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.
阿森纳医疗公司是一家临床阶段的公司,开发由创新生物材料制成的医疗设备,今天宣布启动NeoCast的EMBO-02临床研究。™用于治疗慢性硬膜下血肿(cSDH)。NeoCast是一种首创的剪切响应型、非粘性、无溶剂的液体栓塞材料,专为深远穿透而设计。这项研究在澳大利亚的三个地点招募了多达10名受试者;第一位患者已在澳大利亚维多利亚的莫纳什健康中心招募。
“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.”
“我们对在cSDH中使用NeoCast的经验感到鼓舞。最初的病例是EMBO-01中脑膜栓塞的优秀转化,该研究旨在研究高血管性脑肿瘤。NeoCast在整个注射过程中表现出可预测的性能,并提供了强有力的远端阻塞,进一步展示了其独特的性能,使其与当前的栓塞产品不同。”Monash Health的介入神经放射学家和EMBO-02和EMBO-01试验的主要研究者Lee-Anne Slater博士说。“需要更好的创新解决方案来管理这种重要的神经血管疾病。我们期待EMBO-02的继续招生,并发现NeoCast对这一群体的潜力。”
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.
阿森纳医疗公司总裁兼首席执行官Upma Sharma博士评论道,“最近的资料表明,脑膜中动脉栓塞术(MMAe)治疗cSDH的次数迅速增加,预计将超过大血管卒中。EMBO-02的推出,是我们与NeoCast合作的第二项研究,是公司的一个重要里程碑,也是提供差异化栓塞解决方案的下一步。