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Noah Medical发布肺部导航手术机器人的首次人体试验数据

Noah Medical posts first-in-human trial data from its lung-navigating surgical robot

Biotech Today 等信源发布 2023-11-16 00:52

可切换为仅中文


Surgical robot maker Noah Medical has delivered first-in-human clinical data from its Galaxy system, designed to navigate through a patient’s airway and probe the lungs for potential cancers and other conditions.

外科机器人制造商Noah Medical已经从其Galaxy系统提供了首次人体临床数据,旨在导航患者的气道并探测肺部潜在的癌症和其他疾病。

The company was buoyed by a $150 million venture capital funding round earlier this year, which paired up with an FDA clearance for its Galaxy bronchoscopy system in March.

今年早些时候,该公司获得了1.5亿美元的风险资本资助,并于3月份获得了FDA对其Galaxy支气管镜系统的许可。

The system combines single-use hardware with real-time imaging software and allows the surgeon to collect biopsy samples from suspicious nodules in the periphery of the lungs via a video-game-like controller.

该系统将一次性硬件与实时成像软件相结合,允许外科医生通过类似视频游戏的控制器从肺部周围的可疑结节收集活检样本。

Preliminary results from the clinical trial, which was conducted at Macquarie University Hospital in Sydney, showed the system had a 100% success rate in navigating the bronchoscope to each of 19 targeted lung lesions, using integrated tomosynthesis and fluoroscopy imaging.

在悉尼麦格理大学医院进行的临床试验的初步结果显示,该系统使用集成的断层合成和荧光成像技术,在将支气管镜导航至19个靶向肺部病变中的每一个时,成功率为100%。

The study also confirmed that the biopsy tool was able to be placed within the lesion in every case, resulting in diagnostic yields between 89.5% and 94.7%—though Noah said patient follow-ups will be needed to establish final yield data.

该研究还证实,活检工具能够在每种情况下放置在病变内,导致诊断率在89.5%和94.7%之间-尽管Noah表示需要患者随访以确定最终产量数据。

“The ability to accurately and safely navigate to and biopsy lung nodules with complete confidence is a game-changer for pulmonologists in the fight against cancer,” Macquarie University’s Tajalli Saghaie, M.D., the study’s co-principal investigator, said in the company’s announcement.

该研究的联合首席研究员麦格理大学的Tajalli Saghaie博士在该公司的公告中说:“能够完全自信地准确,安全地导航和活检肺结节是肺科医师抗击癌症的游戏改变者。”。

Noah did not list any major complications during the procedure nor in the seven days that followed. The trial’s results were presented at the annual conference of the American Association of Bronchology and Interventional Pulmonology.

Noah没有列出手术过程中或随后的七天内的任何重大并发症。该试验的结果在美国支气管病学和介入肺病学协会年会上提出。

The company previously kicked off the commercial launch of the Galaxy system in May, disclosing its first use at the University of Chicago.

该公司此前于5月启动了Galaxy系统的商业发布,披露了其在芝加哥大学的首次使用。