share_log

Glucotrack Announces Start Of Enrollment For Human Clinical Study Of Continuous Blood Glucose Monitor

Glucotrack Announces Start Of Enrollment For Human Clinical Study Of Continuous Blood Glucose Monitor

Glucotrack宣佈開始進行持續血糖監測器的人體臨床研究的招募
GlucoTrack ·  12/03 13:00

Feasibility study underway for the Company's novel continuous blood glucose monitor in patients with diabetes, with data expected within 6-8 weeks

公司正在進行可行性研究,針對患有糖尿病的患者使用新型連續血糖監測儀,預計數據將在6-8周內出爐。

Rutherford, NJ, Dec. 03, 2024 — Glucotrack, Inc. (Nasdaq: GCTK) ("Glucotrack" or the "Company"), a medical technology company focused on the design, development, and commercialization of novel technologies for people with diabetes, has announced the commencement of patient enrollment for its short-term human clinical study. The study will focus on the Company's continuous blood glucose monitor ("CBGM") and will include participants with both type 1 and type 2 diabetes. Data from the study is expected to be available within 6-8 weeks.

新澤西州拉瑟福德,2024年12月3日 — Glucotrack, Inc.(納斯達克:GCTK)("Glucotrack"或"公司"),是一家專注於爲糖尿病患者設計、開發和商業化新技術的醫療科技公司,宣佈開始進行其短期人類臨床研究的患者招募。該研究將集中於公司的連續血糖監測儀("CBGM"),並將包括1型和2型糖尿病患者。該研究的數據預計將在6-8周內公佈。

Unlike traditional continuous glucose monitors that measure glucose levels in interstitial fluid, Glucotrack's CBGM measures glucose directly from blood, aiming to provide real-time readings without the lag time typically associated with interstitial glucose measurements. The CBGM is a long-term implantable device with no on-body external component, designed for three years of continuous, accurate blood glucose monitoring, offering a more convenient and less intrusive glucose monitoring solution.

與傳統連續葡萄糖監測器測量間質液中的葡萄糖水平不同,Glucotrack的CBGM直接從血液中測量葡萄糖,旨在提供實時讀數,避免通常與間質葡萄糖測量相關的滯後時間。CBGM是一種長期植入設備,沒有外部組件,設計用於連續三年的準確血糖監測,提供更便捷、不那麼侵入性的血糖監測解決方案。

The prospective, single arm study is a short-term in-hospital study in which the CBGM sensor will be placed intravascularly for a period of four days. Study participants, who have been diagnosed with diabetes mellitus requiring glucose monitoring and intensive insulin therapy, will participate in several fixed meal and glucose challenges during the study period.

這項前瞻性、單臂研究是一項短期住院研究,CBGM傳感器將在體內置入,持續四天。通過對參與者進行固定餐和葡萄糖挑戰,來研究已被確診需要葡萄糖監測和密集胰島素治療的糖尿病患者。

The study is being conducted under Principal Investigator Dr. Alexandre Abizaid, MD, PhD. Dr. Abizaid is the Director of Interventional Cardiology at Instituto do Coração in São Paulo, Brazil, and a Visiting Professor of Medicine at Columbia University Medical Center in New York City. He is a key faculty member of the Cardiovascular Research Foundation in New York and a world-renowned interventional cardiologist who has conducted numerous first in human clinical studies in the cardiology field. The study will be conducted at Instituto do Coração (InCor) of the Hospital das Clínicas of Faculdade de Medicina da Universidade de São Paulo, which is widely considered the best cardiology hospital in Brazil and Latin America, according to Newsweek.

該研究由首席研究員Dr. Alexandre Abizaid, MD, PhD主持進行。Abizaid博士是聖保羅聖保羅聖心醫院介入心臟病學主任,以及紐約哥倫比亞大學醫學中心的客座教授。他是紐約心血管研究基金會的重要成員,是一位世界知名的介入心臟病學家,在心臟病學領域進行了衆多首次人體臨床研究。該研究將在聖保羅大學聖保羅聖心醫院的醫學院臨床醫院進行,據《新聞週刊》報道,該醫院被廣泛認爲是巴西和拉丁美洲最好的心臟病醫院。

"Following the success of our preclinical program, we are pleased to reach this key milestone in the development of our novel CBGM," said Paul V. Goode, PhD, President & Chief Executive Officer of Glucotrack. "We believe this groundbreaking early feasibility study will demonstrate the potential for our real-time continuous blood glucose monitor to offer a truly differentiated and less burdensome approach to glucose monitoring for people with diabetes."

「在我們臨床前計劃取得成功後,我們很高興達到開發我們新型CBGm的關鍵里程碑,」 Glucotrack的總裁兼首席執行官Paul V. Goode, PhD表示。「我們相信這一突破性的早期可行性研究將展示我們實時連續血糖監測儀在爲糖尿病患者提供一種真正區別化且減輕負擔的血糖監測方式方面的潛力。」

For more information about Glucotrack's CBGM, visit glucotrack.com. Information on the Company's website does not constitute a part of and is not incorporated by reference into this press release.

有關Glucotrack CBGm的更多信息,請訪問 glucotrack.com. 公司網站上的信息不構成本新聞稿的一部分,也不被納入參考。

# # #

# # #

About Glucotrack, Inc.

關於Glucotrack,Inc。

Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes.

Glucotrack,Inc.(納斯達克代碼:GCTK),專注於爲糖尿病患者設計、開發和商業化新技術。該公司目前正在開發一種長期可植入的連續血糖監測系統,以幫助糖尿病患者。

Glucotrack's CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. For more information, please visit .

Glucotrack的CBGm是一種長期植入式系統,可以持續測量血糖水平,傳感器壽命長達3年,無需佩戴在身上,且校準工作量最少。要了解更多信息,請訪問 .

Forward-Looking Statements

前瞻性聲明

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "believe", "expect", "plan" and "will" are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack's results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack's future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack's filings with the U.S. Securities and Exchange Commission (the "SEC"), including its Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the SEC on March 28, 2024.

本新聞稿包含《1995年私人證券訴訟改革法案》(Private Securities Litigation Reform Act of 1995)規定的前瞻性聲明。本新聞稿中的陳述可能會被視爲前瞻性陳述。這些非歷史性陳述是基於管理層的信念和管理層目前已獲得的信息所做的假設。這些聲明僅涉及發表聲明的時間內的事件,Glucotrack無需公開更新任何前瞻性陳述,無論是因爲新信息、未來事件或其他原因,除非依據法律規定。本新聞稿中所做的所有前瞻性陳述均受到這些警示性聲明的限制,而且Glucotrack無法保證Glucotrack預期的實際結果將實現或即使實現了也會對我們或我們的業務或運營產生預期的後果或影響。讀者應注意,某些重要因素可能會影響Glucotrack的實際結果,並導致這些結果與本新聞稿中可能做出的任何前瞻性陳述不同。可能影響Glucotrack結果的因素包括但不限於,Glucotrack籌集資金以資助其運營的能力(無論是通過公開股票或私人股票融資、債務融資、戰略合作還是其他方式);有關審批的接受(和時間)的風險(包括美國食品和藥物管理局的批准);有關患者登記和臨床試驗進行的風險;有關Glucotrack未來分銷協議的風險;有關其能夠聘用和留住合格人員,包括銷售和分銷人員的風險;以及在Glucotrack向美國證券交易委員會(SEC)提交的備案申明書中所述風險還有其他附加風險因素。

Contacts:

聯繫人:

Investor Relations:
investors@glucotrack.com

投資者關係:
investors@glucotrack.com

Lisa Wilson
In-Site Communications
T: 917-543-9932
E: lwilson@insitecony.com

Lisa Wilson
In-Site通訊
電話:917-543-9932
E: lwilson@insitecony.com

Media:
GlucotrackPR@icrinc.com

媒體:
GlucotrackPR@icrinc.com


big

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
    搶先評論