Globus Medical获得美国食品药品监督管理局批准的矫形机器人-动脉网

Globus Medical gets FDA nod for ortho robot

MedTech Dive 等信源发布 2024-06-21 11:35

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Dive Brief:

潜水简介：

Globus Medical received 510(k) clearance from the Food and Drug Administration for its ExcelsiusFlex orthopedics robot, according to a posting from the agency.

据美国食品和药物管理局发布的公告称，Globus Medical的ExcelsiusFlex骨科机器人获得了美国食品和药物管理局510（k）的许可。

CEO Dan Scavilla said in a May investor call that Globus had filed a submission for a reconstruction robot with the FDA and expected clearance late in the third quarter. A June 14 filing describes ExcelsiusFlex as a device that provides stereotaxic guidance during orthopedic joint or spine surgeries..

首席执行官丹·斯卡维拉（DanScavilla）在5月份的一次投资者电话会议上表示，Globus已向FDA提交了一份重建机器人的申请，预计将在第三季度末获得批准。6月14日的一份文件将ExcelsiusFlex描述为一种在骨科关节或脊柱手术中提供立体定向指导的设备。。

RBC Capital Markets analyst Shagun Singh, who first pointed out the FDA’s notification in an emailed research note, said that Globus hopes to gain share in the roughly $15 billion global reconstruction market with the new robot.

RBC资本市场分析师沙根·辛格（ShagunSingh）在一份电子邮件研究报告中首次指出了FDA的通知，他表示，Globus希望通过这种新型机器人在全球约150亿美元的重建市场上获得份额。

Dive Insight:

潜水洞察：

Orthopedics firm Globus Medical currently sells a robotic navigation system for spine surgeries, called ExcelsiusGPS, and a related imaging platform. Both products have driven growth for the company. In the first quarter, Scavilla said sales of robotic and imaging systems drove Globus’ enabling technology segment to grow 27% year over year to $32 million, making for the “highest Q1 since launch.” .

骨科公司Globus Medical目前销售一种用于脊柱手术的机器人导航系统，称为ExcelsiusGPS，以及相关的成像平台。这两种产品都推动了公司的增长。Scavilla表示，第一季度，机器人和成像系统的销售推动Globus的赋能技术部门同比增长27%，达到3200万美元，创下“自发布以来的最高第一季度”。

Globus also acquired a spine surgery platform, called Pulse, with its recent $3.1 billion purchase of Nuvasive.

Globus还收购了一个名为Pulse的脊柱手术平台，最近斥资31亿美元收购了Nuvasive。

Now, the company is looking to expand further into joint reconstruction procedures. Discussing the new robot in May, Scavilla told investors that he expected it to be “one of the most exciting things I think we’ll get out the door this year,” adding that the company was building inventory to prepare for a rollout as it awaited FDA authorization. .

现在，该公司正在寻求进一步扩展到联合重建程序。在5月份讨论新机器人时，斯卡维拉告诉投资者，他预计这将是“我认为我们今年将推出的最令人兴奋的事情之一”，并补充说，该公司正在建立库存，为首次推出做准备，因为它正在等待FDA的授权。。

The robot will be “in a different marketplace that will allow us to have more volume ramp-up of our implants of knees and hips,” Scavilla said. “And so I think that there will be a benefit there to the overall business.”

斯卡维拉说，该机器人将“进入另一个市场，这将使我们的膝盖和臀部植入物有更多的销量增长”。“因此，我认为这将对整个业务产生好处。”

The earlier-than-expected clearance will allow Globus to expand into the global hip and knee market and provide another enabling technology, Singh wrote. Globus expects its reconstruction robot will stand apart from competitors “as it leverages its imaging, navigation, and robotics expertise in a market where implants are fairly commoditized,” she added..

辛格写道，早于预期的许可将使Globus能够扩展到全球髋关节和膝关节市场，并提供另一项使能技术。Globus预计其重建机器人将在竞争对手中脱颖而出，“因为它在植入物相当商品化的市场上利用了其成像、导航和机器人专业知识，”她补充道。。

The company also plans to launch a cementless knee later this year.

该公司还计划在今年晚些时候推出无骨水泥膝关节。

A Globus spokesperson confirmed the clearance in an email. Singh wrote that the company expects a minimal sales contribution in 2024 with a soft initial launch and hopes to gain market share annually in the U.S. reconstruction market.

Globus发言人在一封电子邮件中确认了这一许可。辛格（Singh）写道，该公司预计2024年的销售贡献将微乎其微，并希望在美国重建市场每年获得市场份额。