So I guess I'll introduce myself. I'm Philip Dantoin, an associate on the Piper Sandler MedTech team. Very excited to have Anika Therapeutics here with us. And here with us today is the President and CEO, Cheryl Blanchard. So with that, I'll turn it over to Cheryl. Thank you.
Thank you. Good morning, everyone. I've also got Steve Griffin, our CFO, here with me today. So Q&A at the end, he'll be happy to step up with any relevant questions. So let me dive in. Anika is a company that's in our 31st year of business. We're a company that has been built on proprietary hyaluronic acid technology. And our two biggest products, Orthovisc and Monovisc, are sold through our partner, J&J MedTech, in the United States. With those two products, we actually hold combined the number one U.S. market share position. And that is a very healthy business for us. It's a very cash flow positive business for us.
On the HA side, we have continued to build out, with that proprietary technology, a number of other products that are some of them here, some of them here outside the United States, and some of them coming in the United States that are going to drive a very significant amount of value. First of all, on the OA pain management side, we have a product called Cingal, which is a next generation osteoarthritis pain management product. We sell that outside the United States alongside Orthovisc and Monovisc, and that business has generated 14% growth year-to- date, so very healthy business combined OA pain management, and we've made a lot of progress in bringing Cingal into the United States. I'll also talk a little bit today about Integrity, our new rotator cuff repair system that includes a regenerative augmentation patch.
We are selling that globally today, primarily in the United States. It's doing very well. It's been out about a year now, driving 40% sequential growth. So we're very excited about that, a highly differentiated product. Coming down the line by 2026 is Hyalofast, our single stage cartilage repair product. Again, I'll speak in more detail about that. A product that we're very excited about is going to compete very well in the cartilage repair market in the U.S. We already sell it outside the United States in over 35 countries. I will also talk today about our refocus strategy that we have recently started talking about. You can see on the chart on the right the two different colors that represent our top line.
We're now kind of talking about our OEM channel, where we manufacture product that others distribute, like the J&J partnership, and that's in the dark blue. Our commercial channel is the part of the business that we manage commercially. That's our OUS business, both OA pain management and regenerative, and our U.S. business on the regen side. There's a significant growth trajectory that we're already experiencing with that commercial channel. And our OEM channel is really today where our profitability comes from. So I want to talk for a minute about capital allocation. We have recently talked about our refocus strategy that is really driving focus around our capital allocation with our highly differentiated hyaluronic acid platform business. That's on the OA pain management side and on the regenerative side.
We are very excited about what that business is doing today, both from a profitability perspective on the OA pain side and a growth perspective on the regenerative side. We are also in the process of divesting a couple of non-core assets. One we announced signed and closed on our Q3 call. The other is in process. That's the sale of Parcus Medical, which is a sports medicine business. That is all ongoing and will be completed in the future. That will kind of, I think, clear the smoke for the business where we're very focused on the highly differentiated HA products. We continue to develop products and make investments that we think are very valuable going forward, bringing Hyalofast into the United States, which will happen by 2026, and bringing Cingal into the United States, which we're making significant progress on. We have launched Integrity.
It is growing well in the United States. And all of those investments that we're making are starting to really bear fruit. I mentioned before about the two channels that we're talking about how we sell our products through, the highly cash generative OEM channel and then the higher growth commercial channel. So the commercial channel is something that I'm going to be a little bit more focused on today, talking about products that we have already and the products that are coming. So in terms of those key value drivers, I talked about Orthovisc, Monovisc, and Cingal. Orthovisc, Monovisc sold in the U.S. today through J&J MedTech. Cingal, we've made a lot of progress bringing that to the United States. The FDA had thrown up a hurdle for us here recently that we've overcome.
We have a Type C meeting coming with them that will kind of define the final regulatory path and allow us to talk a little bit more about timing. But Cingal is a great OA pain product. It has OA pain data that I've never seen in my 35 years of doing this for a living. And we are excited about the fact that we already sell that product. We know what it does outside the United States in over 40 countries. We also see all three of those products grow together. We do not see Cingal cannibalizing Monovisc, which is our single injection HA product. Outside the United States, we continue to see very strong double digit growth with that OA pain portfolio that we also sell through our commercial channel. On the regen side, we've talked about the fact that we launched Integrity.
That's the image that you see in the lower left hand corner. It is a system to repair the rotator cuff with an augmentation patch that is regenerative. It is made out of hyaluronic acid. It is largely resorbable, but it is differentiated from the products that are in the market today, first generation collagen products in that it is about three times as regenerative as collagen, and it is strong even when wet. So it has high suture retention strength. The surgeons are really excited about the product. We're feeling a real pull from the marketplace and not just in the rotator cuff, which is also part of our product development pipeline, products that we'll be launching next year that are additional shapes, sizes, and configurations that will be used across the body in other tendon repair applications.
That product is experiencing 40% sequential growth right now and will do so into next year. Hyalofast, our single-stage cartilage repair product. This product is going to play into a market that exists today in the United States. Again, we sell at OUS. We actually have 15-year clinical data that just got published on this product. It is a single-stage, one surgery, off-the-shelf product that will be competing against MACI in the United States. MACI is a two-stage product that requires two separate surgeries for the patient to go through. It is supremely expensive. It's about $60,000 for the product alone, and I think the market that it has carved out is exciting. It's growing at about 20% right now, but is limited by the fact that it requires two surgeries and the cost associated with it.
We're excited to bring Hyalofast into that market and we think grow the market. We think there's over $1 billion market opportunity for Hyalofast just in the United States alone. A lot of cartilage lesions today just go untreated because of the complexities of the MACI product. Hyalofast is a hyaluronic acid product. Again, it is fully resorbable, has 15-year data on it. We'll have our clinical readout happening in the middle of next year with our definitive clinical trial. We have Breakthrough Device Designation and we'll be filing this through a Modular PMA. We have already filed the first module and the second and third modules will follow on. The third module is the clinical module and will be reviewed after all of the other two modules are complete. We will be launching this product into the market in the U.S.
With over 40 clinical publications, 15-year data, and a definitive clinical trial randomized to microfracture in the United States. We're very excited about this. It will fit nicely into our existing regenerative portfolio in the U.S. That also includes Tactoset, a bone regenerative product that is largely sold into the sports medicine regenerative space. We will already have Integrity products that are being launched following on Integrity that use that Integrity platform to sell across all tendon repairs and then a cartilage repair product. We also have additional products in the pipeline that leverage this highly differentiated regenerative platform that we have not talked about in a lot of detail, understanding that the competition is watching, but we will give more information out about that going forward.
Very excited about this regenerative product portfolio that we're building in the United States with Integrity here, more products coming next year, Hyalofast launching by 2026. Cingal, progress made on that in the United States and our commercial channel really looking to drive a significant growth number while our OEM business is driving our profitability profile today. This slide shows our financial highlights. Again, we have 20% EBITDA margins on that core OA pain business, a very strong business in the United States that plays into a $1 billion market with Cingal coming that adds an additional $1 billion addressable market just in the United States alone, with Hyalofast coming adding an additional $1 billion market opportunity in the United States alone, and with our renewed capital allocation strategy, really focusing on driving the growth of those new highly differentiated products.
We are also in the midst of a share repurchase program. We've already repurchased 5.3 million of a $40 million buyback and look forward to continuing driving profitability in our OEM channel with growth out of our commercial channel and into the future, getting to much more attractive adjusted EBITDA numbers across the company. So I'll just summarize so I have time for questions here. We are in the process of completing the second divestiture of Parcus Medical. The Arthrosurface divestiture is complete. We are now completely focused on our hyaluronic acid piece of the business with our OA pain products, Orthovisc, Monovisc, and Cingal, driving profitability with Cingal coming into the U.S. into the future with an over $1 billion market opportunity there and continued growth in our OA pain business outside the United States in the double digit range.
The Hyalofast PMA submission completion is coming in 2025 with a launch by 2026. And we'll continue to grow our highly differentiated regenerative products in the United States and globally this year into next year as we look forward to bringing Hyalofast into the United States market. And of course, we'll continue to support our OEM partners, primarily with Orthovisc and Monovisc, with the J&J relationship in the United States. Again, that piece driving a significant portion of profitability that we see good opportunity from a capital deployment perspective to make the right investments in this highly differentiated regenerative business. So with that, I will pause and take questions. Yes, sir.
It's hard to go by. You have a very hot product. We do. What are you doing with respect to capacity for that product? What are the opportunities that you are getting whatever needs to expand exactly what you're doing?
Capitalizing. Yep. It's a great question. It's one that I get asked on a regular basis, especially with the administration change. Cingal is a great product. I spend a lot of time looking at all of the OA pain data that is either out there with products that are in the market. In the United States, it's really viscosupplement products. Outside the United States, there are a couple of other products, but this product has incredible pain data. 75% pain reduction at six months, even further out than six months. Short term pain relief, long term pain relief. It's highly differentiated. We sell it in over 40 countries, so we know what it's doing commercially. Outside the United States, yes, we have sales and marketing infrastructure that certainly tout all of the features and benefits of Cingal, and that is why it does so well.
In the United States, our hurdle has been with the FDA, and they have changed how they regulate this product twice during our clinical development program. They've thrown a couple of barriers up for us, but we are knocking them down, and there's a very significant opportunity in the United States, especially in light of the opioid crisis. This is a non-addictive intra-articular injection. You're welcome. Other questions? Yes.
Can you go into much more detail about what the FDA is asking from you for Cingal and the timeline and what you need to do?
Yep. Yep. I'm happy to. One of the things the FDA did in 2018, so it was smack in the middle of our clinical development program, was they sort of unofficially designated hyaluronic acid when used to treat osteoarthritis pain as a drug. It is today sold as a device.
It is sold as a device with 12 products, two of them ours, one of them Monovisc. Monovisc is the HA in Cingal. So FDA said, well, in Cingal, it's a drug, which makes Cingal a drug-drug combination product, and that requires us to meet the Fixed Combination Rule. So we had to do work on Monovisc as a drug instead of a device. One of the things we've had to do is additional animal studies, which we've talked about the fact that we're starting those in Q1 of 2025. So that's one of the barriers. The second one is around the triamcinolone hexacetonide, the steroid that is the steroid in Cingal. That steroid is approved in the United States as a product called Aristospan. That product stopped being sold in 2012.
So when Anika did our clinical trials that had to meet the Fixed Combination Rule, we used a product called Lederspan, which is the equivalent of Aristospan sold outside the United States. What that did was it put us in a position where we have to do bioequivalent studies to demonstrate Aristospan and Lederspan are bioequivalent. So we have a Type C Meeting that we are setting up with FDA to get final definition around what that bioequivalent study looks like.
When do you think you'll be in the clinic? To resubmit what? We have not submitted to the FDA yet.
Yeah. We have yep. That's okay. I just want to make sure I understand your question. So we have not filed with the FDA because we know that those two topics I just described to you are filing issues.
We need to get them done even before we file. Once I have had this Type C meeting that is coming up with FDA, then I will have a better sense of timeline because I'll know the exact study design of the bioequivalent study. And as soon as we get that information, I'll provide an additional update. Looks like we've got about a minute left if there's another question. Go ahead. Hyaluronic acid has been around a long time. A lot of different companies have used it.
What makes Anika's iteration of hyaluronic acid pain different than?
Yeah. It's a great question. In the viscosupplement space, I would tell you that there's a lot of great clinical data out there that speaks to kind of the molecular weight range that drives the greatest degree of efficacy from a pain relief perspective. Anika's got great clinical data.
It's really why we have the number one market share position in the United States with those combined products. And we feel very good about where we are OUS and the growth that we drive, again, with that clinical data. From a Cingal perspective, it's really the combination of our HA and the way we formulate the triamcinolone hexacetonide into it that gives us a combined pain relief and responder rate that I haven't seen in anybody else's data. On the regenerative side, our regenerative products are esterified hyaluronic acid, and they're fully resorbable. They're highly regenerative. That is proprietary technology to Anika that we're really leveraging with our regenerative products. You're welcome.
All right. I think we're out of time.
Thank you. I'll hang around, and so will Steve if you have additional questions.