WALTHAM,Mass.—First Patient Enrolled in Trial to evaluate Safety and Feasibility of Innovative Embolic Agent in Expanded Patient Population Utilizing Middle Meningeal Artery Embolization(MMAe)
马萨诸塞州沃尔瑟姆--首例患者入组试验，以评估创新栓塞剂在使用中脑膜栓塞术（MMAe）的扩大患者群体中的安全性和可行性。
Arsenal Medical,a clinical-stage company developing medical devices from innovative biomaterials,today announced the initiation of the EMBO-02 clinical study of NeoCast™to treat chronic subdural hematomas(cSDH).NeoCast is a first-of-its-kind,shear-responsive,non-adhesive,solvent-free,liquid embolic material designed for deep distal penetration.The study is enrolling up to 10 subjects at three sites in Australia;the first patient has been enrolled at Monash Health,Victoria,Australia.
利用创新生物材料开发医疗设备的临床阶段公司Arsenal Medical今天宣布启动NeoCast™治疗慢性硬膜下血肿(cSDH)的EMBO-02临床研究。NeoCast是一种首创的剪切响应型、非粘附性、无溶剂液体栓塞材料，专为深部远端穿透而设计。这项研究正在澳大利亚的三个地点招募多达10名受试者；第一名患者已在澳大利亚维多利亚州的莫纳什健康中心注册。
“We are encouraged by our experience with NeoCast in cSDH.The initial case was an excellent translation of middle meningeal embolization from EMBO-01,which studied hypervascular brain tumors.NeoCast performed predictably throughout injection and provided robust distal occlusion,further demonstrating its unique properties,which sets it apart from current embolic products,”said Lee-Anne Slater,MBBS MMed FRANZCR,Interventional Neuroradiologist at Monash Health and the principal investigator of both EMBO-02 and EMBO-01 trials.“Better performing,innovative solutions are needed to manage this significant neurovascular condition.We look forward to continuing enrollment in EMBO-02 and uncovering the potential for NeoCast for this population.”
“NeoCast在cSDH中的应用经验令我们深受鼓舞。最初的病例是对EMBO-01中脑膜栓塞的出色转化，EMBO-01研究的是高血管性脑肿瘤。NeoCast在整个注射过程中表现出可预测性，并提供了稳健的远端闭塞，这进一步证明了它的独特性能，使其有别于目前的栓塞产品，"莫纳什卫生院介入神经放射科医师、EMBO-02和EMBO-01试验的主要研究者Lee-Anne Slater（医学博士、医学硕士、FRANZCR）说。“我们需要性能更好的创新解决方案来控制这种严重的神经血管疾病。我们期待着继续参加EMBO-02试验，发掘NeoCast在这一人群中的潜力。
Upma Sharma,Ph.D.,President and CEO of Arsenal Medical commented,“Recent data suggest middle meningeal artery embolization(MMAe)procedures for treating cSDH are estimated to rapidly increase in frequency and are expected to surpass those for large vessel stroke.¹The launch of EMBO-02,our second study with NeoCast,is an important milestone for the company and a next step toward delivering a differentiated embolic solution.I am grateful to all of our clinical and scientific collaborators who are helping us to advance our next-generation embolic material and,most importantly,the patients who participate in these important studies.”
Arsenal Medical总裁兼首席执行官Upma Sharma博士评论说："最近的数据表明，治疗cSDH的脑膜中动脉栓塞术（MMAe）的频率估计会迅速增加，有望超过治疗大血管中风的手术。我感谢所有帮助我们推进下一代栓塞材料的临床和科研合作者，最重要的是感谢参与这些重要研究的患者。
about Chronic Subdural Hematoma(cSDH)
关于慢性硬膜下血肿(cSDH)
cSDH is the persistent bleeding of an injured vessel in the membrane that protects the brain(dura).It is typically caused by a fall or injury to the head(including minor head trauma)and can result in significant physical and cognitive decline.It is the most common neurosurgical condition in those 65 and older and has been categorized as a sentinel health event in the elderly.MMAe is an emerging minimally invasive procedure to treat and prevent the recurrence of cSDH.
cSDH是指保护脑膜（硬脑膜）的受伤血管持续出血。它通常由跌倒或头部受伤（包括轻微头部外伤）引起，可导致身体和认知能力显著下降。它是65岁及以上人群中最常见的神经外科疾病，已被列为老年人的哨点健康事件。MMAe是一种治疗和预防cSDH复发的新兴微创手术。
about EMBO-02
关于EMBO-02
EMBO-02 is an open-label,multi-center,prospective clinical trial to evaluate the early safety and feasibility of Arsenal Medical’s NeoCast to embolize target vessels of the subject’s middle meningeal artery(MMA)in order to treat cSDH and potentially reduce hematoma recurrence.EMBO-02 is the second study for NeoCast,following EMBO-01 which demonstrated safety and feasibility in hypervascular brain tumors.
EMBO-02是一项开放标签、多中心、前瞻性临床试验，旨在评估Arsenal Medical的NeoCast用于栓塞受试者脑膜中动脉(MMA)的靶血管以治疗cSDH并减少血肿复发的早期安全性和可行性。EMBO-02是NeoCast的第二项研究，此前的EMBO-01研究证明了该疗法在高血管性脑肿瘤中的安全性和可行性。
Primary endpoints for EMBO-02 include the following:
EMBO-02的主要终点包括以下内容：
Safety,defined as freedom from device-related disabling stroke or neurological death within 30 days of the embolization procedure.
安全性，即在栓塞手术后30天内没有发生与设备相关的致残性中风或神经系统死亡。
Feasibility,defined as the successful injection of NeoCast into the MMA,resulting in complete occlusion at or distal to the point of embolysate injection.
可行性：将NeoCast成功注入MMA，导致栓塞物注入点或其远端完全闭塞。
about NeoCast™
关于NeoCast™
NeoCast™is a next-generation,solvent-free,non-adhesive liquid embolic material designed to preferentially reach distal microvasculature.Doing so provides a complete cast of the vessel,achieving robust occlusion to stop unwanted blood flow.Developed with funding from the National Cancer Institute,NeoCast leverages shear-thinning science to reach the smallest vessels and halt blood flow to tumors and injured or diseased tissues.Its unique material characteristics deliver enhanced control during injection,eliminating harsh solvents and adhesive glues often found in current liquid embolic products.NeoCast addresses the limitations of existing embolic products for deep penetration into the microvasculature,offering easy deployment and consistent performance.
NeoCast™是新一代无溶剂、非粘性液体栓塞材料，可优先到达远端微血管。这样就能完全覆盖血管，实现强力闭塞，阻止不必要的血流。NeoCast是在美国国家癌症研究所的资助下开发的，它利用剪切稀化科学到达最小的血管，阻止血液流向肿瘤、受伤或患病组织。其独特的材料特性加强了注射过程中的控制，避免了目前液体栓塞产品中常见的刺激性溶剂和粘合剂。NeoCast解决了现有栓塞产品在深入微血管方面的局限性，具有易于使用和性能稳定的特点。
