Good afternoon. We are at the end of the first day of the 46th Annual TD Cowen Healthcare Conference. I'm Josh Jennings from the TD Cowen Medical Devices Research Team. We are excited to have a first-timer at the conference, BioStem Technologies CEO, Jason Matuszewski. We are learning more and more about BioStem. You guys are coming out of a storm in the wound care space. You made a recent acquisition. A lot of exciting stuff going on. Looking forward to learning more today, I'll hand it over to you to give the presentation.
Awesome. Thanks so much, Josh. Really appreciate it. First and foremost, thanks to TD Cowen for hosting us here at the Global Healthcare Conference today. Before we begin, I wanna note today's discussions contain forward-looking statements. With that said, I wanna spend the next 20-25 minutes walking you through not just what BioStem is doing, but why we believe we are building one of the most differential regenerative medicine platforms in this space. At BioStem, our mission is simple: to create and deliver the most advanced wound healing technologies in the world in the relentless pursuit of healing. Wounds are relentless. They devastate patients, they burden families, they strain healthcare systems, and they remain one of the most stubborn and costly challenges in medicine. We exist to change that trajectory. We believe regenerative medicine should not be incremental, it should be transformational.
To capture the essence of BioStem, we are built on three key pillars: a differentiated technology, a strong operational, clinical, and scientific foundation, and a scalable growth engine. Our differentiated technology platform includes three core technologies, BioRetain, CryoTek, and SteriTek. CryoTek and SteriTek are recent acquisitions, as Josh just mentioned. We've built on six perinatal-derived allograft brands, including the more recently Neox and Clarix families. We have a industry-leading IP portfolio, including 58 issued U.S. patents and 68 pending in both method and composition. We have a large targeted patient population across all soft tissue wounds. We have a 90+ clinical publications across to all products, a national sales force, and more recently, addition of 18 direct sales representatives and 32 independent sales agents that came over with the BioTissue acquisition.
We'll continue to expand on our addressable market, broaden our commercial reach, Really excited about a 510(k) product that we're looking forward to in the middle to back half of this year. As you can tell, this is not just a single product company anymore. This is a platform company. The distinction matters. Let's zoom out for a second. Chronic and acute wounds affect millions of patients annually in the United States. The economic impact is estimated at about $30 billion-plus each year for complications and infections. On a patient level, over 155,000 lower limb amputations happen annually, and over 800,000 DFU hospitalizations are annualized. These wounds are not cosmetic. They are limb-threatening, they are life-threatening, they often lead to infection, hospitalization, and amputation.
We believe evidence and biology matter, and that belief defines our strategy. Now let's think a little bit farther beyond wound care. Our addressable markets now include six core segments: orthopedics, chronic wound care, foot and ankle, urology, spine, and women's health. Across these six verticals, we are addressing a multi-billion dollar market, north of $23 billion in soft tissue allograft opportunity. The BioTissue acquisition was a catalyst in expanding this footprint. The addition of the Neox and Clarix family significantly diversified our portfolio. As you can tell, when we started out with our legacy products, that family was the VENDAJE and VENDAJE AC products. We are now across both wound and surgical with the Clarix family and the Neox family.
These products extend into the surgical setting, OR-based procedures, and hospital channels, in 2025 generated approximately $29 million in revenue, in surgical revenue, largely unaffected by CMS's wound pricing changes and coverage determinations. This diversification reduced the volatility, it increases our resilience and enhances our growth runway. To talk a little bit about our three core technologies, as you might have heard some of our previous presentations, our organic technology that we developed was the BioRetain technology, focused on a proprietary method to dehydrate placental-based tissues, more specifically the amnion and amnion intermedia and chorion layers. More recently, when we acquired the BioTissue surgical wound care assets, we were able to acquire the CryoTek and SteriTek technology platforms. CryoTek is focused on cryopreserved wet tissue, specifically placental-based tissue and umbilical cord tissue.
The SteriTek is a room temperature wet tissue, specifically placental-based and umbilical cord. The unique attributes of the BioRetain technology was really retaining a lot of the natural factors within the placental-based tissue. Some of the key factors include anti-inflammatory cytokines like IL-1RA, PDGF-BB, hyaluronan, and collagen. The really interesting thing is the collagen structure. What we found through the BioRetain process is that these long collagen strands stayed intact, mostly to help support elements transversing across those collagen structures and supporting repair, as well as the anti-inflammatory properties of IL-1RA. Turning to some of the more recent data and publications, we just published top-line results of our DFU study.
That study was across 10 clinical sites enrolling over 70 patients, and the probability of healing with that BR-AC arm was 53%, while the probability of healing in the standard care arm was 31%. This evidence is truly our moat, and we will be looking to announce our top-line results in our VLU study soon, as well as our full results of our DFU study. In the technology that we've just recently acquired from BioTissue, the surgical and wound care assets, they also had an ambulatory study. That study focused on very severe chronic wounds, mostly Wagner 3 and 4 wounds. That study demonstrated a 66% closure at 26 weeks and an average number of applications of 1.6.
That's really unique in this space, because one of the things that CMS and FDA are looking at is how do we close these wounds with the least number of applications and getting patients healed. As I mentioned earlier, we now have more than 90 clinical publications across our portfolio, and we're building clinical credibility because in the reimbursement-constrained environment, proof wins. To talk a little bit more about our channel, as many of you probably have seen some of our previous presentations, we were really focused in the physician office segment through a singular distributor, Venture Medical.
We acquired the BioTissue surgical and wound care assets, we have the ability to expand that penetration across direct relationships through ISAs and W-2 folks and have commercial coverage as well as purchasing groups like Premier, Vizient, and HPG, larger group purchasing organizations. We'll look to expand our commercial efforts outside of the physician office and mobile wound care segment and start to look to penetrate within the hospital, surgery centers, and VA. To talk a little bit about coverage. Previously, through the VENDAJE product family, we were heavily focused in the physician office segment. Most of those payers were CMS or Medicare. Now with the acquisition of the BioTissue surgical and wound care assets, majority of those products are actually reimbursed by commercial payers via a DRG or a bundled payment system.
Now with the combination of both the VENDAJE product family and the Neox and Clarix product family, we are broadening our reimbursement portfolio and reducing risk associated with payer mix. To talk a little bit about where we are as far as commercialization efforts. As you can tell, there's a lot of green space left on this map. We are looking to expand our access across some of these key states and key territories and look to grow our distribution efforts through our direct and indirect sales representatives. As you can tell, we have decent concentration in California, Texas, mostly in the southeast, and areas of focus that we're looking to expand on are obviously the northeast and northwest.
To talk more recently about the changes within the Medicare reimbursement system, I would say this is more of a digestion period and not structural damage. In the hospital and ASC settings, we're seeing a removal of the bundled rate. If you're familiar with last year and the 2025 reimbursement methodology, in the hospital outpatient, we saw a bucketed rate of $1,800 that was inclusive of the placement of the tissue or the allograft on the patient, plus those services. In the ambulatory surgery center, we saw $860 for that bundled rate, which is inclusive of the product and the services. Fast-forward to 2026, we're seeing a fixed rate of $127 a square centimeter plus additional application fee.
In the ASC, we're seeing $127 per square centimeter and the $400 application fee. Why does that matter? Why is that important? What it does is it allows these sites of service, the hospital outpatient center and the wound care centers and the ASCs to treat larger wounds. Before, they were capitated at the $1,800 and $860. Now being able to actually treat a patient with a larger 50, 60, 100 square centimeter wound, that facility can actually be able to pay for those larger size products and get reimbursed for application. We see a great opportunity in these sites of service and especially paired with now our commercial team of 18 W-2 sales representatives and those GPO agreements.
We feel like there's a lot of opportunity in this space. To talk a little bit about our facility. Our facility is based in just north of Fort Lauderdale in Pompano Beach. It's about 6,100 sq ft. We have just over 100,000 sq cm monthly capacity in that facility. We just commissioned a new clean room to support the opportunity of bringing over those BioTissue surgical and wound care products, the Neox and Clarix family. Right now, BioTissue is manufacturing those products on our behalf for the next 12 months, and then we look to tech transfer those products into our facility.
We feel strongly that at the end of the day, we have the capacity to manufacture our VENDAJE product family, as well as in the next 12 months, bring over those products through a tech transfer, and be able to manufacture it in our facility as well. Nothing happens without amazing leadership, and we have assembled a management team with deep expertise across clinical research, commercial education, manufacturing, regulatory, and finance. This team is not only built on innovation, but the ability to operate and execute. We're really excited to just more recently announce that Barry Hassett moved to the Chief Commercial Officer role, and we were able to bring Lita Lilly in as VP of Sales.
Both were former employees at BioTissue years ago and have had a lot of experience in the early onset of growing those surgical and wound care businesses. We're really excited to have Barry and Lita really lead this commercial effort and the growth of an internal organized sales team. To talk a little bit about what is our current financial outlook throughout this year and years to come. As I mentioned earlier, the BioTissue surgical and wound care assets in 2025 delivered $29 million in top-line revenue with a single-digit positive EBITDA. The first half of this year in the physician office segment, we anticipate to be a little rocky, especially with new providers getting used to the reimbursement profile of $127 per square centimeter.
We continue to execute on strong manufacturing margins, and we've had a track record of positive adjusted EBITDA. We financed the initial tranche of the BioTissue acquisition with our own cash, and that left us with just around $16 million still of cash on the balance sheet. We're gonna continue to look to invest in growth and be obviously judicious and disciplined here on our cash management. On the up-list efforts, we continue to make progress towards that effort. We more recently brought KPMG as our new audit firm. They are working on completing the 2024 and 2025 audit, which we expect to be completed in the end of Q1 of 2026.
Upon completion of that audit, we look to pursue the up-listing process, as we've mentioned on several calls before. We're well-positioned to capitalize on the opportunities ahead, and it's through these three strategic pillars: generating evidence, diversifying our portfolio, and driving growth. I think what we've set out to demonstrate on the evidence side is completing the full readout of our DFU study, top-line results of our VLU study coming up, continuing to generate retrospective and real-world data with our clinical folks in the field, continuing to build case series support on the expansion of the use case of our BioTissue surgical and wound care products across those six sites of service that we talked about earlier. We're gonna look to continue to diversify the portfolio as we move through this year.
Looking at that 510(k) product hopefully showing up in the middle of the year and be able to execute and deliver that product into a multitude of orthopedic and other use cases. On the driving growth side, we're gonna continue to invest in the commercial team. As I mentioned earlier, we have 18 W-2 direct sales representatives, over 30 independent sales agents. We'll continue to move and drive growth there. As I showed in the map earlier, looking to penetrate other greenfield opportunities. Using that team, we'll leverage our GPO agreements, Premier, Vizient, and HPG, and we'll continue to drive patient access through the existing products and KOL events.
In closing, we are building a regenerative medicine platform grounded in perinatal tissue, validated by rigorous clinical evidence, diversified across the wound and surgical markets, supported by vertically integrated, guided by financial discipline, and well-positioned for a Nasdaq up-list. We believe we are well-positioned to capitalize on the long-term opportunity in regenerative medicine, leveraging our platform of perinatal tissues. We will remain relentlessly in the pursuit of healing. Thank you. Can we take a couple questions from the audience?
Sure.
Oh, excellent.
Well, congratulations on the progress and on the acquisition again. Wanted to just circle back on the BioTissue strategy and that portfolio. You have a couple of products that are commercial and ready to roll. Did that acquisition come with a pipeline, and how do you see that your offerings into that kind of hospital, ASC channel evolving?
Yeah. There's one product. There's a milestone payment in that transaction. It was $10 million for a particulated umbilical cord and placental-based product. That milestone is initiated when they get 510(k) clearance for that product. We're looking at a lot of great opportunities for use case, not only in the orthopedic space, but also in the urology space, and some of the other areas, you know, in the wound care space for a topical covering, in abdominal recon or hernia repair, looking at using it as a product that could be used more in a free format. I think there's a lot of great attributes of that product and hoping to get that 510(k) approved here pretty soon.
Excellent. I mean, just on the reimbursement dynamic where that $1,800 bundle now converts to, you know, $127 per square centimeter plus the $750 application fee, and it opens up to treat larger wounds, really big wounds. How does that play out in the marketplace? I mean, are the clinicians and practices aware of this dynamic? Are they still getting educated? I mean, should we start to see that channel open up more fully for your core products as we get into the second quarter, third quarter, fourth quarter?
When you look at the messaging, a lot of our peers and others, you're seeing a lot of folks, you know, talk about, you know, I'll call it the rockiness or uncertainty, especially in the Q1 of this year. I think most of that's focused on physician office use of these products and not so much in the HOPD ASC. Personally, I'm pretty concerned about, you know, access to these products in those areas, right? When we talk about mobile wound care providers, not being able to round and make access to these products at a $127 rate, there is some concern to that.
We're actively, you know, on the Hill articulating that maybe there needs to be an effort and change to this and look at ways to support those folks so the patients get access, especially also in the rural communities as well. There's also a throughput issue, right? In HOPD and ASC settings, you know, there's a lot of these facilities are already at capacity from a throughput perspective. I don't know if we see this kinda tsunami or wave in which a bunch of patients that were being treated in their homes via a mobile wound care provider happen to show up in the hospital outpatient center. Although the economics support what you just described, right?
In a situation where before they were getting bundled at $1,700 or $860 in ASC, now the economics support that effort of treating these patients in those two sites of service. I think we'll see how things play out. You know, it's wound care in general has been up and down. We've seen LCDs come and go. We've seen payment methodologies come and go. I'm hoping that we look more towards evidence-based approach, looking at some of these LCDs that are really focused on what is the mechanism of action, what is the efficacy of the products. That's why we started off and really focused on getting the DFU data and the VLU data.
If you're looking at these products from an FDA category, they're considered 361 tissue allografts, you don't really need data to go through an approval process like a BLA, right? You can commercialize the products as long as you have payment coverage. I'm hoping that when we get to the point where maybe we have a new coverage risk policy, an LCD or NCD, that our data demonstrates, hey, there is a use case for this technology, and they are a valid option to be on a covered list. Then hopefully, you know, we'll see where things go on the HOPD, ASC, and physician office segment.
I'm hopeful that a lot of the conversations that are being had on the Hill, there's an opportunity to meet in the middle and where there may be some reform on the hospital outpatient side to make sure the economics support patients being treated in their home with these products.
Excellent. Any other questions from the audience? Jason, thanks so much.
Thanks, Josh.
Appreciate the time, looking forward to catching up later tonight.
All right. Sounds good. Appreciate it.