All right, welcome to our next company presentation, which comes from Jason Matuszewski, the CEO and founder of BioStem Technologies. Jason, take it away.
All right, thank you so much. Thank you, HC Winrich, for having us here today. As you mentioned, my name is Jason Matuszewski, Co-Founder and CEO of BioStem Technologies. Today, I'll be discussing some forward-looking statements throughout this presentation. BioStem Technologies is a vision of pioneering advanced healing solutions and improving our patients' quality of life through unwavering commitment to innovation. We deliver this vision by executing our mission, which is creating and delivering the most advanced wound healing technologies in the world. To give you guys a little bit of highlight about, through the last few years, our core TAM is over a multi-billion dollar market opportunity, $11.3 billion specifically in the advanced wound care market. There's north of 7 million Medicare patients with a chronic non-healing wound. We've developed a proprietary technology called BioREtain®.
We have roughly about 55 issued patents and 53 pending patents around this technology and other technologies around the use of placental and perinatal tissue products for advanced wound care. Currently, we have actively five products in the market space, targeting diabetic foot ulcers or DFUs, venous leg ulcers or VLUs, and pressure ulcers or PUs. We have an exclusive relationship and distribution relationship with Venture Medical and commercializing our products specifically in the physician office segment and mobile wound care segment. Venture has over 150 field representatives in the field across the United States. On the manufacturing side, we have a scalable facility. It's about 6,100 square feet located in South Florida in Fort Lauderdale, just north of Fort Lauderdale. We have the capacity of manufacturing north of 30,000 square centimeters on a monthly basis. We also have the capability of manufacturing OEM-based products as well.
As I mentioned earlier, 2024 was a remarkable year for our organization. We delivered just over $300 million in top-line revenue, just over $39 million in adjusted EBITDA, and as of today, we have just over $30 million in cash on hand. To talk a little bit about the chronic non-healing wound space, it impacts a significant amount of patients. As I mentioned earlier, just north of 7 million patients. That's broken down specifically in three categories: PU or pressure ulcers, DFU or diabetic foot ulcers, and VLU, venous leg ulcers. In the pressure ulcer segment, it encompasses about roughly 41% of that 7 million patient market. DFU is about 30% and VLU is about 11%. This is a compounding issue and continues to compound as we go forward here, with significantly more Medicare beneficiaries having these chronic wounds.
To talk more specifically about the sites of care where these wounds are being treated, it encompasses several sites, things like private office, mobile health, ambulatory surgery centers, hospital outpatient centers, or HOPD, as well as the veteran affairs segment. Our core focus, like I said earlier, is more in the mobile health space and private office space, but we're looking to expand in the ASC or ambulatory surgery center space, hospital outpatient, and veteran affairs, not the veterinary affairs. To kind of really give you a little bit more clarity around the 7 million mark, there's 7 million chronic non-healing wound patients and growing, to kind of highlight how big of a problem this is. By 2030, there'll be an increase of roughly about 20% of Medicare beneficiaries that will have this non-healing chronic wound. You know, this number continues to compound at an extreme, extreme rate.
To give you a little bit more clarity around where the advanced wound care segment sits, the U.S. advanced wound care market is roughly about $11.3 billion. Of that $11.3 billion, $8.5 billion is in the wound biologic segment. Where we play is right in here at that 75%, which is specifically placental-based tissue products. To dive a little bit deeper on our proprietary technology, BioREtain®. One of the unique things about BioREtain® and what we found in real-world data is that when comparing it to competitor-peer products, the BioREtain® technology was able to reduce the number of applications as well as reduce the number of treatment days, demonstrated by roughly a reduction of about 25% of number of applications. So, roughly about eight applications versus a competitor product, roughly about 10.5 or 11 applications, as well as the treatment days. Why is that important?
One, obviously, we want to get these wounds healed as quick as possible, right? We want to reduce the potential chance of infection, or frankly, you know, lead to a closure versus saline amputation, possibly, if they don't get closed. This is kind of the early onset of us doing some due diligence around the real-world data of our product versus peers. We're actively now working through a clinical trial for diabetic foot ulcers and DFUs, as well as venous leg ulcers. I'll get into that a little bit later in the presentation. To highlight some of the attributes of BioREtain®, one of the things that is noticeable when comparing it to competitor-based products is we retain, hence the name BioREtain®, a lot more of the interleukins, IL-1RA, PDGF-beta, hyaluron, and collagen. All of these elements really drive these wounds to wound closure.
Upon testing competitor products as well as our products, we found that there is a kind of a logarithmic order of magnitude concentration higher in a lot of these core elements. These core elements, like I said earlier, drive a lot of the wounds to closure. To highlight some of the clinical trials that I mentioned earlier, we're actively enrolling patients in two DFU studies, as well as one VLU study. VENDAJE AC® is actively being used in two studies, one for DFU and one for VLU. We anticipate readout in our DFU study at the end of this year. It enrolled roughly 70. We completed enrollment. We enrolled 71 patients across 10 sites, and we're looking at complete closure of the wound over 12 weeks versus standard of care. We are actively enrolling patients now in the VLU study, and we anticipate a readout sometime in Q1 of 2026.
On the VENDAJE® side, we are still enrolling patients. This is kind of lagging the first DFU study a little bit, and we anticipate a readout in Q1 of 2026 as well. All of these trials are product versus standard of care, and we're excited to see the results. Hopefully, they mirror some of the real-world data that we're seeing in real time today. To talk about the processing pathway, we recover successful cesarean birth tissue. We work with a multitude of recovery providers that recover that material on our behalf. Mom has to be okay, baby has to be okay, and the donor has to consent to donation. We're really grateful for these donors. These donors consent to a lot of medical and social history about their own health. We use that data to make sure that the donor is eligible for use as far as manufacturing.
There's a lot of forward education around why you should donate your perinatal tissue. We're really thankful for our donor recovery teams for being able to educate why, you know, you should donate this material and the use case and some of the success stories that we've seen with this material. We have used, we, when working through the BioREtain® process, we really looked at upstream processes, like looking at what medias we use when we collect the material at the recovery site, as well as transportation to our facility, and then some of the methods and drawing methods and medias that we use within our facility to process the material into what it is today. It's kind of a full-scope process.
One of the unique attributes as well, by doing a lot of the upfront processes, is that we don't have to dose it with e-beam sterilization as much as competitors, which also helps us retain some of the growth factors that I mentioned earlier. A little bit about the facility. As I mentioned, it's about 6,100 square feet. We're located in South Florida, amazing 18 feet above sea level. I know that doesn't sound like a lot, but when you're in South Florida, it does. We're continuing to expand capacity, with just commissioning a new clean room four suite with eight more BSCs. Anticipating forward demand for our product and being able to satisfy that demand. The current product portfolio, as I mentioned, VENDAJE AC®, VENDAJE®, as well as AmnioWrap2™.
We just announced at SAWC, or Society of Advanced Wound Care, just last week that we're launching an American Amnion brand focused in the VA segment. Looking to expand our reach into the VA segment where we think there's a lot of opportunity for the use case of these products treating veterans. All of these products are commercialized via what's called the 1271-361 pathway. It's a tissue transplant pathway, which doesn't require the rigorous clinical trials that you would see in more of a BLA or 351 pathway. I know this is a burning topic that everyone loves to talk about: what is the reimbursement landscape? It's been tumultuous for this industry over the last few years.
Coming up in 2026, we anticipate seeing a pivot from ASP plus six to what is currently in a proposed state of a flat-rate reimbursement across all sites of service, meaning hospital outpatient, ambulatory surgery center, and physician office. To give you guys a little bit of a reminder on where we are today, we currently, these products are reimbursed in the hospital outpatient and a bundled payment of roughly about $1,780. In the ambulatory surgery center, they're bundled at $860. In the physician office segment, which includes mobile wound care, it's ASP plus 6, so very similar to biologics or drugs, reimbursed by Medicare. That ASP is included with a placement code of a CPT code. This has been challenging for this industry. I can't say that with any more importance than the fact that we need to have a change, right? We continue to see escalating prices.
There's a lot of reports around the industry growing from the $2+ billion to $10 billion in a very short period of time. We've been actively working with both sides of the administration as well as actively working through the commenting periods to hopefully get to a more normalized pathway for reimbursement. I think this was a good start, where we're looking at flatlining reimbursement across sites of service. I think there's still definitely room for improvement. We anticipate some room of improvement on this price profile. We anticipate somewhere between $400 to $700 a square centimeter versus the $125 mentioned here. We're advocating through the comment period that we're going to flatline or stabilize this pricing for placement to be normalized across all sites of service, meaning being the same rate.
If we anticipate some sensitivity analysis around this, we do feel strongly that we will maintain very good gross margins going forward, as well as I think we see a reduction of opportunistic players in the space and it really allows folks like us that are focused on clinical data, R&D, and advocacy for patients to really shine in this space and be kind of, you know, the shining light for the industry. To kind of discuss what are our strategic priorities going forward. As I mentioned earlier, you know, 2026 is going to be kind of a step change around reimbursement. What are we looking to do to drive growth? We're going to continue to expand on our commercial team, working with folks like Venture Medical as well as looking at a direct sales force.
As I mentioned earlier, looking at the federal system and VA, and having a direct team to support those sales initiatives. We're going to continue to work with Venture Medical to increase penetration in the office and mobile segment. We are looking to establish our presence in the hospital markets as well in early 2026. We're going to continue to increase patient access to our products with our clinical data, hoping to look at expanding access through GPO, group purchasing organization agreements, as well as IDN agreements.
On the portfolio side, we're going to continue to look at ways to innovate our BioREtain® process, things outside of placental-based tissue and into other perinatal tissue-based tissue types for different use cases, as well as expand our strategic acquisition strategy, looking at patents, alternative biologic technologies, advanced wound care external devices, and other products that are addressing alternative sites of care within the chronic wound segment. I think when I always articulate about where we are today with our product portfolio, I always allude to we are looking to expand across the continuum of care. We're treating patients currently with our portfolio at the end of the continuum of care where all the leading products weren't able to help and support that patient to get to wound closure. Now we're looking to expand and have touchpoints across day one when that patient shows up into day closure with products.
As I mentioned, we're excited to have some data published here at the later end of this year on our first DFU study and then into next year with our VLU and lagging DFUs, other DFU study. To highlight our exclusive partnership with Venture Medical, this has been an amazing partnership with them over the last few years. We've really grown together as an organization and really allowed us to leverage their expertise on the commercial side, get to market really quickly with over 100 FTEs on day one. To kind of identify the shared responsibilities between both parties, Venture Medical is really focused on the sales and reimbursement logistics, as well as billing support side. We're really core focused on the product development, manufacturing, clinical trials, and government relations.
Between the two of us, obviously, we collaborate and approve all of the marketing materials that Venture uses to distribute and commercialize the product, as well as the medical education. I can't say this enough. This partnership has been strategic in us going from, you know, sub $16 million in 2023, all the way up to over $300 million in 2024. It's been an amazing partnership, and we're excited to see how things grow, post reimbursement changes. As I mentioned, we do, it's a, literally a hockey stick, of success from 2021 to 2024. Some of the key milestones there, like I mentioned earlier, Venture Medical's partnership was initiated in late Q3. Q4, we launched coverage of AmnioWrap2™ in all MAC regions. In Q4 of 2024, we also got coverage for VENDAJE AC® in all MAC regions.
A combination of AmnioWrap2™ and VENDAJE AC®, along with the amazing partnership with Venture Medical, we've delivered amazing growth over 2023 and 2024. To give you a little bit more clarity around quarter to quarter and kind of first half of 2025 versus last year, we wanted to articulate, you know, really where our revenue was at in Q1 and Q2. As we mentioned in our Q2 earnings call, our products were initially left off the proposed file for reimbursement on ASP file, and then ultimately were put back on. We did see a downturn in Q2, but we anticipate continuing to move forward with 2025 revenue in a good cadence. The gross margins on our products remain strong in the mid to upper 90%. Our sales and marketing as a percent to sales continue in a somewhat fashion of 73% to 80%.
We anticipate as we go forward into the new reimbursement segment that these sales and marketing percent of sales will come down as different methodologies for commercializing the product will be needed to be looked at. We continue to drive positive EBITDA across all of the quarters and we continue to build on our cash position. As I mentioned earlier, as of 6/30/2025, we had just over $30.8 million in cash on hand. Here's the team. We just announced that we brought Brandon Poe on as Chief Financial Officer. We're excited to have Brandon join the team. He was a CFO at MIDI Health and some other private and public, specifically Lumina, financial roles. We're excited. This team, I think, is an amazing team that can really help deliver and expand on success going into 2026. Barry Hassett, we brought in.
Barry was Head of Marketing at BioTissue, which is a leader in the use of amniotic tissue in the optics space, as well as they had a small surgical line. We're really excited to bring on these individuals and look at forward growth going forward. What are we at and what are we looking to capitalize in the future? As I mentioned earlier, this market is a very large and growing market. Sadly, chronic wounds aren't going away, and our patient population isn't getting any smaller. We're going to continue to see large growth in the market, specifically on number of patients. I think with looking at how the reimbursement pathway changes for 2026, it gives us a lot of opportunity to look at extending our product into patients that we didn't have a chance to in this year and the previous years.
We're going to continue to expand our clinical evidence. As I mentioned, having the ability to publish our clinical data on our DFU study late this year and then also our VLU and additional DFU study later next year, and continue to drive looking at real-world data around our product portfolio. We're going to look at diversifying our commercial product portfolio. As I mentioned earlier, looking to launch products into the VA space with our American Amnion brand, as well as looking at other commercial opportunities to drive adoption of our products. Last but not least, continue to drive a strong financial position to support our growth initiatives. As I mentioned earlier, we continue to hit positive EBITDA quarter over quarter over quarter, and we anticipate continuing to look at positive EBITDA profile as we close out this year and going into next year. That's it. Any.