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Microbot Medical Partners With Brigham and Women's Hospital for Its Pivotal Human Clinical Trial

Microbot Medical Partners With Brigham and Women's Hospital for Its Pivotal Human Clinical Trial

microbot medical与布里格姆妇女医院合作进行其关键性人体临床试验
Microbot Medical ·  06/20 00:00

Following FDA Approval to Commence the Clinical Trial, an Official Site Initiation Has Taken Place as Preparation for Patient Enrollment Advances

在FDA批准开展临床试验后,已进行了正式的现场启动,以准备进行患者招募工作。

Multiple Robotic Systems Already Received by the Site to Allow Inventory Readiness in Support of Trial

网站已经收到了多个机器人系统,以支持该试验的库存准备工作。

BRAINTREE, Mass., June 20, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) announced its agreement with Brigham and Women's Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, to serve as one of the sites to perform the pivotal human clinical trial for its LIBERTY Endovascular Robotic Surgical System, as part of its Investigational Device Exemption ("IDE") application.

美国马萨诸塞州布莱恩特里市,2024年6月20日(全球新闻电)-Microbot Medical Inc.(纳斯达克:MBOT)宣布与布鲁斯顿和妇女医院(BWH)达成协议,BWH是位于马萨诸塞州波士顿的一家领先的学术医疗中心,为其Liberty的重要人体临床试验之一提供服务。经过申请授权试验装置(“IDE”)的一部分,这将是其关键人体临床试验的一部分。

This development, previously announced on June 17, 2024, follows the U.S. Food and Drug Administration's approval to commence Microbot's pivotal human clinical trial.

此进展在2024年6月17日之前宣布,接着美国食品和药物管理局批准Microbot开展关键人体临床试验。

The Company has completed the Site Initiation Visit, during which BWH clinical staff was trained on the clinical study protocols and the use of the LIBERTY Endovascular Robotic Surgical System. In addition, the first shipment of LIBERTY investigational systems arrived at BWH this week in support of the clinical trial. Dr. Dmitry Rabkin, MD, PhD (Assistant Chief, Division of Angiography & Interventional Radiology), will lead the study for the site as principal investigator at BWH.

公司已经完成了现场启动访问,期间BWH临床工作人员接受了临床研究协议以及使用Liberty的培训,Endovascular Robotic Surgical System。此外,支持临床试验的第一批Liberty调查系统本周已到达BWH。Dmitry Rabkin博士,MD,PHD(二级主任,血管造影与介入放射学),将作为BWH的主要研究员领导该研究。

"We are pleased to work with Dr. Rabkin and the team at Brigham and Women's Hospital on this clinical study," commented Harel Gadot, CEO, President and Chairman of Microbot Medical. "We believe their commitment to research and the advancement of science make them an ideal clinical study site."

“我们很高兴与Dmitry Rabkin博士和布莱格姆和妇女医院的团队合作进行这项临床研究,” Microbot Medical的首席执行官,总裁和董事长Harel Gadot评论道。 “我们相信他们对研究和科学进步的承诺使他们成为理想的临床研究场所。”

The Company is in the process of engaging additional leading centers to participate in the clinical trial.

公司正在与其他领先的中心联系,参与临床试验。

About Microbot Medical

关于Microbot Medical

Microbot Medical Inc. (NASDAQ: MBOT) is a clinical stage medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body.

Microbot Medical Inc.(纳斯达克:MBOT)是一家临床医疗器械公司,专注于转型微机器人技术,旨在通过人体内的自然和人工腔道改善患者的临床结果,并提高可访问性。

The Investigational LIBERTY Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY Endovascular Robotic Surgical System's remote operation has the potential to be the first system to democratize endovascular interventional procedures.

拟议中的LIBERTY内科手术机器人系统(调查装置豁免申请)。LIBERTY的测试目的是通过消除大型、笨重的复杂的资本设备,同时减少放射线暴露和外科医生的负担,改进目前在内科手术机器人中使用机器人技术的方法。公司相信,远程操作具有成为民主化内脏介入手术程序的第一个系统的潜力。关于Microbot Medical的更多信息,请访问www.microbotmedical.com

Further information about Microbot Medical is available at http://www.microbotmedical.com.

"与管理层表达的其他关于未来预期、信念、目标、计划或前景的声明并非历史事实(即,包括最终招股书补充中控制成本的描述),除非纳斯达克或其他执法机构还要求否认,否则您不应将其视为准确的说明。因为这些声明涉及未来事件的风险和不确定性,无法保证实际结果将不会与这些声明中所述的实际结果有所不同。除非另有规定,否则Microbot Medical不承担更新前瞻性声明的责任。"Hingham公司于2024年6月3日Global Newswire发布.

Safe Harbor

免责声明

Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects" and "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of the LIBERTY Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company's pivotal study in humans is successful, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading "Risk Factors" in Microbot Medical's periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC's web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law.

未来财务和/或运营结果、研究、技术、临床开发以及Microbot Medical Inc.及其子公司的潜在机会的陈述,以及其他关于未来期望、信恳智能、目标、计划或前景的其他陈述,都构成《1995年私人证券诉讼改革法》和联邦证券法的前瞻性陈述。任何不是历史事实(包括但不限于包含诸如“将”、“相信”、“计划”、“预计”和“估计”之类的字眼的陈述)也应视为前瞻性陈述。前瞻性陈述涉及风险和不确定性,包括但不限于市场环境、LIBERTY内科手术机器人系统的开发和/或商业化风险,以及其评估LIBERTY内科手术机器人系统的研究结果。LIBERTY内科手术机器人系统的评估结果。该公司认为,调查的LIBERTY内部循环机器人手术系统的远程操作有潜力成为第一个民主化的内部循环介入手术系统。www.sec.gov微型机器人医疗公司声明除非法律要求否则不承担更新这些前瞻性声明的任何意图或义务。

Investor Contact:
Michal Efraty
IR@microbotmedical.com

投资者联系人:
米哈尔·埃夫拉蒂
IR@microbotmedical.com

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Source: Microbot Medical Inc.

来源:微型机器人医疗公司

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