[角色] 你是一名拥有10年投资银行从业经验的资深研究分析师，专门负责上市公司、行业研究。你擅长解读公司财报、行业动态、宏观市场，发现潜在的投资机会和风险。 [任务] 你需要仔细研读一份上市公司或者行业研究的电话会议记录，请阅读全文，一步一步思考，总结全文列出关键要点，不要错过任何信息，包括： * 纪要涉及的行业或者公司 * 纪要提到的核心观点和论据 * 其他重要但是可能被忽略的内容 如果没有相关内容，请跳过这一部分，进行其他的部分。 总结时要全面、详细、尽可能覆盖全部的内容、不遗漏重点,并根据上述方面对内容进行分组。 要引用原文数字数据和百分比变化,注意单位换算(billion=十亿,million=百万,thousand=千)。 [注意事项] 1) 使用中文,不要出现句号 2) 采用markdown格式 3) 不使用第一人称,以"公司"、"行业"代替 4) 只输出关于公司和行业的内容 5) 在每一个关键点后用[序号]形式引用原文档id 6) 一个[序号]只应该包含一个数字，不能包含多个，如果多个就用[序号][序号]分开写，不要写成 [序号-序号] 7) 每个关键要点后边的 [序号] 不要超过 3 个 Content: --------- Biostem (OTCPK:BSEM) FY Conference September 10, 2025 03:20 PM ET Speaker1 Let's kick off. I'm Dennis Keller, Vice President with Morgan Stanley. Happy to be hosting BioStem Technologies with us today. Jason Matuszewski, CEO. Before we dive in, I just want to note for important disclosures, please see the Morgan Stanley Research Disclosure website, MorganStanley.com, Research Disclosures. If you have any questions, please reach out to your Morgan Stanley sales rep. With that, let's get started. Thanks for being here, Jason. With some investors maybe not up to speed on the company, can you spend the first minute or two just giving us a quick overview of the company and your core technology? Speaker0 Sure. First and foremost, thank you, Dennis, for having us here. I really appreciate the first opportunity to speak at the Morgan Stanley Global Healthcare Conference. Great opportunity. BioStem Technologies, we are a profitable medtech company focused in advanced wound care. Our core technology is BioREtain®. It's a proprietary technology that we process placental-based tissue allografts for the advanced wound care space, specifically looking at treating diabetic foot ulcers, pressure ulcers, and venous leg ulcers. This patient population is roughly about 7 million Medicare beneficiaries and a total market of about $11.3 billion in the advanced wound care space.</doc> <doc id='3'>Speaker1 Great. What is the BioREtain® process exactly, and how would you compare it to alternatives in the market? Speaker0 Yeah, I think, you know, it's definitely differentiated. We've published some real-world data so far on the BioREtain® process. We actually retain a large portion of the natural elements of the tissue, including the extracellular matrix, some of the growth factors and cytokines that are naturally found in placental-based tissue. As I mentioned earlier, our real-world data demonstrated that we, with the BioREtain® process, these allografts have supported a less number of applications to close a wound as well as less time to close a wound.</doc> <doc id='4'>Speaker1 Can you help us understand how you think about the addressable market today with the existing portfolio, and how that could expand over time as products get developed? Speaker0 Yeah, I think, you know, right now it's, call it the wound biologics TAM is roughly about$11.3 billion in the advanced wound care space. I think when we look at other areas of focus for BioStem, we're looking at areas like the hospital outpatient, surgical, OR suites, and things of that area where we could actually focus on leveraging our core technology of BioREtain® to those areas, as well as looking at synergistic M&A opportunities to target those areas as well. Speaker1 Help us understand the clinical data portfolio of the company, kind of key highlights from the clinical trial data set at this point. Speaker0 Yeah. Right now we're actively running three RCTs. We just finished enrollment in our first diabetic foot ulcer study, with roughly 72 patients enrolled across 10 sites. We're looking to report out data on that diabetic foot ulcer study later this year. We're also enrolling patients in two additional studies, one in the venous leg ulcer space, same number of sites, roughly about 10, and similar patient population size, about 60 patients. A secondary diabetic foot ulcer study on our AmnioWrap2â"¢, our BRAM trial, is just solely focusing on the amnion layer of the placenta. Similar size trial, roughly 60 patients across 10 sites. The last two trials we're aiming to get readouts kind of the mid to beginning of mid to next year on those two trials. Speaker1 Great. I guess pivoting to the partnership with Venture Medical, it's been a key driver for the business. Can you help us understand kind of just at a high level what the partnership brings and how we should think about the partnership on a go-forward basis? Speaker0 Yeah, I think the partnership has been instrumental in our growth. Definitely a story from, you know, 2022 to 2024. 2023 was roughly about $16.9 million top line revenue, 2024 over$300 million. We entered into that partnership with Venture Medical in late 2023. The partnership really represented both their recognition of our BioREtain® process and the product portfolio, and they really realized that this is a differentiated product line for the advanced wound care market. What we saw in Venture Medical is they've developed a software platform called OneView, and we felt that that was a really amazing platform to support providers not only from a compliance perspective, but also from a cash flow management perspective on managing where claims are and how to appropriately process those claims and really help and support those providers, especially when we're talking about their core focus in the mobile wound care segment as well as physician office segment. Those are areas where they're smaller groups, right? They're not institutionalized hospitals, large organizations where they have the infrastructure to support that cash flow management side of the business as well as the compliance side. I think it was a really good synergistic opportunity between both groups. We kicked off with over 100 FTEs into the field on day one. The opportunity to really scale very quickly with the commercial team on day one was a great opportunity. They came over from an existing product line as well, a placental-based tissue product line. It was a quick study for their reps and their team to get out and go to work, and that's kind of what's led to the success of late 2023 and into 2024 and what it is today. Speaker1 Excellent. As you think about your commercial strategy on a go-forward basis, what are the puts and takes relative to going direct versus your distribution channel? Speaker0 Yeah, I mean, I think, you know, obviously, which we haven't really got to yet is some of the headwinds around reimbursement and some of those struggles, or opportunities, I should say, coming forward. I think when we look at the model with Venture Medical and the opportunity that we've had in an exclusive partnership to really capitalize on the mobile wound care segment, physician office segment, you know, as we go into 2026, I think some things may change in regards to how we look at commercializing the product. You know, we are looking to internalize some of the commercial team on the core focus in hospital, OR, and into the federal space, so VADOD. I think the hybrid model where Venture has really demonstrated their knowledge and success in the mobile wound care segment will continue to leverage that partnership and continue to hopefully flourish. Speaker1 Now, a good segue to reimbursement. You've got proposed changes to CMS or PPS fee schedule, which were published in mid-July for skin substitutes. Some uncertainty around the final pricing for the products. What will the competitive landscape kind of look like moving forward? Can you share your perspectives on what these changes mean for you short term and maybe medium term from a market opportunity perspective? Speaker0 Yeah, sadly, we only have 27 minutes left. It's a long topic for sure. It's somewhat contested. There's a lot of changes potentially coming up. I think ultimately, I think these are good changes, right? I think this administration, along with leadership at CMS and HHS and even, frankly, even in the medical community, KOLs in the space like Dr. Bill Pettibuck and others have really kind of called out and said, "Look, there needs to be reform here." I think we have a runaway spend specifically utilizing the ASP plus six methodology that products are being priced at in the physician office and mobile wound care space, which aren't really tied to the payment structure that we find in HOPD and ASC, where it's a bucketed rate, right? This new OPPS and PFS, physician fee schedule, and outpatient physician fee schedule, are trying to align those things. We have a kind of continuous payment methodology for product across all sites of service. Looking at where we end up with specific placement reimbursement outside of product, it kind of gleans towards more of the traditional pass-through methodology that you've probably seen in the past. I think it's going to hopefully normalize this industry. I know wound care has been a struggle on ever-changing dynamics around reimbursement. I'm hopeful that ultimately we see a normalization past 2026. I am a little concerned about the low initial price that they propose, about $125. I think that ends up being a challenge for mobile wound care providers to service patients that have an underserved community or rural areas where they don't have access to get into a clinic and need that mobile wound care provider to get out to them and treat their wound.</doc> <doc id='14'>I'm hopeful that we see a price increase from that$125 number. We'll be actively commenting through the comment process. I think it ends on the 12th, so near term here. Hopeful to see what the outcome is in November as well on the final price for effective January 2026. Speaker1 As that process kind of moves forward, can you help us think through milestones such as clinical data and where you could have kind of more visibility for reimbursement that could come into effect at that time? Speaker0 Yeah, I mean, I think for us, we're in a new position, right? Because we do have clinical data coming out back half of this year. I think that will help substantiate our differentiation in the marketplace and say to folks, "Hey, we are a leader in this space, right? We're committed to this space. We're committed to investing in the clinical trial to demonstrate the purity of our product." I'm hopeful that driving that clinical data along with other initiatives creates more of a long-term initiative for our organization. Speaker1 Great. I guess pivoting to the business in the first half of 2025, you reported $121.8 million in revenue, which is up 5$10.3 billion. It's a very large market. We delivered just over $300 million last year, so somewhat small and diminished, I guess, in the overall market opportunity. I think, like I said, we'll see how things suss out, you know, moving forward from 2026 and how that changes not only the TAM, but also, you know, who's left and who's interested in being a long-term player in this space. We'll continue to try to drive the BioREtain® message and, as I alluded to, getting into the hospital and things of that nature hopefully drives that as well. Speaker1 I guess if you look at it slightly differently, how many relevant accounts are out there, and how do you expect to kind of incrementally penetrate those accounts over time, recognizing the backdrop? Speaker0 I think ultimately, as I kind of alluded to, there's roughly about 7 million Medicare patients out there with a chronic wound. That number is growing exponentially as well. The problem isn't going away. I think when we look at how many patients we ultimately are not currently addressing right now just due to the market dynamics of high ASP products and other things, I think there's still a decent amount of market opportunity in the mobile wound care physician