GATT Technologies BV

一根纤细的医用缝合线，不仅是外科手术中的常见材料，更是连接健康与恢复的纽带。它的历史源远流长，从古代的简单材料到现代高科技的产物，缝合线的演进见证了医学技术的飞速发展。 在古代，人们使用的材料包括亚麻、头发、丝等作为缝合材料。随着时间的推移，缝合材料经历了革命性的变化。在现代社会，医用缝合线发展了羊肠线、高分子聚合物缝合线、胶原蛋白缝合线等多样化产品。 而在众多缝合线品牌中，Ethicon始终走在行业的前沿。在过去七十余年间，Ethicon推出的多种首创医用缝合线产品，不仅提高了手术的安全性和有效性，也为患者的康复带来了更多可能。    缝合线发家， 已成全球最大缝线制造商 故事始于1949年，Ethicon作为强生集团的子公司宣告成立。其产品主要包括人工合成的可吸收和不可吸收两大缝线系列以及不锈钢针，满足了手术领域日益增长的客户需求。特别是在二战以后，Ethicon的缝线产品在全球范围内的市场占有率从15%升至70%以上，在美国市场的占有率更是超过了80%，成为世界上品种最齐全的缝线制造商。 Ethicon旗下缝合线部分产品 截至目前，Ethicon已经推出普理灵®聚丙烯缝线、薇乔®缝线、普迪思®可吸收缝线、单乔®可吸收缝线、多抹棒®皮肤粘合剂等多款医用缝合线相关产品。 在不可吸收缝合线布局上，Ethicon的产品如PROLENE（普理灵）、ETHIBOND（爱惜邦）、ETHILON（爱惜良）和MERSILK（慕丝）等，均以其卓越的质量和性能，在全球范围内被广泛使用。 以普理灵®聚丙烯缝线为例，作为一款不可吸收缝合线，普理灵®聚丙烯缝线由聚丙烯制成，具有良好的生物相容性，不会引起过敏反应或其他不良反应。不仅如此，普理灵®聚丙烯缝线还具有较高的强度和耐久性，可以承受较大的张力，不易断裂，能够有效地固定和连接组织。 而在可吸收缝合线的布局上，Ethicon提供了VICRYL、MONOCRYL及PDSII等产品。其中，薇乔®缝线是由聚乙醇酸和乳酸共聚物制成的。这种材料在人体内能够逐渐被水解吸收，无需二次手术取出，从而减轻了患者的术后负担。 Ethicon并未止步于单纯的可吸收与不可吸收技术迭代，而是敏锐地捕捉到了手术感染控制这一关键医疗挑战。自1998年多抹棒®皮肤粘合剂的推出，标志着Ethicon正式踏入了缝合线抗菌性能研发的全新领域。这一创新不仅增强了伤口闭合的物理强度，更重要的是，通过提供即时的微生物屏障，有效降低了手术部位感染（SSI）的风险。 Ethicon官方披露体外研究数据表明，与深层真皮缝线共同使用时，多抹棒®皮肤粘合剂可增强伤口闭合强度，至少在72小时内提供微生物屏障阻止可感染手术部位的细菌，甚至可以抑制某些耐药细菌，例如金黄色葡萄球菌（MRSA）。 进入21世纪，Ethicon更是加大了对抗菌缝合线的研发投入。2003年，Ethicon推出“薇乔抗菌缝线”。这款缝线通过独特的抗菌机制，有效抑制了缝线上的细菌定植，进一步降低了手术部位感染的发生率，为全球医疗界提供了更为安全、高效的缝合解决方案。 整理来看，从普理灵®聚丙烯缝线的高强度与耐久性，到薇乔®系列缝线的卓越可吸收性，再到多抹棒®皮肤粘合剂的快速愈合与抗菌特性，以及后续更多抗菌型缝合线的推出，Ethicon的每一次创新都在突破缝合线的技术难点。 收购GATT Technologies B.V.，推出全球首款双面止血剂 2023年11月，Ethicon宣布CE批准其止血贴片---ETHIZIA。ETHIZIA是第一种也是唯一一种两面都有同等活性和有效性止血基质的止血贴片，将用于除心血管和神经系统外的内脏破坏性出血。 值得一提的是，ETHIZIA背后的技术支持源自荷兰企业GATT Technologies B.V.。事实上，早在2020年，强生便投资了GATT Technologies B.V.，并于2022年成功将其纳入麾下，进一步巩固了其在医疗科技领域的领先地位。 ETHIZIA之所以能在止血领域脱颖而出，关键在于其融合了GATT Technologies B.V.独有的NHS-Pox技术。这项技术通过在明胶贴片上均匀涂覆N-羟基琥珀酰亚胺酯(NHS)官能化的聚(2-恶唑啉)(简称NHS-Pox)，实现了双面高效止血功能，不仅能够有效应对严重出血，还兼容抗凝血治疗的需求。 与传统的NHS-PEG聚合物止血技术相比，NHS-Pox技术拥有超PEG四倍的NHS基团含量，实现ETHIZIA更强的组织黏附力和更快的止血速度，同时展现出优异的抗凝特性，在与血液、体液及水的相互作用中保持高效。 此外，ETHIZIA还具备高度的临床适应性，其NHS-Pox侧链活化的NHS酯异常稳定，允许根据具体临床需求调整组织粘附基团的数量及生物降解速率，甚至实现完全不可降解的效果。这一特性使得ETHIZIA在手术操作中展现出极高的灵活性，无论是填充、滚动、拉开、修剪还是定制形状，都能轻松应对，极大地提升了手术效率和患者安全性。 Ethicon披露临床研究表明，ETHIZIA在80%的受试患者中实现了30秒内的快速止血，这一速度平均比当前领先的纤维蛋白封闭剂快了6倍。  打破外企垄断， 国产企业开始发力 在全球缝合线行业的激烈竞争格局中，强生Ethicon、美敦力柯惠及贝朗公司凭借其强大的技术实力、深厚的市场积淀与广泛的品牌影响力，稳坐全球市场的头三把交椅。 再聚焦中国市场，Ethicon、泰科医疗、贝朗医疗等国际品牌仍然在中高端市场占据了显著优势。然而，随着中国医疗产业的发展，国内缝合线生产企业如山东康利达、上海天清生物材料、江苏鱼跃医疗、青岛耐丝克医材司、江西龙腾生物等创新企业正逐步崛起。 以湖南然元公司生产的佳修®纯天然可吸收胶原蛋白缝合材料为例，这种缝合材料是一种由海狸鼠尾部肌腱提取、采用物理和生物学加工方法制成的纯天然可吸收胶原蛋白缝合线，生物相容性好，其胶原蛋白含量高达 93%，在体内通过胶原酶降解为小分子多肽和氨基酸，被机体所吸收并促进愈合，没有化学残留。 同时，该缝合线在体内 8～15天就可以完全吸收降解，在降解的过程中又与人体成纤维细胞增长愈合同步进行，既保证了切口在愈合过程中适宜的张力，又使得皮肤在愈合过程中不会有形成疤痕组织的机理，最终达到无瘢痕愈合。 从整体来看，尽管在产品质量、技术创新及品牌知名度上，国内企业与国际巨头相比尚存差距，但凭借成本优势和对本土市场的深理解，国内企业在中低端市场已占据较大份额，并持续向中高端市场发起挑战。国内企业正不断加大研发投入，提升产品质量，加强品牌建设，力求在激烈的市场竞争中脱颖而出。 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

Made from synthetic polymer technology, ETHIZIA is an adjunctive haemostat solution designed to achieve sustained haemostasis in difficult to control bleeding conditions Ethicon has received European approval for ETHIZIA sealing patch. (Credit: Debora Alves from Pixabay) Johnson & Johnson MedTech’s Ethicon, a surgical instruments maker, has received the CE Mark for the ETHIZIA haemostatic sealing patch. ETHIZIA is an adjunctive haemostat solution designed to achieve sustained haemostasis in difficult to control bleeding conditions. Made from synthetic polymer technology, the sealing patch is said to be the first and only haemostatic matrix designed to be equally effective and active on both sides. According to Ethicon, the patch allows easy handling in both open and minimally invasive procedures due to its maximum adaptability design. Additionally, ETHIZIA can be packed, rolled, pulled apart, trimmed, and tailored. The haemostatic sealing patch stopped bleeding in 30 seconds in 80% of the patients who were examined in a clinical trial. The results were equal to an average of six times faster than the leading Fibrin Sealant Patch, the Johnson & Johnson MedTech company said. Ethicon company group chairman Vladimir Makatsaria said: “As a global leader in surgery, we are committed to empowering healthcare providers to safeguard patients from surgical complications by continuously delivering breakthrough solutions. “Disruptive bleeding can contribute to serious complications, and with the addition of ETHIZIA to our portfolio, we are well positioned to deliver critical haemostasis solutions for patients.” The surgical instruments maker has received European approval for the sealing patch as an adjunctive haemostat for internal organs’ disruptive bleeding with the exception of cardiovascular and neurological. With regulatory permissions in place, ETHIZIA is anticipated to launch in Q1 2024 across Europe, the Middle East and Africa (EMEA) and other markets in North America, Asia–Pacific (APAC), and Latin America. In May last year, Ethicon acquired Netherlands-based GATT Technologies, which is engaged in the development of haemostatic and sealant products by using synthetic polymer to handle difficult surgical bleeding and leak issues. The synthetic technology from GATT and the company’s acquisition enhances Ethicon’s existing capabilities to create new solutions including ETHIZIA haemostatic sealing patch for critical unmet needs.

Addition of hemostatic patch complements Ethicon's comprehensive Biosurgery portfolio and ability to address critical unmet needs in controlling bleeding RARITAN, N.J., Nov. 15, 2023 /PRNewswire/ -- Ethicon*, a Johnson & Johnson MedTech company**, today announced the approval of ETHIZIA™, an adjunctive hemostat solution which has been clinically proven to achieve sustained hemostasis in difficult to control bleeding situations.1 Comprised of unique synthetic polymer technology, ETHIZIA™ Hemostatic Sealing Patch is the first and only hemostatic matrix designed to be equally active and efficacious on both sides***.2 Designed for maximum adaptability, it can be stuffed, rolled, pulled apart, trimmed and tailored,3, 4 making it easy to handle in both open and minimally invasive surgeries.5 In 80% of clinical trial patients studied****, ETHIZIA™ Hemostatic Sealing Patch stopped bleeding in 30 seconds, an average of six times faster than the leading Fibrin Sealant Patch*****.6 7 ETHIZIA™ Hemostatic Sealing Patch has received CE Mark approval as an adjunctive hemostat for disruptive bleeding on internal organs, except cardiovascular and neurological, and is expected to launch in EMEA in Q1 2024, and other key markets in North America, APAC and LATAM following regulatory approvals. "As a global leader in surgery, we are committed to empowering healthcare providers to safeguard patients from surgical complications by continuously delivering breakthrough solutions," said Vladimir Makatsaria, Company Group Chairman, Ethicon. "Disruptive bleeding can contribute to serious complications, and with the addition of ETHIZIA™ to our portfolio, we are well positioned to deliver critical hemostasis solutions for patients." In May 2022, Ethicon acquired GATT Technologies B.V., a Netherlands-based company using differentiated synthetic polymer to create hemostatic and sealant products to address complex surgical bleeding and leak challenges. The acquisition of GATT and the addition of its synthetic technology complements Ethicon's current capabilities, enabling the development of innovative solutions that address critical unmet needs, such as ETHIZIA™ Hemostatic Sealing Patch which can offer sustained hemostasis in difficult to control bleeding situations. As a global leader in surgery, Ethicon harnesses deep expertise to design surgical solutions that are smarter, less invasive, and more personalized. The introduction of ETHIZIA™ provides a unique design that surgeons can trust to work equally effective on both sides*** 8, giving surgeons the confidence they need in any surgical situation. About Ethicon At Ethicon, a Johnson & Johnson MedTech company, putting humanity at the core of care is our passion and our purpose. In collaboration with clinicians and health care experts around the world, we develop clinically-differentiated surgical technologies and solutions to help address some of the most pressing health challenges of our time such as metabolic disease, cardiovascular disease and cancer. Through our efforts and ingenuity, we aspire to elevate standards of care and create a healthier future for the patients of today and tomorrow. Visit to learn more about us. About Johnson & Johnson MedTech At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized. For more, visit . Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the ETHIZIATM adjunctive hemostat solution. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc., Ethicon Endo-Surgery, LLC, Johnson & Johnson Enterprise Innovation Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Ethicon, Inc., Ethicon Endo-Surgery, LLC, Johnson & Johnson Enterprise Innovation Inc. nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments. *Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. All other trademarks are the property of their respective owners. **Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson's MedTech segment. ***Pre-clinical test data are not necessarily indicative of clinical performance. ****Based on clinical trial data. The Full Analysis Set showed 32/39 patients (82%) achieved hemostasis in 30 seconds. *****Tachosil Fibrin Sealant Patch is leading in EMEA region based on market share data. Tachosil time to hemostasis is 3 min per IFU. Media Contact: Paloma Feliciano [email protected] Investor Contact : Sarah Wood [email protected] ©Ethicon US, LLC. 2023. All Rights Reserved. Logo -