核心观点 - 公司公布2025年第三季度财务业绩，尽管营收同比下降，但连续第七个季度实现调整后EBITDA盈利，并取得多项临床、监管和战略进展 [3][5][9] 财务业绩 - 第三季度净营收为1050万美元，同比下降43%，主要原因是报销政策不确定性和竞争加剧导致伤口护理产品销量下降 [7] - 毛利润为930万美元，毛利率为88.5%，高于去年同期的77.0%，反映出产品组合向不含许可费的产品转移 [7] - 营业费用为780万美元，高于去年同期的490万美元，主要由于临床试验活动增加和为未来增长进行的基础设施投资 [8] - GAAP净收入为80万美元，每股收益0.05美元，去年同期为680万美元，每股收益0.42美元 [8] - 调整后EBITDA为270万美元，去年同期为1040万美元，下降反映了营收和毛利润降低以及营业费用增加 [8] - 截至2025年9月30日，现金及现金等价物总计2720万美元 [10] 临床与监管进展 - BioREtain®同种异体移植物治疗糖尿病足溃疡的随机对照试验取得积极顶线结果，证明具有优越疗效，结果已发表于《国际组织修复杂志》并提交给CMS考虑纳入地方覆盖决定 [9] - BioREtain静脉性腿部溃疡随机对照试验的受试者入组进度超前，支持在2026年第一季度公布顶线结果的进展 [9] - 公司解决了FDA在2023年检查中指出的所有问题及相关483表缺陷，本季度FDA进行的新的361检查顺利完成，无不符合项、评论或观察意见 [9] 战略扩张与合作伙伴关系 - 公司与一家残疾退伍军人所有的小企业建立合作伙伴关系，通过在美国退伍军人事务部推出American Amnion产品，于第四季度进入VA市场 [9] - 公司在佛罗里达大西洋大学研究园购置土地，用于建设未来总部 [9] - 公司任命毕马威会计师事务所为其独立注册公共会计师事务所 [9] - 公司根据美国GAAP会计准则报告了重述后的财务报表，反映了对其向商业合作伙伴Venture Medical支付的真实服务费的会计处理调整 [9]

公司财务重述 - BioStem Technologies公司宣布已完成并提交了重述后的财务报表，涵盖期间包括2023年和2024年的年度财报，以及2024年第一季度至2025年第二季度的中期财报 [3] - 此次财务重述是公司全面审查美国公认会计原则收入确认准则并与外部技术会计顾问协商后的结果，旨在更准确地处理与Venture Medical的分销协议 [4] - 重述后的财务报表调整了对Venture Medical分销协议相关真实服务费的会计处理和报告方式，此项变更对利润表和资产负债表均产生影响 [4] 会计处理变更细节 - 此前，真实服务费在合并利润表中被记录为销售和营销费用；在重述后及自2025年第三季度起，这些费用被重新分类为收入抵减项，即作为总收入的减项以得出净收入 [5] - 此项会计变更降低了报告的收入和销售与营销费用，降低金额相同，因此对税息折旧及摊销前利润、净利润或现金流没有影响 [5] - 由于收入现在按净额报告，基于百分比的指标如毛利率和EBITDA利润率将略有不同 [5] - 在资产负债表上，公司应付给Venture的真实服务费此前显示为独立的流动负债；现在，这些款项与Venture应付的应收账款进行抵销，有效抵消了两家公司之间的应付金额 [6] 重述目的与公司展望 - 公司管理层强调，业务的基本面未受影响，公司继续向市场提供经过临床验证的伤口护理产品 [7] - 重述财务报表是公司迈向升级上市的重要一步，公司对未来的发展前景感到兴奋，并将继续加强财务、运营和临床基础 [7] - 此次重述尚待公司新任命的外部审计机构毕马威完成独立审计，公司预计2024财年和2025财年的独立审计将在2026年第一季度末前完成 [8] - 公司致力于通过领先的毛利率和严谨的成本结构实现持续盈利，并在业务扩展中产生强劲现金流 [7]

核心观点 - 美国医疗保险和医疗补助服务中心针对皮肤替代物发布了2026年最终版医生付费标准 公司认为该规则是迈向更透明、可预测和可持续报销体系的决定性一步 尽管报销水平低于公司最初主张 但此框架为更健康、证据驱动的市场奠定了基础 [1][2] - 公司强调其BioREtain处理的胎盘同种异体移植物与CMS的改革目标高度一致 并预计在新的报销模式下 凭借其临床优势、垂直整合的制造和高效的成本结构 公司产品利润率将保持强劲 且能有效竞争 [2][3][4] 行业政策环境 - CMS的2026年最终版医生付费标准改革了医疗保险对皮肤替代物的报销方式 新的报销模型反映了CMS恢复市场平衡和奖励临床绩效而非价格差异的意图 [1][2] 公司产品与临床优势 - 公司的BioREtain处理的胎盘同种异体移植物与CMS改革目标一致 其发表的1级随机对照试验证明相较于标准护理 患者预后更优 该研究已提交给CMS以支持覆盖决策 [2] - 公司的产品组合包括AmnioWrap2™、VENDAJE、VENDAJE AC和VENDAJE OPTIC等品牌 [5] 公司运营与成本结构 - 公司拥有专有的BioREtain制造工艺和垂直整合的制造能力 这使其销售成本显著降低 并具备可扩展的生产能力 [3] - 公司位于佛罗里达州庞帕诺比奇的制造基地经FDA注册和AATB认证 其质量管理体系符合现行良好组织规范和现行良好生产规范 [5] 公司战略与展望 - 公司预计CMS的改革将加速医疗服务提供者采用像BioREtain这样能带来经证实疗效和经济价值的技术 [4] - 公司继续与临床合作伙伴、政策制定者和倡导组织合作 以确保不断发展的报销框架支持创新、财政责任和最佳患者护理 [4]

财务报告与电话会议安排 - 公司将于2025年11月13日发布2025年第三季度财务业绩 [1] - 业绩发布后将于美东时间下午4:30举行电话会议和网络直播 [1] - 电话会议将由首席执行官Jason Matuszewski和首席财务官Brandon Poe主持 [2] 公司业务与产品组合 - 公司是一家专注于开发、制造和商业化用于先进伤口护理的胎盘来源产品的领先医疗技术公司 [1] - 核心业务是利用围产期组织的天然特性开发用于再生疗法的同种异体移植物 [3] - 公司拥有专有的BioREtain加工方法，旨在维持生长因子并保留组织结构 [3] - 产品组合包括AmnioWrap2™、VENDAJE、VENDAJE AC和VENDAJE OPTIC等品牌 [3] 质量体系与生产设施 - 公司的质量管理体系和标准操作程序已获得美国组织银行协会的认证 [3] - 相关体系符合现行良好组织规范（cGTP）和现行良好生产规范（cGMP） [3] - 所有胎盘同种异体移植物均在位于佛罗里达州庞帕诺比奇的FDA注册且AATB认证的工厂进行加工 [3]

审计师变更 - 公司审计委员会已批准任命毕马威会计师事务所为公司新的独立注册公共会计师事务所，自2025年10月22日起生效，并结束了与前任审计机构Marcum LLP的合作 [1] - 此次更换审计师的决定是基于对公司长期增长计划和资本市场战略的全面考量，旨在支持公司计划中的纳斯达克升级 [2] - 在解聘Marcum LLP前的最近两个财年及后续任何中期期间，公司与Marcum LLP在会计原则、财务报表披露、审计范围或程序方面均无分歧 [2] 纳斯达克升级计划 - 公司在完成2024年和2025年全年审计后，计划推进其在纳斯达克资本市场的升级上市 [3] - 公司管理层认为升级上市将提升公司知名度、改善股票流动性、提供精确的市场估值，并增强公司吸引顶尖人才的能力 [4] - 升级上市是公司的一项关键优先事项，公司正为此构建坚实的基础 [4] 公司业务与产品 - BioStem Technologies是一家领先的医疗技术公司，专注于开发、制造和商业化用于先进伤口护理的胎盘来源产品 [1][4] - 公司利用其专有的BioREtain加工方法制造产品，该方法应用再生医学的最新研究，旨在维持生长因子并保存组织结构 [4] - 公司的产品组合包括AmnioWrap2™、VENDAJE、VENDAJE AC和VENDAJE OPTIC等品牌，所有胎盘同种异体移植物均在位于佛罗里达州庞帕诺比奇的、经FDA注册和AATB认证的工厂进行加工 [4]

合作项目核心内容 - BioStem Technologies成为佛罗里达美洲豹队“Heroes Among Us”项目的新赞助合作伙伴，该合作将持续整个2025-26年北美冰球联赛赛季[1] - 该项目在每个主场比赛中表彰一位军事英雄，通过国歌献礼和记分板视频展示其故事[2] - 公司同时继续赞助“Seats for Service”计划，该计划为退伍军人及其家人提供比赛门票、停车通行证和50美元的餐饮信用，旨在创造有意义的比赛日体验[2][4] - “Seats for Service”合作始于2024-25赛季，截至目前已支持125个座位[4] 公司战略与背景 - 此次赞助是公司对军人牺牲精神持续认可的延伸，其联合创始人Andrew Van Vurst是美国海军陆战队退伍军人[2] - 合作项目与公司即将推出的American Amnion产品线发布相契合，该品牌致力于推进军事社区的伤口护理[2] - BioStem Technologies是一家专注于开发、制造和商业化胎盘来源产品的领先医疗技术公司，其产品用于高级伤口护理[1][8] - 公司利用其专有的BioREtain®加工方法制造产品，该方法旨在维持生长因子并保存组织结构[8] 项目历史与影响 - “Heroes Among Us”项目自2013年创建以来，已在美洲豹队主场比赛中表彰超过500名当地退伍军人和现役军人[1][2] - 受表彰的军人包括超过125名二战老兵、50名越南战争老兵和20名朝鲜战争老兵等[2] - 该项目被描述为比赛中最具影响力的环节之一，为球迷和社区提供了每晚感谢这些英雄的机会[3]

[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: --------- <doc id='1'>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?</doc> <doc id='2'>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.</doc> <doc id='5'>Speaker1 Help us understand the clinical data portfolio of the company, kind of key highlights from the clinical trial data set at this point.</doc> <doc id='6'>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.</doc> <doc id='7'>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.</doc> <doc id='8'>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.</doc> <doc id='9'>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.</doc> <doc id='10'>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.</doc> <doc id='11'>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</doc> <doc id='12'>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.</doc> <doc id='13'>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.</doc> <doc id='15'>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.</doc> <doc id='16'>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% year on year. Can you break down kind of the growth drivers in terms of expanding accounts, driving higher utilization with your existing users? Speaker0 Yeah, a combination of both. I think we saw some good utilization within the existing accounts. Frankly, looking to expand into areas geographically, you know, Venture Medical is kind of core to the West Coast, west of the Mississippi. We're looking to target some of the east marketplace for these products. Really trying to partner with more sophisticated long-term partnership as we bridge from this ASP plus six methodology into the new methodology and really looking for mobile wound care providers, specifically on the Venture side, as well as physician office folks that want to be here long term. It would be great partners that really value the technology and value how BioREtain® supports their patients in closing wounds. We're looking forward to seeing where that growth goes and continues to grow.</doc> <doc id='17'>I think there's other opportunities for us, specifically from a growth driver perspective, that come where maybe M&A opportunities come along or other areas to diversify into other segments, like I alluded to earlier in the hospital outpatient and the OR space.</doc> <doc id='18'>Speaker1 If you think about your current product suite and some of the selling points that are most attractive to the clinical community, could you walk through some of those? Speaker0 Sorry, can you ask? Speaker1</doc> <doc id='19'>Yeah, some of the selling points of the products that are most attractive to the clinical community.</doc> <doc id='20'>Speaker0 Yeah, I mean, obviously the BioREtain® process is definitely very attractive to them. I think what they've seen, at least initially on the real-world data, like I kind of alluded to earlier about less number of applications and quicker time to heal on very hard-to-heal wounds, that's very attractive to providers that really want to utilize a product that's going to get some of these hard-to-heal wounds. I think even frankly, you know, it's great to hear testimonials from providers that say, "Hey, I've been using a synthetic product or another competitor product. I've been trying to treat this patient. You know, we're going on 12 months, 18 months. We still have not gotten this wound closed. And we were able to use your product in three or four applications to get the wound closed, right?" It's extremely satisfying and gratifying in a way, right, to hear that.</doc> <doc id='21'>Yeah, it's kind of cool.</doc> <doc id='22'>Speaker1 Yeah, it seems like if you had those kind of referenceable proof points, you'd use those with the next center and kind of get the keeps giving.</doc> <doc id='23'>Speaker0 Yeah, and I think I hope, you know, going forward, at least, you know, with the readout of the RCT, that will also be more of a validating point, right? Some of these real-world data sets or real-world data patients aren't as compliant as when you're running a clinical trial, right? Getting a patient to be compliant is some of the biggest challenge in wound care, right? Getting a patient to come in, offload, do some of the things that are necessary for a proper blood flow and making sure that they're not continuing to propagate a wound. When you're in a more rigorous clinical trial, it's a lot easier to kind of hold some of those variables a little closer.</doc> <doc id='24'>Speaker1 even for the diabetic foot ulcer and the venous leg ulcers? Speaker0 Yeah, absolutely. Absolutely.</doc> <doc id='25'>Speaker1 Interesting. I guess stepping back, can you help us think through the growth trajectory over the next few years? Speaker0 Yeah.</doc> <doc id='26'>Speaker1 As a company? Speaker0 I think obviously going into 2026, we'll kind of have a reset based on the framework of reimbursement. I think that will also lend itself to really get some clarity around what does growth look like over the next four to six years. I think for us, we'll continue to kind of drive adoption of our existing BioREtain® platform in the mobile wound care space, hospital outpatient space, look to start getting involved onto GPO agreements, IDN agreements into the hospital setting, and look at other sites of service within, or frankly, call points within the hospital system, not so focused in chronic wound, but more gravitating to some of the acute wound space as well. I think there's a lot of M&A opportunities within this space as well.</doc> <doc id='27'>I think values are suppressed and some really nice targets that will kind of expand what I always say is the continuum of care, areas where we don't have a product that touches a patient across that value stream, and</doc> <doc id='28'>where we are currently kind of at the end of that continuum of care where all these other products didn't work on that patient and were a product of last resort. It'd be great to have an opportunity to expand our product portfolio and be able to service a patient on day one and hopefully on day wound closure.</doc> <doc id='29'>Speaker1 Really exciting. How would you evaluate where you are at from a market share perspective now, and then where you expect that to go over time? Speaker0 Yeah, no, it's a great question. I mean, as I kind of alluded to, it's $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.</doc> <doc id='30'>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

**Biostem Technologies (OTCPK:BSEM) FY 会议纪要** **公司及行业** * 公司为 BioStem Technologies 专注于开发先进伤口愈合技术 其核心市场为价值 113 亿美元的先进伤口护理市场 其中 85 亿美元属于伤口生物制剂细分市场[2] * 行业涉及先进伤口护理 特别是基于胎盘和围产期组织的生物产品 用于治疗慢性不愈合伤口[2][3] **核心产品与技术** * 公司拥有专有技术平台 BioREtain® 并拥有约 55 项已授权专利和 53 项待批专利[3] * 目前拥有 5 款商业化产品 包括 VENDAJE AC® VENDAJE® 和 AmnioWrap2™ 主要针对糖尿病足溃疡(DFU) 静脉性腿部溃疡(VLU) 和压力性溃疡(PU)[3][11] * BioREtain® 技术经真实世界数据验证 可比竞品减少约 25% 的敷料使用次数（约 8 次 vs 竞品约 10.5-11 次）并缩短治疗天数[6] * 该技术能保留更多关键生长因子 如 IL-1RA PDGF-β 透明质酸和胶原蛋白 其浓度比竞品高数个数量级[7] **市场机会与患者群体** * 核心目标市场（TAM）超过 70 万 Medicare 慢性不愈合伤口患者 其中压力性溃疡(PU)占 41% 糖尿病足溃疡(DFU)占 30% 静脉性腿部溃疡(VLU)占 11%[4] * 预计到 2030 年 患有慢性不愈合伤口的 Medicare 受益人数将增加约 20%[5] * 治疗场所有私人诊所 移动医疗 门诊手术中心(ASC) 医院门诊(HOPD) 和退伍军人事务部(VA) 公司当前聚焦私人诊所和移动医疗 并计划向 ASC HOPD 和 VA 扩展[5][16] **财务表现** * 2024 年实现营收略超 3 亿美元 调整后 EBITDA 为 3900 万美元[4] * 截至 2025 年 6 月 30 日 持有现金 3080 万美元[21] * 产品毛利率保持在 90% 的中高水平 销售和营销费用占销售额的 73% 至 80%[20] * 连续多个季度实现正 EBITDA 并预计此趋势将持续至年底及明年[20][23] **临床开发** * 正在积极进行两项 DFU 和一项 VLU 的临床试验 产品与标准护理对照[8] * 首项 DFU 研究已完成招募 共 71 名患者 涉及 10 个中心 预计 2025 年底公布结果（主要终点为 12 周内伤口完全闭合）[8] * VLU 研究正在招募中 预计 2026 年 Q1 读出结果 另一项 DFU 研究（VENDAJE®）也预计在 2026 年 Q1 读出结果[8] **制造与运营** * 拥有一个 6100 平方英尺的可扩展生产设施 位于佛罗里达州 月产能超过 3 万平方厘米[3][11] * 具备 OEM 产品制造能力[3] * 正扩大产能 新设了拥有 8 个生物安全柜(BSCs)的洁净室套间以满足预期需求[11] **商业合作与分销** * 与 Venture Medical 拥有独家分销合作关系 利用其超过 150 名现场代表覆盖美国市场 专注于医师诊所和移动伤口护理领域[3][18] * 该合作被视作关键增长驱动 帮助公司营收从 2023 年的不足 1600 万美元增长至 2024 年的超过 3 亿美元[19] * 分工明确 Venture Medical 负责销售 报销物流和账单支持 BioStem 负责产品开发 生产 临床试验和政府关系[18] **报销环境与监管** * 产品通过 1271-361 组织移植途径商业化 无需像 BLA 或 351 途径那样进行严格的临床试验[12] * 当前报销环境面临挑战 不同场所报销率不同（医院门诊约 1780 美元 门诊手术中心约 860 美元 医师办公室/移动医疗为 ASP + 6）[13] * 预计 2026 年将转向跨所有服务场所的统一费率报销（提案中约为每平方厘米 125 美元）[13][14] * 公司正在积极游说 期望最终定价能维持在每平方厘米 400 至 700 美元的范围 并认为统一费率将有利于拥有临床数据和研发能力的公司 淘汰机会主义者[14] **战略重点与增长计划** * 扩大商业团队 包括与 Venture Medical 合作以及建立直销团队 重点拓展联邦系统和 VA 市场[15][16] * 计划在 2026 年初建立医院市场 presence[16] * 寻求通过 GPO（集团采购组织）和 IDN（综合交付网络）协议扩大患者可及性[16] * 产品组合创新 探索 BioREtain® 技术在其他围产期组织类型和适应症的应用 并寻求战略收购（专利 替代生物技术 先进伤口护理设备等）[17] * 推出针对 VA 领域的新品牌 American Amnion[11][23] * 目标是从 continuum of care 的末端治疗扩展到患者就诊初期即开始使用其产品[17] **管理团队** * 新任命 Brandon Poe 为首席财务官（CFO） 其曾在 MIDI Health 和 Lumina 担任财务职务[21] * 新引入 Barry Hassett 负责营销 其曾是在眼科领域使用羊膜组织的领先企业 BioTissue 的市场负责人[22] **风险与机遇** * 报销政策的变化（2026年）是主要外部因素 可能影响定价和商业模式 但公司视其为规范化并扩大市场渗透的机遇[14][15][22] * 慢性伤口患者数量庞大且在不断增长 是持续的市场驱动因素[4][5][22] * 临床数据的读出（2025年底及2026年）是验证产品优势和推动 adoption 的关键[8][23]

公司动态 - 公司管理层将在纽约举行的摩根士丹利全球医疗保健会议和H C Wainwright第27届全球投资会议上进行演讲[1] - 演讲形式包括炉边谈话和演示 分别定于2025年9月8日下午3:20 ET和2025年9月9日上午11:00 ET举行[5] 业务信息获取渠道 - 可通过公司网站投资者关系板块ir biostemtechnologies com获取演讲的实时和存档网络直播[2] - 可通过公司官网注册邮件分发列表及关注X和LinkedIn社交媒体账号跟踪公司最新发展[3] 公司业务概况 - 公司是一家专注于开发、制造和商业化胎盘来源生物制剂用于先进伤口护理的领先MedTech公司[1] - 公司利用专有BioREtain加工方法开发围产期组织同种异体移植物用于再生疗法 该方法专注于维持生长因子和保护组织结构[4] - 公司质量管理体系和生产流程已获得美国组织银行协会认证 并符合现行良好组织规范和生产规范[4] - 产品组合包括AmnioWrap2™、VENDAJE、VENDAJE AC和VENDAJE OPTIC等品牌[4] - 所有胎盘同种异体移植物均在佛罗里达州Pompano Beach经FDA注册和AATB认证的设施中加工[4]

公司内部交易 - 公司董事长兼首席执行官Jason Matuszewski于2025年8月19日以约10万美元购入15,500股普通股[1][2] - 交易分两笔完成：2,500股均价6.28美元及13,000股均价6.51美元[2] - 交易后该高管持股总数达1,145,362股[2] 公司业务定位 - 公司专注于开发、制造及商业化胎盘来源的先进伤口护理产品[1][3] - 核心专利技术BioREtain处理法可保持生长因子活性并保护组织结构[3] - 生产设施获FDA注册及美国组织银行协会(AATB)认证[3] 产品与资质体系 - 产品组合包括AmnioWrap2™、VENDAJE系列等胎盘同种异体移植物[3] - 质量管理体系符合cGTP（现行良好组织规范）和cGMP（现行良好生产规范）标准[3] - 所有产品均在佛罗里达州波姆庞帕海滩的AATB认证工厂完成处理[3]