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CollPlant和Stratasys宣布对再生商业尺寸乳房植入物进行临床前研究

CollPlant and Stratasys Announce Pre-clinical Study for Regenerative Commercial-Sized Breast Implants

businesswire 等信源发布 2024-08-19 18:30

可切换为仅中文


REHOVOT, Israel & EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--In a significant step in the advancement of regenerative medicine, CollPlant Biotechnologies (Nasdaq: CLGN) and Stratasys Ltd. (Nasdaq: SSYS) today announced the initiation of a pre-clinical study with 200cc commercial-sized regenerative implants printed on a Stratasys Origin® 3D printer..

以色列REHOVOT和明尼苏达州EDEN PRAIRIE(商业新闻短讯)——CollPlant Biotechnologies(纳斯达克股票代码:CLGN)和Stratasys Ltd.(纳斯达克股票代码:SSYS)今天宣布启动一项临床前研究,在Stratasys Origin®3D打印机上打印200cc商业尺寸的再生植入物。。

The collaboration between CollPlant and Stratasys is currently focused on the development of a bioprinting solution for CollPlant’s breast implants, in addition to finding solutions to scale-up the implant’s fabrication process. The study is intended to test the ability of the implants to promote the growth of natural breast tissue and completely degrade over time..

CollPlant和Stratasys之间的合作目前主要集中在为CollPlant的乳房植入物开发生物打印解决方案,以及寻找扩大植入物制造过程的解决方案。这项研究旨在测试植入物促进天然乳房组织生长并随着时间的推移完全降解的能力。。

CollPlant’s novel breast implants have been designed to regenerate an individual’s natural breast tissue without eliciting an immune response, and could provide a revolutionary alternative for both reconstructive and aesthetic procedures, which represents a significant portion of the overall $3 billion addressable breast implant market..

CollPlant的新型乳房植入物旨在再生个体的天然乳房组织而不引起免疫反应,并且可以为重建和美学程序提供革命性的替代方案,这代表了30亿美元可寻址乳房植入物市场的重要组成部分。。

“This pre-clinical study marks a significant step forward in our effort to provide patients with care using regenerative medicine instead of traditional implants,” said Stratasys CEO Dr. Yoav Zeif. “CollPlant's work is truly inspiring, and our collaboration exemplifies how Stratasys partners with customers to push the timeline and the boundaries of innovation.

Stratasys首席执行官Yoav Zeif博士说:“这项临床前研究标志着我们在使用再生医学而不是传统植入物为患者提供护理方面迈出了重要的一步。”。“CollPlant的工作确实令人鼓舞,我们的合作体现了Stratasys如何与客户合作,推动创新的时间表和边界。

Together, we are driven by a shared mission to challenge the status quo and find new ways to improve lives and advance healthcare.”.

我们共同的使命是挑战现状,寻找改善生活和推进医疗保健的新途径。”。

Yehiel Tal, CEO of CollPlant, commented, “We are extremely happy about the progress we’ve made with our breast implants program, and with Stratasys’ successful achievement to develop a printer that enables us to print a commercial-size implant with high resolution and optimal physical properties. The combined pioneering technologies of both companies is expected to streamline the development and production process so that we have the most efficient means to produce our regenerative breast implants.

CollPlant首席执行官Yehiel Tal评论道:“我们非常高兴我们在隆胸项目方面取得的进展,以及Stratasys在开发打印机方面取得的成功成就,该打印机使我们能够打印具有高分辨率和最佳物理性能的商用尺寸的植入物。两家公司的开创性技术相结合,有望简化开发和生产过程,使我们拥有最有效的手段来生产再生隆胸。

We believe that our rhCollagen-based regenerative implant has the potential to overcome the challenges of existing breast procedures that use silicone implants or autologous fat transfer, thereby significantly improving patient outcomes.”.

我们相信,我们的基于rhCollagen的再生植入物有可能克服使用硅胶植入物或自体脂肪转移的现有乳房手术的挑战,从而显着改善患者的预后。”。

Stratasys is a leader in polymer 3D printing solutions and CollPlant is a pioneering regenerative and aesthetics medicine company developing innovative technologies and products based on its rhCollagen for tissue regeneration and organ manufacturing.

Stratasys是聚合物3D打印解决方案的领导者,CollPlant是一家开创性的再生和美学医学公司,开发基于其rhCollagen的创新技术和产品,用于组织再生和器官制造。

Since announcing the collaboration in April of 2023, Stratasys has adapted the Origin printer to print the regenerative implants, and CollPlant successfully managed to 3D-print them at 200ccs. CollPlant is expecting to have initial results from the study in the first half of 2025.

自2023年4月宣布合作以来,Stratasys已经调整了Origin打印机来打印再生植入物,CollPlant成功地以200ccs的速度进行了3D打印。CollPlant预计将在2025年上半年取得初步研究结果。

Currently the global breast implant market is estimated to be $3.0 billion,1 while breast reconstruction and augmentation procedures represent the second most common plastic surgery procedure performed worldwide2. The most common breast augmentation or reconstruction procedures utilize synthetic breast implantations made of silicone, an artificial substitution for natural regenerated tissue with a risk of complications..

目前,全球乳房植入市场估计为30亿美元,1而乳房再造和隆胸手术是全球第二常见的整形手术2。最常见的隆胸或重建手术使用硅胶制成的合成乳房植入物,这是一种人工替代天然再生组织的方法,有并发症的风险。。

Earlier this year, CollPlant announced additional positive data from its previous pre-clinical studies that are currently underway which showed evidence of well-developed connective tissue containing blood vessels (i.e., neovascularization) within the implant. Progressing tissue ingrowth inside the implant was also observed confirming tissue regeneration.

今年早些时候,CollPlant宣布了之前正在进行的临床前研究的其他积极数据,这些数据显示植入物内含有血管(即新血管形成)的结缔组织发育良好。还观察到植入物内组织向内生长的进展,证实了组织再生。

An initial biodegradation process was noticed, while the original structure of the 3D breast implant was preserved. No adverse tissue reaction was present, confirming the safety profile of this novel implant in development..

注意到最初的生物降解过程,同时保留了3D乳房植入物的原始结构。没有出现不良组织反应,证实了这种新型植入物在开发中的安全性。。

1 https://www.thebrainyinsights.com/report/breast-implants-market-14142

1 https://www.thebrainyinsights.com/report/breast-implants-market-14142

2 ISAPS International Survey on Aesthetic/Cosmetic Procedures, 2021

2 ISAPS国际美容/美容程序调查,2021年

About Stratasys

关于Stratasys

Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products, healthcare, fashion and education. Through smart and connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys solutions deliver competitive advantages at every stage in the product value chain.

Stratasys正在引领全球向增材制造的转变,为航空航天、汽车、消费品、医疗保健、时尚和教育等行业提供创新的3D打印解决方案。通过智能连接的3D打印机、聚合物材料、软件生态系统和按需部件,Stratasys解决方案在产品价值链的每个阶段都提供了竞争优势。

The world’s leading organizations turn to Stratasys to transform product design, bring agility to manufacturing and supply chains, and improve patient care..

世界领先的组织转向Stratasys,以改变产品设计,为制造和供应链带来灵活性,并改善患者护理。。

To learn more about Stratasys, visit www.stratasys.com, the Stratasys blog, X/Twitter, LinkedIn, or Facebook. Stratasys reserves the right to utilize any of the foregoing social media platforms, including the Company’s websites, to share material, non-public information pursuant to the SEC’s Regulation FD.

要了解更多有关Stratasys的信息,请访问www.Stratasys.com、Stratasys博客、X/Twitter、LinkedIn或Facebook。Stratasys保留根据美国证券交易委员会FD法规,利用上述任何社交媒体平台(包括公司网站)共享重大非公开信息的权利。

To the extent necessary and mandated by applicable law, Stratasys will also include such information in its public disclosure filings..

在适用法律规定的必要范围内,Stratasys还将在其公开披露文件中包含此类信息。。

Stratasys and Origin One are trademarks or registered trademarks and the Stratasys signet is a trademark of Stratasys Ltd. and/or its subsidiaries or affiliates. All other trademarks are the property of their respective owners.

Stratasys和Origin One是商标或注册商标,Stratasys图章是Stratasys Ltd.和/或其子公司或附属公司的商标。所有其他商标均为其各自所有者的财产。

About CollPlant

关于CollPlant

CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. CollPlant's products are based on its recombinant human collagen produced with its proprietary plant based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine..

。CollPlant的产品基于其专有的基于植物的基因工程技术生产的重组人胶原蛋白。这些产品针对组织修复、美学和器官制造等不同领域的适应症,正在开创再生和美容医学的新时代。。

In 2021 CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market.

2021年,CollPlant与AbbVie公司Allergan签订了皮肤和软组织填充剂的开发和全球商业化协议,Allergan是皮肤填充剂市场的全球领导者。

For more information, visit http://www.collplant.com

For more information, visit http://www.collplant.com

Safe Harbor for Forward-Looking Statements

前瞻性声明的安全港

This joint press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to Stratasys’ and/or CollPlant’s objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that Stratasys and/or CollPlant intend, expect, project, believe or anticipate will or may occur in the future.

本联合新闻稿可能包括前瞻性声明。前瞻性陈述可能包括但不限于与Stratasys和/或CollPlant的目标、计划和战略有关的陈述,以及涉及Stratasys和/或CollPlant打算、期望、预测、相信或预期未来将或可能发生的活动、事件或发展的陈述(历史事实除外)。

These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of the companies’ respective management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate.

这些陈述通常以“相信”、“希望”、“可能”、“预期”、“应该”、“打算”、“计划”、“意志”、“预期”、“估计”、“项目”、“定位”、“战略”等术语为特征,并基于根据公司各自管理层的经验和对历史趋势、当前状况、预期未来发展和其他认为适当的因素所做的假设和评估。

Forward-looking statements included in this press release include, but are not limited to, statements regarding the following: the companies’ ability to develop a 3D bioprinter that is based on Stratasys’ P3™ 3D printing technology and can be used with CollPlant's rhCollagen-based BioInk; CollPlant’s expectations regarding the cost and timing of commencing or concluding pre-clinical and clinical trials, with respect to breast implants, tissues and organs based on its rhCollagen based bioinks and other products for medical aesthetics; CollPlant’s ability to obtain favorable pre-clinical and clinical trial results with respect to the foregoing trials; regulatory action with respect to rhCollagen based bioinks and medical aesthetics products including but not limited to acceptance of an application for marketing authorization review and approval of such application, and, if approved, the .

本新闻稿中的前瞻性声明包括但不限于以下声明:公司开发基于Stratasys的P3™3D打印技术的3D生物打印机的能力,可与CollPlant的基于rhCollagen的BioInk一起使用;CollPlant对开始或结束临床前和临床试验的成本和时间的期望,涉及基于rhCollagen的生物墨水和其他医学美学产品的乳房植入物,组织和器官;CollPlant就上述试验获得有利的临床前和临床试验结果的能力;关于rhCollagen基生物油墨和医学美学产品的监管行动,包括但不限于接受上市授权申请,审查和批准此类申请,以及(如果批准)。