All right, thanks for joining us. We've got Anika Therapeutics up next. Very excited to have them here at the conference. Cheryl is the CEO of the company, so I will go ahead and turn it over to her.
Thank you. Good afternoon, everyone. Are we good to go? Audio? Okay. Thanks for coming, and thanks for your interest in Anika. I'm gonna start out with just a, a quick overview of where we are as a company. About three years ago, we initiated a transformational growth strategy pivot, and on the left-hand side, you can see effectively the, the legacy business. It's not moving? It's on my computer. Oh, okay, good. On the left-hand side, you can see the, basically, the legacy part of the business, which was a result of 30 years of focus on developing hyaluronic acid technologies, primarily in the orthopedic space, in early intervention and pain management. This was a business that Anika had built up over time.
It is a very strong business for us, and in fact, Monovisc and Orthovisc are sold in the United States through our partnership with J&J Mitek. And Cingal, which is our next generation OA pain product, it's a combination of hyaluronic acid and a steroid, triamcinolone hexacetonide, is sold in over 35 countries outside the United States, and we now have line of sight to bringing this into the United States, where we think there's an additional billion-dollar market opportunity for a, a truly next-generation osteoarthritis pain product. So this is really the base of the business around that proprietary hyaluronic acid technology. And what we've done is leverage that into a focus on joint preservation and orthopedics in the surgical space, so from injections then into the surgical space.
What you can see on the right-hand side, we have spent a lot of time since this pivot about three years ago, where we acquired two companies, a sports medicine company and a joint solutions company, developing products that were critical to that area, filling the bag on the sports side with X-Twist, our new fixation system, and then RevoMotion, our new reverse shoulder. I'll talk about those in a, a little bit more in a minute. Really leveraging that hyaluronic acid proprietary technology in the regenerative space and all the other products that you see on here really leverage that technology. I'm gonna talk about Integrity, our new rotator cuff patch system that we just announced this week, having done first surgeries this week. We're very excited about that. Tactoset is an injectable settable bone void filler, also leverages that regenerative hyaluronic acid technology.
Hyalofast, we sell currently outside the United States and have a very well-defined pathway now through FDA, now that the clinical trial is fully enrolled on that truly breakthrough cartilage repair product that will kinda take the United States market by storm when we get that launched in the 2026 timeframe. And then Cingal, which I just mentioned, but that, the next step for that is really bringing that into the United States. So a number of key product launches have happened this year, either full market release or limited market release with our Integrity rotator cuff patch or with Hyalofast and Cingal. We have now line of sight to bringing those into the market in the U.S. here in the next couple of years.
So let me dig in a little bit on these new products, because these new products are really, from a joint preservation perspective, providing the growth drivers that we are looking to next year and in the out years. So the Integrity patch is gonna be launched into a current market today, call it a $150 million plus market, fast-growing market. A lot of unmet needs still in that space that we think we really address with the product that we've developed. The reverse shoulder area is the largest part of the shoulder arthroplasty market. We have had an anatomic offering in that space. We did not have a reverse offering. That constitutes about 80% of that market of that total shoulder arthroplasty market.
We now have a product in that space that really is in line with the Arthrosurface design philosophy, that a lot of surgeons who use the RevoMotion, the anatomic shoulder, are really excited about this product. Again, plays into a $1 billion+ market opportunity. And then X-Twist, the sports medicine soft tissue fixation system, largely used in lateral row procedures in the shoulder for rotator cuff repair, being launched into a $600 million+ market opportunity. We launched the PEEK version in January in a full market release, and we're talking about the fact that we've got a biocomposite version that's received 510(k) clearance and will launch in Q1 of 2024. So these new products really are the basis for the growth that we are looking to accelerate into next year in the joint preservation market.
I'm gonna spend a little bit of time on each of these because this is really, the story at this point in time for the fact that Anika has done all of this work over the last three years, and now these products have arrived. So let me start out with Integrity. So the rotator cuff patch market today is about a $150 million market in the United States, and it is largely occupied by a product called REGENETEN, that is sold by Smith and Nephew. There are a couple of other new entrants into the market that were acquired, one by Zimmer Biomet, one by ConMed, for around $250 million in total consideration. So this is a market that has very strong, comps in terms of demonstrated market value for technologies. And those technologies are. They're good technologies.
They're based on collagen, kind of first generation regenerative technology. The product that we've come up with here leverages that proprietary hyaluronic acid technology that Anika had developed for many years. This product is an esterified form of hyaluronic acid, so it's basically a polymer of hyaluronic acid that gets spun into fibers and then knitted into the patch that you see in, on the left-hand side. Some of the unmet needs in this space were around strength. So collagen, when you get it wet, is kind of like wet tissue paper. It's not very strong. The surgeons are trying to accomplish a biomechanical construct that is strong, that will result in very good biological healing, that will reduce the re-tear rates.
There are a whole bunch of things that the collagen patches are just not accomplishing right now, that this technology is, is going to bring a solution to the table with our HYAFF technology and the high strength when wet, which is really all that matters, because these things get put into a scope and they immediately are hydrated. So we've really demonstrated significant strength, tensile strength, tear resistance, but also suture retention, because the surgeons wanna put suture through this, and if it can't retain a suture with any kind of strength, then they really don't have the confidence in that biomechanical repair that they just did. The other thing that we were focused on here, though, is providing a full solution to the market.
So we really looked at the surgical technique that's used today, wanted to make sure that we put together a surgical technique that was easier, that really facilitated an efficient surgery. So we've got a lateral technique, a lateral first technique, that allows for fixation on the lateral side of the shoulder and then fixation to complete the biomechanical construct. So the versatility of that technique is something that the surgeons are very excited about and the fixation that we provide. There's a little picture of the caddy that we provide with both bone darts and soft tissue tacks. So there's a very easy procedure with great instrumentation. It is an all-arthroscopic technique. But the other huge advantage here is the Hyaluronic acid and its regenerative capacity, which is significant.
We've now done a head-to-head animal study to the market-leading product, the collagen product I just mentioned, that demonstrates that we have about three times the regenerative capacity compared to that collagen, which is a big deal when you're trying to get kind of a recalcitrant rotator cuff to heal. So between the patch technology, the great regenerative capacity that it has, the ease of surgical technique, the instrumentation kit, and the fixation kit, we've got a full solution. It's kitted. The surgeons can also buy the patch separately, though, because we have a general tendon indication, and there's interest already that we're hearing about using this in the foot and ankle, for example, for Achilles repairs. There are applications in the knee and in the hip.
And so while we're excited to get this out there in the current market with rotator cuff repair, we're also very excited to start to leverage this technology into other anatomic locations. There's a lot of unmet need in the regenerative space, in orthopedics, in early intervention repairs. So we announced our first surgeries performed this week. We've already got a lot of interest from the surgeon community on this, and we will be increasing our quantities as next year we get to kind of building into the full market release during the first quarter. We're looking forward to getting that early feedback from the surgeons right now. So that's Integrity, a product that we're really excited about. I'll mention the Reverse Shoulder. We did our full market launch of this product in September at the OSAT meeting. This product is great.
It's bone preserving, the smallest glenoid base plate on the market, which gives the surgeons a lot of options on where to place it when there's a difficult anatomy to work around. It's very personalized. The Midlay humeral design is a design philosophy that a lot of surgeons like, and we were very focused on enhancing efficiency and only providing instruments in two trays, because we're focused on the ASC strategy. Good news, just in the last couple of weeks, CMS announced that they will be paying for total shoulders in the ASC. Prior to that, it was just a private pay opportunity in the ASC, but that news is good for us, given that we put together a really efficient two-instrument tray set here.
And then the other thing I'll announce at this meeting is we've recently launched our AIM preoperative planning software, which is something that the surgeons really want when using this and the anatomic shoulder, the OVOMotion product that we have. So this implant management preoperative planning software is now launched and is in use. So we really now have a full solution for total shoulder arthroplasty, both anatomic, reverse, and the preoperative planning software. And then the last thing I'll mention in a bit of detail is X-Twist. We've talked about this before. Again, we launched the PEEK version in a full market release at the beginning of this year. We will get into a limited launch of our biocomposite version in the first quarter of 2024.
Of the $600 million+ market opportunity that this plays into in the United States, Biocomposite represents about half of that. So we've been able to play to about half the market with the PEEK version, and we look forward to getting the Biocomposite version out. It is a philosophy that about half the procedures, about half the surgeons like. So we look forward to getting that out in 2024. The other thing I wanna mention today is a little bit further out, but with line of sight now to Hyalofast. This is our single-stage. Sorry about that. That's my phone ringing. Forgot I had my watch on. This is our single stage cartilage repair product. It is off the shelf. Single stage, meaning it only requires one surgery. The competitive product on the market today, MACI, requires two separate surgeries.
It's, it's very costly. This will be economically much more advantageous for the surgeons, for the payers, for the facilities. So we're very excited. We've now fully enrolled this clinical trial. We will be starting to file a modular PMA in 2024. We will get all those modules filed and completed, and then in early 2025, when we're at last patient out with the clinical trial, we will file the final module, that being the clinical module. So we're looking to a U.S. launch, again, leveraging that hyaluronic acid technology in 2026. And then the last piece is Cingal, again, leveraging the HA technology. And this really is a U.S. story at this point. We sell it in over 35 countries outside the United States and are in good discussions with FDA.
We had a Type C meeting in April and have some additional non-clinical work to do to complete the package before we file the NDA for Cingal. So in summary, I want to just mention, from a top-line perspective, we look for JPR to be growing double digits next year, above-market growth in OA pain management. Our OpEx spending is stabilizing. As we grow the top line, we're going to be driving leverage, and we're starting to build out a few direct sales force folks that are targeted to regen and sports med, augmenting the hybrid sales force that we have. And we're funding this pivot all on our own. We have no debt. We have a strong balance sheet. So I want to leave a couple minutes for questions. I've got our CFO, Mike Levitz, here, if you have financial questions. Any questions? Yes.
Yeah, so for Hyalofast, most of the spend is already done. It was really on the clinical trial. So we'll obviously have some spend around the PMA filing and finishing up the clinical trial. I'm not sure how much information we've provided publicly on the dollars, but know that the lion's share of the spend is already done on the development of that product. Yeah, please. Correct. Around the way you want. So for Cingal, we sell Cingal outside the United States. In every country we sell Cingal, we sell Monovisc and Orthovisc, and we continue to grow all three products next to each other. We do get a lot of questions whether Cingal is going to cannibalize Monovisc, in particular, since they're both single injection products. But what we see is Cingal gets used instead of a steroid injection.
It has a steroid in it, so it does the same thing as a steroid injection, but then it lasts for six months. It's also chondroprotective, so that you can give multiple injections where you might need a steroid. So we don't think that it's going to significantly cannibalize Monovisc because it just hasn't in the 35 countries where we sell both of them together today. Yes. Right. In the United States today, everything is sold through our hybrid sales force, so we have 1099 distributors. There are a few distributors that are not as focused on the sports and regen side. They're not investing, they're not growing it like we think there's opportunity to do. So the direct reps that we will hire will be fully focused on sports and regen.
They will be augmenting that hybrid sales force, and we will not be adding to OpEx to do that because we've already invested in the R&D significantly. We had to invest in MDR. A lot of that cost is behind us, so we're really shifting where the investment goes by doing that and being, now that we have the products, being more focused on that commercial execution piece. All right. Great. Thank you, everybody.