Fractyl Health said its experimental outpatient procedure helped preserve weight loss after discontinuation of a GLP-1 drug, sending the company's shares 23% higher in premarket trading on Friday. ...

新华财经伦敦9月24日电（记者赵小娜）英国伦敦股市《金融时报》100种股票平均价格指数24日报收于 9250.43点，较前一交易日上涨27.11点，涨幅为0.29%。欧洲三大股指当天涨跌不一。 当天伦敦股市成分股中位于涨幅前五位的个股分别为：矿业公司安托法加斯塔股价上涨9.26%，英美资 源股价上涨4.70%，企业服务外包商巴布科克国际股价上涨4.33%，嘉能可股价上涨2.95%，英国航空航 天系统公司股价上涨2.18%。 当天伦敦股市成分股中位于跌幅前五位的个股分别为：国际设备租赁商阿什特德集团股价下跌2.33%， 工程公司埃迈集团股价下跌2.00%，医疗技术公司康维德公司股价下跌1.84%，贵金属生产商弗雷斯尼 洛公司股价下跌1.79%，英国奢侈品集团博柏利股价下跌1.71%。 欧洲其他两大主要股指方面，法国巴黎股市CAC40指数报收于7827.45点，较前一交易日下跌44.57点， 跌幅为0.57%；德国法兰克福股市DAX指数报收于23666.81点，较前一交易日上涨55.48点，涨幅为 0.23%。 （文章来源：新华财经） ...

Masimo (MASI) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #1 (Strong Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a changing earning ...

公司概况 - Teleflex Incorporated(NYSE:TFX)是一家全球性医疗技术公司 专注于为医院和门诊环境提供危重症护理和外科手术设备 产品组合包括血管通路、介入泌尿科、呼吸和麻醉设备以及外科工具 [2] - 公司致力于通过创新性手术支持改善患者治疗效果 [2] 战略举措 - 计划于2026年完成分拆为两家独立上市公司 新实体("NewCo")将包含泌尿科、急症护理和OEM业务 剩余公司("RemainCo")将专注于血管通路、介入和外科领域 此次分拆旨在优化运营重点、简化制造流程并加速增长 预计对美国股东免税 [3] - 计划以7.6亿欧元收购Biotronik血管介入业务 预计2025年第三季度完成 此举将增强公司介入护理产品组合并支持收入增长 [4] 财务表现 - 2025年第二季度收入增长4.2%至7.809亿美元 每股收益为3.73美元 净利润率达到6.31% 显示分拆前运营实力强劲 [4] 产品创新 - 在日本推出Barrigel直肠间隔物 旨在减少前列腺癌放射治疗的长期副作用 体现公司专注于提升患者生活质量的专科微创技术 [5] 行业地位 - 被列为当前值得购买的廉价医疗保健股票之一 [1][2]

财务数据和关键指标变化 - 第一季度总收入1940万美元 同比增长52% [17] - 毛利率为457% 相比去年同期的329%显著提升 连续第七个季度实现毛利率扩张 [8][17] - 每安装成本同比下降约20% 调整后每安装收入同比增长约20% [17] - GAAP运营费用3770万美元 包含290万美元非经常性上市公司成本 去年同期为2260万美元 [19] - GAAP净亏损2580万美元 去年同期为2030万美元 [20] - 调整后EBITDA亏损1940万美元 去年同期为1570万美元 [20] - 截至2025年7月31日 现金及现金等价物为2012亿美元 [21] 各条业务线数据和关键指标变化 - ASSURE系统处方量超过4200份 同比增长51% [8] - 转换率约为47% 相比去年同期的调整后转换率40%有所提升 [18] - 网络内患者比例从IPO时的70%提升至接近80% [10][27] - 每日中位佩戴时间超过23小时 患者依从性表现良好 [76] 各个市场数据和关键指标变化 - 美国市场覆盖约50%的领土 仍有大量未覆盖区域 [59] - 覆盖约90%的美国保险覆盖人口 [27] - 存在超过3000家支付方 网络内比例持续缓慢提升 [11][27] 公司战略和发展方向和行业竞争 - 积极扩大销售组织 目标进一步渗透现有账户并开发新处方医生 [9] - 更新商业策略 包括扩大的临床专家角色以补充销售领土经理 [9][64] - 继续改善收入周期管理能力 同时吸引更多支付方加入网络 [10] - 采用租赁商业模式 设备池每年可支持约三次患者佩戴 [11] - 建立临床证据体系 FDA批准后研究已完成入组 预计纳入24000-25000名患者 [12][70] - 研究结果将在11月美国心脏协会科学会议上作为最新突破性进展发布 [13][70] - 可穿戴心脏复律除颤器(WCD)市场仅覆盖14%的美国适格患者群体 存在巨大增长空间 [13] - 竞争对手开展的SCD-PROTECT研究显示心衰患者心脏骤停风险高于预期 支持WCD市场扩张 [14][15] 管理层对经营环境和未来前景的评论 - 对2026财年实现70%以上毛利率充满信心 [8][17][18] - 预计2026财年收入8800万美元 同比增长47% 高于此前8500万美元的指引 [21] - 现有现金余额预计足以支持公司实现现金流盈亏平衡和盈利 [21] - 新增1500万美元贷款额度可供使用 目前尚未提取 [21] - 收入增长将保持稳定 不会过度向后倾斜 [40] - 运营费用投资将保持稳定和适度节奏 [79] 其他重要信息 - 公司使命是保护心脏骤停风险患者的生命 第一季度促成多次类似救命事件 [7][8] - ASSURE系统提供全程护理 continuum：指导治疗的洞察、救命治疗和紧急支持 [7] - 最近签署Oscar Health 增加区域支付方覆盖 [55] 问答环节所有提问和回答 问题: 业绩指引上调的原因及全年节奏展望 [24] - 第一季度表现强劲 对全年充满信心 目前对指引更新感到满意 将观察后续季度表现 [25] 问题: 网络内组合改善的具体措施及对毛利率的影响 [26] - 网络内比例从IPO时70%提升至80% 预计缓慢上升 有3000家支付方需要逐步签约 [27] - 新增销售领土时优先选择已知WCD需求和高支付方覆盖地区 提高效率 [28] - 网络内支付方贡献将逐步增加 推动每安装收入持续增长 [28] 问题: 网络内扩张进程的量化说明 [32] - 支付方增加不是线性过程 可能在某些时期增加大型区域支付方 其他时期增加小型支付方 [33] - 策略是确保新增销售代表时提供包括保险覆盖在内的所有工具 [34] - 转换率目标是从当前高水平40%区间在未来几年达到高水平50%区间 不需要立即覆盖所有3000家支付方 [36][37] 问题: 收入增长的季度间分布 [38] - 年度增长指引从42%上调至47% 随着新领土经理增加 预计剩余季度收入将稳定增长 不会过度向后倾斜 [39][40] 问题: 处方量强劲增长的原因及年末市场份额展望 [43] - 现有代表指标持续改善 新代表 onboarding 和生产力达到预期 两方面共同推动处方量增长 [44][45] - 新代表优先瞄准高处方医生 然后横向扩展市场 现有代表则进一步渗透账户并开发新账户 [47][49] 问题: 转换率年度指引及达到最佳水平的驱动因素 [53] - 预计转换率提高25-3个百分点 主要驱动是网络内患者比例提升 领土经理部署到高处方高支付方地区 以及RCM团队投资 [55] - 转换率是年度指标 将持续推动逐年改善 [56] 问题: 当前市场份额及实现 category leadership 的时间表 [57] - 当前市场份额约12% [58] - 关键驱动是销售覆盖 目前仅覆盖美国50%领土 有很大扩展空间 [59][60] - 覆盖速度将决定达到 category leadership 的时间 [60] 问题: 扩展临床专家角色的具体内容 [64] - 策略是将部分账户管理职责从销售代表转移给临床专家 让销售代表开发新处方医生和新账户 [65] - 初始将在高绩效领土部署 然后根据进展决定推广范围 [66] 问题: FDA批准后研究的具体内容及预期影响 [67] - 研究纳入约24000-25000名患者 主要终点包括 shock success rate 安全性终点包括 inappropriate shocks 其他终点包括 false alarm rate 和 patient compliance [70] - 数据将消除关于公司缺乏临床数据的竞争异议 证明 ASSURE 系统的承诺 [71][72] 问题: 患者依从率的发展趋势 [76] - 每日中位佩戴时间超过23小时 患者愿意长期佩戴 through the duration of their prescription [77] 问题: 运营费用投资的节奏和重点 [78] - 投资将保持稳定和适度 按年度业务计划精确执行 重点增加团队以支持新领土和新代表 [79] - 策略是招聘高质量代表 建立持久的商业团队 [80]

财务数据和关键指标变化 - 第一季度总收入1940万美元 同比增长52% [18] - 毛利率为457% 相比去年同期的329%显著提升 连续第七个季度实现毛利率扩张 [8][18] - 净亏损2580万美元 去年同期净亏损2030万美元 [20] - 调整后EBITDA亏损1940万美元 去年同期亏损1570万美元 [21] - 截至2025年7月31日 现金及现金等价物为2012亿美元 [22] - 成本每安装下降约20% 调整后收入每安装增长约20% [18] 各条业务线数据和关键指标变化 - 心脏复苏系统Assure接受超过4200张处方 同比增长51% [8] - 转换率约为47% 相比去年同期的调整后转换率40%有所提升 [19] - 网络内患者比例从IPO时的70%提升至接近80% [10][28] - 每日中位佩戴时间超过23小时 患者依从性表现良好 [77] 各个市场数据和关键指标变化 - 目前覆盖美国约50%的销售区域 仍有大量未覆盖市场 [60] - 市场份额估计约为12% 目标成为品类领导者 [59] - 有超过3000家支付方 正在逐步与区域和地方支付方签订合同 [11][28] 公司战略和发展方向和行业竞争 - 积极扩大销售团队 第一季度新增销售区域符合招聘计划 [9] - 更新商业策略 包括扩大临床专家角色以补充销售区域经理 [9][66] - 采用租赁商业模式 设备车队每年可支持约三次患者佩戴 [12] - FDA批准后研究已完成入组 预计纳入24000-25000名患者 将成为WCD类别中最大规模研究 [12][71] - 研究数据将在11月美国心脏协会科学会议上作为最新突破性进展发布 [13][72] - 竞争对手最近发布了大型德国WCD研究结果 显示心源性猝死风险高于预期 表明市场有扩张潜力 [15] 管理层对经营环境和未来前景的评论 - 对2026财年营收指引从8500万美元上调至8800万美元 同比增长47% [22][40] - 预计毛利率将继续扩张 有信心在未来几年实现70%以上的毛利率 [9][18] - 现有现金余额预计足以支持公司实现现金流盈亏平衡和盈利 [22] - 1500万美元的定期贷款额度已可用 但目前尚未提取 [22] - 预计转换率将逐步提高 未来几年目标达到50%以上 [37][56] 其他重要信息 - 公司使命是保护心搏骤停风险患者 第一季度团队和技术帮助促成了多次类似拯救生命的事件 [7][8] - 分享了具体患者案例 说明Assure系统如何检测危险心律并实施电击 拯救患者生命 [4][5][6][7] - WCD疗法仍未得到充分利用 仅覆盖14%的美国合格患者群体 意味着七分之六的适应症患者未受到保护 [14] 问答环节所有提问和回答 问题: 关于业绩指引上调的原因和年度内节奏 - 第一季度表现强劲 对全年持乐观态度 目前对指引更新感到满意 预计将稳步进入第二季度 [25][26] - 指引上调基于第一季度业务表现的信心 预计剩余季度营收将稳步增长 不会过度向后倾斜 [39][40][41] 问题: 关于网络内支付方组合的改善策略和影响 - 网络内患者比例从IPO时70%提升至80% 预计将继续缓慢上升 [27][28] - 策略是在已知WCD需求高且支付方覆盖好的地区增加销售区域 [28][29] - 转换率提升主要得益于网络内患者组合改善 预计未来几年将从目前的高40%水平提升至高50%水平 [37][55][56] 问题: 关于销售区域扩张和支付方覆盖的进展 - 支付方增加不是线性过程 可能在某些时期增加大型区域支付方 其他时期增加小型区域支付方 [34] - 策略是确保新增销售代表拥有所有必要工具 包括保险覆盖 以便他们能够成功 [35] 问题: 关于处方量强劲增长的原因和市场份额展望 - 处方增长得益于现有代表指标持续改善以及新代表顺利上岗并达到预期生产力水平 [45][46] - 新代表首先针对高处方量医生 然后横向扩展市场 现有代表则进一步渗透现有账户并开拓新账户 [48][50] - 市场份额估计约为12% 目前仅覆盖美国50%的销售区域 覆盖范围扩大将是主要驱动因素 [59][60][61] 问题: 关于转换率指引和提升驱动因素 - 2026财年指引假设转换率提高约25-3个百分点 认为非常可实现 [56] - 转换率提升主要驱动因素包括:在网络内高处方区域部署区域经理、与更多支付方签订合同、投资收入周期管理团队和能力 [55][56] 问题: 关于扩展临床专家角色的细节 - 临床专家角色将承担部分账户管理职责 让销售代表能够培养新处方医生和新账户 [66] - 将首先在一些高性能区域部署 然后根据进展决定进一步推广范围 [67] 问题: 关于FDA批准后研究的关键细节和预期影响 - 研究纳入约24000-25000名患者 主要终点包括电击成功率、不适当电击、误报警率和患者依从性 [71][72] - 这将埋葬竞争对手关于缺乏发表临床数据的论点 提供大量临床数据支持 [72] - 预计将报告心梗后患者与非缺血性患者之间的差异等数据 [72] 问题: 关于患者依从性趋势 - 每日中位佩戴时间超过23小时 患者愿意长期佩戴 through处方持续时间 [77][78] - 依从性是家庭护理类别的最大挑战 公司产品在这方面表现良好 [77] 问题: 关于运营费用投资节奏和重点 - 投资节奏将是稳定和有节制的 重点增加商业覆盖范围 [80] - 策略是招聘高质量代表 建立持久的商业团队 而非尽可能快地招聘最多代表 [81]

Question-and-Answer SessionThanks for being here, Jason. With some investors maybe not at the 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.Jason MatuszewskiCEO, President, Secretary & Chairman Sure. So first and foremost, thank you, Denis , for having us here. Really appreciate first opportunity to speak at the Morgan Stanley Global Healthcare Conference. So great opportunity. So BioStem Technologies. So we are a profita ...

[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

公司信息 * 公司为iRhythm (纳斯达克代码: IRTC) 是一家提供动态心脏监测解决方案的医疗科技公司 其核心产品为Zio系列监测贴片 [3] * 公司近期业务势头强劲 过去两个季度实现了过去五年（除新冠疫情期间外）最大的业绩超预期和指引上调 [3] * 公司已向FDA提交了新一代产品Zio MCT的510(k)申请 预计在2026年下半年上市 [12][45][46] * 公司与FDA的关系在过去18-24个月内得到显著改善 从过去的紧张转变为如今高度协作的关系 [15][47][49] 核心业务表现与驱动因素 * 第二季度的业绩超预期主要由核心业务驱动 [4] * 核心业务增长得益于新客户获取和同店销售增长 [4] * 新客户平均体量更大 公司现具备能力一次性转换整个大型医疗网络 而非过去的逐个账户转换 [4][5] * 同店销售增长得益于将业务从心脏科（Cardiology）和电生理科（EP）向上推进至初级保健（Primary Care）领域 [7][8] * 目前约三分之一的处方来自初级保健渠道 且该渠道是业务中增长最快的 [7][10] * 临床数据（Camelot和Avalon研究）证明了Zio产品的优越性 在超过30万患者的CMS数据集和超过40万患者的商业数据集中均显示其能更快诊断、具有更高的诊断产出率、并降低医疗资源使用成本 [6][7] * 创新渠道合作伙伴业务（针对无症状患者）增长迅速 从一年前的零起点增长至第一季度占总量的约3% 第二季度继续攀升 [10] 市场机遇与战略转型 * 公司认为潜在市场远大于当前行业认知的650万次动态心脏监测（ACM）测试 估计约有2700万未确诊且无症状的心律失常患者 [11][37] * 这些无症状患者大量存在于具有共病（如2型糖尿病、COPD、CKD、OSA）的人群中 [11][24] * 公司战略是通过初级保健渠道和创新渠道合作伙伴（如支付方和有风险实体）来寻找这些患者 [11][22][35] * 创新渠道合作伙伴模式不仅销售贴片 还提供包含AI算法（用于筛查患者）、诊断工具（Zio）和远程心脏学服务的完整项目 以降低下游护理成本 [22][35] * 目前已与12家合作伙伴签约 覆盖约200万潜在患者生命 另有40家合作伙伴正在积极洽谈中 [36][37] * 按每片贴片250-300美元计算 现有12家合作伙伴的年化收入机会达4.5亿至6亿美元 [36] * 若与全部潜在52家合作伙伴签约 可覆盖约700万潜在患者 该机会规模已超过当前服务的市场 [37][39] 人工智能（AI）与算法进展 * 公司投资开发了基于EMR的AI算法 通过分析患者病史标记来识别可能患有心律失常的无症状者 [21] * 在初步的1000名患者试点中 算法识别出920名患者实际存在心律失常 准确率极高 [21] * 在后续的另1000名患者中 识别出超过800名患者存在心律失常 两组合计准确率超过80% 接近90% [22] * 此AI能力尚未对当前增长做出贡献 但未来与支付方合作时有巨大潜力 [20][22] 产品管线与监管进展 * Zio AT产品表现超出公司预期 [11] * 新一代产品Zio MCT的510(k)申请已于昨日（2025年9月9日）提交FDA [12][45] * Zio MCT设计为单次使用21天 不同于竞争对手需佩戴多个5-7天的贴片才能达到20-30天监测期 [52] * MCT申请中还包含了算法能力的增强 [52] * FDA审批流程为90天 但预计会有问询回合 公司计划于2026年下半年推出该产品 [45][46] * 公司目前在中长时程监测（MCT）市场占有率约为12% 预计年底接近15% 目标是达到25%-35%的市场份额 [15][53] * 公司拥有清晰的产品创新路线图 并与FDA就未来功能（如睡眠应用、生命体征监测、儿科应用）进行了积极沟通 [48][49] 财务目标与盈利能力 * 公司重申了到2027年实现10亿美元收入和15%调整后EBITDA利润率的目标 [57] * 公司认为有清晰路径实现25%的EBITDA利润率 主要杠杆在于大幅降低目前中位40百分比的G&A（行政管理费用）开支 使其向同行低20百分比的水平看齐 [57][58] * 毛利率也有持续改善空间 公司通常假设每年有200-300个基点的定价压力 但明年定价预计相对平稳 [58] * 今年投入了2500万美元用于质量体系补救 其中约1500万美元的费用将在明年消失 为利润表带来杠杆效应 [49] 风险与挑战 * 创新渠道合作伙伴业务的增长速度和规模仍难以精确预测 因其依赖于合作伙伴的决策和推广节奏（例如 Signify 用了18个月试点后全国推广 而 CenterWell 在90天内就全国推行） [40][41] * 公司曾因FDA的警告信和483观察项而延误了约两年时间 未能如期推出MCT产品 [14][15] * 在推广MCT产品的降级功能（downgradable capability）时 需谨慎避免对现有业务造成蚕食 [56]

Scout Investments, Inc., an affiliate of Carillon Tower Advisers, released the “Carillon Scout Mid Cap Fund” second quarter 2025 investor letter. A copy of the letter can be downloaded here. The Russell Midcap Index posted positive returns in the second quarter despite a sharp sell-off at the beginning of April following the liberation Day tariff announcement. However, the delay in collecting additional tariffs provided more time for trading partners to negotiate better terms. In addition, please check the ...