Instylla完成Embrace™水凝胶栓塞系统上市前批准申请的提交-动脉网

Instylla Completes Submission of Premarket Approval Application for Embrace™ Hydrogel Embolic System

CISION 等信源发布 2025-03-11 20:02

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BEDFORD, Mass.

马萨诸塞州贝德福德

，

March 11, 2025

2025年3月11日

/PRNewswire/ --

Instylla, Inc.

英斯泰拉公司

, a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, announced that it recently submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval application (PMA) for the Embrace

，一家私人持有的临床阶段公司，致力于开发外周血管栓塞治疗解决方案，近日宣布其已向美国食品药品监督管理局（FDA）提交了Embrace产品上市前批准申请（PMA）的最终模块。

™

Hydrogel Embolic System (HES).

水凝胶栓塞系统 (HES)。

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In this final PMA module, Instylla has submitted clinical study results to the FDA, advancing our pursuit of the indication for the embolization of hypervascular tumors. With previous modules covering pre-clinical testing and manufacturing already completed, this marks a key step toward bringing our novel solution to the market..

在这一最终的PMA模块中，Instylla已向FDA提交了临床研究结果，推动我们寻求高血管性肿瘤栓塞的适应症。随着先前涵盖临床前测试和制造的模块已经完成，这标志着将我们的创新解决方案推向市场的关键一步。

In this final PMA module, Instylla has submitted clinical study results to the FDA.

在最后一个PMA模块中，Instylla已向FDA提交了临床研究结果。

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'This submission marks a significant milestone for Instylla, demonstrating our team's dedication and execution,' said

“这次提交标志着Instylla的一个重要里程碑，展示了我们团队的奉献精神和执行力，”

Amar Sawhney

阿马尔·萨赫尼

, CEO of Instylla, Inc. and Managing Director of Incept, LLC. 'We have leveraged the FDA's modular submission program to streamline the approval process, enhance efficiency, and accelerate our path to market.'

Instylla股份有限公司首席执行官兼Incept有限责任公司董事总经理表示：“我们利用了FDA的模块化提交程序来简化审批流程、提高效率并加速产品上市进程。”

About Embrace Hydrogel Embolic System:

关于Embrace水凝胶栓塞系统：

Embrace HES is an investigational device intended to embolize hypervascular tumors in vessels ≤ 5 mm. Embrace HES consists of two injectable liquid precursors that solidify when simultaneously delivered into blood vessels, forming a soft hydrogel that fills the vessel lumens during embolization. Embrace HES embolization uses no solvents, does not need sizing to the vessel diameter, and eliminates the possibility of catheter entrapment.

Embrace HES 是一种研究性装置，旨在栓塞血管 ≤ 5 毫米的富血管肿瘤。Embrace HES 由两种可注射的液态前体组成，当同时注入血管时会固化，形成一种柔软的水凝胶，在栓塞过程中填充血管腔。Embrace HES 栓塞过程无需溶剂，不需要根据血管直径调整尺寸，并且消除了导管滞留的可能性。

Its main components are water and polyethylene glycol (PEG)..

其主要成分是水和聚乙二醇（PEG）。

About Instylla:

关于Instylla：

Instylla, Inc. is a privately held company based in

Instylla, Inc. 是一家私人控股公司，总部位于

Bedford, MA

马萨诸塞州贝德福德

, focused on developing novel resorbable embolic agents to advance interventional radiology, with initial clinical applications in interventional oncology and the peripheral vasculature. Instylla was founded in 2017 by Incept LLC and is funded by several leading venture capital groups.

，专注于开发新型可吸收栓塞剂以推动介入放射学的发展，其初始临床应用在介入肿瘤学和外周血管领域。Instylla 由 Incept LLC 于2017年创立，并受到多家领先风险投资集团的资助。

To learn more, please visit

要了解更多信息，请访问

https://www.instylla.com/

Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.

注意：研究用设备。根据联邦（或美国）法律，仅限于研究使用。不可销售。

SOURCE Instylla, Inc.

来源：Instylla公司

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