CHAPEL HILL, N.C., May 2, 2024 /PRNewswire/ -- SonoVascular, Inc., a private medical device company focused on the development of its SonoThrombectomy™ System, a novel pharmaco-mechanical ultrasound facilitated thrombectomy system that utilizes microbubble-mediated cavitation as a core enabling mechanism of action to treat patients with venous thromboembolism (VTE), has executed an exclusive clinical supply agreement with Lantheus Holdings, Inc.

北卡罗来纳州教堂山，2024年5月2日/PRNewswire/--SonoVascular，Inc.，一家私人医疗器械公司，专注于开发其SonoThrombectomy™系统，这是一种新型的药物-机械超声促进血栓切除系统，利用微泡介导的空化作为治疗静脉血栓栓塞症（VTE）患者的核心使能机制，已与Lantheus Holdings，Inc.签署了独家临床供应协议。

(Lantheus) to use Lantheus' microbubbles in combination with SonoVascular's SonoThrombectomy System to treat deep vein thrombosis (DVT) and pulmonary embolism (PE)..

（Lantheus）使用Lantheus的微泡结合SonoVascular的SonoThrombectomy系统治疗深静脉血栓形成（DVT）和肺栓塞（PE）。。

VTE is a condition that occurs when a blood clot forms in a deep vein, resulting in DVT. One of the most serious complications of DVT happens when a part of the clot breaks off and travels through the bloodstream to the lungs, causing a PE. SonoThrombectomy uniquely combines ultrasound, microbubbles, low dose thrombolytic drug, and mechanical retrieval or aspiration, delivered via an integrated intravascular catheter system to treat DVT and PE more effectively and safely..

VTE是一种在深静脉形成血块导致DVT的情况。DVT最严重的并发症之一是部分凝块脱落并通过血流进入肺部，导致PE。超声血栓切除术独特地结合了超声波，微泡，低剂量溶栓药物和机械取出或抽吸，通过集成的血管内导管系统输送，以更有效和安全地治疗DVT和PE。。

The microbubbles are activated by intravascular ultrasound and will be investigated in ongoing pre-clinical and upcoming clinical studies. The SonoThrombectomy System has been engineered to address and overcome the deficiencies and limitations of current interventional devices. It is a catheterization laboratory-based solution that has been designed to maximize the reduction in clot burden, reduce the dose and duration as well as enhance the delivery of thrombolytics to levels that optimize safety and effectiveness, and eliminate the need for patients to be treated in the intensive care unit.

微泡被血管内超声激活，将在正在进行的临床前和即将进行的临床研究中进行研究。超声血栓切除术系统的设计旨在解决和克服当前介入设备的缺陷和局限性。它是一种基于导管插入实验室的解决方案，旨在最大程度地减少凝块负担，减少剂量和持续时间，并将溶栓药物的输送提高到优化安全性和有效性的水平，并消除患者在重症监护室接受治疗的需要。

SonoVascular's SonoThrombectomy System has been successfully evaluated in in vitro and in vivo preclinical studies and is now poised to initiate first-in-human (FIH) studies in 2024 in partnership with Lantheus to evaluate safety and feasibility of the SonoThrombectomy System for treatment of DVT and PE prior to moving forward with pivotal studies in the U.S.

SonoVascular的SonoThrombectomy系统已在体外和体内临床前研究中得到成功评估，现在准备于2024年与Lantheus合作启动首次人体（FIH）研究，以评估SonoThrombectomy系统治疗DVT和PE的安全性和可行性，然后在美国进行关键研究。

for both indications..

对于这两种迹象。。

Lantheus will supply its microbubbles and activation devices, while SonoVascular will be responsible for executing clinical studies and future regulatory submissions and commercialization. Additionally, upon completion of a FIH study, SonoVascular has an option to enter into a long-term exclusive commercial supply agreement with Lantheus..

Lantheus将提供其微泡和激活设备，而SonoVascular将负责执行临床研究以及未来的监管提交和商业化。此外，在完成FIH研究后，SonoVascular可以选择与Lantheus签订长期独家商业供应协议。。

'We are excited to partner with SonoVascular to extend our microbubble franchise into a novel treatment for VTE,' said Etienne Montagut, Chief Business Officer of Lantheus. 'Our collaboration with SonoVascular leverages both companies' strengths to help change the paradigm in the treatment of venous disease - a large and growing clinical condition.'.

Lantheus首席商务官艾蒂安·蒙塔古特（EtienneMontagut）说：“我们很高兴与SonoVascular合作，将我们的微泡特许经营权扩展到VTE的新型治疗方法。”我们与SonoVascular的合作利用了两家公司的优势，帮助改变静脉疾病治疗的范式-这是一种巨大且不断增长的临床病症。

'SonoVascular is honored to have the opportunity to partner with Lantheus, a leader in microbubble development,' said Daniel Estay, Founder and Chief Executive Officer of SonoVascular. 'Our SonoThrombectomy System, combined with Lantheus' microbubbles, is designed to provide a true, next generation solution for the treatment of DVT and PE that overcomes the drawbacks associated with catheter-based thrombectomy and thrombolysis devices.'.

SonoVascular创始人兼首席执行官丹尼尔·埃斯泰（DanielEstay）说，SonoVascular很荣幸有机会与微泡开发领域的领导者兰修斯（Lantheus）合作我们的超声血栓切除术系统与Lantheus的微泡相结合，旨在为DVT和PE的治疗提供真正的下一代解决方案，克服基于导管的血栓切除术和溶栓装置的缺点。

About Venous Thromboembolism

关于静脉血栓栓塞

Venous thromboembolism is a condition that occurs when a blood clot forms in a vein. As many as 900,000 VTE events occur each year in the United States.1 VTE includes DVT and PE. DVT occurs when a blood clot forms in a deep vein, usually in the lower leg, thigh or pelvis. The most serious complication of DVT happens when a part of the clot breaks off and travels through the bloodstream to the lungs, causing a blockage called PE.

静脉血栓栓塞症是当静脉中形成血块时发生的一种疾病。美国每年发生多达90万次VTE事件。1 VTE包括DVT和PE。DVT发生在深静脉血栓形成时，通常在小腿，大腿或骨盆。DVT最严重的并发症发生在血栓的一部分脱落并通过血流进入肺部，导致称为PE的阻塞。

If the clot is large, it can stop blood from reaching the lungs and can be fatal. One-third to one-half of people who have a DVT will have long-term complications caused by damage to the valves in the vein called post-thrombotic syndrome (PTS).2 In some cases, PTS symptoms can be so severe that a person becomes disabled.

如果凝块较大，它可以阻止血液进入肺部，并可能致命。三分之一到一半的DVT患者会因静脉瓣膜受损而产生长期并发症，称为血栓后综合征（PTS）。2在某些情况下，PTS症状可能非常严重，以至于一个人变得残疾。

PE can be life-threatening, with 10-30% of individuals dying within one month of diagnosis.3.

PE可能危及生命，10-30%的人在诊断后一个月内死亡。

About SonoVascular, Inc.

关于SonoVascular，股份有限公司。

SonoVascular designs and develops innovative therapeutic ultrasound-based medical devices for treating vascular disease. Founded in 2018 with exclusively licensed technology developed by scientists at the Joint Department of Biomedical Engineering between the University of North Carolina at Chapel Hill and North Carolina State University, SonoVascular developed the SonoThrombectomy System, a novel pharmaco-mechanical ultrasound facilitated thrombectomy system for VTE that utilizes microbubble-mediated cavitation as a core enabling mechanism of action to more effectively remove VTE blood clots.

SonoVascular设计并开发用于治疗血管疾病的基于超声波的创新治疗医疗设备。SonoVascular成立于2018年，拥有由北卡罗来纳大学教堂山分校和北卡罗来纳州立大学生物医学工程联合系科学家开发的独家许可技术，开发了SonoThrombectomy系统，这是一种新型的药物-机械超声促进VTE血栓切除系统，利用微泡介导的空化作为核心使能机制，更有效地去除VTE血栓。

The system uniquely combines: (i) ultrasound, (ii) microbubbles, (iii) low dose thrombolytic drug, and (iv) mechanical retrieval or aspiration, delivered via an integrated intravascular catheter system. The SonoThrombectomy System has been engineered to address and overcome the deficiencies and limitations of current interventional devices.

该系统独特地结合了：（i）超声波，（ii）微泡，（iii）低剂量溶栓药物，以及（iv）通过集成的血管内导管系统输送的机械回收或抽吸。超声血栓切除术系统的设计旨在解决和克服当前介入设备的缺陷和局限性。

It is a catheterization laboratory-based solution, that has been designed to maximize the reduction in clot burden, reduce the dose and duration as well as enhance the delivery of thrombolytics to levels that optimize safety and effectiveness, and eliminate the need for patients to be treated in the ICU.

它是一种基于导管插入实验室的解决方案，旨在最大程度地减少凝块负担，减少剂量和持续时间，并将溶栓药物的输送提高到优化安全性和有效性的水平，并消除患者在ICU接受治疗的需要。

SonoVascular is headquartered in Chapel Hill, NC..

SonoVascular总部位于北卡罗来纳州教堂山。。

1 Gregson J, Kaptoge S, Bolton T, et al. Cardiovascular Risk Factors Associated With Venous Thromboembolism. JAMA Cardiol. 2019;4(2):163–173. doi:10.1001/jamacardio.2018.4537.

1 Gregson J，Kaptoge S，Bolton T等。与静脉血栓栓塞相关的心血管危险因素。JAMA Cardiol公司。2019年；4（2）：163-173。doi:10.1001/jamacardo.2018.4537。

2 Wendelboe AM, Campbell J, McCumber M; Bratzler D; Ding K, Beckman M, Reyes N; Raskob G. The Design and Implementation of a New Surveillance System for Venous Thromboembolism using Combined Active and Passive Methods. American Heart Journal. 2015.

2 Wendelboe AM，Campbell J，McCumber M；布拉兹勒D；丁K，贝克曼M，雷耶斯N；Raskob G.使用主动和被动相结合的方法设计和实现一种新的静脉血栓栓塞监测系统。美国心脏杂志。2015

3 American Lung Association; https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism#:~:text=Pulmonary%20embolism%20affects%20around%20900%2C000,that%20travel%20to%20the%20lungs

3美国肺协会；https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism#:~：text=肺栓塞影响大约20900%2C000，即旅行到肺部

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SOURCE SonoVascular, Inc.

来源：SonoVascular，股份有限公司。