The Zoom question-and-answer interface will open to your questions. With that, Alex, I'll turn it over to you.
Thanks, Alex, and good morning, everyone, and thank you to Sidoti for hosting us. I'm Jason Matuszewski, Chair and Chief Executive Officer of BioStem Technologies. We trade on the Nasdaq Capital Market under ticker BSEM, and we uplisted to Nasdaq just 12 days ago on August 7th. Today's presentation contains forward-looking statements as described on this slide, which applies to everything I say this morning, including our guidance. You'll find this presentation and our filings on the investor page of our website at ir.biostemtechnologies.com. What I want to do in the next 20 minutes is explain why this company you're looking at today is fundamentally different business than the one that carried the name 18 months ago, and why we think we're building one of the most differentiated regenerative medicine platforms in this space. Let me start with the basics.
BioStem develops and commercializes perinatal tissue-based allografts derived from donated placental and umbilical cord tissue, supporting healing across the continuum of care. That spans surgical applications in the operating room and advanced wound care in the outpatient setting. We're headquartered in Fort Lauderdale, Florida, and we have a manufacturing facility in Pompano Beach, Florida. I'll come back to that facility because it's where our margin expansion comes from later on in the story. For fiscal year 2026, we've guided to revenue of $26 million-$29 million, and we raised the low end of that target range last week alongside our second quarter results. Market cap is roughly $57 million on about 17.5 million shares outstanding. We're governed by a seven-member board, myself, our Chief Executive Officer and co-founder, and five independent directors. Four of those seven joined this year, and the additions were deliberate.
Steve Sonenreich spent nearly 40 years running hospitals, including as Chief Executive Officer of Mount Sinai Medical Center. Jodi Ungrodt chairs our audit committee with a long career as a senior partner at Ernst & Young's life sciences practice, with more than 30 IPOs advised, and she qualifies as a designated financial expert under SEC and Nasdaq rules. Rayna Lesser Hannaway spent 29 years as an institutional investor, including leading the small cap company growth team at Polen Capital. Last but not least, Mark Glickman, who built commercial organizations at TherapeuticsMD and Esperion, and now leads the famous BioFlorida nonprofit here in sunny South Florida. We built this board for the company we're becoming, not the one we were. That's the shape of the company, and here's the mission behind it.
Our mission is to create and deliver the most advanced healing technologies in the world, and here's what backs that up today. 10+ commercial products, which are broad, clinically differentiated, and patent-protected. We recently just announced that we added to our IP in the second quarter earnings results. Eight new U.S.-designed patents covering fenestrated placental allograft technologies. We have 60+ sales representatives across the direct and independent agents, leveraging our GPO contracts for account access, and 4x our current capacity available in manufacturing. We are not capacity constrained on the growth I'm going to describe. A $26 billion addressable market across U.S. surgical and chronic wound applications. Why does this market exist as it starts in the operating room? Over 40 million major surgical procedures are performed per year in the United States, one in nine Americans reportedly having surgery in the past 12 months.
This is not a niche, and surgery has a complication problem. Infections and post-surgical complications cost the health system an estimated $30 billion annually. Surgical site infections alone are roughly 30% of that. Here's why that matters commercially. In a hospital, that cost lands on the hospital. Under bundled payment, a complication isn't incremental revenue, it's a margin erosion. When we walk into a value analysis committee, we're not asking a hospital to fund a nice-to-have. We're talking about a cost they're already absorbing. Why does our technology actually do what we say it does? The unique thing about perinatal tissue is it optimizes the healing environment, and that shows up in five ways. It modulates inflammation, minimizes scarring and adhesion, helps prevent infection, helps manage pain, and collectively helps reduce complications, including the risk that an acute wound becomes a chronic non-healing one.
The through line is the biology of perinatal tissue does the work. We place a native tissue matrix into the surgical site and let it do what it does in utero. That's the science. Now the most important thing I'll say this morning, the BioTissue acquisition did not add products to BioStem. It changed who BioStem is. Look at the before and after on this slide. Before, we were wound-centric, dependent on CMS wound reimbursement and pricing, weighted to the physician office, and had a single commercial engine, Venture Medical. After the transaction, we are surgical-centric, commercial payers plus CMS, hospital and office, direct sales force, independent agents, and distributors.
Every one of those four lines is a reduction in risk. The acquisition brought six things: new products, placental and umbilical cord tissues across dry, hydrated, and cryopreserved formats; new customers, hospitals, ambulatory surgery centers, VA, and Department of Defense; and new channels, 30 direct reps and 30+ independent agents with GPO and IDN access that have taken us years to build. We are now looking at new end markets, urology, orthopedics, colorectal, burn, other soft tissues. These come with new economics and reimbursement, procedural-driven hospital use with commercial payer exposure. Something I will cover in more detail later on is the new margin lever, which is transferring manufacturing into our own facility after the tech transfer. Let me be direct about the last one, because it's what investors most often miss. We acquired a revenue stream that we do not yet manufacture.
Today, we buy that product from BioTissue on a cost-plus basis. Fixing that is central to our margin event in this story, and I will show you both that timeline and the size of it later on. Let me stay on the channel shift, because moving into the hospital changed the quality of our revenue. If you remember one thing from this presentation, make it the chart on this slide. Before the acquisition, 100% of our revenue was product-based reimbursement. The product itself is billed, and CMS sets the reimbursement rate and the price. Today, 87% of our revenue is tied to surgical procedural-based reimbursement under the DRG. 13% is product-based. That is a fundamentally different business, and it is the single most important de-risking element of our story today. You can see it in the second quarter mix directly.
Hospital revenue was $6.7 million, up from $5.7 million in the first quarter, and physician office was $1.1 million, up from $800,000. Both growing, but the hospital channel is now our engine. Why hospital matters specifically to us. We have broad surgical applications with established reimbursement. We have materially reduced our dependence on CMS wound pricing, which as the audience knows, has been the defining source of volatility in our sector. Our product is purchased as an expense under a procedural bill to the payer. So the hospital's decision is a value decision, not a reimbursement decision. Then there is access. Hospitals buy through group purchasing organizations or GPOs. If you are not on contract, you generally do not get considered at all.
We hold four GPO contracts covering roughly 2/3 of U.S. hospital beds, and during the second quarter, we transitioned all of the major agreements from BioTissue that came over with the acquisition. So the access is ours. Let me be precise about what that gets us. It is eligibility, not revenue. Being on contract means a hospital is permitted to buy us. The surgeon still has to want the product, and the value analysis committee still has to approve it.
What it removes is the procurement barrier that keeps most companies our size out of the hospital entirely. Last, adoption is led by physician champions. That is what makes this repeatable rather than lumpy. A surgeon who adopts in a procedure does that procedure every week. This is exactly why we put a former hospital system Chief Executive Officer on our board this year. Steve Sonenreich ran Mount Sinai Medical Center.
He has sat on the other side of this table, deciding whether a product like ours earns a place on a hospital shelf. That perspective is worth a great deal when your growth depends on winning value analysis committees. So we have the channel, but how big really is it? This $26 billion market breaks into six segments, and notice the distribution. Wound care is largest at roughly $15.3 billion. Diabetic and venous leg ulcers, pressure ulcers, and burns make up that concept.
That is where we came from, and we are not leaving it. Then the surgical segments, orthopedics and sports medicine, about $3.1 billion. Foot and ankle, $2.6 billion. Spine, another $2.6 billion. Urology, $1.2 billion. Last but not least, colorectal, $1.2 billion. So roughly $11 billion of surgical opportunity and have almost no share of it today. That is not a weakness in the story. That is the story.
To go after six markets, you need a portfolio, not just one product. We have three platform technologies, and they map to how tissue is preserved and where it is used. BioRetain is our dry platform, SteriTek is hydrated and shelf-stable, and CryoTek is cryopreserved. Different clinical settings need different formats. A surgeon in an OR with a freezer nearby has different needs than a clinician in a physician office, and a room temperature product travels into places a frozen one can't. Office and wound is our VENDAJE and VENDAJE AC and Neox wound family products. Hospital and surgical is our Clarix family and our American Amnion in the VA and DoD facilities. Our portfolio breadth lets us position the right product against the specific clinical need rather than forcing our product into every situation. Our next step is pretty straightforward.
Add BioRetain products to the GPO contracts where it makes sense and deepen penetration accounts that we already know use our Neox and Clarix product families. Here is the portfolio in detail. I will not walk you all through this table line by line. It is more of a reference, and my team can go through any product with you in a one-on-one outside of this presentation. Three takeaways. Breath, cryopreserved, hydrated, and dry. Membrane and particulate, amnion only, and amnion with ultra-thick, as well as umbilical cord. Sizes up to 10 c entimeters by 20 centimeters. Second, the products marked as coming in from the acquisition, the Neox and Clarix families, are the ones that opened the surgical door for us, and they were the primary driver of our second quarter revenue. Third, the most important, the surgical revenue is largely unaffected by CMS wound pricing and reimbursement changes.
Diversification here is not a slide word. It reduces volatility and extends our runway. A broad portfolio only sells if the evidence supports it. Four key things here to take away are 400 publications across technologies and products, randomized evidence milestones in diabetic and venous leg ulcers, which are coming in 2026 based on our DFU and VLU clinical trials, a network of key opinion leaders acting as specialty champions, and over 1.2 million product applications to date. The last one I would underline, 1.2 million applications is not early stage. This is a technology with a long clinical track record and demonstrated real-world acceptance. Our near-term agenda is publishing the definitive DFU analysis in our RCTs that we publish top-line results, as well as publishing our VLU top-line data, and actively promoting the 90+ surgical publications we already have.
We are also looking to expand retrospective real-world evidence with investigator-led surgical case series. Then we put all that to work, driving value analysis committee approvals, increasing adoption through peer-to-peer education, and expanding our payer coverage. The commercial motion is deliberately simple: land and expand. One physician champion, one initial use case, and then expand across adjacent procedures and departments in the same hospital. That requires feet on the ground. This slide shows what we inherited and what we have added. Dark blue is coverage at acquisition, hatched is new reps, and light blue is entirely new territory. We are not expanding for its own sake. We have six criteria: GPO access, hospital density, relevant procedural volume, commercial payer mix, physician champions, and our ability to actually cover the territory.
The two deployment models, direct and W2, go to strategic hospital clusters, high-value specialties with physician champions, where we want to own the relationship. Independents and distributors take open territories, relationship-led access, and federal and VA coverage, where an existing relationship opens a door faster than a new hire. The economics of that structure matter. We scale variable capacity through agents and put fixed cost only where account concentration justifies it. In the second quarter, we integrated our CRM and ERP systems, which sounds unglamorous, but it is what makes 60-person commercial organizations measurable. Where does all this get pointed to? It is really two specialties. First, urology. Urology is our first landing point and the clearest illustration of how this works.
Robot-assisted radical prostatectomies, the surgery that treats cancer effectively, but the two outcomes patients care most about afterwards, continence and sexual function, depend on neurovascular bundles sitting right next to the prostate. We use Clarix 1K as an adjunct to protect these bundles. On continence at one month, 30% of control patients had regained continence versus 55% with Clarix. At three months, 52% versus 68%, and six months, 64% versus 85%. At 12 months, 80% versus 90%. Statistically significant higher continence at every measured interval. The benefit was most notable in older patients, over 60 years, and obese patients with BMI over 30, the harder cases where a surgeon most wants an edge. The urology TAM is about $1.2 billion. Radical prostatectomies, like I just mentioned, urethral and ureteral strictures, and reconstruction.
It checks every box we look for in a landing specialty: large opportunity, favorable economics, positive clinical data, and existing physician support. When you have all four, you do not have to create a market. You have to just show up in it. The same theory for a secondary specialty as an example. Foot and ankle is next. Here the endpoint is time to heal in total ankle arthroplasty. Overall, 40 days for control versus 29 days with Clarix 1K. Over 65, 43 days versus 28 days. Obese, 40 days versus 29 days. The diabetic cohort, 92 days versus 57 days. That is 35 days of healing taken out of the hardest patient population in that operating room, and the population where delayed healing most often becomes a wound, an infection, and sadly, a readmission. $2.6 billion is the TAM for foot and ankle. Same four boxes checked.
Faster healing sounds good, but let us put a dollar figure to it. This is a clinical model of 100 patients comparing functional recovery after robotic prostatectomies with and without Clarix against published recovery rates. On continence, 83% of Clarix patients had regained continence at three months, and against a published range of 47%-93%. On erectile function, 75% at six months, against 68%-79% at six and 12 months in the literature. Now the economics, what a value analysis committee actually wants to hear. Consider what patients use while recovering. Pads, pelvic floor therapy, and in severe cases, an artificial urinary sphincter. For erectile dysfunction, medication, injections, and in severe cases, a prosthesis. Modeling two pads a day and four pills a month, the control cohort of 100 patients spent over $130,000 more on treatment across 12 months.
So per patient function returning at 12 months instead of six is over $2,000 of incremental costs. The argument isn't does it improve outcomes? It's this reduces the cost of recovery you're already paying for, and that's actionable for a Value Analysis Committee. Next, a regulatory step that makes this conversation a little bit easier. Today, our Clarix Flo and Neox Flo are sold as HCT/P 361 products. That status limits what we're permitted to say about them. In a market where surgeons decide on evidence, limited ability to market is a real constraint. BioTissue pursued a 510(k) pathway for these products. They submitted in the third quarter of 2025, and FDA reviewed through the first half of 2026. BioTissue received a 510(k) clearance in June, and we are now actively working to complete that milestone payment to bring that over to BioStem.
It changes really three things. It differentiates the product, it strengthens marketability because we can make claims we couldn't before, and it supports generally evidence-based selling, which is how you win surgeons and the Value Analysis Committees. We're targeting a market launch of Catalyze by the end of 2026, and in 2027 and beyond, we intend to continue up-regulating additional product lines. I would frame this as more of an unlock rather than a milestone. The clearance in hand and the value shows up when we launch behind it. On to more structural catalysts, and this one is the margin story. This is a slide I point a margin-focused investor to, and it's the facility I mentioned at the top of our presentation. When we acquired these assets from BioTissue, we did not acquire the manufacturing.
BioTissue supplies Neox and Clarix products under a manufacturing agreement at a cost-plus basis with the option to tech transfer these products after 12 months. BioTissue's markup sits inside our cost of goods. Here's the scale of that. A year ago, in the second quarter of 2025, our gross margin was 94%. This past quarter, it was 61%. The difference is not pricing and it's not the mix. It's that we now purchase finished product we used to have supplied to us under a very different economics. When I talk about the tech transfer, I'm not describing speculative margin upside. I'm describing margin recovery toward what the business has already demonstrated and it can produce. Where we are on the tech transfer. We are working on defining the processes for transfer, quality readiness, marketing launch plans, commercial forecasting, and capacity planning. Where are we going?
In the first half of 2027, we're targeting that transfer of the Neox and Clarix manufacturing into our existing facility with the particulate products to follow later on. At our facility, we're ready. We're AATB accredited. We're current good tissue practices. We have 6,100 sq ft of dedicated space and 3,000 sq ft of ISO clean room space. We have the ability to produce 100,000 sq centimeters a month, roughly 4x what we're using. The economics are direct. Eliminate the cost-plus market, capture low-cost vertical integration with minimal capital expenditure because our facility is already ready to execute. Which brings me to the numbers. Second quarter revenue was $7.9 million, up 29% sequentially from $6.1 million in the first quarter. Gross margin was 61%, flat with Q1. Adjusted EBITDA was a loss of $4.6 million, improved from a $5.7 million loss in Q1.
That's a Non-GAAP measure, and the reconciliation is in our release. GAAP net loss was $9 million or $0.52 a share. We ended the quarter with $7 million of cash against $13.7 million at the end of Q1. Cash used in operations in the quarter was $5.5 million. For the full year, we're guiding to $26 million-$29 million, which as I mentioned is up from our prior guidance of $25 million-$29 million. Let me address two things directly because you should be asking both. First, our year-over-year. Second quarter 2025 revenue was $11 million. We did $7.9 million. So a year-over-year basis revenue is down, and I want to be straightforward about why. Our BioRetain business was concentrated in the physician office, focused on wound care under product-based reimbursement, and that market was reset by CMS pricing.
We saw that coming, and the BioTissue acquisition was the response, not a reaction. What we're doing in 2026 is replacing that, what was exposed to a single reimbursement decision, with revenue that isn't. That transition cost you a year of comparisons. It buys you a durable business. Sequential is the right lens on 2026 and going forward, and sequential is up 29%. Second, the balance sheet. $7 million is cash against a $5.5 million quarter operating burn is a fair question, and I'd rather answer it than have it hang over this presentation. Three things happened in the quarter that won't repeat at that scale. We closed a $2.5 million private placement with our first institutional investor. We resolved $5.3 million of our outstanding debt through a $3.5 million cash payment and a $1 million note, and we absorbed the bulk of our integration spend.
Going forward, the path runs through revenue growth on a 61% margin base, operating leverage on a commercial infrastructure that is now largely built rather than being built. The manufacturing transfer that I just described improves our margins. Our Nasdaq listing also materially broadens our access to institutional capital, which was a core reason we pursued it. One more thing to add on the reporting itself. 12 months ago, this company was quoted on the OTC. Since then, we've published our first audited financial statements, brought in a new Chief Financial Officer and a new auditor, filed the Form 10 with the SEC, and uplisted to Nasdaq. There's a lot to be proud about, and our success in a short time shows how determined we are to succeed. So building momentum, and I think five key takeaways here.
We have a significant unmet need in the hospital against an addressable $26 billion U.S. market. We have a national distribution footprint with expanding payer access, 60+ reps, four GPO contracts, all major GPO agreements now transitioned from BioTissue. We have a differentiated, broad, clinically proven portfolio, 400 publications, 1.2 million applications, and a 510(k) clearance achieved by BioTissue. We have an accredited manufacturing facility with capacity to scale into this growth without significant capital investment. The combination commercial reach plus own manufacturing is what creates a vertically integrated model and a path to profitability. So let me finish with why we do this. We're building a regenerative medicine platform grounded in perinatal tissue, validated by rigorous clinical evidence, diversified across wound and the surgical markets, supported by vertical integration, and guided by financial discipline. As of two weeks ago, we're listed on the Nasdaq.
We believe we are well-positioned to capitalize a long-term opportunity in regenerative medicine, and we remain relentlessly in pursuit of healing. I want to thank everyone for joining the call today. We are hosting one-on-one meetings through Sidoti's platform in the next two days, and we encourage anyone who wants to go deeper on the surgical pipeline or additional questions to request time. Our Investor Relations contact is Philip Taylor at Gilmartin. Happy to take any questions, Alex.
Great. Well, thank you for the presentation, Jason. Let's take a couple of questions. One is, I think you touched on GPOs, group purchasing orgs, VACs, value analysis committees. You have some pretty amazing data. Particularly, I was looking at the confidence data that you showed on the urology side. When you put data like that in front of a value analysis committee, what's the reaction been for you guys?
I think that's one of the thesis of why we decided to pursue the BioTissue transaction, is we noticed that there's a lot of great, robust, either investigator-led clinical case series or data sets that frankly, investigators led most of them. It is compelling to a value analysis committee. This isn't company-sponsored research, right? This is investigator-led research. So it kind of also opens the eyes when value analysis committees review that data set and look at, okay, there is a value to using these products, reducing readmissions, reducing costs to potential complications to those surgeries and things of that nature. So I think it's definitely eyes wide opened when presenting a lot of that data sets.
Great context. Thanks. We will take one from the audience, too. You had a great map about expanding the sales team and leveraging the sales team, and someone asked if your plans include New York and Boston, which were a couple of areas maybe not on the map.
Yeah, I think we're obviously looking at how we can manage that W2 direct team as well as the independent sales agent team, and really looking at where we have data to demonstrate. Do we have GPO access first? Where do we champion a physician champion or KOL in that area? Look at, with those two elements, is there an opportunity to enter into a facility and access? We are located in the southeast region. We have some concentration, obviously, the southeast of the U.S. as well as west coast, and we're going to look to expand. Our goal is to really expand as we talk about on our earnings call, expanding our commercial team. We have 30 directs today.
Our goal is to be at 40 by the end of the year, and we continue to look at growing that commercial team and that commercial infrastructure to support larger coverage in geographic areas throughout the United States.
Makes sense. Maybe we'll end with one more question. For folks who are newer to the name or are newer to regenerative medicine, what would you say to them about why now is a good time to think about an investment in BioStem?
I think when we look at our peers in this space, we are in a great position of having the ability to grow this organization and top-line revenue. It's a great time that we have a lot of the infrastructure and the evidence. As I kind of alluded to in the presentation earlier, we have a great base of evidence to demonstrate why we should get access to these facilities and why providers should look at utilizing these products for patients to have really great outcomes. With that broad evidence and our investment into our commercial team, we think we have the opportunity to really grow and supercharge this company going forward.
Wonderful. Well, thank you so much for sharing. With that, we're at time. I'd like to thank you, Jason, for sharing not just the BioStem story with us, but also like to thank everybody listening for spending time with us today.
Awesome. Thanks, Alex. Really appreciate it.