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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與布里格姆婦女醫院合作進行其關鍵人體臨床試驗
Microbot Medical ·  06/20 12:00

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

在FDA批准開展臨床試驗後,已進行了正式的現場啓動,以準備進行患者招募工作。

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

網站已經收到了多個機器人系統,以支持該試驗的庫存準備工作。

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.

美國馬薩諸塞州布萊恩特裏市,2024年6月20日(全球新聞電)-Microbot Medical Inc.(納斯達克:MBOT)宣佈與布魯斯頓和婦女醫院(BWH)達成協議,BWH是位於馬薩諸塞州波士頓的一家領先的學術醫療中心,爲其Liberty的重要人體臨床試驗之一提供服務。經過申請授權試驗裝置(“IDE”)的一部分,這將是其關鍵人體臨床試驗的一部分。

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.

此進展在2024年6月17日之前宣佈,接着美國食品和藥物管理局批准Microbot開展關鍵人體臨床試驗。

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.

公司已經完成了現場啓動訪問,期間BWH臨床工作人員接受了臨床研究協議以及使用Liberty的培訓,Endovascular Robotic Surgical System。此外,支持臨床試驗的第一批Liberty調查系統本週已到達BWH。Dmitry Rabkin博士,MD,PHD(二級主任,血管造影與介入放射學),將作爲BWH的主要研究員領導該研究。

"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."

“我們很高興與Dmitry Rabkin博士和布萊格姆和婦女醫院的團隊合作進行這項臨床研究,” Microbot Medical的首席執行官,總裁和董事長Harel Gadot評論道。 “我們相信他們對研究和科學進步的承諾使他們成爲理想的臨床研究場所。”

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

公司正在與其他領先的中心聯繫,參與臨床試驗。

About Microbot Medical

關於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.(納斯達克:MBOT)是一家臨床醫療器械公司,專注於轉型微機器人技術,旨在通過人體內的自然和人工腔道改善患者的臨床結果,並提高可訪問性。

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.

擬議中的LIBERTY內科手術機器人系統(調查裝置豁免申請)。LIBERTY的測試目的是通過消除大型、笨重的複雜的資本設備,同時減少放射線暴露和外科醫生的負擔,改進目前在內科手術機器人中使用機器人技術的方法。公司相信,遠程操作具有成爲民主化內臟介入手術程序的第一個系統的潛力。關於Microbot Medical的更多信息,請訪問www.microbotmedical.com

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

"與管理層表達的其他關於未來預期、信念、目標、計劃或前景的聲明並非歷史事實(即,包括最終招股書補充中控制成本的描述),除非納斯達克或其他執法機構還要求否認,否則您不應將其視爲準確的說明。因爲這些聲明涉及未來事件的風險和不確定性,無法保證實際結果將不會與這些聲明中所述的實際結果有所不同。除非另有規定,否則Microbot Medical不承擔更新前瞻性聲明的責任。"Hingham公司於2024年6月3日Global Newswire發佈.

Safe Harbor

免責聲明

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.

未來財務和/或運營結果、研究、技術、臨床開發以及Microbot Medical Inc.及其子公司的潛在機會的陳述,以及其他關於未來期望、信懇智能、目標、計劃或前景的其他陳述,都構成《1995年私人證券訴訟改革法》和聯邦證券法的前瞻性陳述。任何不是歷史事實(包括但不限於包含諸如“將”、“相信”、“計劃”、“預計”和“估計”之類的字眼的陳述)也應視爲前瞻性陳述。前瞻性陳述涉及風險和不確定性,包括但不限於市場環境、LIBERTY內科手術機器人系統的開發和/或商業化風險,以及其評估LIBERTY內科手術機器人系統的研究結果。LIBERTY內科手術機器人系統的評估結果。該公司認爲,調查的LIBERTY內部循環機器人手術系統的遠程操作有潛力成爲第一個民主化的內部循環介入手術系統。www.sec.gov微型機器人醫療公司聲明除非法律要求否則不承擔更新這些前瞻性聲明的任何意圖或義務。

Investor Contact:
Michal Efraty
IR@microbotmedical.com

投資者聯繫人:
米哈爾·埃夫拉蒂
IR@microbotmedical.com

Primary Logo

Source: Microbot Medical Inc.

來源:微型機器人醫療公司

譯文內容由第三人軟體翻譯。


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