Instylla, Inc., a privately held company developing novel resorbable embolics for peripheral vascular embolization, announced premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the company's flagship product Embrace™ Hydrogel Embolic System. Embrace HES has been approved for the embolization of hypervascular tumors in peripheral arteries ≤ 5mm. .

Instylla, Inc.，一家私有公司，致力于开发用于外周血管栓塞的新型可吸收栓塞剂，宣布其旗舰产品Embrace™水凝胶栓塞系统获得了美国食品药品监督管理局（FDA）的上市前批准（PMA）。Embrace HES已被批准用于外周动脉≤5mm的富血管性肿瘤的栓塞。

'I am excited to have this wonderful new tool in the IR repertoire,' said Dr. Nadine Abi-Jaoudeh.

“我很高兴能在IR领域中拥有这个绝佳的新工具，”纳丁·阿比-贾乌德博士说道。

Embrace Hydrogel Embolic System

拥抱水凝胶栓塞系统

Hypervascular tumors (HVTs), which commonly occur in the liver, kidney, bone, and other organs, are characterized by an abnormal increase in blood vessels and are often associated with poor survival outcomes

富血管肿瘤（HVTs）常见于肝脏、肾脏、骨骼及其他器官，其特征是血管异常增多，且常与较差的生存结果相关。

. Their high vascularity can make surgical removal difficult due to the elevated risk of bleeding. For patients with limited progressive disease or for local tumor control, transcatheter arterial embolization (TAE) and transarterial chemoembolization (cTACE) are established and widely used treatment options..

由于其高度血管化，手术切除可能会因出血风险增加而变得困难。对于病情进展有限或局部肿瘤控制的患者，经导管动脉栓塞术（TAE）和经动脉化疗栓塞术（cTACE）是已确立且广泛使用的治疗选择。

Embrace HES consists of two low-viscosity aqueous liquid precursors that interact to crosslink intravascularly when simultaneously injected into blood vessels during the embolization procedure to form a soft, polyethylene glycol (PEG) hydrogel. This liquid embolic is designed to deeply penetrate the tumor vascular bed.

Embrace HES 由两种低粘度的水性液体前体组成，在栓塞手术过程中同时注入血管时，这两种前体会相互作用，在血管内交联形成柔软的聚乙二醇 (PEG) 水凝胶。这种液体栓塞剂旨在深入渗透肿瘤血管床。

, crosslink, and stop blood flow.

，交联，并停止血液流动。

Premarket approval for Embrace HES was granted based on results from a prospective, randomized, multicenter pivotal study that evaluated its safety and effectiveness for the embolization of hypervascular tumors compared to the standard of care, SOC (TAE or cTACE). The study enrolled 150 patients with hypervascular tumors across 22 global institutions and randomized them 2:1 to receive either Embrace HES or SOC treatment.

基于一项前瞻性、随机、多中心关键研究的结果，Embrace HES获得了上市前批准。该研究评估了其在高血管性肿瘤栓塞治疗中的安全性和有效性，并与标准治疗（SOC，即TAE或cTACE）进行了比较。研究共纳入了来自22个全球机构的150名高血管性肿瘤患者，并按2:1的比例随机分配接受Embrace HES或SOC治疗。

. Embrace HES met both primary safety and effectiveness endpoints, demonstrating 88.6% technical success as confirmed by an independent core lab and 99% freedom from major adverse events, as adjudicated by a Clinical Events Committee. Importantly, no adverse events were classified as device-related only..

Embrace HES达到了主要的安全性和有效性终点，经独立核心实验室确认，技术成功率为88.6%，临床事件委员会裁定的重大不良事件发生率仅为1%。重要的是，没有任何不良事件被归类为仅与设备相关。

'The pivotal trial was designed to evaluate the Embrace HES system in patients with hypervascular tumors,' said Dr. Nadine Abi-Jaoudeh, Chief of Interventional Radiology at the

“关键试验旨在评估Embrace HES系统在高血管肿瘤患者中的应用，”介入放射科主任Nadine Abi-Jaoudeh博士表示，

University of California, Irvine

加利福尼亚大学欧文分校

, and National Principal Investigator of the study. 'Embrace HES is the first liquid embolic approved specifically for this indication, with a unique design that enables deep penetration into vessels as small as 10 microns. Delivered as two liquid precursors that polymerize in situ to minimize non-target embolization, the cohesive embolic also avoids catheter entrapment.

，并且是该研究的国家首席研究员。 “Embrace HES 是首个专门针对此适应症批准的液体栓塞剂，其独特设计能够深入渗透到小至10微米的血管中。它以两种液态前体形式递送，原位聚合以尽量减少非目标栓塞，这种内聚性栓塞剂还避免了导管的卡陷。”

Additionally, Embrace HES does not have any imaging artifacts, allowing us to assess follow-up imaging with confidence. The trial met both its safety and efficacy endpoints, and I am excited to have this wonderful new tool in the IR repertoire.' .

此外，Embrace HES没有任何成像伪影，使我们能够自信地评估后续成像。该试验达到了其安全性和有效性终点，我很高兴将这一极好的新工具纳入介入放射学的阵容中。'

'We are incredibly proud to receive FDA approval for Embrace HES, offering a transformational embolic platform technology solving critical unmet needs for cancer patients with hypervascular tumors,' said

“我们非常自豪Embrace HES获得了FDA的批准，这项变革性的栓塞平台技术解决了高血管性肿瘤癌症患者的关键未满足需求。”

Sean Boyle

肖恩·博伊尔

, CEO, Instylla, Inc. 'This milestone represents years of innovation and dedication of our team to advancing interventional oncology. More importantly, it brings new hope to patients and their families facing the challenges of cancer. We are motivated and committed to delivering technically advanced, clinically impactful solutions that empower interventional radiologists and expand therapeutic options across a broad range of vascular conditions.'.

Instylla公司首席执行官表示：“这一里程碑代表了我们团队多年来在介入肿瘤学领域的创新和奉献。更重要的是，它为面临癌症挑战的患者及其家属带来了新的希望。我们有动力并致力于提供技术先进、临床影响显著的解决方案，助力介入放射科医生，并拓展覆盖多种血管疾病的治疗选择。”

About Embrace Hydrogel Embolic System:

关于Embrace水凝胶栓塞系统：

Embrace HES is indicated to embolize hypervascular tumors in peripheral arteries ≤ 5 mm. Embrace HES consists of two injectable liquid precursors that crosslink 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 适用于栓塞外周动脉 ≤ 5 毫米的富血管肿瘤。Embrace HES 包含两种可注射的液态前体，当同时注入血管时会交联形成柔软的水凝胶，在栓塞过程中填充血管腔。Embrace HES 栓塞无需使用溶剂，不需要根据血管直径进行尺寸匹配，并消除了导管卡住的可能性。

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公司是一家总部位于

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 peripheral hemostasis. 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止血。Instylla 于 2017 年由 Incept LLC 创立，并由多家领先的风险投资集团提供资金支持。