide level one clinical evidence, the highest quality possible, which significantly bolsters our growing arsenal of data and peer-reviewed papers, and provides robust data to support surgeon adoption of Avance as the optimal treatment option for many patients with peripheral nerve injuries. We believe the current standard of treatment using Autograft is suboptimal. and can lead to complications with a second surgical site. Use of advanced nerve graft has an established track record and continues to gain traction with surgeons as they adopt the oxygen algorithm. We still have much work to be done prior to filing the actual BLA submission, which we anticipate will occur in the second half of 2023. We're in the process of compiling the appropriate documentation on this clinical study, our facilities, operations, quality systems, and much more, all of which are required for a successful application. I'd like to now turn the call over to Eric Deviney, our VP of Peripheral Nurse Science and Clinical Innovation, who will go over the Recon trial and top-line results. Eric has been with Axigen for 15 years and has been instrumental in the design and execution of the Recon study, and we're happy to have him on the call today.
spk02: Eric? Thank you, Karen. It's a pleasure to be here. I'd like to begin by providing some background on advanced nerve graft and the RECON study. Launched in 2007, there are over 50,000 advanced nerve grafts have been implanted to date. Advanced had a long, successful, and safe track record. Excuse me. Launched in 2007 with over 50,000 advanced nerve graft implants. Avanzas had a long and successful track record on the market. Originally, it was classified and regulated as a 361 tissue product, which fell under the FDA human cells, tissues, and tissue-based products. In 2010, Axigen and FDA aligned on transitioning Avanzas from a 361 tissue to a 351 biologic. As part of this transition plan, FDA granted Axigen an enforcement discretion to allow us to continue to market and distribute advance while working towards our BLA submission. Subsequent to our transition plan, FDA released a guidance document on regulatory considerations for tissue products that included classification of peripheral nerve as a non-structural biologic tissue. In support of our BLA, we underwent a special protocol assessment to gain agreement with the FDA on the robustness of the study design and the analysis plan. Those efforts and discussions led to the creation of the RECON study. RECON is a phase three pivotal clinical trial designed to compare safety and efficacy of advanced nerve graft and conduits for digital nerve injuries in the hand. The study is prospective, randomized, subject and evaluator-minded, and assessed recovery outcomes in nerve discontinuities between five millimeters and 25 millimeters in length across a 12-month period. The study was designed to look at sensory outcomes for advance, with the primary endpoint being a test for non-inferiority to conduits. Additional analyses were performed to test for superiority between the groups. The primary endpoint measure static two-point discrimination outcomes. This is the ability of an individual to feel or discriminate between a single point and two points in the affected area. In other words, it's a measure of sensory density in the skin. The smaller the distance that can be identified as two distinct points, the better the sensation. Static two-point discrimination is a standard and well-accepted measure for determining sensory recovery in the hand. It defines the highest threshold of sensory recovery, and normal sensation in the hand is characterized as static two-point discrimination of six millimeters or less. The study design also included in-depth training for surgeons on tenets of good nerve repair. We were able to leverage the axogen nerve repair training algorithm developed by expert nerve surgeons and the recon lead investigators to ensure attention was given to the important technical considerations that lead to better nerve repair outcomes. This included training on trimming to healthy nerve ends, achieving attentionless nerve repair, and the appropriate surgical techniques to be used during implantation of each of the products. This training and standardization was implemented to ensure that each subject had an opportunity to achieve a good outcome. Recon enrolled its first subjects in 2015, and the last subject completed follow-up on August of 2021. Both study groups were found to be well-balanced across the demographic variables of age, gender, and gap length, and of sufficient sample size to support the analysis. As we outlined today in our press release, the RECON study met its primary endpoint. The predefined analysis found that over all gap lengths, the AVANCE group met non-inferiority testing. This is an important step towards using the evidence from RECON to support our VLA for AVANCE. In addition to the primary endpoint analysis, we also observed that as nerve gap lengths increased, AVANCE performance demonstrated statistical superiority to conduits in the return of static two-point discrimination in gaps greater than 12 millimeters. In addition to demonstrating superior sensory outcomes, as gap lengths increased, subjects repaired with advanced nerve graft were found to have statistically superior time to recovery in gaps greater than 10 millimeters. These patients were achieving normal static two-point discrimination up to three months earlier than those in the conduit group. This follows what we would expect given the mechanistic differences between advanced nerve graft and manufactured conduits. The biologically active laminin structure found in advanced provides the organized architecture inherent to peripheral nerve and the guidance cues that can provide a direct pathway across the nerve defect. In our preclinical evaluations, advanced processed allografts demonstrated superior numbers of axons regenerating across the gap as compared to conduits. We believe this plays a key role in achieving the superior results observed with AVANCE. The safety profile of the study was similar to previously published studies. Nerve-related pain was the most commonly reported adverse event in RECON. Persistent and unresolved pain was observed in 9 or 8.3% of the conduit group and in two subjects or 1.8% of the AVANCE group. The incidence of pain was observed across all gap lengths. We're excited with these top line results, and we are continuing our analysis of the additional data that includes quality of life measures, pain medication, usage, and other outcome measures within the study. We look forward to reporting the full analysis of the RECOM study results later this year. We're working diligently towards the required tasks and submissions of the VLA, and we anticipate submission of the VLA in the second half of 2023. Thank you for the opportunity to share these exciting findings. Now I'd like to turn the call back over to Karen to discuss our first quarter results. Karen? Thanks, Eric.
spk03: We could not be more excited about this huge achievement, and I want to thank all of our participating subjects, clinical sites, and investigators, and all of our employees who have contributed to this accomplishment. Returning to our first quarter results, we were pleased that our revenue increased each month of the quarter and across each of our nerve repair applications of extremities trauma, breast, pain, and OMF. With COVID-related hospitalizations peaking early in the quarter and then declining, surgical schedules gradually improved across the quarter despite ongoing hospital staffing challenges. For example, after suspending breast reconstruction procedures for several weeks. Most of our breast customers had restarted reconstruction procedures by the end of the quarter, providing the opportunity to begin catching up on a growing backlog of patients. We anticipate hospital staffing issues will improve over the course of the year and are optimistic about our growth prospects. Our commercial focus remains on driving deeper penetration into customer accounts while also continuing to add new accounts. We continue to expand surgeon adoption of the Axigen nerve repair algorithm across our accounts, leveraging the numerous clinical publications featuring our products, and now supported by the positive top line results of our recon trial to lead discussions with surgeons. As of the end of the quarter, we had 288 core accounts, and 926 active accounts, representing an increase of 5% and 1% versus prior year's first quarter, respectively. As a reminder, active accounts are those that have ordered at least six times in the last 12 months and may still be in the early stages of adoption. Active accounts continue to represent about 85% of our total revenue, with the top 10% contributing about 35% of revenue. Core accounts represent more penetrated accounts, defined as those that have had greater than $100,000 in revenue in the trailing 12 months. Our core accounts continue to represent about 60% of our revenue and typically contain at least one surgeon who's adopted the oxygen nerve repair algorithm for a significant portion of his or her nerve injury patients. Leveraging this surgeon's success with our products, we focus on gaining more cases with that first surgeon, and gaining adoption by additional surgeons in that account. We continue to see that our best opportunity for growth is within our core accounts by more deeply penetrating the treatment of traumatic injuries and continuing to expand into other nerve repair applications, including breast, OMF, and the surgical treatment of pain. We ended the quarter with 116 direct sales representatives. an increase of one during the quarter, and up from 106 a year ago. As we commented in February, we expect that our growth expectations can be delivered primarily through improvements in sales rep productivity. However, we do anticipate adding five to 10 sales representatives this year to increase our number of territories based on growing sales and market opportunities. Our direct sales force continues to be supplemented by independent sales agencies that represent approximately 10% of our total revenue. We continue to build market awareness of nerve repair with healthcare providers and through our direct-to-patient initiatives, particularly in our market development efforts for the breast and pain applications. We continue to see strong traffic at both our Resensation and Rethink Pain websites. These educational marketing tools are aimed at increasing awareness of the potential for nerve repair procedures to improve outcomes for patients undergoing mastectomy and reconstruction and those suffering from chronic neuropathic pain. We continue to achieve our goals with our surgeon education program, including training more than 75% of the current class of hand and microsurgery fellows. With our return in the fall to in-person education programs that include hands-on nerve repair training, there has been significant educational interest among surgeons resulting in strong attendance at both our fellows and our best practices programs. We will continue these programs throughout the year. Our ranger and match registries continue to enroll, now with over 2,600 advanced nerve graft repairs enrolled in ranger. Data from these two clinical registries continue to play an important role in forming surgeons in their clinical decision process. Enrollment in the comparative phase of REPOSE, our study of Axigard nerve cap compared to standard treatment for a symptomatic neuroma, is ongoing, and we anticipate completing enrollment in Q2 of this year with a top-line data readout from the comparative phase in Q3 of 2023. The results of the proposed pilot phase were published in February in foot and ankle surgery. Results from this study concluded that subjects showed significant and durable improvements in pain over the 12-month follow-up period, which the authors stated is indicative of lack of neuroma reoccurrence. Subjects who reported opioid use for pain treatment before surgery had discontinued use by three months post-surgery. In addition, subjects showed significant and clinically meaningful improvements in quality of life measures. The authors further concluded that while the study population had neuromas in the foot, the procedure has applicability for neuromas in all other areas of the body. Also with our ExaGard nerve cap, we initiated a new study for large diameter nerve caps called Repose XL. This pilot study focuses on a line extension of AxiGuard nerve caps with diameters from 5 to 7 millimeters. This study is currently enrolling. Marketing our products with a solid foundation of clear, high-quality clinical evidence is a priority, and we believe that our growing collection of meaningful data publications is the most comprehensive in the area of peripheral nerve repair. As of the end of the quarter, we now have 188 peer-reviewed papers with growing numbers among all our nerve repair applications, including trauma, breast, OMF, and the surgical treatment of pain. We remain committed to developing the clinical evidence to demonstrate the safety, performance, and utility of our nerve repair solutions to support the continued adoption of the Axigen algorithm across our full portfolio of nerve repair products. Moving on to our foliar guidance, We continue to expect that full-year revenue in 2022 will be in the range of $135 to $142 million. This revenue guidance represents 10 to 15% growth over 2021, excluding the above revenue from last year. Full-year gross margin is still expected to be above 80%. As we noted in our February call, We're being measured in our outlook for the procedure volume improvements and revenue growth in the first half of the year compared to 2021. But we anticipate a return to more normalized growth rates in the second half of the year. Our progress this year is meeting our initial expectations, and we're confident that we've built the right organization with a solid foundation of clinical evidence that will allow us to deliver sustainable, long-term growth as the impacts of the pandemic abate. We continue to view Axigen as a long-term growth company, delivering sustainable annual revenue growth in the high teens to low 20% range. Now, I'll turn the call over to Pete for a review of financial highlights. Pete?
spk01: Thank you, Karen. First quarter revenue was $31 million, matching first quarter of 2021, and an increase of 6%, excluding the $1.7 million of above revenue in the first quarter of 2021. First quarter revenue was negatively impacted by the Omicron variant and related hospital staffing challenges, particularly in the first half of the quarter. Revenue was negatively impacted by a 4% decrease in unit volume, which is offset by changes in price and product mix. And if you exclude the impact of Avive revenue in the prior year, units increased by 3% and price and mix combined for a similar 3% impact. Gross profit for the first quarter was $25.5 million compared to $25.9 million in Q1 of 21. Gross margin was 82.1% for the quarter compared to 83.3% in the prior year. Total operating expense in the first quarter increased 15% to $36.8 million compared to $32.1 million in the prior year. The increase in total operating expenses was primarily due to increased sales and project-related headcount, and the return of in-person sales team and physician meetings and education events, travel, and increased professional services spending. Sales and marketing expense in the first quarter increased 16% to $20.9 million, compared to $18 million in the prior year. The increase was primarily due to marketing development programs, compensation-related and travel-related expenses, from increased sales activity with greater hospital access. As a percentage of total revenue, sales and marketing expenses increased to 67% for the three months ended March 31st, compared to 58% in the prior year. Research and development expenses increased 9% to $6.3 million, compared to $5.7 million in the prior year. The increase in R&D expenses reflects increased spending in specific programs, including our efforts related to the BLA for advanced nerve graft and a next-generation advanced product. Product development expenses represented approximately 66% of total research and development spending in the first quarter of both 2022 and 2021. Clinical trial expenses represented approximately 34% in both quarters. As a percentage of total revenue, research and development expenses were 20% in Q1 compared to 19% in the prior year. General and administrative expense in the first quarter increased 15% to $9.6 million compared to $8.4 million in the prior year. G&A as a percent of revenue was 31% compared to 27% in the prior year. The net increase is due primarily to increased professional services in the quarter, and facilities-related costs. Adjusted net loss and net loss per share was $8.5 million.20 per share in the first quarter of 21 compared to $3.1 million.08 per share last year. Adjusted EBITDA loss in the quarter was $7.4 million compared to an adjusted EBITDA loss of $1.9 million in prior year. The reconciliation of these non-GAAP financial measures to GAAP can be found in today's earnings release and on our website. The balance of all cash, cash equivalents, and investments March 31st of 2022 was $73.7 million, compared to a balance of $90.3 million at year end. The net change includes capital expenditures of $5 million related to the construction of our new processing facility in Dayton, Ohio, and approximately $7.6 million related to items which typically occur in the first quarter of each year, including payment of our annual bonus, sales meetings and awards, and insurance payments. With $74 million in cash, our balance sheet is strong and we expect to end the year well-positioned to continue funding our growth while maintaining an appropriate level of cash. Our annual guidance remains unchanged with revenue of $135 to $142 million which is about 10% to 15% growth, excluding the $4.1 million of abide revenue from 2021. The year is progressing well and in line with our initial expectations. We anticipate to return to more normalized growth rates in the second half of the year, and we continue to expect gross margins to remain above 80%. At this point, I'd like to open the line for questions. Operator?
spk04: Thank you. The floor is now open for questions. If you do have a question, please press star 1 on your telephone keypad at this time. Please hold while we poll for questions. Our first question comes from Danielle Antlesey. Please state your question.
spk05: Hey, guys. This is Erin on for Danielle. Thanks for taking our questions, and congrats on a great quarter and the recon results. I think just starting off for us, you know, with the recon results, I was hoping you guys could just frame for us the potential impact this will have on revenue and growth. Where do you expect this study to have the most meaningful impact? Would it be within kind of existing surgeons or potentially help penetrate new surgeons and accounts? Thanks so much.
spk03: Sure. Thank you. Yeah, we're very happy to have the results and complete this study. It's an exciting milestone for us, so we'll break out the champagne in a little bit. But in terms of the impact, I think I'll put it, we've talked about in the past about early adopters and middle adopters. And early adopters are usually those surgeons who are are willing to try things for themselves, build their own databases, and we're certainly the early adopters of the Axigen algorithm, and in many cases are the faculty that teach our nerve programs today. But middle adopters tend to look for more confidence and security of data, and that the experts in front of them have already evaluated that data. And so to complete a study like this with the rigor of a phase three study, with the independence of a phase three study and level one evidence, I think will bring middle adopters who may have been sitting on the sidelines to begin to think about changing their algorithm. Now, I do want to caution. This is not like a pharmaceutical where everybody changes what their prescribing patterns, and it changes all at once. I still believe these middle adopters will trial. So they'll do a few implants. They'll wait and see their outcomes. They'll see how that progresses in this first segment that they adopt, and they'll continue to adopt in this stair-step pattern. But it will help us as we continue to drive penetration in our active and core accounts to bring in those not only the second and third surgeon, but many of the other surgeons in those same centers.
spk05: Okay, great. Thanks so much. And then I guess just turning to the quarter and revenue, if you guys could just talk sort of about the trends that you've seen in the quarter, how things are looking into April, just maybe by the different areas like trauma, breast pain, And then just how we should be thinking about the cadence for the rest of the year.
spk03: Sure. Well, I'll start and Pete will chime in as we start to talk about the rest of the year. But the quarter definitely had challenges. January was very disruptive to procedures actually in all of our segments. In fact, if I look at our more elective procedures, we had a near shutdown of those procedures at points in the month of January. That's because these elective procedures like breast and oral maxillofacial are very both elective but also resource intensive. They're inpatient procedures. They're long OR procedures. and we saw a significant disruption of those. Now, I'm happy to say that as the quarter progressed, obviously COVID hospitalizations went to a much, much more manageable level, but hospitals are also beginning to manage their staffing challenges and we're able to open up even these inpatient procedures as well as bring back procedures like some of the trauma procedures that sort of dispersed into community and ambulatory surgery centers to try and allow some of those to even occur. where hospitals didn't have the capacity or the capability to do it. So we saw things improving each month in the quarter, and each of our segments got better as we went through the quarter. And again, as we ended the quarter, the breast reconstruction sites were up and starting to do surgery again. The oral maxillofacial program was back to doing surgery again, and we were seeing a rebound in the surgical treatment of pain as well as trauma. And Pete, you want to talk about going forward?
spk01: Yeah, no, we're happy with the way things came out for the quarter. We had in our guidance at year end, we suggested that we thought first half growth would look like low to mid single digits in the first half and then a return to more normalized growth in the second half of the year. We achieved 6% growth here in the first quarter. We would continue to take that same measured approach here over the second quarter, and we're off to a good start. We've got lots of optimism about where the business is, but continue to be measured here in the near term, and then return to more normalized growth in the back half.
spk05: Okay, great. Thanks so much for taking the questions, and congrats again.
spk06: Thanks.
spk04: Okay, our next question comes from Frank Pinal. Please state your question.
spk08: Hi, guys. Congrats on the compelling data on recon and a nice quarter. I hope you're all doing well. Just two quick ones for me. A follow-up to the recon question, I'm wondering if there's an opportunity for with the headline data here early on in the year to sort of use that as part of your marketing plan or if there's an opportunity there to bolster sales for the back half of the year. I guess that's one. And then I'll just ask my second one now. And, Pete, I think you gave some guidance on the cadence of margins for the balance of the year. The call accidentally dropped on me. If you can – If you can restate that, that would be extremely helpful. Thanks, guys.
spk03: Well, so I'll start with the recon data. We're very excited about it. In fact, we have a little bit later tonight the rollout with the broader investigators where the lead investigators will be presenting the data and reviewing it with them. And I think it will create some positive scientific discussion that will happen amongst the investigators and amongst their peers. We fully expect that this will be data that will be compelling and interesting. Well, I can't guarantee it because it's not within our control. I expect it will be discussed and presented at some of the upcoming hand conferences later this year. Again, given the rigor and level of evidence, it's truly unique in this area, and so I know that surgeons are excited to talk about it, and hopefully it will be something that will be a major part of their agenda. And then as the paper comes out, which will certainly follow all of this, then the reps will be able to provide that as additional scientific evidence in their discussions. So absolutely, it's something we plan to talk about. We plan to continue to build on. But of course, we're going to do it in the rigors of good clinical evidence.
spk01: Yeah, and Frank, what I mentioned was that we just reiterated our guidance that margins will continue to be above 80%. Great.
spk08: Thank you, guys. Appreciate it.
spk01: Yep.
spk04: Our next question comes from Ross Osborne. Please state your question.
spk09: Hi, congrats on the quarter. Thanks for taking my questions. So I guess sticking with gross margin quickly, you know, it was obviously still above 80%, but are there any headwinds or tailwinds you would highlight that occurred during the quarter that maybe we should be thinking about for the balance of the year?
spk01: No, look, I think we've had, our margins have been sort of in the low 80s consistently, and they've moved around up and down. from quarter to quarter, just with changes in the pace of manufacturing or processing throughput, just normal ups and downs of the manufacturing process. We're comfortable with margins continuing to be in historical ranges.
spk09: Okay, great. And then one more on the sales and marketing side of things. Would you just remind us of the direct to patient educational campaigns you guys have ongoing? And then as a follow-up, could you share any quantitative measures on your resignation or rethink pain, maybe if website hits or if you've seen any changes in traffic, you know, as the year started?
spk03: So, first, the outreach that we have, the education activities, we look at educating both consumers and surgeons. So, on the surgeon side, We have always educated 75% of the hand and microsurgery fellows. Of course, during the pandemic, we had to go to virtual education, which was good, but it's never as good as these hands-on programs. In the fall of last year, we were able to return back to in-person education, both for fellows. We also have a separate program, a little different targeting on the level of information provided to attendings. In fact, I just came from one of these programs in Atlanta and surgeons are frankly just super excited to get back together and talk about an important topic like nerve repair. We see very good initial trial and then progressed adoption from the surgeons who attend these programs. But it really starts with an education. They're very not promotional. They are very much on the techniques and principles of nerve repair. And when you go through that, you step back, and it's logical and clear why we've developed the algorithm and portfolio that we have is that it answers the needs that surgeons have as they go into these different types of nerve injuries. And so we find that a very helpful and impactful tool process to help surgeons think about what they're doing, be confident in what they're doing, and expand their work. And of course, Recon will help to continue to support that. On the patient side, much of what we try and do is actually just increase awareness. Patients don't think anything about nerves, and they don't know that nerves are a cause of either a problem or a quality of life impact that they have. So what we found with breast reconstruction, and we're applying some of that learning now to the surgical treatment of pain, we've been doing the breast reconstruction work with patients for about four years, was that patients were unaware that when they had a breast reconstruction that they would likely be numb. And it was just something that wasn't discussed. We found a real gender difference in even the ways they talked about it after surgery with their surgeons, in that if they had a female surgeon, it was one of the top things that they would bring up and talk about. I'm numb. Is this what's happening here? Why don't I feel anything? And they almost never mentioned it to their male surgeons. And so what we were trying to do in our education program was raise awareness before the surgery to say, if sensation is important to you, then ask your surgeon about it up front and open up that dialogue. And then we also provided them access to tools that explain in a very simple way what nerves are, why it makes a difference. We had patients tell their own story. There's little videos of patients talking about sensation and what it meant to them to be able to hug their baby and feel the baby. That's an important... characteristic that women identify with. And what we found is it has greatly increased the number of patients. I hear this anecdotally. I guess I don't have a good measure for this. But anecdotally, I hear from many surgeons how often now patients walk into their breast reconstruction discussion and say, and sensation is one of the things on their list. They ask, I want to understand what my sensation outcomes could be. Do you do sensory reconstruction? And if not, who does? And so we see anecdotally that it's become a much bigger topic. I don't at my fingertips have the click-throughs of the number of subjects that we get through the website, but we do have, if they go on the website, there is a surgeon locator that they can click through and find a surgeon who does the resensation work. Again, Rethink Pain is at a much earlier stage. It's a little more complex because pain is multifactorial and we're trying to help patients identify whether they have nerve pain or something else that they need to see a pain specialist on. I can say initially that we're quite pleased with the initial traffic we're getting on the Rethink Pain website and we hope to continue to learn and expand on that and help refer those patients to a surgeon who can help them with their chronic pain problem.
spk09: Sounds great. Thanks for taking my question.
spk04: Bar one on your telephone keypad at this time. Our next question comes from Dave Terkelay. Please face your question.
spk07: Thanks. Congrats. And I want to congratulate Ed for coordinating the first quarter results with the top line release.
spk00: Impressive.
spk07: Karen, can you remind us, I may have missed this, but how many advanced grafts and conduits or treatments in total were in the recon study?
spk03: So the enrollment was 220 subjects.
spk07: And that's the number of nerve repairs that there were as well?
spk03: Yes. So we evaluated only one nerve injury per patient. Some patients might have had more than one nerve injury, but the protocol was written to address that. So no patient is included in the study twice. They're only in the study once.
spk07: Got it. And, you know, when you look at the algorithms that surgeons use, the conduits, the collagen tubes and the like, are Are they indicated specifically for certain length of gap or, I mean, where are they most commonly used?
spk03: Yeah, great question. So historically, well, conduits have an indication of up to 30 millimeters, and I say that there's some variation with some brands, but they're typically in the up to 30 millimeters. That is actually still the exam question for surgeons as they come out of their – program as a fellow and move into being an attending one of the questions is you know what is the appropriate gap length for conduits and it still says up to 30 millimeters we have said from even the prior data that that was generous to a fault to where they're shown to be effective and And that was the point of this study is to help be able to demonstrate that, you know, A, Avance is an appropriate treatment for nerve repair. And I think we've clearly demonstrated that with these results. But to also demonstrate that there is the conduit performance decreases as the length increases. And that's what we saw in this study as well.
spk07: Got it. And, you know, I guess... So clearly you wanted to hit the primary endpoint, and then when you look at some of the other data, I guess I just love your thoughts on, I mean, we all know they're good, but the return of function, the 12 millimeter, the time to recovery of the three months and the 10, and the pain delta, which was the most surprising to you, or which do you think is the most powerful in terms of secondary observations?
spk03: Yeah. Well, I'll answer those as two separate things, and I'll look at my friend Eric to see if he has any additional comments. But I guess we fully believed and expected that ADVANCE would be superior in these longer lengths, and we were pleased to see we were able to demonstrate that. I think the thing that was probably more surprising and it's just a finding that helps us solidify things that I've heard surgeons talk about but give us data was in the safety side of looking at the persistent pain and the difference between conduits and advance. And these are patients that, you know, the pain is not letting up for them. It's unresolved, may very likely be something that will result in a revision or this will be an impact on their quality of life going forward. And this is a hard thing to study in something like our registry because it needs a very rigorous and consistent way of asking about the pain and following up on the pain. And in a registry study, it's just hard to be sure that you have that. So while anecdotally I've heard surgeons talk about this, we are pleased to be able to see this type of data and it's something we'll dig into a little bit more because We really think it's impactful for surgeons to understand that. And then, interestingly, the returning normal sensation up to three months earlier, I think there's a good scientific explanation as to why it does that, but we have not seen that in some of our previous results. Again, it takes a study of this type of rigor and structure to be able to pick up a trend like that. And three months is pretty meaningful to be able to get back to normal sensation that much earlier.
spk07: No, I agree, and maybe if I could slip one last one in for your colleague. The pain one, I mean, I know it may be too early to answer this, but is there any sort of reason or, you know, obviously we know what a VANS is versus what a tube collagen is, but why that would be the case, like initial thoughts on why that would be so?
spk02: Yeah, when you look at the mechanism of how conduits support regeneration and No matter what's on the inside, it still relies upon a fibrin matrix forming and filling that tubular structure. And that doesn't have the organization and the alignment that you see in something like a nerve allograft. It's that active laminin scaffold and an organization inside a advanced nerve graft that provides the structure to support regeneration across versus the disorganized regeneration you see inside a tube. And that disorganized regeneration, if it's incomplete or if it's suboptimal, disorganized regeneration results in essentially a neuroma or neuroma-like pain. And if that becomes symptomatic, you detect that, and that's an unfortunate impact on the patient's quality of life. So if you look at how these products work and the importance of that active laminin scaffolding, that makes a huge difference in how the nerves regenerate the disorganized regeneration of these manufactured tubes potentially leads to this greater risk of seeing this type of chronic pain.
spk07: Much appreciated. Thank you.
spk02: Thank you.
spk04: Okay, that was our final question. I'd like to turn the floor back over to Cameron Zadere for closing remarks.
spk03: Thank you. Well, I believe we're off to a solid start this year, and we could not be more excited about our recount achievement announced today. I am proud of all our members of Team Axigen who remain committed to our mission of improving nerve function and quality of life for patients with peripheral nerve injuries. I want to thank everyone for joining us on today's call, and we look forward to speaking with you in the near future.
spk04: Thank you. This concludes today's conference call. We thank you for your participation. You may disconnect your lines at this time and have a great day.
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