Closure Medical Corp.

在医疗技术进步、外科手术量增加、患者对医疗质量的期望提高等因素的驱动下，可吸收止血材料行业迎来新的发展契机。在这一领域，动脉网关注到一家成立于2007年的美国伤口护理产品开发商——Medcura。 该公司研发出全球唯一一款因“无膨胀”特性而获得 FDA 突破性设备认定的可吸收手术止血材料。对此，动脉网已在《获FDA突破性设备认定，它靠新型可吸收止血剂融了一个亿》一文中进行详细介绍。 近日，动脉网对Medcura总裁、首席执行官兼董事Jim Buck进行了专访，以对Medcura的核心技术、商业打法、未来规划等进行更为深入的了解。  Medcura总裁、首席执行官兼董事Jim Buck Buck拥有30年成功开发和商业化创新医疗技术的经验，自2018年以来担任Medcura的董事会董事，并于2022 年担任Medcura CEO。在此之前，Buck在医疗行业积累了丰富的收购并购经验，曾就职于雅培，强生的BD部门。此外，Buck曾担任 Closure Medical的营销和业务开发副总裁，负责指导新型外科密封剂和粘合剂技术的产品规划和战略执行，该技术后来被强生以超过 3.7 亿美元收购。 十年探索，成为全球唯一攻克壳聚糖疏水改性技术的企业 外科止血场景大多依赖于一种牛血或猪血中提取的衍生物——凝血酶。该物质在止血过程中发挥着重要作用，但也存在诸多缺陷。如传统的凝血酶生产受来源限制较大，复杂的提取和纯化过程导致其生产成本较高，适应症有限以及出血倾向、血栓形成等不良反应。 这使得Medcura团队意识到，用非凝血酶聚合物开发的产品将在止血市场中大有可为。于是，团队将目光转向了壳聚糖，其资源可及、成本低廉的特性恰巧弥补了凝血酶的固有缺陷。但是，新的问题横亘在了团队面前——虽然壳聚糖在止血方面有效性出色，但不能在体内使用，因为它在被吸收时具有很高的细胞毒性和神经毒性。也正因如此，壳聚糖基可吸收止血剂此前从未获得 FDA 批准用于体内非创伤性手术应用。 为了啃下这一“硬骨头”，团队开始了对壳聚糖改性技术的探索。Buck坦言，这也是Medcura在产品研发过程中遇到的最大困难：“我们花了近十年的时间，终于攻克了这一难关，使壳聚糖在保持止血特性的同时消除了毒性，能在人体内安全地被吸收。” 据Buck介绍，虽然其他公司也曾尝试过对于壳聚糖进行改性，但目前，Medcura是唯一取得成功的企业，并且拥有围绕这一成果的强大知识产权和专利保护壁垒。公司在过去十年中发表在了12篇不同的高影响力、同行评审的期刊文章。 颠覆性的创新背后离不开Medcura创始人早期的学术科研成果。Medcura 首席科学家、创始人兼董事Matthew Dowling博士是新型止血材料领域公认的思想领袖，在用于伤口治疗的壳聚糖自组装软材料研究方面资历丰厚。 在公司成立的最初四五年里，Dowling和马里兰大学生物化学学院的团队经过深入研究，创造了一种新的生物化学工艺来重新格式化壳聚糖，并开发出一种新型的快速止血材料。这项获得专利的止血技术基于改良的壳聚糖，是一种从虾、蟹等甲壳类动物的外骨骼中提取的生物聚合物，不仅可与组织紧密贴合，还能在不造成进一步伤害的情况下从患者身上移除，应用场景十分广泛。 后来，Medcura团队对上述技术进行了更深层次的应用研究，开发了一种基于两亲性自组装生物聚合物的生物材料平台，并推动其进行商业化落地。该平台的生物聚合物骨架主要是亲水或水溶性的，并从聚合物的骨架上延伸出疏水部分。这使得该材料在接触到血液或生物液体时能够自组装并形成各种新的形状。 目前，Medcura已基于此开发了可应用于外科手术的产品系列LifeGel。它可以装入注射器中进行灭菌，并通过注射器尖端进行输送。LifeGel易于在伤口表面上应用，并且具有较好的弹性。医生只需轻轻施力，便可将其涂抹在不规则形状的伤口表面，以覆盖和密封伤口、出血和其他渗出物来源。 避免脊柱术中止血产品膨胀导致的神经损伤，成本仅为同类产品的1/3 根据QY Research最新调研报告显示，预计2029年全球可吸收止血材料市场规模将达到38.64亿美元，未来几年年复合增长率为6.8%。目前，市面上的可吸收止血材料产品种类繁多，入局该赛道的企业也不在少数。那么，在这一竞争趋于激烈的赛道中，LifeGel的差异化优势何在？ Buck指出，LifeGel在安全性、有效性、经济性三大方面表现都较为出色，是目前全球唯一一款获得FDA突破性设备认定的可吸收止血材料产品。 从有效性角度来看，LifeGel可达到与美国主流止血产品相同的功效。Life Gel 由三种成分组成：自组装的疏水改性壳聚糖、交联的完全水合明胶颗粒和水，作为一种完全水合、可吸收的止血凝胶，旨在止住轻微、中度的手术出血。 安全性则主要体现为LifeGel不会遇湿膨胀，这是这款产品最大的亮点。对于复杂手术尤其是脊柱手术，止血剂膨胀可能会导致神经损伤，在狭窄区域使用时甚至会造成瘫痪。Medcura 的 LifeGel专为脊柱手术等高度专业化的外科手术而设计，是首款也是唯一一款能够解决止血剂膨胀问题的可流动止血凝胶，能有效降低神经损伤和瘫痪等重大不良事件的风险，在开放和微创手术中均能非常有效地治疗旁组织出血。 基于这一优势，Medcura 将 LifeGel的战略重点锚定在脊柱手术应用场景中。而公司在脊柱手术研究方面也具有深厚的积累。首席医疗官Kenneth Renkens曾是印第安纳脊柱集团的联合创始人，并参与了现已在全球范围内常规使用的生物外科产品的研究、开发和商业化。Renkens是治疗复杂的脊柱和脊髓疾病的资深专家，曾担任印第安纳大学医学院骨科手术的临床讲师，是美国神经外科医师协会、北美脊柱协会的成员。 脊柱转化研究主任Bryan Cunningham在骨科和神经外科基础科学和临床研究领域工作超35年，曾担任华盛顿特区乔治城大学医学院骨科教授。Cunningham发表了超过135篇同行评审的期刊文章，并在骨科和神经外科专业学会会议上发表了超过500篇摘要，曾获得 24 项国家认可的研究奖项，其中包括北美脊柱协会亨利-法尔范终身成就奖（Henry Farfan Lifetime Achievement Award），以表彰他对骨科研究的贡献。 基于在脊柱手术领域的多年深耕，Medcura的LifeGel获得了诸多神经外科、脊柱外科医生的高度评价。“我们邀请了24位神经外科医生和骨科脊柱外科医生到LifeGel产品演示实验室，并在出血场景下使用该产品，这些场景与他们每天在人体中处理的情况非常相似。”Buck介绍到，这些临床医生的反馈直接体现在了他们实际的投资行动当中——在产品展示之后，Medcura获得了来自这些医生总计800万美元的投资。 并且，LifeGel具有较为明显的成本优势。“市面上大部分止血材料都依赖于凝血酶，其价格高昂且储存条件苛刻。而LifeGel则摆脱了凝血酶的限制，无特殊储存要求，且在原材料上与其他止血产品有显著差异。”Buck介绍到，与同类产品相比，LifeGel的成本仅为竞争对手的1/3。 目前，对于可吸收止血凝胶的市场需求正逐步增加，但由于成本较高，其在部分手术场景中并没有得到经常性的使用。而这正是Medcura渴望填补的空白。“我们的成本优势将为医院显著降低止血成本，促进可吸收止血凝胶在手术止血场景中的广泛应用。在包括欧洲和亚洲在内的全球市场中，Medcura有望通过经济效益抢占市场份额并提高可吸收止血凝胶的使用率。”Buck介绍到。 致力于改变外科止血材料市场秩序，或将入局中国市场 通过对丰富、天然且生物相容性高的壳聚糖进行专利性改良设计，Medcura的产品具有极强的可拓展性和多功能性，可以以高成本效益的方式开发多种产品形式。在应用场景上，Medcura将脊柱手术的术中止血作为战略重点，同时进军其他非战略性市场。“这些市场使我们能够在不分散公司注意力的情况下获得较为可观的收入和利润，并且占业务管理时间不到1%。”Buck补充道，目前，公司的可吸收止血材料已覆盖了消费、临床、军事、宠物等多个市场。 纵观可吸收止血材料行业，巨头企业已占据主导地位超过二十年，并有着优秀的管理团队、营销团队的赋能。“想要打破这种根深蒂固的垄断格局，难度不言而喻，且需要一种变革性极强、拥有广泛应用潜力的创新技术。但我们相信，Medcura止血产品的无膨胀安全优势、多形态的性能优势和低成本的经济优势将足以改变外科止血材料行业的市场秩序。”Buck对于以LifeGel为核心的可吸收止血产品的市场潜力拥有十分坚定的信心。 目前，LifeGel处于临床前动物实验阶段，预计将于2025年结束。其临床研究将于2025年下半年在美国开始，然后转向欧洲。公司目前正着力将LifeGel可吸收流动止血凝胶快速推向市场，在市场份额显著增加后，将利用相同的核心生物聚合物推出其他形式的产品，如粉末、泡沫、片材、吸附剂和薄膜。“这些产品将使我们能够在规模达28亿美元的止血市场的所有细分市场中，以高效、高安全性和低成本的产品获得竞争优势。”Buck解释道。 关于Medcura的未来规划，Buck指出，公司会继续将重点聚焦于脊柱外科领域的手术止血，这是对于Medcura来说机会最大、最能树立优质产品形象的领域。“在这个市场规模接近30亿美元的止血市场中，脊柱外科将是最大的应用领域。加之LifeGel在脊柱外科应用场景中出色的安全性优势，将有力地影响医院及医生的购买决策。”Buck介绍到，在市场区域方面，Medcura计划将LifeGel首先在美国和欧洲推出，并表示中国是公司可能进入的下一个优秀市场。 “凭借这一极具市场颠覆潜力的核心技术，我们致力于成为外科出血管理的新护理标准。”在访谈的最后，Buck对Medcura提出了这样的期望。Medcura将如何改变可吸收止血材料的行业格局？又将谱写出怎样的精彩故事？我们拭目以待！ 如果您想对接文章中提到的项目，或您的项目想被动脉网报道，或者发布融资新闻，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。 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

Demand for surgical sutures in Europe is expected to register a growth of 5.2% over the next ten years. U.S., China, India, and Germany are the key producers of surgical sutures. Coated sutures (anti-bacterial) are expected to present high growth at a CAGR rate of 5.5% by the end of the forecast period. NEWARK, Del., Nov. 3, 2022 /PRNewswire/ -- The global surgical sutures market is expanded at a healthy CAGR of 5.4% across the projection period from 2022 to 2032. The market is expected to enjoy a valuation of around US$ 8.2 Bn by the end of the year 2022 and further reach an estimation of around US$ 13.9 Bn by the year 2032. As per the latest reports by Future Market Insights, surgical sutures are leading the market in the product segment with a share of about 56.1% in the year 2021, within the global market. The market value of surgical sutures was calculated at approximately 41.4% of the overall US$ 18.8 Bn of the global Wound Closure Devices market in 2021. The sale of surgical sutures expanded at a CAGR of 4.9% from 2017 to 2021. Surgical sutures have diverse applications as they hold tissues together after any sort of injury or surgery in order to assist the natural process of healing. Common places where these sutures are used are on the skin, internal tissues, organs, and blood vessels. Get a Sample Copy of the Report @ After a pre-determined amount of time, the body tends to either absorb or break down the absorbable suture used in surgery. These types of sutures are developed of synthetic materials like caprolactone, polyglycolic acid, polydioxanone, polyglactin, and polyglyconate as well as natural materials like catgut. There are two types of absorbable sutures: knotted absorbable sutures and knotless absorbable sutures. Once the predetermined time period is over then it is crucial to remove the non-absorbable sutures because they are composed of a substance that is immune to biological bodily processes. They are made use of materials like silk, nylon, polypropylene, and polyester sutures. There are two types of non-absorbable sutures: knotted non-absorbable sutures and knotless non-absorbable sutures. Over the last few years, the surgical sutures industry went through some major technological advancements which have led to the increased adoption of surgical sutures in comparison to other wound closure methods. Key Takeaways Some of the major advancements within the surgical sutures market include massive utilization of synthetic materials that are imbibed with special tissue-holding properties and are associated with less risk of infection and scar formation, suture coatings, braiding technologies, barbed sutures, and new specialty sutures, which are in the pipeline. Antibacterial-coated suture like Triclosan-coated polyglactin 910 reduces surgical site infection prevalence by 30%. The handling and tension force of these sutures was comparable to standard suture materials. These surgical sutures are excessively used in therapeutic procedures along with a rising surgery market, incorporating the importance of patient outcome improvement and ensuring safe recovery from surgeries continues to drive the growth of the surgical sutures market. Key players in healthcare facilities and regulators are meticulously focusing on the outcomes of the patient and quality improvement. In addition to that, positive changes in reimbursement policies and widespread healthcare coverage are also expected to drive the market. Key Market Players B.Braun Melsungen AG, Johnson & Johnson (Ethicon), CP Medical, Atramat, Medtronic (Covidien), DemeTECH Corporation, Teleflex Incorporated (Teleflex Medical OEM), Sutumed, Kono Seisakusho Co.,Ltd, Mani Inc., Olimp- Surgical Sutures, Lotus Surgicals, Unisur Lifecare Pvt Ltd. (Universal Sutures), GMD Group, Dynek Pvt Ltd., Unilene, Advanced MedTech Solutions Pvt. Ltd, Corza Medical, Dolphin Sutures Before Buying, Visit for Customization @ Competitive Landscape The overall surgical sutures market is known to be highly fragmented owing to the presence of several competitors within the surgical sutures production spheres. In order to meet consumer demand and simultaneously expand their customer base, these companies are implementing methods such as mergers and acquisitions, partnerships and collaborations, and new product launches. More Insights into the Surgical Sutures Market India is expected to account for the highest market share by accounting for the total revenue of around 52.3% in the South Asian market in 2021 and is also expected to display growth at a lucrative CAGR of around 7.3% in the global surgical sutures market during the forecast period. The growth in the Indian market is attributed to the presence of a large number of surgical sutures manufacturers in India which are exporting their products to underpenetrated countries like Vietnam, South Africa, Zambia, Sudan, Portugal, etc. The U.S. dominates the entire North American region as it accounted for a total market share of around 93.5% in 2021 and is expected to continue to experience the same growth throughout the forecast period. The growth in the market is attributed to the presence of leading market players from this country. Germany is yet another country that is set to exhibit a CAGR of around 4.4% in the European surgical sutures market across the assessment period. Germany ranks third after China, on the basis of revenue generation with a global market share of around 7.0%. Contact Sales for Further Assistance in Buying this [email protected] Table of Content 1. Executive Summary 1.1. Global Market Outlook 1.2. Demand Side Trends 1.3. Supply Side Trends 1.4. Analysis and Recommendations 2. Market Overview 2.1. Market Coverage / Taxonomy 2.2. Market Definition / Scope / Limitations 2.3. Inclusion & Exclusion 3. Key Market Trends 3.1. Product Type Adoption / Usage Analysis 3.2. Product Type Development Trends/ New Launches 4. Key Inclusions 4.1. Key Regulatory Guidelines 4.2. Key Reimbursement scenario 4.3. Value Chain Analysis 4.4. Product Adoption Analysis 4.5. Key Manufactures Promotional Strategy 4.6. PESTLE Analysis 4.7. Porters Analysis Source: Explore FMI's Extensive Ongoing Coverage on Healthcare Domain   Dental Sutures Market Size : The global dental sutures market reached a valuation of US$ 453.8 Mn in 2021, and poised to expand at a CAGR of 6.5%, surpassing US$ 892.9 Mn by 2032. Catgut Sutures Market Value : Sutures are surgical accessories used to hold the body tissue together, which helps in timely healing of a wound. Catgut sutures are used to cure various conditions, such as neuropathic ulcers, chronic wounds, etc. Dental Diagnostic and Surgical Equipment Market Growth : Expanding at a CAGR of 7.3%, the global dental diagnostic and surgical equipment market is projected to increase from a valuation of US$ 11.2 Bn in 2021 to US$ 20.6 Bn by 2032. Directed Energy-Based Surgical Systems Market Share : The directed energy-based surgical systems market is likely to secure a CAGR of 14% during the forecast period. The market is projected to be valued at US$ 7.98 Bn in 2022 and likely to be valued at US$ 29.58 Bn by 2032. Biomaterial In Surgical Mesh Market Forecast : Biomaterials is an organic or artificial material which can be introduced into body tissue as part of an implantable medical device or it can also be used to replace an organ etc. About Future Market Insights, Inc. Future Market Insights, Inc. is an ESOMAR-certified business consulting & market research firm, a member of the Greater New York Chamber of Commerce and is headquartered in Delaware, USA. A recipient of Clutch Leaders Award 2022 on account of high client score (4.9/5), we have been collaborating with global enterprises in their business transformation journey and helping them deliver on their business ambitions. 80% of the largest Forbes 1000 enterprises are our clients. We serve global clients across all leading & niche market segments across all major industries. Contact Us    Future Market Insights Inc.          Christiana Corporate,          200 Continental Drive,          Suite 401, Newark,          Delaware - 19713, USA          T: +1-845-579-5705          For Sales Enquiries: [email protected]              Logo: SOURCE Future Market Insights