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Biostem (OTCPK:BSEM) FY Conference Transcript
2025-09-10 20:22
[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 (OTCPK:BSEM) FY Conference Transcript
2025-09-09 16:02
**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]
BioStem Showcasing its Leading BioREtain® Technology at the Symposium for Advanced Wound Care (SAWC) Fall Meeting
Globenewswire· 2025-09-05 16:19
公司动态 - BioStem Technologies与商业合作伙伴Venture Medical LLC共同参展 重点展示慢性伤口护理管理的协同创新价值[1][2] - 公司核心产品AmnioWrap2®和Vendaje AC®通过Venture Medical独家提供 结合Venture OneView™平台优化护理服务流程[3] - 展会设置专门时段供参会者与关键利益相关方交流慢性伤口护理的最佳实践方案[3] 技术展示 - 公司展示三篇临床与科研海报 涉及胎盘移植物处理技术的真实世界数据对比[5][6][10] - BioREtain®专利处理技术保留天然组织特性 采用六步温和处理法维持羊膜组织完整性[7][8] - 技术对比研究包括胎盘组织移植物处理方法比较及脱水出生组织灭菌方法评估[10] 活动安排 - 周六早间7:30(太平洋时间)举办专题早餐研讨会 主题为"伤口护理未来导航"[4] - 周五下午1:00-2:00举办伤口护理误区解析专题会议[9] - 周六中午12:30-1:30举办移动伤口护理实践准则专题讨论[9] 公司背景 - BioStem专注于围产期组织同种移植物开发 采用FDA注册和AATB认证的佛罗里达生产基地[11] - 产品组合包括AmnioWrap™、VENDAJE系列 质量管理体系符合cGTP和cGMP标准[11] - Venture Medical拥有15年伤口护理领域经验 是美国领先的生物制剂分销与数字解决方案提供商[13] 数据披露 - 临床研究包含真实世界压疮数据对比分析[6] - 科学研究展示BioREtain®处理技术与竞品的直接对比结果[7][10]
BioStem Technologies Appoints Brandon Poe as Chief Financial Officer
GlobeNewswire News Room· 2025-08-14 20:01
高管任命 - 公司任命Brandon Poe为首席财务官 原首席财务官Michael Fortunato转任首席会计官[1] - Brandon Poe自2022年起担任公司董事 拥有超过25年医疗保健和生命科学领域财务领导经验[1][2] 高管背景 - Brandon Poe曾担任私营数字女性医疗公司Midi Health首席财务官 及私营生命科学公司Jumpcode Genomics首席财务官[2] - 更早曾在上市公司Illumina工作8年 担任产品开发研究和全球运营财务副总裁等高级财务职位[2] - 拥有巴克内尔大学本科学位和芝加哥大学布斯商学院MBA学位[2] 战略发展 - 公司正处于增长和创新关键时期 计划拓展新市场并推进纳斯达克上市[2] - 公司拥有BioREtain®胎盘处理技术平台 具备可扩展制造能力和不断扩大的临床证据[3] - 产品组合包括AmnioWrap2™、VENDAJE®、VENDAJE AC®和VENDAJE OPTIC®等品牌[3] 公司资质 - 质量管理体系和标准操作程序获得美国组织银行协会认证 符合现行良好组织规范和良好生产规范[3] - 所有胎盘同种异体移植物均在FDA注册且AATB认证的佛罗里达州Pompano Beach工厂处理[3]
BioStem Technologies to Host Second Quarter 2025 Financial Results Conference Call on August 14, 2025
Prism Media Wire· 2025-07-30 11:00
公司财务披露安排 - 公司将于2025年8月14日发布2025年第二季度财务业绩 并在美东时间下午4:30召开电话会议和网络直播 [3] - 电话会议将回顾第二季度业绩 并更新公司Form 10文件申报和纳斯达克升级计划 [4] 公司业务概况 - 公司是专注于围产期组织技术开发的领先医疗技术企业 主要开发和商业化先进伤口护理同种异体移植物 [6] - 公司采用专有BioREtain®加工技术 该技术基于先进伤口护理最新研究 专注于维持生长因子和保护组织结构 [6] - 公司质量管理体系获得美国组织银行协会(AATB)认证 符合cGTP和cGMP标准 [7] - 产品组合包括AmnioWrap2™、VENDAJE®系列和American Amnion™系列等品牌 [7] - 所有胎盘同种移植物均在佛罗里达州Pompano Beach的FDA注册和AATB认证设施中处理 [7] 投资者关系 - 投资者可通过公司电子邮件分发列表、X和LinkedIn平台关注最新发展动态 [5] - 投资者关系联系人为Adam Holdsworth 电话917-497-9287 [11] - 同时可通过Gilmartin Group的Philip Trip Taylor联系 电话415-937-5406 [11]
Ernst & Young LLP (EY US) Announces Jason Matuszewski, CEO of BioStem Technologies, as an Entrepreneur Of The Year® 2025 Florida Award Winner
Globenewswire· 2025-06-17 12:59
文章核心观点 - 安永宣布BioStem Technologies首席执行官兼董事长Jason Matuszewski荣获2025年佛罗里达年度企业家奖,他有资格角逐全国奖,该奖项旨在表彰企业家和高增长公司领导者 [1][4] 奖项相关 - 年度企业家奖是针对企业家和高增长公司领导者的卓越竞赛奖项,40年来安永一直表彰改变行业、影响社区和创造长期价值的企业家 [1] - 该奖项由安永创立和制作,包括主赞助商PNC Bank、Cresa、LLC、Marsh USA和SAP [6][7] - 1986年创立,已表彰超1.1万名美国成功企业领导者,现扩展到全球近60个国家 [8] - 美国项目包括17个地区项目,6月独立评委选出地区获奖者,11月在战略增长论坛上宣布全国决赛入围者和获奖者,全国总冠军代表美国参加世界年度企业家竞赛 [9] 获奖者情况 - Jason Matuszewski由往届获奖者、顶级首席执行官、私募股权和风险投资投资者及商业领袖组成的独立评审团选出,评委根据长期价值创造、创业精神、目标驱动承诺以及显著增长和影响评估候选人 [2] - 他表示该奖项反映了BioStem团队的不懈努力,团队工作以创新为基础,致力于改善慢性难愈伤口患者生活,尤其感谢联合创始人兼首席运营官Andrew VanVurst的运营领导 [3] - 作为佛罗里达奖获得者,他有资格角逐2025年年度企业家全国奖,全国奖获奖者将于11月宣布,全国总冠军将于2026年6月角逐世界年度企业家奖 [4] BioStem Technologies公司情况 - 总部位于佛罗里达州庞帕诺比奇,是一家领先的医疗技术公司,致力于改善慢性难愈伤口患者生活 [3] - 公司使用专有BioREtain®技术开发和制造胎盘源同种异体移植物,旨在保留组织天然特性并优化临床结果,其不断扩大的产品组合被全国各地临床医生使用 [3] - 公司质量管理体系和标准操作程序获得美国组织库协会认证,遵守良好组织实践和良好生产规范,产品组合包括AmnioWrap2™、VENDAJE等品牌,每个胎盘同种异体移植物都在佛罗里达的FDA注册和AATB认证地点处理 [15] 其他 - 可注册BioStem公司的电子邮件分发列表并在X和LinkedIn上关注该公司以了解最新动态 [13] - 提供BioStem公司联系方式,包括电话、网站、电子邮件等,投资者关系联系人为Adam Holdsworth [17]
BioStem Technologies Provides Update on the Company’s Form 10 Submission and SEC Review Process
Globenewswire· 2025-06-03 11:00
公司进展 - 公司预计在2025年6月底前提交修订后的10号表格 包括2023年和2024年财年经审计财务报表以及2025年第一季度未经审计结果 [2] - 公司已于2024年9月首次提交10号表格 并与审计师及SEC密切合作解决收入会计处理问题 涉及最终用户产品销售及向Venture Medical支付的真实服务费 [3] - 公司已提交纳斯达克首次上市申请 转板取决于10号表格生效及满足其他纳斯达克上市要求 [3] 管理层表态 - 公司CEO对进展表示鼓舞 正与SEC积极合作完成审核最终阶段 并对前景表示乐观 [4] - 公司感谢审计师 法律顾问及团队的努力 并赞赏股东的耐心与支持 [4] 业务概况 - 公司专注于开发 制造和商业化胎盘来源产品的先进伤口护理领域 [1] - 采用专有BioREtain®加工方法 专注于维持生长因子和保存组织结构 [6] - 质量管理体系获得美国组织银行协会认证 并遵循cGTP和cGMP标准 [7] - 产品组合包括AmnioWrap2™ VENDAJE VENDAJE AC VENDAJE OPTIC American Amnion和American Amnion AC等品牌 [7] - 所有胎盘同种移植物均在FDA注册和AATB认证的佛罗里达州Pompano Beach工厂处理 [7]
BioStem Technologies to Participate in the Goldman Sachs 46th Annual Global Healthcare Conference
Globenewswire· 2025-05-29 11:00
文章核心观点 BioStem Technologies公司将参加在迈阿密举行的高盛第46届年度全球医疗保健会议 [1] 会议相关信息 - 公司CEO Jason Matuszewski将参加炉边谈话并可进行一对一会议 [2] - 会议参会者若想安排会议可联系公司副总裁Noah Agron,邮箱为nagron@biostemtech.com [2] 公司信息获取途径 - 可注册公司邮件分发列表、关注X和LinkedIn获取公司最新动态 [3] - 可访问公司网站biostemtechnologies.com并关注X和LinkedIn获取更多信息 [5] 公司简介 - 公司是一家领先的医疗科技公司,专注于围产期组织天然特性开发、制造和商业化同种异体移植物 [4] - 公司利用专有BioREtain®处理方法制造产品,该方法基于先进伤口护理最新研究,旨在维持生长因子和保留组织结构 [4] - 公司质量管理体系和标准操作程序经美国组织库协会审核认证,按现行良好组织实践和现行良好制造规范建立 [4] - 公司优质品牌组合包括AmnioWrap2™、VENDAJE、VENDAJE AC和VENDAJE OPTIC [4] - 公司胎盘同种异体移植物在佛罗里达州庞帕诺比奇的FDA注册和AATB认证工厂加工 [4] 公司联系方式 - 电话954 - 380 - 8342,网站http://www.biostemtechnologies.com,邮箱info@biostemtech.com,X账号@BSEM_Tech,Facebook账号BioStemTechnologies [6] - 投资者关系联系人为Adam Holdsworth,邮箱adam@biostemtech.com,电话917 - 497 - 9287 [6]
BioStem Announces Notice of Allowance for Three New U.S. Patent Applications
Globenewswire· 2025-05-28 11:00
文章核心观点 - 生物干细胞技术公司宣布美国专利商标局已批准三项专利 这将强化公司在伤口护理创新方面的承诺 推动下一代胎盘同种异体移植技术发展 [1][4] 公司专利情况 - 美国专利商标局已批准两项设计专利和一项实用专利 涉及公司使用BioREtain®工艺制造的新型开窗人胎盘同种异体移植物设计和组合物 [1] - 两项设计专利分别为“开窗人胎盘同种异体移植物”的设计专利申请No. 29/860,417和No. 29/860,420 其独特设计可让伤口渗出液穿过移植物 促进引流 利于伤口愈合 [2] - 一项实用专利为“具有多个狭缝 开口和/或开窗的无菌人胎盘同种异体移植物”的专利申请No. 18/926,867 其独特开窗设计可让伤口渗出液穿过移植物 制备方法能保留羊膜和绒毛膜组织的结构和分子完整性 有助于治疗糖尿病足溃疡等伤口 [3] 公司发展战略 - 公司积极扩大专利组合 以加速产品创新 推动新产品开发 提升伤口护理标准 [4] 公司简介 - 生物干细胞技术公司是一家领先的医疗科技公司 专注于利用围产期组织的天然特性开发 制造和商业化同种异体移植物 其产品组合包括AmnioWrap2™等品牌 [6] - 公司采用专有的BioREtain®处理方法 质量管理体系和标准操作程序已获美国组织库协会认证 产品在佛罗里达州庞帕诺比奇的FDA注册和AATB认可的工厂加工 [6] 联系方式 - 公司联系电话954 - 380 - 8342 网站http://www.biostemtechnologies.com 邮箱info@biostemtech.com [10] - 投资者关系联系人为Adam Holdsworth 邮箱adam@biostemtech.com 电话917 - 497 - 9287 [10]