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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报告成功完成了首个报道的长期临床前研究的硬膜外葡萄糖监测传感器。
GlucoTrack ·  06/13 00:00

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

新型硬膜外连续葡萄糖监测研究的完成确认了它在为疼痛性糖尿病神经病患者提供简化疾病管理方面的潜力。

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.

新泽西州卢瑟福,2024年6月13日—— Glucotrack,Inc.(纳斯达克:GCTK)(“Glucotrack”或“公司”),一家专注于为糖尿病患者设计、开发和商业化创新技术的医疗器械公司,今天宣布其可植入式连续葡萄糖监测仪已成功完成为期60天的长期临床前研究,证明了在硬膜外隙进行葡萄糖监测的可行性。

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.

在动物的硬膜外空间内植入的Glucotrack传感器在整个60天的期间内紧密跟踪了商用血糖监测仪和皮下连续葡萄糖监测仪(CGM)中的葡萄糖数值。在研究期间未观察到异常的临床表现,也未在移植后的分析中观察到脊髓或周围组织的异常发现。该研究还证实,植入式传感器在长期期间内不会引起任何延迟的潜在影响,这一点特别重要,因为在动物研究中,植入设备需要几周时间才能完全愈合。

"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:“通过成功完成这项长期研究,我们对我们的硬膜外传感器的性能充满信心,我们很高兴成为硬膜外葡萄糖监测的创新者。现在,我们正在探索将我们的新技术继续开发和应用以造福糖尿病患者的机会。”

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此前曾宣布完成了急性条件下的临床前动物测试,并启动了长期动物研究以评估持续性的血糖监测性能。该研究中使用的CBGM样机使用了改进的生产技术,使设备更接近商业产品所要求的水平。将在今年晚些时候开始人体临床试验。宣布通过对连续60天的持续硬膜外葡萄糖监测性能进行评估的这项长期动物研究的中期性能和安全性结果显示,硬膜外监测葡萄糖的可持续性现已在这项研究中确认。

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是一种渐进性神经系统疾病,影响约3800万美国糖尿病患者中的五分之一,相当于超过700万人。1,2该公司认为,如果获批,可在硬膜外空间内进行读数的连续葡萄糖监测系统可以与现有的治疗方案相结合,简化病患的设备和疾病管理。

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,请访问网站glucotrack.com。公司网站上的信息不构成本新闻稿的一部分,也不是参考。

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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。在英国庞大的社区糖尿病人群中,疼痛性糖尿病神经病的患病率和特征。 2011年 Diabetic Care 34:2220-2224。
2 疾病控制与预防中心。 (2022)。国家糖尿病统计报告网站。https://www.cdc.gov/diabetes/data/statistics-report/index.html

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。该公司目前正在开发一种长期可植入的连续血糖监测系统,以帮助糖尿病患者。

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是一个长期可植入的系统,它通过传感器持续测量血糖水平,在设备使用寿命超过2年的情况下,无需佩戴任何物品并进行最少的校准。更多信息,请访问http://www.glucotrack.com.

Forward-Looking Statements

前瞻性声明

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.

本新闻稿包含《1995年私人证券诉讼改革法案》(Private Securities Litigation Reform Act of 1995)规定的前瞻性声明。本新闻稿中的陈述可能会被视为前瞻性陈述。这些非历史性陈述是基于管理层的信念和管理层目前已获得的信息所做的假设。这些声明仅涉及发表声明的时间内的事件,Glucotrack无需公开更新任何前瞻性陈述,无论是因为新信息、未来事件或其他原因,除非依据法律规定。本新闻稿中所做的所有前瞻性陈述均受到这些警示性声明的限制,而且Glucotrack无法保证Glucotrack预期的实际结果将实现或即使实现了也会对我们或我们的业务或运营产生预期的后果或影响。读者应注意,某些重要因素可能会影响Glucotrack的实际结果,并导致这些结果与本新闻稿中可能做出的任何前瞻性陈述不同。可能影响Glucotrack结果的因素包括但不限于,Glucotrack筹集资金以资助其运营的能力(无论是通过公开股票或私人股票融资、债务融资、战略合作还是其他方式);有关审批的接受(和时间)的风险(包括美国食品和药物管理局的批准);有关患者登记和临床试验进行的风险;有关Glucotrack未来分销协议的风险;有关其能够聘用和留住合格人员,包括销售和分销人员的风险;以及在Glucotrack向美国证券交易委员会(SEC)提交的备案申明书中所述风险还有其他附加风险因素。

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