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GLUCOTRACK'S EPIDURAL GLUCOSE MONITORING SENSOR DEMONSTRATES SUCCESSFUL 30-DAY SAFETY & PERFORMANCE IN LONG-TERM PRECLINICAL STUDY

GLUCOTRACK'S EPIDURAL GLUCOSE MONITORING SENSOR DEMONSTRATES SUCCESSFUL 30-DAY SAFETY & PERFORMANCE IN LONG-TERM PRECLINICAL STUDY

GLUCOTRACK 的硬膜外血糖監測傳感器在長期臨床前研究中成功展示了 30 天的安全性和性能
GlucoTrack ·  05/16 12:00

Promising results support the potential of epidural glucose monitoring for simplified disease management for patients with painful diabetic neuropathy

令人鼓舞的結果支持硬膜外血糖監測有可能簡化糖尿病神經病變患者的疾病管理

Rutherford, NJ, May 16, 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 30 days of a 60-day long-term preclinical study on measuring glucose in the epidural space.

新澤西州盧瑟福,2024年5月16日——專注於糖尿病患者新技術的設計、開發和商業化的醫療器械公司Glucotrack, Inc.(納斯達克股票代碼:GCTK)(“Glucotrack” 或 “公司”)今天宣佈,其植入式連續血糖監測儀已成功完成爲期30天的長期硬膜外血糖測量臨床前研究。

The Glucotrack sensor, implanted in the epidural space of animals, closely tracked both blood glucose and a commercially available subcutaneous continuous glucose monitor (CGM) throughout the 30-day period. The implantation procedure took approximately 20 minutes, and the animals recovered without complications. No abnormal clinical signs or findings in the spinal cord or surrounding tissues were observed.

植入動物硬膜外空間的Glucotrack傳感器可在30天內密切跟蹤血糖和市售的皮下連續血糖監測器(CGM)。植入手術花了大約20分鐘,動物康復後沒有出現併發症。在脊髓或周圍組織中未觀察到異常臨床症狀或發現。

"We are excited by the performance of our epidural glucose sensor in this long-term study, which builds on the encouraging results from our acute testing," said Paul V. Goode, PhD, CEO of Glucotrack. "We are proud to be at the forefront of developing this exciting technology, which has the potential to benefit millions of people with diabetes."

Glucotrack首席執行官保羅·古德博士說:“我們對硬膜外葡萄糖傳感器在這項長期研究中的表現感到興奮,該研究建立在我們令人鼓舞的急性測試結果基礎上。”“我們很自豪能夠站在開發這項令人興奮的技術的最前沿,它有可能使數百萬糖尿病患者受益。”

The 60-day long-term study is ongoing, with periodic glucose tolerance testing to compare the performance of the Glucotrack epidural sensor performance against blood glucose and subcutaneous CGM.

這項爲期60天的長期研究正在進行中,定期進行葡萄糖耐量測試,以比較Glucotrack硬膜外傳感器的性能與血糖和皮下CGM的性能。

Glucotrack previously announced that it had completed preclinical animal testing in an acute setting and had initiated this long-term animal study to assess sustained epidural glucose monitoring performance. While the acute study demonstrated feasibility of accurately measuring glucose in the epidural space over several hours, this long-term study assesses the durability of the epidural glucose sensor measurement over a significantly longer duration of monitoring.

Glucotrack 之前 宣佈了 它已經在急性環境中完成了臨床前動物試驗,並啓動了這項長期動物研究,以評估持續的硬膜外血糖監測性能。儘管急性研究表明,在數小時內精確測量硬膜外空間中的葡萄糖是可行的,但這項長期研究評估了硬膜外葡萄糖傳感器測量在更長的監測時間內的耐久性。

Painful diabetic neuropathy 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 spinal epidural space may be integrated with existing treatments for these patients, simplifying their device and disease management.

疼痛性糖尿病性神經病是一種進行性神經系統疾病,在3,800多萬美國糖尿病患者中,約有五分之一受到影響,相當於超過700萬人。1,2 該公司認爲,如果獲得批准,在脊柱硬膜外空間進行讀數的連續血糖監測系統可以與這些患者的現有治療方法相結合,從而簡化他們的設備和疾病管理。

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 glucotrack.com。公司網站上的信息不構成本新聞稿的一部分,也未以引用方式納入本新聞稿。

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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.(納斯達克股票代碼:GCTK)專注於爲糖尿病患者設計、開發和商業化新技術。該公司目前正在爲糖尿病患者開發一種長期植入式持續血糖監測系統。

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 是一種長期可植入的系統,可持續測量血糖水平,傳感器壽命爲 2 年以上,沒有機身可穿戴組件,校準也最少。欲了解更多信息,請訪問 http://www.glucotrack.com

Forward-Looking Statements

前瞻性陳述

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》所指的前瞻性陳述。本新聞稿中包含的非歷史事實陳述的陳述可能被視爲前瞻性陳述。在不限制前述內容概括性的前提下,諸如 “相信”、“期望”、“計劃” 和 “將” 之類的詞語旨在識別前瞻性陳述。此類前瞻性陳述基於管理層的信念,以及管理層做出的假設和目前可獲得的信息。這些陳述僅涉及截至聲明發表之日的事件,除非法律要求,否則Glucotrack沒有義務公開更新任何前瞻性陳述,無論是由於新信息、未來事件還是其他原因。本新聞稿中發表的所有前瞻性陳述均受這些警示性陳述的限制,無法保證Glucotrack預期的實際業績會實現,即使已基本實現,也無法保證它們會對我們或我們的業務或運營產生預期的後果或影響。讀者請注意,某些重要因素可能會影響Glucotrack的實際業績,並可能導致此類業績與本新聞稿中可能發表的任何前瞻性陳述存在重大差異。可能影響Glucotrack業績的因素包括但不限於Glucotrack籌集額外資金爲其運營提供資金的能力(無論是通過公開還是私募股權發行、債務融資、戰略合作或其他方式);與獲得監管批准(包括美國食品藥品監督管理局批准)(包括美國食品藥品監督管理局批准)(和時機)相關的風險;與Glucotrack註冊和進行臨床試驗相關的風險;與Glucotrack業績相關的風險 cotrack 未來的分銷協議;與其能力相關的風險僱用和留住合格人員,包括銷售和分銷人員;以及Glucotrack向美國證券交易委員會(“SEC”)提交的文件中描述的其他風險因素,包括其於2024年3月28日向美國證券交易委員會提交的截至2023年12月31日的10-K表年度報告。

Contacts:

聯繫人:

Investor Relations:
investors@glucotrack.com

投資者關係:
investors@glucotrack.com

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

1 Abbott CA、Malik RA、van Ross ER、Kulkarni J、Boulton AJ。《2011年英國糖尿病護理》中大量社區糖尿病患者中疼痛性糖尿病神經病變的患病率和特徵;34:2220-2224。
2 美國疾病控制與預防中心。(2022年)。全國糖尿病統計報告網站。 https://www.cdc.gov/diabetes/data/statistics-report/index.html

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