Cordance Medical, a company focused on opening the blood-brain barrier (BBB) to facilitate liquid biopsy, has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its NeuroAccess device.

Cordance Medical是一家专注于打开血脑屏障（BBB）以促进液体活检的公司，已获得美国食品和药物管理局（FDA）为其NeuroAccess设备指定的突破性设备。

NeuroAccess, which is designed for patients 22 and up with known or suspected brain tumors, helps non-invasively elevate cell-free DNA (cfDNA) analytes in blood circulation. The procedure is called SonoBiopsy and the company says it boosts existing oncology liquid biopsy assays.

NeuroAccess专为22岁及以上患有已知或疑似脑肿瘤的患者设计，有助于非侵入性地提高血液循环中的无细胞DNA（cfDNA）分析物。该程序被称为sonobiopy，该公司表示它可以促进现有的肿瘤液体活检检测。

The technology uses focused ultrasound combined with microbubbles to safely and temporarily open the BBB. The portable NeuroAccess device aims to bring SonoBiopsy broadly across community clinics and hospitals.

该技术使用聚焦超声结合微泡来安全和暂时打开BBB。便携式NeuroAccess设备旨在广泛地在社区诊所和医院进行超声检查。

Earlier this year, pioneering studies at Washington University in St. Louis demonstrated a SonoBiopsy procedure in brain tumor patients was safe and feasible to facilitate liquid biopsies. Cordance Medical has partnered with SonoBiopsy investigators Dr. Eric Leuthardt and Dr. Hong Chen and recently announced licensing of intellectual property with Washington University in St Louis. .

今年早些时候，在圣华盛顿大学进行了开创性的研究。路易斯证实脑肿瘤患者的超声活检程序安全可行，便于液体活检。Cordance Medical与SonoBiopsy调查员Eric Leuthardt博士和Hong Chen博士合作，最近宣布在圣路易斯华盛顿大学获得知识产权许可。。.

Cordance’s technology hopes to revolutionize both liquid biopsy and drug delivery techniques for glioblastoma multiforme (GBM), brain metastasis, Alzheimer's, Parkinson's, and other neurologic diseases.

Cordance的技术希望彻底改变多形性胶质母细胞瘤（GBM），脑转移，阿尔茨海默病，帕金森病和其他神经系统疾病的液体活检和药物输送技术。

'This Breakthrough Device Designation from the FDA is a pivotal milestone for Cordance Medical and for patients requiring more efficacious diagnostic solutions,' Cordance Medical CEO Ryan Dittamore told the press. 'We are keen to continue our clinical trials and to collaborate closely with the FDA to bring this groundbreaking technology to market.' .

“FDA的这一突破性设备名称是Cordance Medical和需要更有效诊断解决方案的患者的关键里程碑，”Cordance Medical首席执行官Ryan Dittamore向媒体表示我们热衷于继续我们的临床试验并与FDA密切合作，将这项开创性的技术推向市场。