Earnings Call Transcript
Axogen, Inc. (AXGN)
Earnings Call Transcript - AXGN Q1 2022
Operator, Operator
Good day, everyone, and welcome to the AxoGen, Inc. First Quarter Earnings Call. It is now my pleasure to hand it over to your host, Ed Joyce. Ed, please take it away.
Ed Joyce, Host
Thank you, Dagmar, and good afternoon, everyone. Joining me on today's call is Karen Zaderej, AxoGen's Chairman, Chief Executive Officer and President; Erick DeVinney, 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, Erick 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 Investors section of the AxoGen website. Within an hour following the end of the live call, a replay will be available on the Investor section of the company's website. 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 or financial reporting, our visibility ads 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 Zaderej, CEO
Thank you, Ed, and good afternoon, everyone. It's a pleasure to be talking to you today. I am 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 Avive Soft Tissue Membrane. We are also thrilled to have announced today that our RECON study successfully achieved its primary endpoint, which is a critical milestone towards transitioning Avance 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 RECON top line 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 are 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 Avance Nerve Graft. The results of this study provide level 1 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 Avance Nerve Graft has an established track record and continues to gain traction with surgeons as they adopt the AxoGen 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 Erick DeVinney, our VP of Peripheral Nerve Science and Clinical Innovation, who will go over the RECON trial and top line results. Erick has been with AxoGen 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.
Erick DeVinney, VP of Peripheral Nerve Science and Clinical Innovation
Thank you, Karen. It's a pleasure to be here. I'd like to begin by providing some background on Avance Nerve Graft and the RECON study. Launched in 2007, there are over 50,000 Avance Nerve Grafts that have been implanted to date. Avance has a long successful and safe track record. 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, AxoGen and FDA aligned on transitioning Avance from a 361 tissue to a 351 biologic. As part of this transition plan, FDA granted AxoGen an enforcement discretion to allow us to continue to market and distribute Avance, 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 III pivotal clinical trial designed to compare the safety and efficacy of Avance Nerve Graft and conduits for digital nerve injuries in the hand. The study is prospective, randomized, subject and evaluator blinded and assessed recovery outcomes in nerve discontinuities between 5 and 25 millimeters in length across a 12-month period. The study was designed to look at sensory outcomes for Avance 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 of static 2-point discrimination outcomes, which 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 2-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 2-point discrimination of 6 millimeters or less. The study design also included in-depth training for surgeons on effective 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 intentional 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 favorable outcome. RECON enrolled its first subjects in 2015, and the last subject completed follow-up in August of 2021. Both study groups were found to be well balanced across the demographic variables of age, gender and gap lengths 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 overall gap lengths, the Avance group met non-inferiority testing. This is an important step towards using the evidence from RECON to support our BLA 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 2-point discrimination in gaps greater than 12 millimeters. In addition to demonstrating superior sensory outcomes, as gap lengths increased, subjects repaired with Avance Nerve Graft were found to have statistically superior time to recovery in gaps greater than 10 millimeters. These patients were achieving normal static 2-point discrimination up to 3 months earlier than those in the conduit group. This follows what we would expect given the mechanistic differences between Avance Nerve Graft and manufactured conduits. The biologically active laminin structure found in Avance 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, Avance 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 2 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 RECON study results later this year. We're working diligently towards the required tasks and submissions of the BLA, and we anticipate submission of the BLA 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 Zaderej, CEO
Thank you, Erick. We are thrilled about this significant achievement and I want to express my gratitude to all our participating subjects, clinical sites, investigators, and employees who contributed to this success. Turning to our first quarter results, we were pleased to see our revenue increase each month and across all of our nerve repair applications, including extremities trauma, breast, pain, and oral maxillofacial. After a peak in COVID-related hospitalizations early in the quarter, surgical schedules improved gradually despite ongoing staffing challenges in hospitals. For instance, many of our breast customers resumed reconstruction procedures by the end of the quarter after a brief suspension, allowing us to address a growing backlog of patients. We expect staffing issues to improve throughout the year and are optimistic about our growth potential. Our commercial strategy focuses on deeper penetration into existing customer accounts while continuing to add new ones. We are expanding surgeon adoption of the AxoGen nerve repair algorithm across our accounts, supported by numerous clinical publications and positive results from our RECON trial to engage discussions with surgeons. By the end of the quarter, we had 288 core accounts and 926 active accounts, which is an increase of 5% and 1% compared to the same quarter last year, respectively. Active accounts are those billed six times in the last 12 months and may still be in early adoption stages. These accounts contribute around 85% of our total revenue, with the top 10% accounting for about 35%. Core accounts, which have more engagement, are defined as those with over $100,000 in revenue in the past 12 months and make up about 60% of our revenue, typically housing surgeons who use the AxoGen nerve repair algorithm for a significant number of their nerve injury patients. We focus on maximizing cases with these surgeons and gaining additional adoption from others in the account. We see our best growth opportunities within our core accounts by further penetrating traumatic injury treatments and expanding into other nerve repair applications, such as breast and pain surgery. We ended the quarter with 116 direct sales representatives, an increase of one during the quarter and up from 106 a year ago. As previously mentioned, we expect our growth to come mostly from improvements in sales rep productivity, but we plan to add 5 to 10 sales representatives this year to expand our territories based on growing sales and market opportunities. Our direct sales force is complemented by independent sales agencies, which represent about 10% of our total revenue. We continue to increase awareness of nerve repair among healthcare providers and directly with patients, particularly for breast and pain applications. Our re-sensation and rethink pain websites are generating strong traffic, serving as educational tools to raise awareness about the benefits of nerve repair for patients undergoing mastectomy and reconstruction, as well as those suffering from chronic neuropathic pain. We are achieving our goals in our surgeon and education programs, including training over 75% of the current class of hand and microsurgery fellows. Our return to in-person education programs in the fall has sparked significant interest among surgeons, resulting in high attendance at both our fellows and best practices programs, which we will continue throughout the year. The RANGER and MATCH registries are actively enrolling, with over 2,600 Avance nerve graft repairs now included in RANGER. Data from these registries play a crucial role in informing surgeons’ clinical decisions. Enrollment for the comparative phase of REPOSE, our study on AxoGuard Nerve Cap compared to standard treatment for symptomatic neuroma, is ongoing, and we expect to complete enrollment in Q2, with a top-line data readout in Q3 of 2023. Results from the pilot phase of REPOSE were published in February, indicating significant and durable pain improvements over 12 months, suggesting a lack of neuroma recurrence. Patients who used opioids for pain before surgery stopped using them three months post-surgery, and they also experienced significant enhancements in quality of life measures. The authors noted that while the study focused on neuromas in the foot, the procedure is applicable to neuromas in other body areas. We also initiated a new study for larger diameter nerve caps called REPOSE-XL, currently enrolling. Marketing our products with a solid foundation of clinical evidence is a priority, and our growing collection of meaningful data publications is comprehensive in the peripheral nerve repair field. By the end of the quarter, we had 188 peer-reviewed papers covering all nerve repair applications, including trauma, breast, oral maxillofacial, and pain surgery. We remain dedicated to developing clinical evidence to demonstrate the safety, performance, and utility of our nerve repair solutions, supporting the continued adoption of the AxoGen algorithm across our portfolio. Moving on to our full-year guidance, we expect full-year revenue in 2022 to be between $135 million and $142 million, reflecting a 10% to 15% growth over 2021, excluding last year's Avive revenue. We anticipate a gross margin above 80% for the full year. As mentioned in February, we are taking a cautious approach to outlooks for procedure volume and revenue growth in the first half of the year compared to 2021, but we expect a return to normalized growth rates in the second half. Our current progress aligns with our expectations, and we are confident that we have established a solid organization with a strong clinical evidence base to deliver sustainable long-term growth as the impacts of the pandemic diminish. We view AxoGen as a long-term growth company, aiming for sustainable annual revenue growth in the high teens to low 20% range. Now, I will turn the call over to Pete for a review of financial highlights.
Peter Mariani, CFO
Thank you, Karen. First quarter revenue was $31 million, matching the first quarter of 2021 and an increase of 6%, excluding the $1.7 million of Avive 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 3 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 Avance Nerve Graft and a next-generation Avance 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 was due primarily to increased professional services in the quarter and facilities-related costs. Adjusted net loss and net loss per share were $8.5 and $0.20 per share in the first quarter of '21 compared to $3.1 and $0.08 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 the 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 on March 31, 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 million to $142 million, which is about 10% to 15% growth, excluding the $4.1 million of Avive revenue from 2021. The year is progressing well and in line with our initial expectations, and 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, Operator
Our first question comes from Danielle Antalffy.
Erin Fahey, Analyst
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 with the RECON, I was hoping if 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? Thank you so much.
Karen Zaderej, CEO
Thank you. We're pleased with the results and completion of this study, marking an exciting milestone for us. We anticipate that this study will attract middle adopters who have been hesitant to make changes. Early adopters are those surgeons willing to experiment and establish their own data, and they were the first to adopt the AxoGen algorithm. Many early adopters are also faculty members who teach our nerve programs. In contrast, middle adopters seek reassurance from validated data and the expertise of others. Conducting a study with the rigor of a Phase III trial and obtaining level 1 evidence should encourage middle adopters to consider changing their algorithms. However, I want to emphasize that the shift won’t happen overnight as it may in pharmaceuticals. These middle adopters will likely start with a few implants to assess outcomes before gradually increasing their adoption, allowing us to enhance our presence with both existing and new surgeons in these centers.
Erin Fahey, Analyst
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 trend 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?
Karen Zaderej, CEO
Sure. Well, I'll start, and Pete will chime in as we sit and 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 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 much more manageable levels, but hospitals are also beginning to manage their staffing challenges and were 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 improvements each month in the quarter, and each of our segments got better as we went through the quarter. 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, do you want to talk about going forward?
Peter Mariani, CFO
We are pleased with the results of the quarter. At the end of the year, we projected that growth for the first half would be in the low to mid-single digits, followed by a return to more normalized growth in the second half of the year. We recorded a 6% growth in the first quarter. We will maintain the same cautious approach in the second quarter. Overall, we are off to a strong start and remain optimistic about the business, but we will continue to be cautious in the short term before returning to more typical growth in the latter half of the year.
Operator, Operator
Our next question comes from Frank Pinal.
Frank Pinal, Analyst
Hi, everyone, congratulations on the impressive data regarding RECON and a solid quarter. I hope you’re all doing well. I have two quick questions. First, regarding the RECON data, is there a chance to incorporate the headline data early this year into your marketing plan to help boost sales in the latter half of the year? That’s my first question. For my second question, Pete, I believe you provided guidance on the margin trends for the rest of the year. The call dropped for me, so if you could repeat that, I would really appreciate it.
Karen Zaderej, CEO
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. While 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. 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. Of course, we're going to do it in the rigors of good clinical evidence.
Peter Mariani, CFO
Yes, and Frank, what I mentioned was that we just reiterated our guidance that margins will continue to be above 80%.
Operator, Operator
Our next question comes from Ross Osborn.
Ross Osborn, Analyst
Congrats on the quarter. So I guess sticking with gross margin quickly, 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 through the balance of the year?
Peter Mariani, CFO
No, I believe our margins have consistently been in the low 80s, fluctuating slightly from quarter to quarter due to changes in manufacturing or processing throughput, which are typical variations in the manufacturing process. We are confident that margins will remain within historical ranges.
Ross Osborn, Analyst
Okay, great. And then one more on the sales and marketing side of things. Would you just remind us of direct-to-patient educational campaigns you guys have ongoing? And then as a follow-up, could you share any quantitative measures on your re-sensation or RETHINK PAIN, maybe website hits? Or have you seen any changes in traffic as the year started?
Karen Zaderej, CEO
We focus on educating both consumers and surgeons through our outreach and education activities. On the surgeon side, we have consistently educated 75% of hand and microsurgery fellows. During the pandemic, we transitioned to virtual education, which was beneficial, but it doesn't compare to in-person, hands-on programs. Last fall, we resumed in-person education for fellows. We also have a different program aimed at attending surgeons, and I recently attended one of these programs in Atlanta. The surgeons are very enthusiastic about reuniting and discussing important topics like nerve repair. We observe excellent initial engagement and subsequent adoption among the surgeons who attend these programs, with education being crucial. The focus is strongly on techniques and principles of nerve repair. Understanding this helps clarify why we developed our algorithm and portfolio to address the various needs of surgeons dealing with different types of nerve injuries. This process significantly aids surgeons in enhancing their confidence and expanding their practices. Our RECON initiative will further support this effort. On the patient side, our goal is to increase awareness, as many patients are unaware of the role nerves play in their problems or quality of life. After four years in breast reconstruction, we discovered that many patients were not informed that they would likely experience numbness following the procedure. There is a noticeable gender difference in how patients discuss numbness post-surgery with their surgeons; female patients tend to bring it up with female surgeons but rarely mention it to male surgeons. Our education program aims to raise awareness before surgery, encouraging patients to inquire about the importance of sensation and establish that dialogue with their surgeons. We also provide resources that explain what nerves are and their significance in a straightforward manner. Patients share their stories through short videos discussing how sensation affects their ability to connect with their children. This aspect holds particular importance for women. Anecdotally, many surgeons report that more patients now come prepared to discuss sensation during breast reconstruction consultations, asking about their potential outcomes and sensory reconstruction options. We’ve noticed a beneficial uptick in attention on this topic. While I don’t have specific metrics on website traffic, I can say that we are quite pleased with the initial traffic to the RETHINK PAIN website, and we aim to learn from this to better direct patients to surgeons who can address their chronic pain issues. Thank you for your questions.
Operator, Operator
Our next question comes from Dave Turkaly.
Dave Turkaly, Analyst
Congrats, and I want to congratulate Ed for coordinating the first quarter results with the top line release, impressive. Karen, can you remind us how many Avance grafts and conduits or treatments in total were in the RECON study?
Karen Zaderej, CEO
So the enrollment with 220 subjects.
Dave Turkaly, Analyst
And so that's the number of nerve repairs that they were as well?
Karen Zaderej, CEO
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.
Dave Turkaly, Analyst
Got it. And when you look at the algorithms that surgeons use the conduit, the collagen tubes and the like, are they indicated specifically for certain lengths of gap, or I mean, where are they most commonly used?
Karen Zaderej, CEO
Yes, great question. So historically, 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 at the fellow and move into being an attending. One of the questions is: what is the appropriate gap length for our conduit, 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. That was the point of this study to help be able to demonstrate that; A, Avance is an appropriate treatment for nerve repair and I think we've clearly demonstrated that with these results. It also demonstrates that the conduit performance decreases as the length increases, and that's what we saw in the study as well.
Dave Turkaly, Analyst
I understand. It seems you aimed to achieve the primary endpoint. When examining the additional data, I'm curious about your perspective on the return of function, the 12-millimeter measurement, the three-month recovery time, and the pain difference. Which of these findings was most surprising to you, or which do you believe carries the most significance in terms of secondary observations?
Karen Zaderej, CEO
I think those are two separate issues, and I'll turn to my colleague, Erick, for any additional thoughts. We firmly believe and anticipated that Avance would perform better in longer lengths, and we have been able to demonstrate that. What was perhaps more surprising is a finding that aligns with what surgeons have mentioned regarding safety, particularly concerning persistent pain and the differences between conduits and Avance. Some patients experience unresolved pain, which may lead to revisions or negatively affect their quality of life. Studying this within our registry poses challenges due to the need for a rigorous and consistent approach to assessing and following up on pain. While I have heard surgeons discuss this anecdotally, we are encouraged to see this data and will explore it further as it's crucial for surgeons to understand. Interestingly, we have observed that patients return to normal sensation up to three months sooner, and there’s a solid scientific rationale for this, although we haven't seen it in some past results. It requires a study with this level of rigor to identify such trends, and regaining normal sensation three months earlier is quite significant.
Erick DeVinney, VP of Peripheral Nerve Science and Clinical Innovation
Yes, when you look at the mechanism of how conduits support regeneration, regardless of what's on the inside, it's reliant upon a vibrant matrix forming and filling that tubular structure. That doesn't have the organization and the alignment that you see in something like a nerve allograft. The active laminin scaffold in Avance provides the structure to support regeneration across versus the disorganized regeneration you see inside a tube. That disorganized regeneration, if it's incomplete or if it's suboptimal, results in essentially a neuroma and neuroma-like pain. 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, the importance of that active laminin scaffolding makes a huge difference in how the nerves regenerate. The disorganized regeneration of these manufactured tubes leads to the potential risk of seeing this type of chronic pain.
Operator, Operator
Okay, that was our final question. I'd like to turn the floor back over to Karen Zaderej for closing remarks.
Karen Zaderej, CEO
Thank you. Well, I believe we're off to a solid start this year, and we could not be more excited about our RECON achievement announced today. I am proud of all our members of team AxoGen, 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.
Operator, Operator
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.