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GLUCOTRACK ANNOUNCES 90-DAY PRECLINICAL STUDY RESULTS THAT DEMONSTRATE SUSTAINED ACCURACY OF ITS IMPLANTABLE CONTINUOUS BLOOD GLUCOSE MONITOR

GLUCOTRACK ANNOUNCES 90-DAY PRECLINICAL STUDY RESULTS THAT DEMONSTRATE SUSTAINED ACCURACY OF ITS IMPLANTABLE CONTINUOUS BLOOD GLUCOSE MONITOR

GLUCOTRACK宣佈90天的前臨牀研究結果,顯示其植入式持續血糖監測器的準確性持續。
GlucoTrack ·  06/05 12:00

Highly accurate continuous blood glucose monitor demonstrates Mean Absolute Relative Difference (MARD) of 4.7% at Day 90

90天后,高度精確的連續血糖監測器顯示均方根相對誤差(MARD)爲4.7%

Continuous blood glucose monitor offers the potential for simplified, discreet and less intrusive glucose monitoring for people with diabetes

連續血糖監測器爲糖尿病患者提供了簡化、隱蔽和不那麼侵入性的血糖監測方案

Rutherford, NJ, June 05, 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, today announced that it has successfully completed a second long-term preclinical study for its Continuous Blood Glucose Monitor (CBGM). This study further validates the CBGM's sustained accuracy and performance with a Mean Absolute Relative Difference (MARD) of 4.7% at Day 90, which is considered highly accurate for a continuous glucose monitor.

2024年6月5日,新澤西州盧瑟福市——醫療科技公司Glucotrack,Inc.(納斯達克代碼:GCTK,"Glucotrack"或"公司"),致力於設計、開發和商業化新技術,以幫助糖尿病患者,今日宣佈已成功完成第二個長期的預臨床研究,用於公司的持續血糖監測器(CBGM)。該研究進一步驗證了CBGM在90天時的持續準確度和性能,其平均絕對相對誤差(MARD)爲4.7%,被認爲是連續血糖監測器的高度準確。

MARD is a key metric used to assess the accuracy of glucose monitoring devices, measuring the average difference between the CBGM device's measurement and a reference measurement, most often obtained via capillary blood glucose. Lower values indicate better performance.

MARD是用於評估血糖監測設備準確性的關鍵指標,是測量CBGM設備測量值與參考測量值之間平均差異的方式,通常是通過毛細血管血糖獲得。更低的值表示更好的性能。

Glucotrack's CBGM measures glucose in the blood, without the lag time associated with subcutaneous sensors that measure glucose in interstitial fluid. The ability to directly measure blood glucose in real time and on a continuous basis enables a less burdensome approach to glucose monitoring for extended periods of time.

Glucotrack的CBGM可以測量血液中的葡萄糖,無需皮下傳感器測量間質液中的葡萄糖,並且沒有滯後時間。直接實時連續測量血糖的能力,可以實現更輕鬆的血糖監測方法,可延長較長時間。

The 90-day preclinical study, which included a larger number of animal subjects and a longer duration than the initial 60-day study announced earlier this year, further validates the CBGM's sustained accuracy and performance. The study incorporated periodic glucose tolerance testing to compare the performance of the Glucotrack CBGM against both a commercially available blood glucose monitor and a subcutaneous continuous glucose monitor. The study was completed with no significant adverse effects.

這項長達90天的臨床前研究比今年早些時候公佈的初始60天研究涵蓋更多的動物測試對象和更長的持續時間,進一步驗證了CBGM的持續準確性和性能。該研究融入了定期的葡萄糖耐量測試,比較了Glucotrack CBGM與商用血糖監測器和皮下連續血糖監測器的性能。該研究完成時沒有發現重大的不良影響。

"We are again very pleased with the performance of our sensor during a long-term preclinical study and look forward to moving into human clinical trials" stated Paul Goode, PhD, CEO of Glucotrack. "Our CBGM's ability to continuously measure blood glucose for 2+ years with accuracy, minimal calibration and without a wearable device represents a significant advancement in glucose monitoring. We believe this technology has the potential to greatly improve the quality of life for people with diabetes by providing a more convenient and discreet monitoring solution."

“我們非常高興看到我們的傳感器在長期臨床前研究中的性能,並期待着進入人類臨床試驗。”Glucotrack的CEO Paul Goode博士表示:“我們的CBGM連續2+年測量血糖的能力,準確性高,只需最少的校準而無需佩戴設備,標誌着血糖監測方面的重大進展。我們相信,該技術有潛力通過提供更方便和隱蔽的監測方案,極大地改善患有糖尿病的人們的生活質量。”

Glucotrack previously announced that it had completed preclinical animal testing in an acute setting and had initiated a long-term animal study to assess sustained glucose monitoring performance. The CBGM prototypes used in this study were manufactured using refined production techniques that bring the device closer to the commercially desired product. The Company plans to initiate human clinical trials later this year.

Glucotrack此前曾宣佈完成了急性條件下的臨床前動物測試,並啓動了長期動物研究以評估持續性的血糖監測性能。該研究中使用的CBGM樣機使用了改進的生產技術,使設備更接近商業產品所要求的水平。將在今年晚些時候開始人體臨床試驗。宣佈宣佈公司已在急性情況下完成臨床前動物實驗,並啓動了長期動物研究以評估持續葡萄糖監測性能。在研究中使用了經過精細生產技術製造的CBGM樣機,將該設備與商業上所需的產品更接近。公司計劃在今年晚些時候開始人體臨床試驗。

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 2+ years, no on-body wearable component and with minimal calibration. For more information, please visit http://www.glucotrack.com. Information on the Company's website does not constitute a part of and is not incorporated by reference into this news release.

Glucotrack的CBGM是一個長期可植入的系統,它通過傳感器持續測量血糖水平,在設備使用壽命超過2年的情況下,無需佩戴任何物品並進行最少的校準。更多信息,請訪問http://www.glucotrack.com。公司網站上的信息不構成本新聞稿的一部分,也沒有被納入到本新聞稿中。

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

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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。
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