To limit access, we now have a place at the table that we think we can continue, even when they reduce the number of approved suppliers. Differentiated by science. As I said earlier, and I'll talk about in our product development, we start with a very disciplined R&D process. We believe we have the best products, but that's not enough. You have to invest in the data that's peer-reviewed to differentiate yourself in a crowded space. If you have those elements, broad products, approvals, differentiated by science, then you can deliver consistent growth. We've done that at SeaSpine, and we will do it on a combined basis. Perhaps most relevant to this group is operational leverage and capital efficiency. This is very synergistic with the rest of the business. Why? It's the most, along with BGT, very profitable but very capital efficient. We don't have to buy sets.
When we innovate, we sell through the entire lot. We don't have an E&O experience. That is really kind of harnessed by the two business models, which ironically are synergistic. SeaSpine, vertically integrated. As I talked about before, and if you've been covering SeaSpine, you know that we have been able to contribute significantly to the increase in profitability and gross margins. Why? We can easily scale, add volume without adding any significant capital investment. MTF is another very different business structure. It's a marketing fee structure. It is the most capital efficient that you can have. Now, the disadvantage is you don't get all of the revenue recognition, but you don't have any of the expense. Between these two, we really contribute to the profitability of the organization and positive cash flow.
In addition, with the MTF relationship, we get access to the market leader in tissue processing. They are by far the largest tissue bank in the U.S., and they specialize and lead in aseptic processing, which is their strength. That's also obviously required for Trinity in the cellular graft market, where we have not historically competed, nor did we have the capabilities in Irvine. Again, that's how these pieces really fit together. Now let's shift to our product development process. Here what you have is a depiction on three pillars that are competing when you develop products. For biologics, you have to balance these three competing variables: activity, strong bone-forming capacity, delivery, efficiently deliver, and completely fill the surgical site, and that's procedure-specific. Location, optimize and maintain post-op positioning. What we say it's our version of ADL. What are some examples?
What's the best-forming, most successful product in biologics? Infuse. That's an extreme of a product that can really grow bone well, but when it was first launched, migrated, wasn't controlled, and caused ectopic bone formation and complications. Go to the other extreme. Great handling. You can mold it. It's really good. It can be delivered. A lot of those products historically, the DBMs as the example, had tremendous amount of carrier, up to 70% to 80%. What's the problem? Displacing the active component. Great handling, but doesn't have great bone-forming capacity. These are the pillars that we use to not only position our products in the marketplace, but as tools for product development. It's understanding the procedure requirements. For example, an MIS open versus open spine procedure has completely different requirements.
Even a lateral or an ALIF inner body is completely different than a TLIF. If you don't understand that, and you're not an integrated business, develop great products, but not great procedural solutions. That's where we really differentiate ourselves. We have seven PhDs on our team. Nobody else in the industry can match that. We have two of those are on our marketing side. We have a host of R&D engineers and also other scientists to really complement that. This is where I think combined and you say, "Okay, what's the advantage?" The advantage is we have outstanding engineers, as we'll go through the data, that can help design and lead simple studies that will evidence our products across the board, including those sourced through MTF.
Now let's talk about our largest product family as a company within the biologic space, DBMs. A little refresher, DBMs are sourced from human tissue. We take an example of cortical bone. If we put that cortical bone and placed it in a muscle pouch, it wouldn't grow bone. It's inert. What happens when you transform it, when you demineral it? It now becomes growth factors that are available to the body, and it drives bone formation. Two traditional ways that we manufacture that, DBM particles and DBM fibers. You can see the DBM particles for illustrative purposes here. You see that they're still pretty tightly wound. I would say this is what most companies offer.
What we do and what has allowed us to become the number two DBM player is our Accell Bone Matrix, and that's here. We take tissue from the same donor, we process it traditionally, either as fibers or DBM particles. We take a portion of that from the same donor, 'cause you can't mix donors in the U.S., we process ABM. What's ABM? It's high surface area DBM. It's still a DBM, but if you compare the image on the right to the image on the left, you see something that's fluffy, very open porosity. Why does that matter? The open porosity releases the growth factors faster than the tightly wound DBM particles. Think about it this way. Rock candy in your mouth. Put that on. You get the flavor of sugar, but it lasts for hours. At least minutes, maybe not hours.
A little exaggeration there. When you combine these, the cotton candy portion of it is gone immediately, right? It's the same thing with Accell. When we combine Accell with DBM, we get a biphasic release of growth factors. The ABM is immediately, those growth factors are available in the first week, and if you look at this graph, you see growth factors on the Y-axis, time on the horizontal axis. Why does that matter? ABM signals the body immediately, activates the healing cascade, the DBM gives you sustained release. Another analogy, if you need to start a fire, you need kindling. If you use kindling, it would burn out immediately. You combine it with logs. That's the analogy here.
By combining ABM, we activate the body's healing cascade quicker, and then you have the sustained release of traditional DBMs to complement it. The goal is not only to have best-in-class DBMs, but within each class, a variety of price points and procedural requirements. DBM putties, despite the growth in fiber-based DBMs, are still the bulk of our sales. Why? In volume. Also handling requirements. If a surgeon wants to mix this, the carrier, mix it with autograft or a synthetic bone substitute, it adds in handling. It also really facilitates MIS approaches where you need to be able to deliver it percutaneously. On the top, you see our Accell-based products, OsteoSurge 300, also known as Evo3, OsteoTorrent. Both of these come with and without cancellous. Their premium price and that biphasic release really commands a premium in the marketplace.
We also have traditional more valued products, Legacy from Orthofix and OsteoSparx from SeaSpine. What you're beginning to see is we are not gonna only offer leading products, but at all the various price points, procedural requirements. DBM fibers. The reason that the DBM market has been the fastest-growing segment of bone substitutes is because of fibers. There's a couple of reasons. One is the value proposition, and also the cost of this product. If you look at the image in the center on your OsteoStrand, you see that magnification, that they're all interconnected. These little fibers act like spaghetti when hydrated, and you can look at the image on the right, and you see it has like crab meat consistency. Why does that matter? We get good handling without having to dilute it with a carrier. We have more active components.
Think about that activity delivery location. Not only does it stay there, but it's also flowable. It's gonna resist migration, but not at the expense of a carrier, which dilutes the active component, and when the carrier's gone, can lead to gaps. We offer OsteoStrand and OsteoStrand Plus. Plus is with Accell. We also have a very complementary portfolio from Orthofix and MTF. FiberFuse is another DBM fiber product with cancellous chips. Again, appealing to different surgeons, different preferences, different procedures. We also have the FiberFuse strips, which are strips made of fibers, and they're placed in the posterior lateral gutters that are compressive resistant and hold their shape. Again, procedure-specific. Many options for our customers that are well-positioned. I wanna tell you how we also developed Strand Plus, 'cause I think it's the scientific rigor that we've approached it.
When we developed it was because of this data from Scott Boden. Scott is a leading investigator, published this paper 20 years ago, the fibers were patented in DBMs until about 2017. What his data showed is by taking rabbit bone from the same rabbit and creating fibers and particles, so they were matched, and then devitalizing them. Basically, the other secret on deamine process is it has to be very exact. If you don't remove enough of the mineral, then the proteins aren't available. If you overdeamine, it's basically like overcooking a steak. You can have a great product, but now it's ruined. Here, what they did is they intentionally killed the proteins and tested it for conductivity.
What you see is that particles get 0% fusion in this posterior lateral rabbit model, but fibers get 35%. Why? It's because they're conductive. If I go back to that picture and you look at it, they're all interconnected. That's the conductive matrix. Think of it as like a trail in your garden tracks. Here, the fibers had 91% fusion when they were active on the right versus 60% when deactivated, or 58%. If you take 35% and 58%, it's almost exactly that difference. Fibers are more expensive to manufacture 'cause they don't have the inexpensive carrier, and they also are conductive. We were able to take this data and our own competitive data and go out and really kinda carve out that premium market.
The market's growing, is that we demonstrate improved product efficiency, and we did it through a very disciplined R&D approach. What we did, we didn't just develop fibers. We took multiple geometries, different lengths, different widths, tested them, combined them, and said, "Which ones give us the best handling? Which ones give us the best conductive outcome? Which ones give us the best inductive?" That's how we developed and launched Strand Plus and Strand. The other part of this is we didn't just stop there. Every three weeks, we did a different set of tests based on whether it was moist, how it was sterilized, how it was delivered, and we'll go through those. We thought we had developed the best product. We had great data, how do you prove that?
You take all these products, you put them in a athymic rat. Why in a [thymocrat]? Why not a sheep? This is the only model that you can test human tissue without invoking an immunologic response. It's the only way to test multiple products head-to-head. We took initially seven different DBMs, including our Strand, not Strand+, and tested against them. The other beauty of this is that DBMs are radiolucent. They go on initially at time zero, they're black. When they mineralize and when they fuse, it goes from black to white. When you show a clinician this image, it's very apparent. You see Strand on the far left robust fusion throughout, and also mature cortices on the outer edge.
As you look to the center, the one immediately to the right, it's not even mineralized at all. Third one has clefts in the middle. If it's not bridging bone from TP to TP, from the bottom to the top, it's not fused. However, in the middle, you see Grafton from Medtronic, very good fusion, actually. Who are the top two players in DBMs? SeaSpine Legacy, Orthofix today, and number one is Medtronic. There is data to support that. If you look on the top right, you say, "Why is OsteoAMP kind of radiodense?" It's because it has cancellous chips. When you look at it too has not really matured.
When we look at the data from this study, which has been published and presented at NASS, it was the best paper, one of 13 in 2020 at NASS. You see fusion from 100% to 0%. It is sensitive, and you see everything in between. SeaSpine, Medtronic are statistically similar. The rest, there is a statistical difference. Not to suggest that you're gonna get 100% fusion in a human, but if you can, it does tease out the inductivity, the difference between these different products. Why is that? This is all the factors that we tested. When you look at it, all these products will actually handle and feel the same or similar, but they're not. It's all these variables that we try to individually optimize. Do they make a difference individually? Yes.
Collectively, by optimizing all these different elements, that's how we get better products. That's the benefit of an integrated manufacturing and R&D team. The last thing I'll point out is the lot release testing. Everybody tests their product. The question is, what's your acceptance criteria? Every student gets passed, does that mean they can read? No. It's the same thing with products because we're starting with a very variable human tissue. No matter how well you control your processes, no matter what, there's variability, and we reject 8%-10% of our fiber donors. We're proud of that because what we're trying to do is deliver the best, most consistent product that's gonna help patients. I would challenge you to ask the other tissue banks, what's their rejection rate?
It's funny, one of our competitors, post a article or a advertisement that shows a picture of what they would accept. We would reject that donor. The conclusion at NASS is DBMs aren't the same, and we've demonstrated that. Now when you go into cellular grafts, it's the same concept. They're not all the same. Trinity is the number two player because of its quality. If you use ADL, it's a fiber-based allograft. I just demonstrated the advantage. A number of companies still offer particle-based, and it's the MTF advantage. They really do an outstanding job of controlling donor quality and their processing. We've also innovated last year with the first-- I guess a step back. I think all of you know it, but a cellular graft is a autograft alternative.
It is all three elements of bone-forming capacity of autograft: osteoinductive, osteoconductive, and the differentiator is it's osteogenic. It maintains viable cells. Virtuos was released last year and is the first product to have a shelf-stable cellular allograft that is lyophilized or dried. All these other products need to be stored at -80. That's another example where we're going to invest and partner with MTF to really evidence that data and differentiate ourselves in the marketplace. Where we see the opportunity is we have not had access to a good cellular graft. There are those customers that we have not been able to crack with SeaSpine. Now we have a great opportunity, and I do hear excitement as, you know, working with distributors on some conversions recently. I think, you know, you will see this segment rebound and as we take more share.
Here's the data. Trinity has, as a competitor, by far the most clinical data available on the market. 10 years, 350,000 patients treated, excellent safety record, and most recently, we just published a paper on over 200 lumbar patients with 98% bridging bone defined by CT. That is compelling data. Transitioning to synthetics. This is an area, again, we've been losing share, we've been declining sales, and fortunately, Orthofix has launched Opus BA Bioactive. That will allow us to play in the premium. We also have another product where we will launch later in the year that will have data showing bone growth in a muscle pouch, compete with Korsuva Trax from NuVasive. Once again, what we're trying to do is develop leading products, different price points, different performance characteristics in all of the major segments.
Procedure specific. It's not enough just to have good DBM, you gotta be able to deliver it. OsteoBallast is a great example of a product that has 100% DBM. It's contained in a resorbable mesh bag, it competes with Medtronic's MagnaFuse. We're the only two companies with this type of product out there. I will tell you, developing the bag, you have to do it externally, obviously, is not easy. It is a big advantage because that allows the surgeon to deliver it posterior laterally, elegantly, efficiently. It's compressive resistant, and it resists migration, which are the two problems with posterior lateral fusion. NorthStar, taking a similar concept of improving cervical facet fusion by creating a controlled defect. Again, this is navigated also by 7D.
Lastly, we have, through the integration, both a disposable and a reusable graft delivery system, options for our customers. I think we've established a strong reputation at SeaSpine and really leading with science and data, and you see a lot of these papers. We had two Best in Papers at NASS, and that's where we've led. We have a paper that has been, you know, stood the test of being industry sponsored and published in JBJS. I think that's a testimony to the elegance, the simplicity, and also the strength of our investment in science. When you collect all these products and you put them on the compendium, you see product and performance on there and price. As I went through exhaustively, we have products in every category. The only company that's close to us is Medtronic. They have Infuse.
We wanna compete with Infuse. We now have the marketing strength, we have the capital available to do that, and we also have the license that we announced last year with CGBio. That's our goal, is we have two of the three largest segments covered. We're gonna go to three or four over the next year and a half, and ultimately over the next five to seven years, the goal is to challenge Infuse. In summary, our goal, leading products, hospital access, and distributor access. The combination of biologics with the spinal implants and BGT and 7D is a compelling distributor recruiter tool, but it's also a compelling IDN and GPO value proposition.
Scalable manufacturing, we can double our volume with very minimal capital investment. That translates to profitability and cash back to fund all these efforts that you're gonna hear about today. With that, I'm gonna turn it back over. I guess, actually, we have a break. Wanna make some comments?
Yeah. The good news is we're running slightly ahead of schedule and about 15 minutes. I have the break tentatively scheduled for us to come back here at 4:20 P.M. We're gonna go ahead and adhere to that, and we'll take about a 30-minute break. There's refreshments over here for everyone in-house. The restroom is right around the corner. Thank you, thank you, business presidents. It's really nice to hear from you guys as well. I mean, John and Keith are great, but it's really nice to hear from the rest of our bench. We will be back at 4:20 P.M. for everyone online, and we will take a short break.
Okay, everyone. Thank you so much for hanging in there. Next up, we have Kevin Kenny coming back, and he will talk to us about spinal implants.
Thank you, Alexa. Let me preface my presentation to say that we have not yet developed a full strategic plan. Frankly, we're about two months into this great merger, and maybe I'll share a little bit of what I've been focused on and what my initial impressions are. First and foremost, we said, "Hey, let's keep business as usual and maintain patient care. Don't drop a ball with our surgeon community." I'm really pleased two months into that, we have been very successful on that. We've kept both entities running smoothly while we work to integrate in different areas. We also have had an opportunity to start creating what I would say this new organization for best in class.
I was having dinner with a surgeon on Friday night, he said, "How are you feeling about things?" He goes, "You must be having a lot on your plate." I said, "Absolutely the case." He said, "What do you think about the new entity, and what are your observations and surprises so far?" I said a couple things. One is the wealth of talent on both organizations to put together in a combined team is like nothing I've seen in my career. I also looked at the DNA of both organizations, and while they were very much at different times in their strategy, in deployment from innovation and new technologies and enabling technology, they were so similar to what we were trying to do at Orthofix. We're all talking the same language.
We have a lot of harmony. Now we're just trying to get through a couple of these early phases so that we can execute and really deliver what we all know we're capable of. Let's take a quick look at that, and I'll share with you a few things. First, we put together a fantastic executive commercial leadership team already. They're in place with over 150 years of spine experience. With that comes clinical expertise, relationships with physicians, and relationship with the channel. This group, as you meet them and see them and see the results that they're gonna have on the field, it's outstanding. Second, we just finished this last week, the integration of our sales channel. We definitely had some overlap.
You'll hear a little bit from Boz about some of the synergies and where we're at in the integration. We were able to build a structure with the best AVPs, best area sales directors, and best regional managers to the frontline sales manager. We've done it really what is most tailored for the market. We have some that are just fixation-focused, some only bio, and some that are hybrids. That's really driven sometimes by the players, that they're competing with, the skill sets they have, and once again, tailored for the market. We're in place. We launched that last week. We have the maps. It was a lot to accomplish in two months. We're there.
Talking about the technology, if I were to put together two bags that were complementary in spine, I don't think I could have chosen two better ones. On the Orthofix side, we have the BGT technology. We have M6. We have some great fixation products. On the SeaSpine side, they have what I would say would be a more market-relevant, more competitive bag because they've launched 60 new technologies in the last years. It's taken us up to a market competitive bag. You add on there the biologics offering, an enabling technology that Beau's gonna talk about shortly, it puts us in such a competitive advantage that I'm not sure there are many strategics that have what we have to offer today. Why is that important, though? It's because as a strategic, having worked for them, they're hard to move.
We like to say we think big and act small, we wanna be swifter, we want to attract talent and get people to wanna come work for us because we're the up-and-coming organization. I'll talk a little bit more about that in the presentation. This bag is compelling, it's gonna allow us to attract those strategic distributors that are larger in size, they're gonna have less of a transactional type of relationship with us. We feel great about the portfolio today, we're not gonna stop. We have quite a bit in both pipelines that are gonna leapfrog some of the technology we have really differentiate take us down some different procedural approaches. That investment's gonna continue. It's in the DNA of both organizations. Lastly, we have to ensure that we have great clinical outcomes.
That means making sure our sales leadership, our sales channel through distribution, and our surgeons have the proper hands-on and didactic training to make sure that we have optimal outcomes. We're spending a lot of money in our medical education environment. Let's just take a look at our core end high-level view of the markets. First, in the U.S., most estimate it was a 3%-4% growth last year. I think it's a tough comparable. A lot of softness in COVID from year prior, even with the first quarter was impacted. We won't fully know until all the publics come out, and we can piece together the map. Let's just call it a 3%-4% market. SeaSpine, on the other hand, grew 21% last year in fixation.
Look at the dramatic difference in the share gains and progress that was made. That's remarkable. We're more concerned about capturing share than we are about the market growth rate, which you'll see here in a moment. There's so much opportunity for us to make hay, so to speak. On an OUS side, I think everyone in the room knows that SeaSpine had pulled out of the European market due to the cost and the lack of profitability because of the regulatory changes. We, as Orthofix, were staying within market, but we weren't too deep in the investment. Right now is a perfect time to relook at the strategy and decide what we look like on a go forward.
I'm not gonna focus much on OUS today, other than I would also share we have a really nice business outside of Europe on both sides of the business. We have a presence in Australia, in Latin America, the Middle East, and even the Far East with some biologics. We have some growth opportunity ahead. We have a really nice OUS business, and it's gonna continue to be part of our future. The question still is just remain towards Europe. Taking a look at the global competitive marketplace, I think everybody knows this very, very well. Once again, global, over $10 billion dollar market. You can see the market leader is in Medtronic. Interestingly enough, Globus and NuVasive together are gonna become the number two player. That may sound great on the surface.
We personally think that's a great opportunity for us to take advantage of disruption. The last large two spine companies to put themselves together, Johnson & Johnson and DePuy Synthes, historically had some challenges. I don't want to speak for their strategy in that organization. I just know we believe we can take advantage right now because of the size of our entity and how fast we can be to actually take some share. If you look at our combined share, only at 2.3% global and a little over 3% in the U.S., it doesn't take much of this pie for us to be very successful. Let's just talk for a moment about the combined bags. Once again, not a strategy that's been set, but from my view, what are the strengths right now of this combined organization? Let's start with the interbody.
If you think about materials, anywhere from allograft structural grafts through tissue banks, to PEEK, to 3D titanium, to expandables, to standalones, to some proprietary surface materials what help facilitate bone growth, we have a fantastic portfolio. I would put this up to anybody's in the industry right now. We feel very, very good about this. We actually have some overlap in a couple of segments, for the most part, it's very complementary. Enabling Technologies. I'm not gonna steal Beau's thunder because he is the world-renowned expert at this, having developed it. Every salesperson in the market wants the next Enabling Technologies that can get them into competitive practices and gives them something incredibly relevant to sell. Think about what we're doing with 7D. We're changing the workflow. We're making it a safer technology for both the patient and the physician.
It's a key enabling technology, and if you listen to our earnings, which I'm sure most did, Keith had pointed to the placement program we have. When we do place these into new practices or existing, we actually can tie up a lot of the fixation business for years to come, and it's a huge growth driver. We're excited about this and working with Beau's team. When we think about cross-selling, the energy right now across the channel on the Orthofix side, it's real. We've had so many physicians coming to this facility, the first thing asked about is the 7D FLASH technology. Enough where we didn't plan on it initially, but there's one in our lab. We went out and bought one here in the first couple of months. We installed it, and Beau's gonna have it ready to actually give a demonstration.
We're bringing in groups of physicians, frankly, from some of the largest practices in the local area or even getting on planes to come in and see us 'cause this is central to their decision-making for their patient care. It's an incredibly exciting time for us right now, and we just feel like we're just getting started despite that there's 100 of these placed worldwide. Let's talk about M6-C. This is our cervical disc, and I'll share that we are incredibly proud of the fact that it is still considered the next generation technology. That's despite the fact that there's 75,000 of these implanted worldwide in the cervical area and 20,000 in lumbar discs.
As a refresher, we launched this technology in Germany many years ago because the pathway to the U.S. was a little bit onerous, and then there was a patent infringement situation with Synthes. Orthofix was very fortunate to buy this technology from Spinal Kinetics. We launched it coming up on our fourth year of anniversary, and we are still proud that this is the best technology in the market because it mimics the natural disc, both in movement and progressive resistance, and we have great outcomes with this. We right now have such a leadership position and a responsibility that we're involved in a 10-year IDE study. We're working on real-world evidence so that we can establish what do clinical results look like when they're 10, 12, 15 years out. Survivorship in cervical discs doesn't exist today.
It's not known because they've only been in the U.S. marketplace for 15 or so years. Very different from the orthopedic side, where they can predict how long a hip lasts or how long a knee lasts. We're still learning from this relatively new space. With that, we actually launched an expert panel and showed our leadership to the industry by bringing some of those folks from the orthopedic side, and they have learned so much about technology and bone remodeling and clinical relevance and what's the source potentially of infection. That group has come up with a classification system on bone remodeling. They're writing papers, they're educating the marketplace on it right now, and we're gonna continue to sponsor this close or from afar because we think the responsibility to the industry is to figure this out.
M6 was a huge growth driver for us, and we're so excited now because the new C-spine side, the new channel's gonna gain access to this technology. From a market rate, it's still anticipated to grow double digits over the next few years. In some ways, we're still getting started. We're only 30% penetrated from the available market. You could look at that and probably suggest that some of it was the emerging of technologies, but some of it was reimbursement driven. You also had an ACDF that frankly is the gold standard with really high results. Some surgeons weren't motivated to change their clinical practice. As data gets collected and we show that not only is it beneficial at the index procedure, but over time, you're gonna avoid adjacent level disc disease, the value proposition to patients becomes compelling.
We believe through market development, the entire industry can drive up CDR usage of technology, and M6 can do very well. Competitors have come out with new discs, and we welcome it to the market for those reasons because the more we can invest behind this and educate together, the more we can all benefit. Let's talk for just a moment about our cervical portfolio. I would stack this up to any cervical portfolio in the marketplace. We have not only up at the top left, a posterior cervical with NorthStar that was launched this last year or so that's doing incredibly well in the marketplace. We have standalones, we have the M6 disc, we have a fantastic ACDF plate, and we also have, what I mentioned earlier, the only cervical device for bone growth therapy. Nobody has that.
Map this to any of the strategics, map this to anyone close to us, there's gonna be some gaps. We're also proud of the fact that it's gonna be tailored very well, this portfolio, towards all settings, whether it's hospital, outpatient hospital, or the ambulatory surgery center, which we all know has had rather dramatic growth rates as some of these simple cervical procedures transition. Tyler, you did a great job on the biologics portfolio. It's compelling. It's comprehensive. We have leadership in different categories. Outside of the large company starting with an M, we're in a really, really good position. We know this because the phone's ringing off the hook right now for access to the portfolio. We wanna grow, we wanna get it in the right hands, and we wanna also tie it to our strategic distributors wherever we can.
The great thing about biologics is we're working on increasing ample supply, and then it's a quicker conversion for us when we get this new organization really humming along because with contract access, you can convert an entire segment almost overnight. It's not going through that same evaluation period and building sets and trying to chip away over time. We're a big player in biologics right now. I'm sure that's coming across to everybody on the call or in the room today. Key growth drivers. Key growth drivers. Did I say Keith growth drivers? That's funny, huh? Very appropriate. Hope you're listening, Keith. Key growth drivers for the spine business. We absolutely are integrating procedural solutions, and we're closely on implants, biologics, and how can we change the workflow and tie it to 7D.
There's something very, very significant here where we can change the paradigm and others are gonna have a hard time following. We're spending a lot of intellect on that and a lot of investment. We have that rapidly growing portfolio. I mentioned the 60 technologies that were launched at SeaSpine. We have the same thing going on here at Orthofix. We have fueled that innovation machine, and it was just starting to bring some products out. There's more on the way, and we're now gonna rationalize between the portfolios what makes most sense so that we can leapfrog. I mentioned that cervical leadership. I talked about bringing the bags together. Clearly, we want to improve those optimal outcomes that we will talk about here shortly with 7D. Commitment to training and education, integration with biologics. Let me say this in closing.
Probably the most important on here is the ability to attract surgeons and new channel partners that want our portfolio and they wanna commit to our future. We have never been in a position like we are now, and we're just gonna pick the right partners. There's a tremendous opportunity ahead, especially with some of the unrest on other mergers, and we're gonna try and maximize that. High-level view, growth drivers, I'm gonna turn it over to Beau and ties to 7D.
A couple of words to start we've heard about today. Cross-selling, complementary, growth drivers, synergistic. Hopefully, you've enjoyed learning how that has affected the other business units. My name's Beau Standish. I'm the President of the Enabling Technologies Group, and I'm really excited to share my passion for what we've developed to date and also where we're taking the technology over the coming years, not only in spine, but as we think about the bigger picture across the entire organization. I like to start with the mission, what gets me up and what gets me excited every single day to drive innovation. It's quite simple. I have two jobs. The first being I always want to improve patient outcomes, the second being I want to make those operating procedures as efficient as possible, and we have that ability when we can fully integrate a full product offering.
Thinking about the commercial organization, from the Enabling Technologies Group, we do have a direct sales force in the United States, but we work with distribution partners externally, OUS. What's really exciting about the merger is we've achieved fantastic results outside of the U.S. with the 7D system with a very, very small team, about 2.5 equivalent people. That's not just a really short person. What we wanna focus on is averaging and leveraging what we can with the orthopedics line. That division has a very established footprint outside of the U.S. We've never had that access to expertise before. We have a very talented clinical team and sales team that have extensive skill sets when it comes to capital sales.
We have a technology that not only works in a particular operating situation, but across the entire gamut of those operating theaters. We are stronger together integrating with the product lines and identifying cross-selling opportunities where we're gonna talk about that today. It's not just a capital equipment sale. It can be across different ways of how to try to deploy that technology in the operating system. As I mentioned before, that footprint across the U.S. is quite diversified, and we're planning to keep that for the Enabling Technologies across the globe. The why. Why do we have the Enabling Technologies where we were first focusing with this technology on the spine market? It comes down to this image.
Here's what we call an axial view, cutting through the center of my body, looking at a vertebra, and you're seeing in real-time where a tool is in relation to that patient's spine. Up until now, all of the existing technologies have suffered from too much radiation, requiring the linkage to an intraoperative radiation-emitting device. Can have challenging workflows, adding tens of minutes to a procedure. A lot of the newer technologies can add $1 to $2 million to try to acquire. Just too expensive to navigate the spine. Also, accuracy issues. What happens if that patient moves in the operating room? If there's an alignment adjusted, which happens all the time in spine as you're instrumenting the region itself. Well, we saw this as a new vision for spinal navigation.
It's all built off of this field of study, the way that we are differentiated from what currently exists in the marketplace, off of something called machine vision. Machine vision isn't exactly a consumer-grade phrase just yet, but I guarantee everyone knows what that is. That technology is used in self-driving vehicles. There are cameras on the outside of the car constantly interrogating in full 3D what's going on to be able to make decisions on the next steps. What we've done is we've applied that imaging technology. We've put it into our navigation unit, which also is duplicated as a surgical light. Rather than looking for a pedestrian crossing the road or a speed sign, we're identifying anatomy automatically. Where is bone? Where is soft tissue? Where is the spinous process and a lamina?
Such that we can take that registration process from our competitors, which require ionizing radiation. Here we're using just visible light, it takes only seconds. For those of us who are on-site today, we'll be doing a demo with the technology after the presentations. Here's an example of that 3D image that's acquired by the 7D FLASH system. This image is acquired in actually about three-quarters of 1 second. It's then processed, it's matched to a preoperative dataset. The whole process takes less than 30 seconds, where we're using no intraoperative radiation. Everything here is visible light. When we go into the lab, we won't have to put on leads in order to use our technology.
Some of the advanced features, thinking where we can use modern algorithms, modern technology to push the science, forward, is we have the first one, FLASH Fix. This, what you're seeing here, is the most emotional component of any navigated procedure. What happens if the reference frame is bumped or if the patient is moved? Something that happens on a very routine basis. With any other technology, as you can see in the video, registration accuracy is lost. Now the surgeon has to make a decision. Do I start the registration process again, which can take tens of minutes, expose everyone to more radiation? Can we do something like with the 7D FLASH system, automatically understand what has moved and by how much, and correct for that intraoperatively, almost instantaneously. Extremely powerful. Moving a step further in deformity.
Here we see an image where we have a axial view that actually looks like a sagittal view because the deformity of the spine is such that the visualization is very difficult to interpret. Here, what you're seeing with our reslicer, we can adjust the obliqueness of that slice at any time in the procedure, so you can always achieve a true axial image in that patient's anatomy. Finally, on the far side, FLASH Trajectory . We have video feeds that we can leverage that are taking those three-dimensional images. The FLASH Trajectory , we're now using augmented reality. We're overlaying truly pertinent information on those video feeds at the surgeon's fingertips when needed. This, think of it as a virtual K wire that you can see where to put a tap or a screw.
The strengths of the system, we've just learned that radiation safety profile we're second to none in the world when it comes to that. No intraoperative radiation. We're leveraging advanced algorithms and advanced imaging technologies, we have very fast, efficient workflows. I'm gonna share some of the clinical results we've achieved to date. Low cost. We're also agnostic. Another way to think of that is we're an open-source technology. You can use the FLASH system with any system on the market. Opportunities. You've heard the other groups talk about their business units, the cross-selling, that excitement, whether it's with the orthopedics group in the U.S. or OUS, the implant group, the biologics group. Tons of opportunities here where we can bundle these technologies together.
We also have experience that every time a FLASH system is installed in a hospital, we may not have any implants or biologics there, but every time we put one in, we continue to get product pull-through as the surgeons get exposed to the entire product offering. Finally, as I mentioned, that OUS market is just ripe for the technology to continue to go internationally. We have that infrastructure in place to support that growth. When we think of the other aspects of the system itself, here I've identified the markets we can currently address with the types of procedures that we support. We have three different major product offerings. The FLASH Spine, that's an open procedure, deformity, everything to a mini open, about three centimeters. We have our fully commercial FLASH Percutaneous module that allows us to access that fast-growing percutaneous market.
We're not limited to just spine. The technology is ubiquitous across multiple platforms. Here we also have a fully approved cranial module for our neurosurgical colleagues, whether they are going in to do a biopsy or a tumor resection. Truly cross-platform and all of the tracked trays that go along with the technology. As we expand and provide more clinical utilization, we now have preoperative planning. We can understand, and we can drop in here. We have our true dimensionalized screw. Here's some of the Mariner product line from Legacy SeaSpine . The surgeons use this to understand how many screws they're going to put in a procedure. What is that alignment gonna look like? Even things with identifying and aligning the tulip heads.
We also do interbody measurements, where you can get a sense of what type of interbody am I gonna put into the patient's anatomy, those different sizes. The beautiful thing of this system is that we're already fully approved to work with all the legacy Orthofix implantations. We are currently doing cases with our Orthofix implants, our SeaSpine implants from one case to the next, being able to switch back and forth at will. Product releases. We've been very active across the entire organization on introducing new product. They're truly addressing those two things I spoke about earlier. How do we improve operational efficiency while improving patient outcomes? We're not stopping.
The bigger picture here is as part of a larger organization, every time we do a software release or a new tool deployment, it's just more complex because there's more products to consider as we launch that technology into the marketplace. Talking about the clinical aspects of using the FLASH system, we have an extensive library of peer-reviewed journals, and we're gonna touch upon a couple of those results today. The first being radiation reduction. This was done by a group in Australia, where they were comparing ours to their incumbent navigation system, and we reduced it by 96% per procedure the amount of radiation exposed to the patient and the operating room staff and the surgeon themselves. The next one, because our procedures are shorter, we're not talking just registration, the registration time, we're talking skin to skin.
We have another journal that's in preparation where we reduce blood loss by 44%. This is the standard of care there was fluoroscopy and freehand. When the FLASH system was used in this pediatric cohort, reducing blood loss by 44%. The registration time itself, what is it required to set that technology up in the operating room? On the far right, compared to intraoperative 3D fluoro CT systems, we are 15 times faster during the registration itself. Probably the most important is we've just had an article come out in print that on average, skin to skin when using the 7D FLASH system compared to freehand and fluoro, we're reducing that procedure time by 63.6 minutes. Significant time savings.
Typically, when you have an enabling technology, you want to improve some metric, but it comes at the detriment of typically longer procedures. We're not experiencing any of that. Some of the customer feedback to date is the concept of radiation is becoming so common in discussions with the operating room staff, the nursing unions, the radiation safety, the patients, the surgeons themselves, and we're reducing that radiation. Centrally there, talking about shorter stays because of the beneficial impact of the system. Finally, on the far right, working in the ambulatory center because we're at a cross point that can be consigned or bundled together with implants, biologics for that ecosystem. Really addressing the entire market. Looking at that stronger together and the complementary aspect of the FLASH system and the Enabling Technologies Group, we are in 15 countries now with continued plans for expansion globally.
We're over 104 systems installed, a very rich patent portfolio to protect the underlying innovations. Comparing 2022 to 2021, we had a 40% increase in the overall global footprint, so U.S., OUS. The technology is being adopted very, very quickly. We also have a great team that's combined and consists of R&D done in Toronto, along with our U.S. team, primarily focused on sales and support. As we think about from an organizational point of view, that goal of the pathway to profitability, we have the ability to have that market pull-through of our direct sales force in place, both in the Enabling Technologies Group, working with our own sales expertise, leveraging that strong OUS footprint, those post-merger relationships.
You heard Kevin talk about the excitement from the surgeons coming to see the technology in the Lewisville facility or the Carlsbad facility or in our Philly facility. That is also as important for the distribution networks. They are the key holders, the gatekeepers to getting access to the surgeons, and they are as excited for the technology as the surgeons themselves. Finally, being very creative with having as many different ways that a technology can be acquired by a hospital is so important for that pathway to profitability. Our key growth drivers, we've spoken about radiation safety. The cost point, the ease of use, everything I've spoken about today is surgeon-driven from the operating room. You do not need one, two, or three different people to be in there to operate the technology for the surgeon.
Pipeline integration, we're already fully integrated with our implant lines across the merged company. Low acquisition costs and then very flexible pathways for acquisition. Thinking about where our footprint is today, this is an important slide. We have the ability to get into the major teaching luminary sites from the clinical merits of the technology. Our biggest market is at one to two busy private practice surgeon who historically was a non-navigator using purely fluoroscopy. We're growing very quickly in the pediatrics market because of that reduction in radiation and looks less time with the operating procedures. Also, the ASC market, we've been able to enter those. There were different ways that we can acquire the technology. Even here, we're trying to be innovative, so you're not just relying on a capital sale.
We have different discussions you can have with the hospital system. Everything from capital leasing to spend shifts or what are called earn-outs to even software as a service, a SaaS model for the hospital to access different budgets within the hospital ecosystem and fee per use. As we mentioned, we're super proud to place that one-hundredth unit of the technology just before the end of the year. Here's a map of where we are. There'll be more orange regions here even as we get to the end of Q1. We're now in Latin America. We're in Australia. We're in Pacific. We are in also continuing and continue to expand into the European market. Shifting now for the last part to talk about the technology and where we're taking it. Well, we have that balance. How do we continue to achieve that strong clinical experience?
We need to maintain that edge on having market-making innovation. We are doing both. Coming out in the foreseeable future is the extension of that planning platform for the whole percutaneous module, continuing to integrate additional procedures, example, inclusive of navigating interbodies and different procedures such as TLIF or even the architecture for our single position lateral. Thinking about the market-making innovation, we have our insight suite with the planning, and the key thing here is that part of this merger that is complementary, we can leverage the OrthoNext technology, where they already have pre-planning. We can take that and apply it to the spine world quite efficiently. Things like rod bending, predictive analytics, we are continuing to spend and focus on that market making.
What I'm really excited to share with you, and this is the first time we're showing this publicly anywhere, is this concept of the camera technology. IR tracking, when you're tracking an object, you have these cameras. Every single navigation company on the planet uses one of these IR trackers. They track the little marker spheres of the tools. It's only used to track instruments. Well, we came to the market and we said, "Well, can we do more?" We want to be able to image in three-dimension instantaneously, acquiring millions of points, integrate augmented reality views. Quite frankly, the entire industry is underutilizing the camera technologies that exist today. We thought, can we leverage our systems to do more?
Well, if you can come up with new tracking algorithms, if you can come up with new camera designs, we absolutely are excited to share our next generation of products. Welcome to what we're calling the LiveTrack camera. This is a bit of a blueprint on the right, but this is in pre-production, where we're showing it in its physical form at AANS in just about a month and a bit. Historically, we've been taking camera components, we have been Frankenstein-ing them together to be able to meet the needs of what the technology can do. We've now internally developed that camera system from the ground up internally. We maintain the ability for the tracking, we maintain the ability for three-dimensional imaging, but we're able to do new things. We can now do things like QR code tracking. The overall footprint is smaller.
We're also having the ability to develop things like low-cost disposables, even shifting that financial model, increasing the overall per-procedure revenue from a capital acquisition. Our first product that we're launching is called the FLASH EVD. This is for the external ventricular drain market. Using the technology first, we're now starting to exit the operating room and starting to support procedures in the intensive care unit. This unit itself is small, mobile, coming with all of the modern technologies you'd expect, like touch screen. From turning on to getting to navigation mode, you're now less than 1 minute for this procedure. External ventricular drain, the procedure itself, it's a verily, very wide procedure, it's where you have to put a catheter into someone's brain to reduce swelling.
There are approximately 60,000 procedures of these done per year in the U.S., another 60,000 done external to the U.S. We're focusing on these neurocritical care units, going towards that business model of a per-procedure revenue with significant annual revenue opportunities. Why is this even more exciting than that? What you've learned today is the merged company, we have different product lines. We have a whole orthopedics group. This smaller technology will be the spearhead to be able to bring navigation and advanced imaging technologies to more of our product lines over the coming years. With this LiveTrack, it allows us to do and access two ways that a company grows, new product introduction and also geographic expansion. We now have the expertise to create these sterile products.
These are little elements that are essentially manufactured by the thousands at dollars per particular BOM cost. QR code tracking, the same thing that we all were using when we were trying to get menus using our phones during COVID, that is now going to be part of our tracking technology. We control that entire vertical integration, not even relying on the IR spheres anymore. It also lays the framework for frameless navigation, where you don't have to have things attached to the body itself, and truly exciting on where we are bringing the overall innovation. I'm gonna end here and get ready to pass this over to John.
With the idea of we have the cross-selling opportunities, we have the complementary aspects that the organization, the synergies where all of us are trying to focus on operating in the now, and we truly are stronger together. I'm looking forward for people who are here to come to the lab afterwards to get some demonstrations, and also looking forward to answering any questions, and I'll pass it over to John for finishing up.
Thanks, Beau. It's always hard to follow Beau with his excitement and the coolness of 7D, so I'll do my best with the accounting and finance stuff.
You're cool.
Thanks. I'll also try to do something that I'm not really known for, is being brief, because this is not meant to be a financially-oriented discussion, so I'll keep the closing comments quickly before we turn it over for Q&A. Hopefully, everyone in the room and those on the webcast get a sense of the genuine excitement that the leadership team of the combined company has. I mean, I lost track of the number of times we talked about cross-selling and revenue synergies, right? That's not something that's typically associated with a spine merger. Hopefully you all got a sense of the confidence we have in our ability to grow and leverage these cross-selling synergy opportunities, but also that we're able to mitigate and manage the revenue dis-synergy risk that comes with a spine merger.
As Kevin showed on his chart, right, with less than a 3% combined market share in the spinal implants market where you've got the greatest revenue dis-synergy risk, you wouldn't expect there to be a lot of synergies of companies or dis-synergies of companies of that size. As we went through the portfolio today and all the opportunities, I'm really excited about the cross-selling revenue upside that we can leverage as a combined organization, and hopefully that came through in the presentation today. The combined company is now a $700 million company with a diversified and complementary business and product portfolio with a much larger and broader commercial reach globally. That's something I'm really excited about coming from the SeaSpine side because so, you know, little percentage of our revenue is coming from outside the U.S.
We're excited to be able to take advantage of the larger commercial outreach that Orthofix has globally. Last Monday, on our earnings call, we gave revenue guidance for two periods for 2023. It was $166 million-$170 million for the first quarter of 2023 and $743 million-$753 million for the full year 2023. Those represent high single-digit growth rates over the pro forma combined SeaSpine and Orthofix 2022 revenue base after adjusting for anticipated classifications to conform SeaSpine's revenue recognition reporting to that of Orthofix. Again, hopefully that reinforces the confidence that we have not only to manage the revenue dis-synergy risk, but also take advantage of those cross-selling opportunities on the revenue synergy.
I keep adding to the count of talking about synergies, but that's the message we really wanna drive home. This is not your typical spine merger of two behemoths that creates a revenue dis-synergy risk, but rather it's an organization full of complementary technologies that can create lots of pull-through across the different sales channels. We obviously have a much broader commercial reach, and I think the economies of scale that we're gonna get from this organization is one of the value drivers of the merger beyond the top line growth opportunity.
We've talked about $40 million of OpEx synergies that we can get from the economies of scale. I think as we talked about on the call last Monday, we're well on track to achieve those $40 million of annual synergies by the end of year three. That's just the operating expense synergies. The supply chain efficiencies that the ability to potentially reduce our cost of goods from consolidating suppliers and rationalizing systems, as Kevin talked about, those aging systems become inefficient to manage. If we can take the best of the portfolio from both companies and leverage that, we can improve gross margin over the long term. We should also be able to get supply chain synergies from lower inventory and CapEx investments because we're not investing in three pedicle screw systems and four cervical systems.
We're picking the best of from both companies and focusing on those growth systems, therefore we're just deploying those sets and managing those newer, more robust systems and sunsetting those older systems become more inefficient and costly to maintain over the long term. That $40 million of synergy is just focused on OpEx. It doesn't count potential benefits for the cost of goods sold line or the supply chain side around inventory investments and CapEx investments, which should be more efficient as we rationalize those systems. At the risk of being redundant and repetitive, I can't drive this point home, hopefully everybody leaves this discussion with a better sense of all the different sources of growth that we've got from this combined organization.
I'm not gonna repeat them all, but, you know, every person that came up today talked about cross-selling opportunities and synergies, and we intend to leverage every one of those opportunities over the coming years. I'm really excited about all of these sources of growth from all the different business units. I'll wrap up with just a summary of the new Orthofix, right? We're gonna benefit from the multiple aspects of our broader commercial strategy and sharing best practices between the two companies, right? In a lot of ways, we're very similar, and I think that was, you know, a pleasant surprise as we got deeper into the integration. We do a lot of things the same way. We have a lot of common IT platforms like Oracle R12 that reduces the complexity and the timeline to integrate some of those core foundational information systems.
I'm excited about leveraging the larger scale of the business and taking advantage of those revenue synergy opportunities and the cost savings we're gonna get from the economies of scale of the combined organization. We appreciate everybody who was able to join us here in person today, and for those of you who were on the call and hopefully your takeaway is you're just as excited about the opportunities as hopefully everybody conveyed in our presentation today. At this point, I can turn it over for questions.
Yeah. We're gonna do live Q&A for those who are here in the Lewisville office. We've got a little phone box over here that we can toss around. If you have a question. Looks like Matt has a question. Catch.
Providing you want this.
It's actually a microphone inside there.
Oh.
Just repeat your question?
Yeah, you should. Okay. It's a little weird, but I'll give it a shot. Matthew Blackman, Stifel. John, since you're up there, just give us a sense of when we think about integration mileposts in 2023. Can you maybe map it out a little bit for us? It sounded like the Salesforce.
You've gotten them together, you sort of figured out that piece. What's next? What are sort of the next things you need to tackle here as we think about some of the pressure points as you move through 2023?
I mean, a lot of the headcount synergies, right? Those discussions have taken place, and we've identified the leadership team and had those conversations. There's a lot of operational synergies that we're gonna get from the combined organization. The teams are pretty far down the path of mapping out what those opportunities are. Now the next stage is to really move into the execution phase, right. We've spent a lot of time for the past three months, in particular since the closing, but tried to get a head start ahead of the closing on what we thought would be some obvious operational synergies. The commitment from the organization, again, is more than $40 million of synergies by year three.
I think our expectation for 2023 is to at least implement more than half of those synergies. We won't get the full benefit in calendar year 2023 because a lot of those synergies really won't become effective until probably the second half of this year. I think 2024 will be the year where you see the biggest contribution because you get a full year benefit of the headcount and operational synergies that the teams have been working on. I'm really happy as we've gone through all this, that the thesis around the source of the $40 million plus OpEx synergies is intact, you know, based on the models we put together before the closing as part of the due diligence.
The groups are diligently working towards that, and I think there's been great collaboration in finding opportunities, to achieve that. Our confidence level is high.
Maybe just another question on that. Just any color you can give us, your conversations with distributors, whether it's recruiting new ones or coaxing them to move to more exclusive relationships, just how those conversations are going. Certainly now with the portfolio, it sounds like you're ready to go out and sell. Just any color you could give us there.
Do you wanna chuck that over to Kevin? You're probably closer to.
I'll try.
Conversations with distributors.
I'll tackle that one. I'm probably at the tip of the spear. What I would share is that first, the channel is incredibly excited to have access to both portfolios. In the Orthofix side, we have what we would call our strategic distributors, our largest, most committed, you know, that have infrastructure and revenue. Many of them had to take on competitive lines for some of the products we didn't have, so they could tuck them in and create a complete bag. Right now we're building inventory and working towards giving them that. There's a rather robust list of targets there that they put their hand in the air and said, "That SeaSpine standalone cervical," as an example, "I will replace my other line that I buy from another competitor. Get it to me as fast as you can.
That's it. You need to build sets for that as we design. Yeah. For those who didn't hear the-- Yeah.
I assume to get after those incremental opportunities, you have to build sets which have some lead time, and that's something that may emerge more visibly to us as we exit 2023, that opportunity to gain more share with these distributors.
Yeah. The revenue guidance we provided in the call last week does not assume a lot of that synergy happens this year, you're right, because of the lead time to purchase and deploy those sets. We're having ongoing discussions with suppliers to try to reserve machine time so that we can get into queue ahead of purchase orders and reduce that lead time. You're right, the most meaningful impact of those opportunities aren't gonna happen until the fourth quarter of this year, you'll have obviously a full benefit in 2024.
Okay.
Thanks for hosting us here. A couple questions. I'm gonna bounce around a little bit, so it's gonna be applicable to variety of leadership.
You get to chuck it to whoever you want.
Yeah. That's fine. Number one, you know, as I think about adjusted EBITDA margins, the legacy Orthofix had adjusted EBITDA margins kind of, you know, hitting, topping out near 20%. You know, as we think about the integration, you know, the company over time, how do you see those margins progressing? I mean, they've come in, you know, since 2018, 2019. You know, as you think about kinda your model internally, John, you know, where should we expect EBITDA margins to go? Where do you think they top out at relative to maybe legacy standalone Orthofix, now with SeaSpine involved? Then I have some follow-ups.
You're gonna be disappointed in my answer, but I'm just not prepared to give any kinda long-term guidance beyond what we've provided on the revenue line. As Kevin said, right, we're building an operating plan for this year, then we have to work on the longer-term strategic plan. I don't wanna get ahead of ourselves, sorry to duck the question, I'm gonna duck the question.
All right. Let me ask then on some product questions. Beau, you talked about, you know, extraventricular drain units. This is not a market that SeaSpine or OFX have historically gone after. Are we gonna see a build-out of a separate sales force for this? I mean, I know there's some neurosurgeons that may use legacy product, but that is certainly a different segment.
Alexa, where's the spare mic? Could you get it? Okay.
Great question, Ryan. Part of the Enabling Technologies group is we have our own direct sales force, and our call points are spine surgeons, orthopedic, and neurosurgeons. The neurosurgeons are the use case for the EVD product line. We already have that sales channel in place. We're just giving another reason to go into the hospital to talk to the surgeons about the technology itself.
Okay. Separate for maybe Kevin on BGS. I mean, that's a market that hasn't really grown much more than a few percent a year. You talked about some new indications. You know, if I think back years ago when Brad was maybe running the company, there were some clinical trials in shoulder and knees on, you know, stem and, just curious kinda where you think you could take stem longer term beyond existing markets to.
Ryan, a great question, I would share this. In the short term, it's crystal clear that we can grow the fracture side of the business, that's why we bifurcated the sales force, what I mentioned. You're right, the spine side has been relatively flat, it's been more of a market share capture from each other. The fracture side has compelling growth ahead because not only do we have the Physio product, but now with the AccelStim, I've made mention that look at the EXOGEN market for Bioventus. They have about a $90 million franchise that has been proprietary to them. We now have a competing technology. That's part of our plan. We have many physicians that wanted to have a fresh fracture indication that we didn't have with our older technology or our current one.
It was a nonunion. That in itself is where we've been investing heavily. There's other products in the SeaSpine portfolio that we bought access to for North America, and we're prioritizing those right now. We really wanted to get one to market that was the largest, this was it, and it was the fastest pathway for us with the FDA. We did hire a new scientist that came in, and he's very intrigued on regenerative medicine, and how do we take our bone growth stimulation and work with biologics and consider preclinical work in different areas.
We do have some longer-term thoughts, I would say, that we think we could drive behind, but from the annual operating plan in the next couple of years, we have plenty of growth ahead just with that fracture side and capturing share on the spine side.
Thank you.
You're welcome.
Kyle Rose, Canaccord. I guess just, continuing on the theme of BGT. I think the launch of the fracture indication and, you know, the Exogen, you know, whatever next-gen knock-off, call it what you want, and the whole paper PMA application there. I guess what gives you confidence that we're not gonna see other market entrants? I mean, look, we saw Theragen come in, and they have the EBI 2.0. You have Exogen 2.0. What makes you think that we're not gonna see either a down classification from a regulatory perspective or new entrants come in that make that right to win harder?
Well, I think the pathway we took is a pathway others could take for sure. The question is, are they gonna develop the technology or find a worldwide partner like we did? 'Cause if you have to go out and create that technology and come to market, that's very different than drafting behind the prior work. We felt we had a first-mover advantage to come to market, and we have the expertise in this building of which being BGT experts, we can actually continue to progress and grow. Others could come in this space, but I think they're gonna have to compete with two rather large sales forces.
Is the internal expectation that you'll see any competition from a spine perspective or a PhysioStim kinda, you know, next generation product from a, from a smaller player? Or is there anything from an IP perspective that would block things there?
There are four major competitors. One is a small one, Theragen, that was the newest on the scene. Really nobody has gained the traction or growth ahead, because of the machine we've built from OTC and the channel and all those kind of competitive advantages. Could folks enter the market? Yes. I think they have to look at the barrier to entry and to compete.
Okay. You know, Boz, I know you said you're not giving, you know, long-term numbers, but when the deal was announced, you did give some long-term targets. You know, $1 billion in combined revenues year three, double-digit growth the whole way there. You've given us this year, you know, call it $750 million. That leaves a $250 million jump all for years two and in year three. How should we just think about maybe the puts and takes of what that gap looks like? Then, just kinda help me understand the revenue synergies and dyssynergies, the $25 million and $20 million. That's just for year one, right?
How should we think about the synergies and dyssynergies when we think about years two and three to get to that $1 billion, you know, target?
I think from a revenue dyssynergy perspective, I think the greatest risk is year one because obviously that's where you integrate the sales channel, you integrate the distributors, integrate the sales leadership team. As probably a lot of people are familiar on the spine side, that revenue is sticky, right? The results we've seen in the fourth quarter since the deal was announced, right? I think there was initial concern over, "Hey, is that gonna disrupt the sales channel on either company?" I think the results the two companies put up for Q4 speak to themselves. That didn't happen.
What we talked about on the call last week and the guidance we gave, the results we're seeing year-to-date gave us the confidence to put out those guidance numbers, even though it's still early, because we're not seeing the dyssynergies come to fruition because we are mitigating them, right. That's the sales team being out in front of it, being transparent, having conversations. There's opportunities for, you know, smaller organizations to become part of bigger organizations if that's something they see and the combined portfolio is attractive. We're just not seeing those big revenue dyssynergy risks materialize so far.
I think that's an encouraging sign because if they were gonna happen, I think they would have already started happening, or we would have gotten a lot of chatter about them happening. And we're just not seeing that yet. Longer term, you know, getting to the billion-dollar mark that we talked about when we announced the deal, hopefully you got a sense from the business unit presidents today of there's growth opportunities across the board, whether it's in existing channels, like spine and the disruption that larger mergers might have and the opportunities that'll come our way with the product portfolio, both the combined companies can bring to the market, right? Now with a completely full bag, because there were gaps, I think, in each company's ability to, you know, be a full service provider.
Those gaps have been filled. We're generating historically, you know, high teens growth on the legacy ortho biologics business for C-spine and combined company is still double-digit growth. The spinal implants opportunity is very large. Kevin talked about new opportunities and those, you know, new indications in BGT, which is the largest revenue piece in the portfolio to derive growth. Kim's really done a great job with the orthopedics business and the results of the innovation that they've already started were evident in the growth rate in 2022 and in the expectations for growth in 2023. The 7D technology, right? That opens doors across everything, including orthopedics and pulling through biologics through the orthopedics channel.
It's all those pieces that we hopefully put together for you today that shows that the growth isn't just gonna come from one place, right? We're not putting all our eggs in one basket, but there's lots of opportunity. Bo talked about the EVD opportunity, moving into a new channel for the 7D technology outside our core sales channel right now. There's lots of opportunities that hopefully are very obvious to everybody as we go through the different portfolios. That growth is not just gonna come from one place.
Hey, Jeff Cohen from Ladenburg. I just had three quick random questions. Firstly, on AccelStim, can you talk about non-spine and number of SKUs now and any plans for 2023 on more SKUs, different locations on the body? Secondly, if anyone could talk about two-level M6 and where the company is now. Thirdly, Beau, if you could expand upon your commentary about neuro sales force and neurocritical getting to different departments of a hospital facility or ICU. Thanks.
Question one was on the BGT side, AccelStim, number of SKUs. Kevin, can you field that one?
I wanna make sure I understood the question, Jeff. We have four technologies right now.
Yep.
Two in spine, one is lumbar, one is cervical. Nothing's being added to this year. We're still competing in the market with those. On the fracture side, we have PhysioStim, which is our traditional PEMF technology, and then we added the IGEA AccelStim, so it's one product. We're gonna work on next generation for those in advance, but that's really all the SKUs that we have this year. The bag today, we can sell.
Okay. Got it.
Are you, like, is there, like, supply chain complexities in that business?
No, I was.
Like spinal implants or?
AccelStim and the various joints.
Okay.
Second question I think had to do with M6-C two level. We're progressing on sites. We actually have a strong focus on it right now. You know, we have two arms in that, the ACDF and the two level. I don't know what we've said publicly on percentage enrollment, but we're constantly bringing on new and working with existing. I'll let Boz comment based on what we've said publicly for completion of that or at a future time.
Yeah, I don't know that we've committed to when that's gonna be completed. We'll provide more information on that when we can.
I'll ask you and Matt.
No.
We haven't put a timeframe out for when the M6 clinical study is gonna end, but it should be normal clinical study timeframe, you know, five years or so. We just started enrolling, I think, in the summer of last year. We still have a ways to go on that. We're just in the process still of enrolling, following up with patients and just in process.
Your third question was for Beau.
In general, with the EVD platform for the neurocritical care unit, the first thing is it is a cranial procedure, so reimbursements are in place for navigation. The procedure itself has an extremely high infection rate and extremely high misplaced catheters. Up until now, after we spoke with many of those neurocritical care units themselves, navigation technology has just been too expensive to apply to the ICU itself. With the new technology we have, we're coming in at a fraction of the BOM for the underlying kit, the underlying imaging, and now we shift it to a small disposable per case. I think, I can't help the sales side of me, but it's really important that becomes the platform for different areas to expand in across other business units as well.
Bo, can you check it back over to Matt?
Matthew Blackman from Stifel. Kim, are you still here?
I'm still here. Quick question for you before you sneak out.
You mentioned, the new management for the Orthopedics franchise in the U.S.
Yes.
What are they focused on? Clearly there's an opportunity, as you mentioned, to accelerate growth of that franchise to similar rates perhaps that you're seeing outside the U.S. What's the focus? Are they ready to affect change? How quickly could we see that inflection? Is it, you know, reorganizing the sales channel? Is there disruption before there's improvement? Does it require new products? Just give us some sense of how you accelerate that business so it looks more like the trajectory you see in other geographies.
The sales leadership team that is now in place in the U.S., very strong foot and ankle pedigrees across the board. There is not any disruption that's happening. What is happening is they are identifying the areas that are under-penetrated or we're not even there, and identifying and signing on new distribution. They're doing it very successfully due to their experience, their knowledge, their network that they have. Really pursuing the areas where we excel, foot and ankle, the Charcot foot solutions that we have. The other focus they have is pediatrics. We are actively identifying new distribution and sales talent to pursue our pediatrics opportunity. We believe we have the portfolio.
We've just never exercised really the initiative to go after pediatrics we're actively engaged in training and educating orthopedic pediatric surgeons, getting our portfolio in front of more of the pediatric facilities. one of our best partners is right down the street, Texas Scottish Rite. we've been working with them for decades of our key technologies, our circular frames with surgeons there. it's really incumbent upon us now to take that experience and leverage it with other pediatric facilities.
Okay.
We're very excited about the opportunity, and we've got the right team in place for the U.S.
Just one final one for me for Tyler on biologics.
Yeah.
I don't even know if this is the right way to ask this question, but is there a way to sort of talk about what the attachment rate for biologics was for SeaSpine versus Orthofix? Is there something that can be learned from one team from the other or no, fairly similar? I'm just curious about how successful each of the teams were pulling through the biologics portfolios and if there's, you know, anything that can be learned from one side to the other.
When you say attachment, do you just mean, can you clarify?
Yeah. Just, you know, you're using some hardware that says SeaSpine, and you're pulling through a biologic in that same procedure.
Well, I think when you look at the numbers, the attachment rate is high, right? Just for both companies, because we have the number two position in DBMs. They have number two position in Trinity. The average procedural sell is about 20%, right? I don't know that I can answer quantitatively that, but.
They're both high. Just curious if there was.
Yeah
if there was a disparity, if there's something we've learned from one team versus the other.
I think we both sell outside of our core channel pretty effectively. With the strength of our spinal implant portfolio, we've been able to do it better, simply because I think we have a more competitive product. As Kevin described, they were earlier in the product rejuvenation cycle. We just had a better offering to leverage.
Yeah. I mean, it's not quantitative, but qualitatively speaking, I'm excited to have Trinity in the bag, right? 'Cause if it's a surgeon preference between DBM, cellular grafts or whatever. they. Bad habits. SeaSpine legacy's ability to grow the biologics revenue high teens, you know, is highly correlated to the market share we were taking on the spinal implant side with DBMs, right? Now, with Trinity in the bag, where we weren't able to convert distributors to the biologics, but we got the metal business, in those cases where it was because we didn't have a cellular graft, now we have a cellular graft, right? Same goes for Orthofix, where they didn't have a, you know, a mature DBM product, and it was groups that were, you know, wedded to DBMs.
We now have the best of both portfolios in the bag. It's not quantitative and because, like Tyler, I can't figure out what the attachment rate is. I just know that it's high, and it's gonna get even better now that we've got, you know, the bag full with the best cellular graft on the market and best DBMs on the market.
Just to kinda clarify too, it's difficult to quantify because we have a lot of direct purchase customers on both sides, and so you can't tie a PO for a procedure like you can in spinal implants. You know, there's a high % of our revenue that isn't tied to a PO. Excuse me, a charge sheet for a surgery.
I'll throw the stick mic up.
Throw them both.
Is it on? Is it on? Okay, yeah. It's on. The $40 million in cost savings, both.
You know, you guys have already made some leadership changes, operational changes, et cetera. I'm gonna ask my first question in another way. I mean, if you can't give me adjusted EBITDA margins, that's okay. How much do you think you've knocked off relative to that $40 million in the first year, and what, you know, what is the ramp in savings over the next three years?
Yes. I'm confident we'll have identified more than half of that by year one. We won't have realized it all in year one, right? 'Cause we're only gonna get half the year benefit for most of those initiatives to start paying dividends between headcount, redundant headcount eliminations, and the operational synergies. 2023, you'll see, my, you know, the numbers we're rolling up is, you'll probably see
Close to three quarters of that in the 2024 numbers. Obviously by 2025, you'll have the full benefit of the $40 million.
Thank you.
I'm gonna ask a, another layer of the question I asked earlier, which is just about the jump off of the $250 million. I mean, that implies a 15% growth rate in years two and three. Is it fair Should we be thinking about that in a, in a ratable, like, frame of mind, or is it gonna be more back-end loaded towards, you know, 2025?
I think the growth rate should accelerate to the product development programs that Kim talked about, right? Should add to that growth in 2023. Spinal implants, the opportunities for growth from the organic activities that Legacy SeaSpine was doing and the opportunities, you know, I've been part of the discussions with in the combined company and what Orthofix was going after should create another year of really good growth in 2023. I think the bigger growth trajectory for spinal implants should be 2024, just because the lead time that, you know, the question Matt asked, the lead time around spinal implant sets, we likely won't have those to really meaningfully impact anything other than Q4 this year.
With the opportunities we're seeing, just organically, but also with the other merger activities in the space, I think creating more opportunities, those, I think you'll see a much bigger growth rate in 2024 because not only will we be able to harvest that upside opportunity, but we'll actually have the sets to satisfy it, right? That's the one thing we're being really cautious of is we don't wanna make commitments we can't fulfill because then that's just gonna create more frustration and cost us opportunities. I think the Legacy SeaSpine group had been very successful in some of the larger conversions we had because when we committed to something, we delivered it, right?
We didn't move as fast as we would've liked to, knowing the opportunity was there, but that was intentional because it's like we have to make sure we have the sets because we can't miss a surgery. We know that the distributors we've onboarded in the past year and a half, that have really helped transform the Legacy SeaSpine business, they're our best ambassadors to attract the next distributor, right? If their onboarding experience is flawed and painful and frustrating, they're gonna tell that to their friends. That's why we wanna, as in next distributor and with the lead times what they are, it's gonna be a Q4 situation. That's I think 2024 is kind of the step up, particularly on the spinal implant side, to get to that billion-dollar rate.
Anyone else?
All right.
Going, going.
Well, again, thank you all for attending, either in person or on the phone. We hope it was informative and you guys have a sense of the genuine excitement that this leadership team has for where we can go. I know I'm really excited and I was excited when we announced the merger and as we went through the due diligence and as we've gone through the closing and now, you know, deepen in the integration, I'm even more excited. I think I speak on behalf of the entire leadership team to say we're very excited with the opportunities ahead of us, and we look forward to sharing the results of those execution with everybody as we move forward. Thanks.