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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 的硬膜外血糖监测传感器在长期临床前研究中成功展示了 30 天的安全性和性能
GlucoTrack ·  05/16 00:00

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

令人鼓舞的结果支持硬膜外血糖监测有可能简化糖尿病神经病变患者的疾病管理

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.

新泽西州卢瑟福,2024年5月16日——专注于糖尿病患者新技术的设计、开发和商业化的医疗器械公司Glucotrack, Inc.(纳斯达克股票代码:GCTK)(“Glucotrack” 或 “公司”)今天宣布,其植入式连续血糖监测仪已成功完成为期30天的长期硬膜外血糖测量临床前研究。

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.

植入动物硬膜外空间的Glucotrack传感器可在30天内密切跟踪血糖和市售的皮下连续血糖监测器(CGM)。植入手术花了大约20分钟,动物康复后没有出现并发症。在脊髓或周围组织中未观察到异常临床症状或发现。

"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首席执行官保罗·古德博士说:“我们对硬膜外葡萄糖传感器在这项长期研究中的表现感到兴奋,该研究建立在我们令人鼓舞的急性测试结果基础上。”“我们很自豪能够站在开发这项令人兴奋的技术的最前沿,它有可能使数百万糖尿病患者受益。”

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.

这项为期60天的长期研究正在进行中,定期进行葡萄糖耐量测试,以比较Glucotrack硬膜外传感器的性能与血糖和皮下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 宣布了 它已经在急性环境中完成了临床前动物试验,并启动了这项长期动物研究,以评估持续的硬膜外血糖监测性能。尽管急性研究表明,在数小时内精确测量硬膜外空间中的葡萄糖是可行的,但这项长期研究评估了硬膜外葡萄糖传感器测量在更长的监测时间内的耐久性。

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.

疼痛性糖尿病性神经病是一种进行性神经系统疾病,在3,800多万美国糖尿病患者中,约有五分之一受到影响,相当于超过700万人。1,2 该公司认为,如果获得批准,在脊柱硬膜外空间进行读数的连续血糖监测系统可以与这些患者的现有治疗方法相结合,从而简化他们的设备和疾病管理。

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.

有关 Glucotrack 的更多信息,请访问 glucotrack.com。公司网站上的信息不构成本新闻稿的一部分,也未以引用方式纳入本新闻稿。

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About Glucotrack, Inc.

关于 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.(纳斯达克股票代码:GCTK)专注于为糖尿病患者设计、开发和商业化新技术。该公司目前正在为糖尿病患者开发一种长期植入式持续血糖监测系统。

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 是一种长期可植入的系统,可持续测量血糖水平,传感器寿命为 2 年以上,没有机身可穿戴组件,校准也最少。欲了解更多信息,请访问 http://www.glucotrack.com

Forward-Looking Statements

前瞻性陈述

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.

本新闻稿包含1995年《私人证券诉讼改革法》所指的前瞻性陈述。本新闻稿中包含的非历史事实陈述的陈述可能被视为前瞻性陈述。在不限制前述内容概括性的前提下,诸如 “相信”、“期望”、“计划” 和 “将” 之类的词语旨在识别前瞻性陈述。此类前瞻性陈述基于管理层的信念,以及管理层做出的假设和目前可获得的信息。这些陈述仅涉及截至声明发表之日的事件,除非法律要求,否则Glucotrack没有义务公开更新任何前瞻性陈述,无论是由于新信息、未来事件还是其他原因。本新闻稿中发表的所有前瞻性陈述均受这些警示性陈述的限制,无法保证Glucotrack预期的实际业绩会实现,即使已基本实现,也无法保证它们会对我们或我们的业务或运营产生预期的后果或影响。读者请注意,某些重要因素可能会影响Glucotrack的实际业绩,并可能导致此类业绩与本新闻稿中可能发表的任何前瞻性陈述存在重大差异。可能影响Glucotrack业绩的因素包括但不限于Glucotrack筹集额外资金为其运营提供资金的能力(无论是通过公开还是私募股权发行、债务融资、战略合作或其他方式);与获得监管批准(包括美国食品药品监督管理局批准)(包括美国食品药品监督管理局批准)(和时机)相关的风险;与Glucotrack注册和进行临床试验相关的风险;与Glucotrack业绩相关的风险 cotrack 未来的分销协议;与其能力相关的风险雇用和留住合格人员,包括销售和分销人员;以及Glucotrack向美国证券交易委员会(“SEC”)提交的文件中描述的其他风险因素,包括其于2024年3月28日向美国证券交易委员会提交的截至2023年12月31日的10-K表年度报告。

Contacts:

联系人:

Investor Relations:
investors@glucotrack.com

投资者关系:
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年英国糖尿病护理》中大量社区糖尿病患者中疼痛性糖尿病神经病变的患病率和特征;34:2220-2224。
2 美国疾病控制与预防中心。(2022年)。全国糖尿病统计报告网站。 https://www.cdc.gov/diabetes/data/statistics-report/index.html

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