Good morning. Thanks for joining us at the 25th Annual Needham Healthcare Conference. I'm Mike Matson, and I lead the MedTech and Diagnostics Equity Research team at the Needham & Company. I'm pleased to introduce BioStem Technologies' CEO, Jason Matuszewski, and CFO, Brandon Poe. They're going to give a presentation on BioStem, and then we should have time at the end for questions. If you have questions you'd like to ask, you can submit them electronically through the Needham conference website, or feel free to email them to me at mmatson@needhamco.com and I'll try to fit them in. With that, I'll turn it over to Jason and Brandon, and then I'll come back for questions at the end. Thanks, guys.
Good morning, and thanks, Mike and the Needham team for hosting us today. Before we begin, I'll note that today's presentation includes forward-looking statements and actual results may differ materially, and we refer to our filings in additional detail on our investor website at biostemtechnologies.com. 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. Because wounds are relentless, they devastate patients, they burden families, and 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. This slide captures the essence of BioStem. We are built on three key pillars, a differentiated technology, a strong foundation, and a growth engine.
On the differentiated technology side, we have three industry-leading technologies, BioRetain, and the most recently acquired CryoTek and SteriTek. We have six perinatal-derived allograft brands, including the most recently acquired Neox and Clarix families, a industry-leading IP portfolio, which includes 68 issued U.S. patents and 81 pending patents, and a strong foundation to deliver these technologies through a robust library of clinical data with 90+ clinical publications, a national sales force with over 25 direct reps and over 30 independent sales agents, and existing manufacturing capabilities in Pompano Beach. Our growth engine is expanding across our addressable market, broadening commercial reach, and delivering on a pipeline of innovation through 510(k) and other pathways. At the end of the day, our products are designed to do a few things really well, accelerate healing, reduce complications, and improve our overall patient outcomes. Those outcomes are what ultimately drive physician adoption and reimbursement.
We operate in a very large and growing market segments. Chronic wound care alone represents approximately a $15 billion opportunity in the U.S. What's more compelling is our expansion to adjacent surgical markets, including orthopedics, spine, urology, and women's health, each representing additional billion-dollar opportunities. What's important here is not just the size of these markets, but their structure. Surgical markets tend to have higher reimbursement levels, stronger commercial payer mix, and more predictable utilization. As we expand into these areas, we're not just increasing our total addressable market, we're improving the overall quality of those opportunities. As we move forward with a stronger platform for the next phase, we're diversifying our end markets, expanding our commercial footprint, differentiating our product portfolio, and scaling our operational excellence. Our product roadmap now is the key inflection point for BioStem.
With the acquisition of the Neox and Clarix product families from BioTissue, we've fundamentally changed the trajectory of our business. Prior to this transaction, we were primarily a wound care-focused company with exposure largely tied to CMS reimbursement dynamics. Post this transaction, we now have meaningful exposure to surgical procedures in the hospital-based setting. This shift matters for a few reasons. First, it expands our call points. We're now engaging not just wound care providers, but surgeons across multiple specialties. Second, it improves our payer mix with greater exposure to commercial reimbursement. Third, it increases the value per procedure as surgical applications tend to carry more attractive economics. This is not just a product acquisition, it's a channel expansion and a business model transformation. Importantly, it positions us to scale into a much broader and more durable market.
Our product roadmap supports our continued innovation and regulatory progress, including our 510(k) initiative with the Catalyze product. Importantly, it builds on the platform we've already established with our surgical product portfolio. At the core of everything is our BioRetain platform, our original product and development technology predicated on the dehydrating process of placental-based tissue products, and more recently acquiring the CryoTek and SteriTek preservation and technology platforms, those focusing on wet and cryopreserved and room temperature technology platforms. This slide highlights some of the attributes associated with the BioRetain technology. We have demonstrated significant concentrations higher than our peers in IL-1RA, an anti-inflammatory cytokine, TGF-beta, a key growth factor for tissue regeneration in our products, a significant order of magnitude higher in hyaluronic acid, as well as significant collagen structure that provides new scaffolding for tissue regeneration.
At the core of all of our products is a significant and robust clinical data. Our clinical data is a key driver for adoption. In randomized controlled trials for diabetic foot ulcers, more recently, we demonstrated healing rates of approximately 53% compared to about 31% for standard of care. We also saw fewer applications required and faster time to closure. These are not just statistically significant improvements. They are clinically meaningful outcomes that directly impact patient care. We've also demonstrated strong results in more severe wounds, which are often excluded from clinical trials. From an investor perspective, this matters because physicians adopt products that deliver better outcomes, and payers reimburse products that are supported by strong evidence. As we expand into the hospital and surgical settings, this clinical foundation becomes even more important.
As we expand our commercial strategy, evolving alongside this shift into surgical and hospital markets, we are expanding our direct sales force, building relationships with surgeons, leveraging GPO contracts from the BioTissue acquisition to access the hospital systems, and using distributors to extend our reach in more rural areas. Hospitals are a more complex channel, but they're also significantly more scalable and defensible once you establish a presence in those facilities. One of the most important dynamics in our business today is the shift in our payer mix. Historically, in the advanced wound care and physician office segment, we've been more exposed to CMS reimbursement. As we expand to the hospital-based surgical procedures, we increase our exposure to commercial payers, which tend to offer a more stable reimbursement, better pricing dynamics, and broader coverage.
This shift improves the quality and durability of our revenue base and supports margin expansion over time. Our growth is driven by four primary levers. First, the expansion into surgical and hospital markets. Second, increasing physician adoption through clinical data and clinical use. Third, expanding reimbursement coverage into more commercial payer coverage. Fourth, executing on our product roadmap with our 510(k) Catalyze product in near term. The first lever, surgical expansion, is really the most important and near-term driver for our company. We have a vertically integrated manufacturing facilities that will support our growth and provide scalability, cost control, and a clear path to margin expansion as we internalize the BioTissue products.
We executed a 12-month continuing manufacturing agreement with BioTissue, but we look to move those products over to our facility as soon as we can to increase our gross margin and improve our profitability on the BioTissue products. None of this happens without amazing leadership, and we have assembled a management team with deep expertise across clinical research, commercial execution, manufacturing, regulatory, and finance. This is a team built not only to innovate, but also to operate and execute. From a financial perspective, the key theme is quality of growth. The BioTissue assets contribute a meaningful revenue and are less exposed to certain CMS dynamics, which supports a more diversified and resilient revenue base. We've also demonstrated a track record of positive adjusted EBITDA and cash flow, along with a strong balance sheet following the acquisition.
As we continue to scale into surgical and hospital channels, we see a clear path towards sustained growth and improving margins. The historical BioTissue business generated $29 million in surgical revenue in 2025. As we transition that, there will be a transitional period in the first half of 2026 on the physician office segment, as we mentioned in our Q1 call. As we broaden our institutional participation, we continue to execute on our road to an uplisting. We just recently completed our 2024 and 2025 audits from KPMG, and we'll continue to move forward on our uplisting strategy. Looking ahead, our focus is clear, scaling our presence in the surgical and hospital channels while continuing to build clinical evidence to support our adoption. In closing, I want to thank Needham and the Needham team for having us today.
BioStem is evolving from a wound-care-focused company into a broader regenerative medicine platform with meaningful exposure to surgical and hospital markets. With differentiated technology, strong clinical validation, and a scalable commercial model, we believe we are entering the next phase of growth, and we remain relentless pursuit of healing. With that, I want to open the floor for questions. Mike.
Yeah. Thanks, Jason. I do have a few questions, I guess. First, just on the acquisition, maybe can you just talk about what you've seen since you closed the deal in terms of integrating it between the two sales forces and distribution channels and whatnot?
Yeah. I think we've seen, so far, a very successful integration with the team. One of the great things is, prior to the acquisition of BioTissue, we had some really great management folks that were historically at BioTissue, kind of in its first inning of baseball. By having those folks at the management level, specifically Barry Hassett, Chief Commercial Officer, and then going out and bringing on Lita Lilly and Jim Elia, and those guys were historically BioTissue employees a long time ago, and then bringing them back into BioStem, really set us up for some good success early on. We are seeing some great retention, as well as growth, as we go forward.
Okay. Got it. What's sort of the outlook for the revenue mix by care setting post the deal? How much is in the outpatient and mobile setting versus the inpatient surgical setting?
Yeah. I would say historically, the $29 million that we referenced for previous year, all of that was in the hospital setting, in the OR setting, so non-physician office-based revenue. With the mix of where physician office is going from ASP plus 6% down to that $127 rate, we anticipate a higher concentration on the OR hospital side than the physician office side.
Okay. Is the office setting still financially viable with the new reimbursement, or are you completely moving away from that, or is that still going to be a meaningful part of the business going forward?
I think once we see some of the dynamics play out in the first half of 2026, we are still seeing a flood of product into the marketplace that was kind of a hangover from the end of last year. Once we anticipate seeing that flood of materials subside, these patients still need treatment, right? There's still chronic wounds that need to be treated, either in a mobile setting or a long-term care skilled nursing setting. I think ultimately, decisions are starting to be made more on clinical efficacy and clinical evidence versus price. We anticipate as we get to the back half of 2026 and into 2027 that there will be some continued adoption. We still feel strongly about our margins in that space as well. There's still very strong margins, even at the $127 reimbursement rate, for our products as well.
Okay. Got it. I guess in the surgical setting, can you maybe talk about the competitive landscape? Who are the primary competitors? Is it MiMedx and Organogenesis, or are there other bigger players there? I'd imagine it's not as crowded maybe as the office setting or outpatient setting. Is that fair?
Yeah. I think in the essence of crowdedness, where we're seeing maybe the moat is really around the GPO agreements and some of the value analysis committee acceptances of products. Those are essentially moats to keep some of the other competitors out of the space. What really attracted us to the BioTissue transaction was the fact that they had all these agreements in place. They've had successful, strong clinical evidence supporting their products for over 20+ years. They have a really good footing, one, that we are presenting the product into a value analysis committee at a new facility or hospital system. I think we do face the competitors that you mentioned in those sites of service, but I think we offer not only a differentiated technology with the CryoTek and SteriTek products, but also the BioRetain products as well.
Historically, we didn't have access into those sites of service with our BioRetain products, and now we have the opportunity to not only be a leader with the CryoTek and SteriTek technologies, but also bring in our BioRetain products for those specific use cases that historically we just didn't have an opportunity to sell on.
Okay. Just in terms of surgical applications, I know some of the other companies in the space have run trials looking at certain uses in orthopedics and things like that. Can you maybe talk about your clinical trial efforts and if there's any specific indications you're targeting with those?
Yeah. On the BioRetain side, we completed a diabetic foot ulcer trial. We just finished enrollment in our VLU study, our venous leg ulcer trial, and we're hoping to get some top-line results out here near-term. Those are kind of the two clinical trials that we've run and completed. We are looking at continuing to build our clinical evidence via use case and IRB support for a use case of products. Historically, BioTissue had several BLAs that they were running, one in orthopedics, one in spina bifida. We are looking at some of the, I'll call it, data around that, and if there's an opportunity for us to continue to work with BioTissue on some of those initiatives as well.
Okay. Just the financial question on the outlook from here, I know you may not have given specific guidance on this, but what's the outlook for margins, I guess both gross margin as well as operating margin and cash flow? Post the deal, do you expect to be profitable and cash flow positive, or do you still need to ramp the revenue further to kind of get to that point?
Yeah, I can touch on a high level, and then I can bring Brandon in. High level, our goal is to, as we guided in the Q4 Earnings Call, about $5 million-$6 million in Q1 in top-line revenue, which will require us to look to continue to grow that top-line revenue quarter-over-quarter, year-over-year. I'll hand it over to Brandon to kind of give you a little bit more detail on that side.
Yeah, Mike. I think to get back to profitability of that question, it's going to take a little more revenue growth there. As we said, the majority of the revenue is going to be in the hospital space, so that $5 million-$6 million, the majority of that's going to be in the hospital space, just with the changes on the CMS side, both in terms of just the pricing and then the volume challenges with some inventory being put out there in the space. It's going to take a little while for the transition period for the wound care and the physician office space to come back and make a meaningful contribution. I think it'll take a little bit more revenue there. From a margin perspective, we do think our margins will be down a little bit.
We've got a manufacturing supply agreement with BioTissue for the next year. That'll keep our margins, I think we've said probably kind of in the 60%+ range. We do think over time, we can get that back up to probably not the 90s that you've seen historically for the company, but somewhere in probably the 70s and maybe even the 80s over time. Something we're really focused on, but 2026 or the first half of the year will be a transition, and we'll see how we come out after a couple of quarters.
Okay, great. All right. Well, I don't see any questions from the viewers. I think we're going to have to wrap up there. Thanks, Jason, Brandon, for joining our conference. I hope you have some good one-on-one meetings. Thanks.
Thanks, Mike. Appreciate it.
Thanks, Mike. Appreciate it. Take care.