Mentor Worldwide LLC

整形、隆胸、吸脂...越来越多的人选择完成一项“美丽工程”。胸部是女性重点关注的部位，胸部整形也一直是医美的焦点。国际美容整形外科学会（ISAPS）公布的数据显示，隆胸是2021年全球数量第二的整形外科手术。隆胸的主要方式有自体脂肪注射和假体植入。自1962年第一代硅胶假体问世以来，硅胶假体已完成了四次技术迭代。如今，硅胶假体已成为应用最多、技术最成熟的乳房植入物。2004年成立的Establishment Labs就是一家关注乳房整形和重建市场的公司，主营产品为乳房硅胶植入物。2018年7月19日，Establishment Labs登录纳斯达克（NASDAQ：ESTA），每股发行价为18美元。截止到2023年5月19日，ESTA每股收盘价为69.35美元，较发行价上涨385%，市值达17亿美元。二十年磨一剑Establishment Labs的创始人兼首席执行官JUAN JOSÉ CHACÓN QUIRÓS选择医疗市场并不是偶然。CHACÓN QUIRÓS出生在一个医学世家，他的父亲和兄弟都是整形科医生，母亲是护士，妻子也是一名医生。受家庭的熏陶，他也从医疗行业开始了自己的职业生涯。他起初在整形诊所负责业务工作，后来在拉丁美洲的一家医疗设备公司担任业务经理，负责销售工作。2004年，CHACÓN QUIRÓS在家乡哥斯达黎加创立了Establishment Labs。在公司成立的前四年里， CHACÓN QUIRÓS靠着自力更生和向家人借钱维持公司的运营。随着对市场研究的深入，CHACÓN QUIRÓS意识到乳房植入物市场的潜力，于是他决定扩大经营并开始第一轮融资。这时，Establishment Labs才开始公司化运营。经济学出身的CHACÓN QUIRÓS并不懂技术，于是他找到具有工科背景的Salvador Dada Santos。Santos不仅在各方面都贡献了“工程头脑”，还为公司发展引进了所需的技术人员，其中就包括首席技术官Roberto De Mezerville。融资、开发产品、临床试验、获批、上市销售并扩大营收，Establishment Labs前期的路似乎走得并不艰难。2016年，Establishment Labs营收同比增长106%；2017年，营收同比增长75%。然而Establishment Labs并不满足于此，他们还想登陆美国的证券市场。2018年，Establishment Labs成功登陆纳斯达克，成为第一家在美国上市的哥斯达黎加公司。Santos、Mezerville与 CHACÓN QUIRÓS一起，在交易大厅见证着公司的历史性时刻。Establishment Labs在纳斯达克上市  图源：Establishment Labs官网Motiva Implants：销量近270万个，破裂、包膜挛缩和再手术率更低ISAPS的数据显示，2021年全球约有170万例隆胸手术，这个数量还在逐年递增。另外，美国整形外科医师协会指出，2020年全美共进行13万余次乳房重建手术，到2026年，乳房重建市场预计增长到6.47亿美元。尽管全球对隆胸手术有持续性的需求，但自上个世纪九十年代起，乳房植入物相关的产品创新相对较少。其中的缘由不得不提到FDA颁布的禁令。1992年，由于安全问题，FDA暂停在美国销售硅胶乳房植入物，该禁令于2006年取消。这就给了Establishment Labs进入市场的机会。Establishment Labs的第一款乳房植入物于2009年完成研发并在2010年获批上市。随后，公司不断推陈出新，迄今为止，共了推出了五代植入物，包括四个系列的假体Motiva Implants和组织扩张器Motiva Flora。Establishment Labs的主要产品  图源：Establishment Labs年报许多传统的乳房植入物都有相对较高的并发症概率。Establishment Labs表示，一项为期十年的前瞻性研究中，Sientra、Allergan 和 Mentor的产品都存在一定程度的破裂、包膜挛缩和再手术的风险。目前，获得FDA批准销售乳房假体的公司仅此三家。Establishment Labs竞品并发症发生率  图源：Establishment Labs年报高并发症概率背后的原因，除了血肿、感染、患者体质和手术操作之外，还跟假体材质密切相关。就包膜挛缩而言，光面假体更易植入，价格更便宜，但术后容易发生移位，有更大概率发生包膜挛缩。毛面假体易固定，发生包膜挛缩的概率更小，但植入难度更大，切口可能更大，价格更高。Motiva Implants假体介于两者之间，它采用专利SmoothSilk表面技术，旨在增强生物相容性，减轻炎症和纤维化反应。Establishment Labs公布的数据显示，从2010年第一款植入物Motiva Implants上市到2022年12月末，公司共销售近270万个乳房植入物。患者发生假体破裂、包膜挛缩和因不良反应再手术的概率均低于0.1%。Motiva Implants并发症发生率  图源：Establishment Labs年报除了Establishment Labs自己公布的数据，发表在《Aesthetic Surgery》上的文章也证实了Motiva Implants较低的再手术概率。2013年至2016年英国的一项单中心研究显示，5813名接受Motiva Implants假体植入的患者，因不良事件再手术的概率为0.76%。而2010年到2013年，使用FDA批准的硅胶假体植入的患者，再手术概率为8.43%。Motiva Implants和竞品的再手术概率  图源：Establishment Labs年报此外，Motiva Implants还拥有多项专利技术，其硅胶假体破裂的可能性较低，且当患者躺下时假体保持圆形，在站立时形成自然的泪滴形状。Motiva Implants随体位变化的形状改变  图源：Establishment Labs年报Establishment Labs还提供了一种射频识别设备微应答器（Qid）。它作为可选功能，放置在硅胶植入物中。患者术后可通过设备获取植入物类型、尺寸和其他信息，便于日后保修和更换。Establishment Labs称，Motiva Implants是目前国际市场上唯一采用Qid技术的乳房植入物，他们未来也会考虑把这些微应答器出售给该领域的其他医疗公司。  Motiva Flora：首款MRI兼容的组织扩张器大部分全乳切除患者在术后无法立即植入假体，她们需要先在乳房缺损部位放置组织扩张器。组织扩张器是一种球囊样的临时假体，医生定期给扩张器内注入生理盐水。待3-4个月之后患者皮肤拉伸，获得放置假体的空间后，才接受假体植入手术。但是绝大部分扩张器的端口都是金属材质，这是MRI扫描的禁忌症。Establishment Labs的组织扩张器Motiva Flora采用无磁端口，支持植入该扩张器的患者安全地进行MRI检查。同时，Motiva Flora还包含一个无线射频识别（RFID）线圈，医生可以利用端口定位器精准定位。Establishment Labs称，Motiva Flora是市场上第一款MRI兼容的组织扩张器，也是目前唯一具有集成RFID端口的组织扩张器。到目前为止，Establishment Labs的产品已在除美国之外的85个国家/地区实现商业化。据ISAPS的数据，2021年美国隆胸手术例数全球占比第一（23%）。Establishment Labs显然不愿意放弃美国市场这一块巨大的蛋糕，获得FDA批准并进入美国市场一直是Establishment Labs的重要战略。Establishment Labs已于2018年获得FDA的研究器械豁免（IDE），随后积极进行临床试验。Motiva IDE临床试验在美国、德国和瑞典32个中心招募了827名患者，包括562名隆胸患者和265名重建患者，相关手术已于2022年夏季全部完成。“砸钱卖货”，营收五年翻四倍Establishment Labs主要财务数据  数据来源：Establishment Labs年报  动脉网整理从公布的财务数据可以看出，COVID-19的肆虐对Establishment Labs的业务产生了重大影响。尤其是2020年，全球众多手术室关闭，Establishment Labs出现运营中断，故公司2020年营收出现5%的下降。但除了2020年，Establishment Labs的营收呈现逐年上升趋势，从2017年的3468万美元到2022年的1.61亿美元，足足翻了4.64倍。Establishment Labs表示，营收增长的主要原因是产品全球市场份额的增加，尤其是最近拉丁美洲和亚太市场的扩张。其中原因不仅有整形医生和患者对产品的认可，也是Estab lishment Labs团队在多个地区扩大直接销售的结果。但大幅增长必定有其代价，Establishment Labs的经营费用也在逐年攀升。除了研发费用持续增加外，销售及管理费用占据了营业费用的大头，一直居高不下。公司2022年销售及管理费用达1.26亿美元，占营收77.91%。虽然近四年毛利率都超过60%，但Establishment Labs仍未开始盈利，还处在“砸钱卖货”推动营收增长的阶段。Establishment Labs表示，公司短期内还将继续蒙受亏损，他们将通过股权融资、债务融资及销售产品获得资金以支持公司运营。截止到2022年12月31日，Establishment Labs的现金储备为6640万美元，他们相信这些资金能满足公司未来至少一年的流动性需求。2023年4月27日，Establishment Labs完成了126.5万股普通股的增发，募资9040万美元。可见市场对于这个上升期的公司的信任，以及对于乳房植入物行业背后增量空间的看好。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

The City of Warsaw, Indiana and the Kosciusko Economic Development Corporation (KEDCO) has announced that global supply chain solutions company Mentor Supply Chain USA (Mentor Media) will establish a sterile packaging and supply chain management hub in Warsaw Technology Park. Mentor Media will locate operations in a portion of the 100,000-square-foot shell building at 1395 Polk Drive that is under development at the Warsaw Tech Park. The operation will consist of medical device end-of-line processing and supply chain management services. West Hill Development will complete buildout of the state-of-the-art 30,000-square-foot space for the company by Fall 2023. Warsaw mayor Joe Thallemer said: "We’re pleased Mentor Media will be joining our medical device community in the Warsaw Technology Park. The city continues to support and incentivise companies in advanced manufacturing with Mentor Media as the latest to call Warsaw home." A ribbon-cutting celebration will take place later this year when the company formally opens the new location. "We welcome another global-leading company to Kosciusko County to strengthen The Orthopedic Capital of the World," said KEDCO CEO Alan Tio. "Mentor Media meets a long-known need for sterile packaging services that complements and bolsters our local industry." The Warsaw operation will serve as a medical device service hub, including controlled storage warehousing, ISO Class 7 cleanroom, and final packaging lines. The cleanroom will house a pre-validated sterile packaging system compliant with the new EU Medical Device Regulations. Mentor Media, president & CEO, said: "We are excited and humbled by the warm welcome and support given by the City of Warsaw, Kosciusko County and the State of Indiana in this venture. Warsaw is such a unique proposition with its strong orthopaedic ecosystem and community. We look forward to offering valuable state-of-the-art supply chain and medical device packaging solutions to this region." The company will offer a full suite of supply chain services including sourcing and procurement, operations management, customer service, warehousing, and global distribution services. The company plans to hire nearly 50 employees in the next three years. The company will begin hiring before Fall 2023. Ann Lathrop, chief strategy officer for the Indiana Economic Development Corporation (IEDC), said: "Mentor Supply Chain USA’s choice to locate operations in Indiana is a win for Hoosiers. The company’s strong reputation and subject matter expertise in medical devices and logistics adds to two of the state’s strongest ecosystems and will create high-quality career opportunities in and around Warsaw." Based on the company’s job creation plans, the IEDC committed an investment in Mentor Supply Chain USA Inc. of up to $750,000 in the form of incentive-based tax credits and up to $75,000 in training grants. These tax credits are performance-based, meaning the company is eligible to claim incentives once Hoosiers are hired. Warsaw Technology Park is one of approximately two dozen Certified Technology Parks in the State of Indiana. The development-ready business park is a partnership between the Warsaw Redevelopment Commission and West Hill Development that offers 100+ acres with underground utilities, stoplight access to US Highway 30, and access to an onsite Ivy Tech Community College facility.

The Lake Forest, California-based implantable eye lens maker named Warren Foust as its new COO. Magda Michna takes over as chief clinical, regulatory and medical affairs officer. Staar’s global head of regulatory affairs, Denise McEachern, plans to retire. Both positions report to Staar President and CEO Tom Frinzi. Frinzi recently took over the corner office for Caren Mason, who retired at the end of last year. Analysts quickly asked questions over this move, calling it a “curve ball.” “The addition of two highly regarded ophthalmic leaders to our team exemplifies the success, momentum and opportunity for Staar as we work with surgeons to expand the market for refractive vision correction with our proprietary EVO ICL lenses to the millions of people seeking visual freedom from contact lenses and glasses,” Frinzi said in a news release. “Today, STAAR is a company delivering industry leading growth and with increasing momentum for even greater growth. Our focus remains capturing the tremendous whitespace opportunity in front of us.” About the new Staar Surgical executive appointments Most recently, Foust served as worldwide president at Johnson & Johnson Vision, Surgical, since December 2019. There, he worked alongside Frinzi, who spent time in the same role. Frinzi called Foust “uniquely qualified” as he takes on the responsibility of leading growth objectives at Staar. Before that, he held the role of worldwide president at Mentor, a breast reconstruction and aesthetics unit at Johnson & Johnson. He also served as VP of U.S. sales and marketing for three years at Mentor. Other roles include sales leadership positions at DePuy Synthes and a sales representative at Roche. “I am so grateful to be part of the ophthalmic community,” Foust said. “It is an honor to work at Staar. I believe Staar has the right technology at the right time to establish a new standard of care for refractive vision correction. My focus will be on empowering our Staar teams and equipping our surgeon customers with the tools they need to drive growth and adoption of the EVO family of lenses. I am also very happy to work with Tom again.” Michna joins Staar having most recently served as chief global, clinical, medical and regulatory affairs officer at AcuFocus. She held that role since April 2018. Bausch & Lomb acquired AcuFocus in January 2023. Other roles included chief clinical officer at Presbia. Michna led the clinical development for intraocular lenses and surgical devices supporting the Alcon Surgical franchise. She began her time in the industry as a vision scientist at Vistakon, a J&J Vision unit. Frinzi called Michna “an important addition” to oversee and advance the company’s pipeline. “I have admired STAAR’s technology and its management team for several years and look forward to leading clinical, regulatory and medical affairs,” stated Magda Michna, Ph.D. “The safety and effectiveness of the EVO family of lenses is well established, and I am confident we can facilitate even broader awareness and understanding of the data within the ophthalmic community.”