After activation with light and removal of silicon accessories, the nerve grows and attaches inside the chamber. Credit: natrot via Shutterstock.

在使用光激活并移除硅胶配件后，神经在腔室内生长并附着。图片来源：natrot 通过 Shutterstock。

The US Food and Drug Administration (FDA) has granted de novo marketing authorisation to TISSIUM’s COAPTIUM CONNECT, representing the first atraumatic option for repairing peripheral nerve damage.

美国食品药品监督管理局（FDA）已授予TISSIUM公司的COAPTIUM CONNECT“de novo”上市许可，这是首个用于修复周围神经损伤的无创选择。

Tissium’s Coaptium Connect comprises a 3D-printed chamber and a liquid polymer which affixes to the nerve. After activation with light and removal of silicon accessories, the nerve grows and attaches inside the chamber. The chamber itself is bioresorbable, meaning no implant is left permanently.

Tissium的Coaptium Connect包括一个3D打印的腔室和一种附着在神经上的液态聚合物。在通过光激活并移除硅胶配件后，神经在腔室内生长并连接。腔室本身是生物可吸收的，意味着不会永久留下植入物。

Go deeper with GlobalData

深入探索GlobalData

Dura Substitutes Market Size (Value, Volume, ASP) by Segments, Shar...

按细分市场、份额统计的Dura替代品市场规模（价值、数量、平均售价）...

Innovation in Medical Devices: Tissue Reconstruction Implants

医疗器械创新：组织重建植入物

Data Insights

数据洞察

The gold standard of business intelligence.

商业智能的黄金标准。

Find out more

了解更多

Current approaches to treat nerve damage use sutures, which can damage tissue and impair long-term nerve repair. Additionally, sutures may not be suitable for all types of nerve injury, and operations are complex and subsequently require significant training.

当前治疗神经损伤的方法使用缝合线，这可能会损害组织并影响长期的神经修复。此外，缝合线可能不适用于所有类型的神经损伤，手术复杂，随后需要大量的培训。

Tissium’s CEO Christophe Bancel told

Tissium的首席执行官克里斯托夫·班塞尔告诉

Medical Device Network

医疗器械网络

: “Nerve repair options are pretty broad and with limited innovations in the last few years, and we believe that with our technology, we will be able to bring this area to a new age.”

：“神经修复的选择相当广泛，但近年来创新有限，我们相信，通过我们的技术，能够将这一领域带入一个新时代。”

Tissium, which is headquartered in France, plans to initiate commercial rollout of Coaptium Connect in the coming months.

总部位于法国的Tissium计划在未来几个月内启动Coaptium Connect的商业推广。

Tissium’s platform, which does not use sutures at any stage of the procedure, gives it an edge over currently marketed products. BioCircuit’s Nerve Tape, which received FDA clearance in 2022, signalled a shift away from sutures, using a tape lined with miniature hooks. Although this removed much of the trauma seen with traditional approaches, it is still not completely atraumatic.

Tissium 的平台在手术的任何阶段都不使用缝合线，这使其相较于目前市场上的产品具有优势。BioCircuit 的 Nerve Tape 在 2022 年获得了 FDA 的批准，标志着从缝合线的转变，它使用了一种带有微型钩的胶带。尽管这减少了传统方法中常见的许多创伤，但仍然不是完全无创的。

Orthocell won FDA clearance for a collagen-based wrap, branded as Remplir, though this is designed to help reduce suture requirements during surgery..

Orthocell 获得 FDA 批准的基于胶原蛋白的包裹物，品牌为 Remplir，尽管这旨在帮助减少手术过程中的缝合需求。

GlobalData Strategic Intelligence

全球数据战略情报

US Tariffs are shifting - will you react or anticipate?

美国关税正在变化——你会反应还是预见？

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

不要让政策变化让你措手不及。通过实时数据和专家分析保持主动性。

By GlobalData

来自GlobalData

Learn more about Strategic Intelligence

了解有关战略情报的更多信息

Tissium highlighted results from a clinical study reported in April in which Coaptium Connect was used on 12 patients with digital nerve injuries. Participants achieved 100% procedural success, defined as successful atraumatic sutureless coaptation, with all patients regaining full flexion and extension of the injured digit and reporting no pain a year after the procedure..

Tissium 强调了四月份报告的一项临床研究结果，该研究中 Coaptium Connect 被用于 12 名指神经损伤患者。参与者达到了 100% 的手术成功率，定义为成功的无创伤无缝合对接，所有患者在手术一年后都恢复了受伤手指的完全屈曲和伸展，并报告没有疼痛。

According to Orthocell, the global nerve repair market is estimated to be worth more than $3.5bn.

据奥索赛尔公司称，全球神经修复市场估计价值超过 35 亿美元。

Bancel told

班塞尔表示

Medical Device Network

医疗器械网络

that the simplicity of the company’s technology means it can have wide-ranging applications beyond peripheral nerve repair. Tissium, which has raised over €170m ($197m) since its founding in 2013, is targeting broadening horizons into hernia repair and cardiovascular sealing.

公司技术的简单性意味着它除了在周围神经修复方面有广泛应用外，还可以有更广泛的应用。自2013年成立以来，Tissium已筹集超过1.7亿欧元（1.97亿美元），正致力于拓展腹股沟疝修补和心血管密封等领域。

“We believe that our technology has the potential to transform how surgeries are performed. We are going where we can have an impact. Today, we have seven products in development, and those seven products in three domains represent a total addressable market of $4.5bn,” Bancel said.

“我们相信，我们的技术有潜力改变手术的进行方式。我们正在朝着能够产生影响的方向前进。目前，我们有七种产品正在开发中，这七种产品涵盖三个领域，代表着总计 45 亿美元的潜在市场，”巴菲说。