All right. Morning, everybody. Thanks so much for coming out and seeing Axogen here. We're really excited to have them here. From the company is the Chief Executive Officer, Karen. I'll go ahead and turn it over to her and hop out of the way here.
Thank you. Thank you, and nice to see everybody this morning. Again, I'm Karen Zaderej. I'm from Axogen. Axogen is a company entirely focused in the area of nerve repair. We're really leading the market, creating a marketplace with an exclusive and unique platform of differentiated technologies. We've really invested in clinical data so that we can continue to expand the foundation of knowledge of surgeons in making their clinical choices. And from that, there are now over 200 peer-reviewed clinical publications, both from our studies and confirmatory studies from independent investigators. To date, we have over 75,000 Avance Nerve Grafts , our flagship product, implanted. We've built some significant barriers to competitive entry, so we continue to lead in this market with our differentiated platform.
We've also built a strong commercial team with 116 sales reps here in the U.S. that sell direct into the accounts where they have the needs for nerve repair. We continue to also think about how do we activate patients so that patients are more aware of their nerve injuries, and we can guide them to the surgeon that can provide the solution for that condition. We'll talk a little bit more about that. As well as supported by significant surgeon education programs, we've really built a program that now many of the fellowship programs consider the standard for their nerve repair education for their fellows. So people may not be familiar with nerves. Nerves are like the wires of your body.
They carry signals from your central nervous system out to tell your muscles to move or giving you feedback into the environment, things like sensation, vibration, temperature. All of those are sensations that are carried on these signals on the nerves, and that signal can be disrupted in many ways. And conceptually, we help surgeons with three types of things. We help surgeons when a nerve is cut. How do you repair that nerve so you restore transmission, restore regeneration and then transmission of the signals, again, allowing your muscles to move or have sensation? Those are differentiated between short gaps, where they can do a direct repair, where there is no tension on the nerve, and longer gaps. They need to do a tensionless repair.
It cuts off the blood supply if they pull the nerves together, where they need to do a bridging material between the two ends of the nerve. I'll show you we have solutions for both of those. Compression can also alter the signal conduction of a nerve. So you're probably familiar with that with carpal tunnel syndrome, but that concept is true of any nerve in the body. When there's pressure on the nerve, it can cause pain, it can cause loss of sensation, or it can cause muscle weakness. We have products that help a surgeon protect that nerve to reduce the compression of the nerve. Ultimately, when nerves are cut, think of an amputation as an example. When nerves are cut, there's an opportunity for what's called a stump neuroma to form.
A neuroma is the nerve fibers sprouting out, but they have no direction or guidance. They tangle up into a ball of scar tissue that can send aberrant signals back to the brain. You're probably familiar with phantom limb pain, but that, again, concept is true in any surgical procedure where a nerve is cut. Nerves are, you know, frankly, the shiny white things that are in the way of what they're trying to get to. If you're doing a total joint replacement, you will always cut nerves. These patients that end up in chronic pain are trying to address that pain symptom. Some of those are the cause is actually a stump neuroma. We try and provide a suite of products that help surgeons solve these problems.
So when they have a connection issue between a transected nerve, we have our flagship product, Avance Nerve Graft, which is able to bridge a gap between 5 to 70 millimeters of the nerve. We have Axoguard Nerve Connector for those direct repairs where there's no tension, they can bring the two nerve ends directly together. We have our protection suite. I'll talk about our new product, Axoguard HA, in just a second. And then our Axoguard Nerve Cap for resolution of stump neuroma. Now, we just in August launched Axoguard HA+ . We've had our classic Axoguard protector for a number of years on the market, and one of the things we recognized, that there are different segments of protection where there are some slightly different needs, and need a slightly different technology for those applications.
In one of those areas are areas where there's a lot of excursion of the nerve. In particular, think about cubital tunnel syndrome, which is your nerve right here in the elbow. It needs to glide freely over that bone, that's your funny bone, if you've ever smacked that. That's what that issue is, but this is a case where there's compression on that nerve. It's causing pain, it might tether the nerve in place, and yet the nerve needs to freely glide over that bony impingement. Axoguard HA+ is our introduction to help solve that. Although this is just an example, there are other places in the body where it can also be solved around any other major joint where you need to have a lot of movement of that nerve.
This is our Axoguard product, which we'll remodel into a sleeve around the nerve, creating a permanent protection sleeve, allowing the nerve to glide. But it's coated on each side with an HA+ layer, which provides a nice gliding gel that keeps it freely moving and is also a short-term protection from soft tissue attachments. And so we introduced this product in August. We're seeing good uptake from surgeons as they continue to expand their protection algorithm. Now, the nerve repair market is large. It's broken into a number of segments that we focus on today, predominantly, the trauma is the largest area. These are traumatic injuries that present into the emergency department. We also have compression injuries like carpal tunnel and cubital tunnel, the oral maxillofacial , so these are predominantly, mandible reconstructions due to tumors.
We've also entered into breast neurotization, so these are women that have a mastectomy, and then have a reconstructive procedure, either a flap procedure, which is what this market size is based on, and we've also expanded recently into some of the implant-based procedures as an expansion area. Recently, we started to break this out so you can get some more visibility as to where we're selling amongst these areas. It is the same product suites for the most part that are moved in all of these areas, so it's not an individual product for one application. Emergent trauma procedures are again those urgent procedures. They present into the emergency room, but then they're referred to a surgeon for an OR repair, and it's repaired by a plastic surgeon or a hand surgeon, typically.
Our scheduled procedures would be the breast reconstruction neurotization, repaired by a plastic recon surgeon; mandibular reconstruction, which would be an ENT or an oral maxillofacial surgeon; and then neuroma repair, again, those tangled scar balls that can cause pain, again, typically a hand or plastic surgeon. In that, about half of our revenue is from the emergent trauma space. Again, it's our largest space. A lot of room to continue to grow that, and we've seen that be in the mid-single-digit range of growth. Revenue from the scheduled procedures is growing faster. It's been approximately 20%. Overall, our revenue for the quarter was $41.3 million, and we continue to have a premium gross margin in our manufacturing processes of approximately 80%.
So our guidance is this year will be $154 million to $159 million. We also continue to see that our gross margin will be approximately 80%. We are in the midst of transitioning to a new manufacturing facility. We actually started processing tissue there in August of this year. We will be out of our lease space towards the end of this year. We do have dual facilities during this time period. We are ramping up this new facility as a part of our transition to be a licensed biologic for Avance Nerve Grafts .
This has been a long process that we've been working on, actually, since 2010 and working with the FDA, and we are nearing the end here, where we expect to have our pre-BLA meeting in the early part of next first quarter of next year. We'll start a rolling submission, and should have that rolling submission completed by the end of second quarter, and then we'll expect within a year of that point that we would get the approval of Avance Nerve Graft. Same indication, but now as a licensed biologic. That gives us some competitive barriers to entry. It provides, obviously, a much higher regulatory hurdle for other companies.
If they chose to figure out a way to make an allograft, they would need to go through a licensed biologic, and no one is doing that at this point in the United States. Or they would be a biosimilar, but there's 12 years of protection for the reference product, the first product in a category. So we would have a continued runway to continue to build our, our business with a unique product in the marketplace to solve surgeons' issues. The APC center is, you know, it's a thing of beauty, I think. But I think it's a great facility to have. It really supports, again, as I said, our biologics requirements for advanced processing, but importantly, it also provides about 3 times the capacity, so that as we continue to grow, we can grow in this center.
It was also designed that we can continue to expand this facility, so we've got a very long runway in this facility. Our cash outlays are essentially done. The capital is the construction is complete. The validation of the tissue is complete. We are completing right now the validation of the biologic. Yes, there are two validations because the rules are a little different for each of those, but we're completing the validations biologics now, and that will be what we roll into the into the submission early next year. So we have been creating this market and developing the market, and we have what we call our five pillars of market development. I'll go through these quickly, but we are very clinically and data driven.
We have sponsored a number of studies in the area of nerve repair to help surgeons in their decision making. A few that I want to highlight are RECON Study, which is our pivotal study for the BLA. We had a data readout last year of the top-line data. Clearly, we met our primary endpoint, that's always exciting, which was non-inferiority to the control. In addition, we showed as gap lengths increase, Avance Nerve Graft is superior to the control as well, and then obviously, a very strong safety profile.
In addition, this year, we had an important publication called the Meta-Analysis, and so this is a broad analysis of all of the literature looking at both Avance Nerve Graft as compared to alternatives, which are predominantly surgical techniques, so an autograft, which is taking a nerve somewhere else in the patient's body and transplanting it. What we show in that is that we are comparable to an autograft without the downside morbidity of an autograft, so the patient does not have to lose something to fix something that's more important. That's been the value proposition they've always had, is you have to have a second surgery to take a nerve out of your body, to transplant it, and you will give up function in one part of your body to fix something else in another part.
In addition, having a second entire procedure obviously creates risk in the surgical procedure, creates additional scarring, cosmetic issues, risk of surgical site infection, and we obviously eliminate all of those risks by not having a second surgery. So from a functional recovery standpoint, we are statistically equivalent to that autograft. We get the same outcomes, regardless of long gaps, short gaps, sensory nerves, motor nerves. Across the gamut, we provide the same outcomes. We also do that at the same, essentially the same cost to the hospital facility. And so there's not a cost constraint in using our product as compared to an autograft, while there is significant upside for that patient and a much shorter surgical time. It reduces surgical time 30 to 90 minutes in that operating room.
We validated that data with a second set of looking at economic data through premier commercial payers and showed essentially the same thing, that economically, that this is not a cost induction to bring in an allograft and do that and instead of doing that traditional autograft procedure. As I mentioned, we're focused on patients and helping them be aware of what having a transected nerve will mean in terms of their quality of life. And we've really piloted a lot of this work in the area of breast neurotization. So historically, when women had a reconstruction, they were given the shape of breast, but the woman did not feel normal. There was no sensation. It wasn't a part of the procedure to repair the nerves in the breast.
What we heard very strongly from women is things like, "When I hug my children, I want to feel them. I have a big pillow strapped in front of me. I can't feel anything. I lean over a pot when I cook, and I actually get burned." All of those are very real scenarios when you have numb breasts. By providing sensation, you return to a sense of normalcy for these women who have gone through this episode of cancer or prophylactically are concerned about having cancer. We raised awareness with women to talk about a choice that they have. If they're interested in having sensation, then we have the Resensation technique, and there are trained surgeons on this technique.
We find this resonates very strongly with patients, and a significant number of women will actually change their surgeon so that they have the opportunity for sensation. Now that we understand how to reach women and reach patients who are going through this decision process, we're broadening this to apply these same sorts of tools in our chronic pain business and our oral maxillofacial business, so the patients can be advocates for their own health care. As I mentioned before, we're very strong in surgeon education. We have programs for both fellows and attendings. We have really a class A faculty group from many academic teaching hospitals across the United States who participate and do the actual education. And it's really meant to be education.
It's not a show commercial about our products, but obviously, our products solve problems, and they're featured in the education. From a sales execution standpoint, we focus predominantly on what we call core accounts. Core accounts are defined as having $100,000 in trailing revenue. They account actually for about 65% of our overall revenue, and are growing and continuing to grow. Obviously, we do this primarily with our direct sales team of 116 reps. We do supplement that with some independent agencies, especially in more remote trauma centers. Trauma is geographically diffuse, so we do have additional independent agencies here in the U.S. Nerves are all over the body, so we continue to see opportunities to expand. We see opportunities. Today, we're focusing in looking at lower extremity or podiatry.
Much of foot pain in the feet, there are often times where foot pain can be caused by a nerve issue, either a compression issue or a neuroma. Some podiatrists and certainly some lower extremity orthopedic surgeons are well-trained in this area, and we see it as an opportunity to continue to expand our reach in impacting patients with nerve issues. Another interesting area is corneal neurotization. One of the causes of blindness is a loss of sensation of the cornea. You can, from early clinical data that we've worked with surgeons on, you can essentially rewire that using our Avance Nerve Graft so that you can restore sensation to the cornea, and it stops the ulceration of the eye, which eventually makes patients go blind.
So we think those are interesting expansion areas that we continue to explore as new potential future applications. So we have many short-term growth drivers. I mentioned those three clinical studies. Our sales team has those publications all today. RECON has recently published as well. So those are all key pieces that they can continue to educate surgeons on the outcomes and nerve repair. We continue to innovate with the launch of our Axoguard HA+, and we've announced that we'll have Avive+ Soft Tissue Matrix launching coming up here in Q1, so an additional short-term protection product adding into our protection portfolio. We will continue to expand our Resensation and breast neurotization in the implant-based procedures, as well as continuing to expand our autologous graft autologous breast reconstruction flap procedures.
Our patient activation programs, which drive patients to these, to be advocates for things that are important to them. Our emergent trauma logistics, as we continue to see some transition of emergent trauma into the ASCs, where we have a strong reimbursement strategy in place and are able to expand into that market as well, and continuing our surgeon education. So with that, I'd like to thank everybody for attending.