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GLUCOTRACK REPORTS SUCCESSFUL COMPLETION OF FIRST REPORTED LONG-TERM PRECLINICAL STUDY OF ITS EPIDURAL GLUCOSE MONITORING SENSOR

GLUCOTRACK REPORTS SUCCESSFUL COMPLETION OF FIRST REPORTED LONG-TERM PRECLINICAL STUDY OF ITS EPIDURAL GLUCOSE MONITORING SENSOR

GLUCOTRACK報告成功完成了首個報道的長期臨床前研究的硬膜外葡萄糖監測傳感器。
GlucoTrack ·  06/13 12:00

Completion of the novel epidural continuous glucose monitoring study confirms its potential for providing simplified disease management for patients with painful diabetic neuropathy

新型硬膜外連續葡萄糖監測研究的完成確認了它在爲疼痛性糖尿病神經病患者提供簡化疾病管理方面的潛力。

Rutherford, NJ, June 13, 2024 — Glucotrack, Inc. (Nasdaq: GCTK) ("Glucotrack" or the "Company"), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced that its implantable continuous glucose monitor has successfully completed a 60-day long-term preclinical study demonstrating the feasibility of glucose monitoring in the epidural space.

新澤西州盧瑟福,2024年6月13日—— Glucotrack,Inc.(納斯達克:GCTK)(“Glucotrack”或“公司”),一家專注於爲糖尿病患者設計、開發和商業化創新技術的醫療器械公司,今天宣佈其可植入式連續葡萄糖監測儀已成功完成爲期60天的長期臨床前研究,證明了在硬膜外隙進行葡萄糖監測的可行性。

The Glucotrack sensor, implanted in the epidural space of animals, closely tracked glucose values from both a commercially available blood glucose monitor and a subcutaneous continuous glucose monitor (CGM) throughout the 60-day period. No abnormal clinical signs were observed throughout the study period, and no abnormal findings were observed in the spinal cord or surrounding tissues during post-explant analysis. The study also confirmed that the implanted sensor did not cause any delayed latent effects over the long-term period, which is particularly important as a complete healing process in animal studies with implanted devices may take several weeks.

在動物的硬膜外空間內植入的Glucotrack傳感器在整個60天的期間內緊密跟蹤了商用血糖監測儀和皮下連續葡萄糖監測儀(CGM)中的葡萄糖數值。在研究期間未觀察到異常的臨床表現,也未在移植後的分析中觀察到脊髓或周圍組織的異常發現。該研究還證實,植入式傳感器在長期期間內不會引起任何延遲的潛在影響,這一點特別重要,因爲在動物研究中,植入設備需要幾周時間才能完全癒合。

"With the successful completion of this long-term study, we are confident in the performance of our epidural sensor, and we are excited to be an innovator in epidural glucose monitoring. We are now exploring opportunities for continued development and application of our novel technology to benefit people living with diabetes," said Paul V. Goode, PhD, CEO of Glucotrack.

Glucotrack的CEO Paul V. Goode博士表示:“通過成功完成這項長期研究,我們對我們的硬膜外傳感器的性能充滿信心,我們很高興成爲硬膜外葡萄糖監測的創新者。現在,我們正在探索將我們的新技術繼續開發和應用以造福糖尿病患者的機會。”

Glucotrack previously announced interim performance and safety results from this long-term animal study assessing sustained epidural glucose monitoring performance. With the completion of this study, the durability of the epidural approach for continuous glucose monitoring has now been confirmed over the 60-day period.

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。宣佈通過對連續60天的持續硬膜外葡萄糖監測性能進行評估的這項長期動物研究的中期性能和安全性結果顯示,硬膜外監測葡萄糖的可持續性現已在這項研究中確認。

PDN is a progressive neurological disorder that affects approximately one-fifth of the more than 38 million Americans with diabetes, equating to more than 7 million individuals.1,2 The Company believes that, if approved, a continuous glucose monitoring system that takes readings in the epidural space may be integrated with existing treatments for these patients, simplifying their device and disease management.

PDN是一種漸進性神經系統疾病,影響約3800萬美國糖尿病患者中的五分之一,相當於超過700萬人。1,2該公司認爲,如果獲批,可在硬膜外空間內進行讀數的連續葡萄糖監測系統可以與現有的治療方案相結合,簡化病患的設備和疾病管理。

For more information about Glucotrack, 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的更多信息,請訪問網站glucotrack.com。公司網站上的信息不構成本新聞稿的一部分,也不是參考。

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1 Abbott CA, Malik RA, van Ross ER, Kulkarni J, Boulton AJ. Prevalence and characteristics of painful diabetic neuropathy in a large community-based diabetic population in the U.K. Diabetes Care 2011;34:2220-2224.
2 Centers for Disease Control and Prevention. (2022). National Diabetes Statistics Report website. https://www.cdc.gov/diabetes/data/statistics-report/index.html

1Abbott CA,Malik RA,van Ross ER,Kulkarni J,Boulton AJ。在英國龐大的社區糖尿病人群中,疼痛性糖尿病神經病的患病率和特徵。 2011年 Diabetic Care 34:2220-2224。
2 疾病控制與預防中心。 (2022)。國家糖尿病統計報告網站。https://www.cdc.gov/diabetes/data/statistics-report/index.html

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.

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.

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。

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