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GLUCOTRACK ANNOUNCES EXPANSION OF ITS CONTINUOUS GLUCOSE MONITORING TECHNOLOGY TO EPIDURAL GLUCOSE MONITORING

GLUCOTRACK ANNOUNCES EXPANSION OF ITS CONTINUOUS GLUCOSE MONITORING TECHNOLOGY TO EPIDURAL GLUCOSE MONITORING

GLUCOTRACK 宣布将其连续血糖监测技术扩展到硬膜外血糖监测
GlucoTrack ·  04/16 12:00

Expansion offers the potential for continuous, discreet and simplified epidural glucose monitoring solutions for patients with Painful Diabetic Neuropathy

扩张为糖尿病痛性神经病患者提供持续、谨慎和简化的硬膜外血糖监测解决方案提供了潜力

Rutherford, NJ, April  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, announced that it is expanding its glucose monitoring technology to include measuring glucose in the epidural space. A continuous glucose monitoring system that takes readings in the spinal epidural space may be integrated with existing treatments for patients with Painful Diabetic Neuropathy (PDN).

新泽西州卢瑟福,2024年4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”)宣布正在扩展其血糖监测技术,将硬膜外领域的血糖测量包括在内。在脊柱硬膜外空间进行读数的连续血糖监测系统可以与糖尿病疼痛性神经病变(PDN)患者的现有治疗相结合。

PDN is a progressive neurological disorder that affects approximately one-fifth of the more than 38 million Americans with with diabetes, equating to more than 7 million individuals.1,2 Its symptoms include pain and numbness in the feet, legs, and hands which can significantly impact patients' quality of life and functional ability.3 Recently, Spinal Cord Stimulation (SCS) technology has been indicated as a treatment option providing significant long-term pain relief to these patients.4 A spinal cord stimulator is an implanted device, with electrodes placed in the epidural space, that sends low levels of electricity directly into the spinal cord to relieve pain.5 Glucotrack's sensor has the potential to be integrated with existing SCS devices to measure epidural glucose in patients with PDN who are undergoing SCS treatment. Combining SCS and continuous glucose monitoring (CGM) could provide several possible advantages, such as simplifying device management for those patients.

PDN 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 其症状包括脚、腿部和手部疼痛和麻木,这可能会严重影响患者的生活质量和功能能力。3 最近,脊髓刺激(SCS)技术被列为一种治疗方案,可以显著缓解这些患者的长期疼痛。4 A 脐带刺激器是一种植入式设备,其电极放置在硬膜外空间,可将低水平的电量直接输送到脊髓以缓解疼痛。5 Glucotrack 的传感器有可能与现有的 SCS 设备集成,用于测量正在接受 SCS 治疗的 PDN 患者的硬膜外血糖。将SCS和持续血糖监测(CGM)相结合可以提供多种可能的优势,例如简化这些患者的设备管理。

Glucotrack has successfully completed preclinical animal testing in an acute setting. Building on the success of the acute studies, the Company has now initiated a long-term animal study to assess sustained epidural glucose monitoring performance. This is the second application of Glucotrack's technology for implantable continuous glucose monitoring, in addition to its development of a long-term Continuous Blood Glucose Monitoring (CBGM) system.

Glucotrack已成功完成了急性环境的临床前动物试验。在急性研究成功的基础上,该公司现已启动一项长期动物研究,以评估持续的硬膜外血糖监测性能。这是Glucotrack技术在植入式持续血糖监测方面的第二次应用,此外还开发了长期持续血糖监测(CBGM)系统。

The preclinical testing compared the Glucotrack sensor against blood glucose and a commercially available subcutaneous CGM in an acute large animal model while varying blood glucose levels for several hours. The results demonstrated the Glucotrack epidural glucose values closely tracked both the blood glucose and subcutaneous CGM values. The study was completed with no adverse effect on the animals. A second acute study successfully confirmed the repeatability of these results.

临床前测试将Glucotrack传感器与血糖和急性大型动物模型中的市售皮下CGM进行了比较,同时血糖水平变化了几个小时。结果表明,Glucotrack硬膜外葡萄糖值与血糖和皮下CGM值密切相关。该研究已完成,对动物没有不良影响。第二项急性研究成功证实了这些结果的可重复性。

"We have always been committed to developing a portfolio of innovative glucose monitoring technologies to offer patients with diabetes more choice; today's announcement underscores this commitment." said Paul V. Goode, PhD, CEO of Glucotrack. "We are excited to pioneer the epidural glucose monitoring space which we believe holds meaningful strategic potential. By making disease management more intuitive and less intrusive, Glucotrack is looking beyond traditional approaches to improve the quality of life for millions of people with diabetes."

Glucotrack首席执行官保罗·古德博士说:“我们一直致力于开发一系列创新的血糖监测技术,为糖尿病患者提供更多选择;今天的公告强调了这一承诺。”“我们很高兴开创硬膜外血糖监测领域,我们认为该领域具有重要的战略潜力。通过使疾病管理更加直观,减少干扰,Glucotrack正在超越传统方法,改善数百万糖尿病患者的生活质量。”

For more information about Glucotrack, visit glucotrack.com.

有关 Glucotrack 的更多信息,请访问 glucotrack.com

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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 the 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 current and 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, 2023.

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 当前和未来的分销协议;与其相关的风险雇用和留住合格人员(包括销售和分销人员)的能力;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2023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

References:

参考文献:

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
3 Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002;18(6):350-354. doi:10.1097/00002508-200211000-00002.
4 Erika A. Petersen, Thomas G. Stauss, James A. Scowcroft, Elizabeth S. Brooks, Judith L. White, Shawn M. Sills, Kasra Amirdelfan, Maged N. Guirguis, Jijun Xu, Cong Yu, Ali Nairizi, Denis G. Patterson, Kostandinos C. Tsoulfas, Michael J. Creamer, Vincent Galan, Richard H. Bundschu, Neel D. Mehta, Dawood Sayed, Shivanand P. Lad, David J. DiBenedetto, Khalid A. Sethi, Johnathan H. Goree, Matthew T. Bennett, Nathan J. Harrison, Atef F. Israel, Paul Chang, Paul W. Wu, Charles E. Argoff, Christian E. Nasr, Rod S. Taylor, David L. Caraway, Nagy A. Mekhail; Durability of High-Frequency 10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy Refractory to Conventional Treatments: 12-Month Results From a Randomized Controlled Trial. Diabetes Care 5 January 2022; 45 (1): e3-e6. https://doi.org/10.2337/dc21-1813
5 Dydyk AM, Tadi P. Spinal Cord Stimulator Implant. [Updated 2023 Jul 3]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK555994/

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
3 Schmader KE。带状疱疹后神经痛和糖尿病性神经病变的流行病学及其对生活质量的影响。Clin J Pain。2002;18 (6): 350-354. doi: 10.1097/00002508-200211000-00002。
4 埃里卡·A·彼得森、托马斯·施陶斯、詹姆斯·斯考克罗夫特、伊丽莎白·布鲁克斯、朱迪思·怀特、肖恩·西尔斯、卡斯拉·阿米尔德尔凡、马吉德·吉尔吉斯、徐继军、余聪、阿里·奈里齐、丹尼斯·帕特森、科斯坦迪诺斯·索尔法斯、迈克尔·克雷默、文森特·加兰、理查德·邦德舒和尼尔·梅赫 Ta、Dawood Sayed、Shivanand P. Lad、David J. Dibenedetto、Khalid A. Sethi、Johnathan H. Goree、Matthew T. Bennett、Nathan J. Harrison、Atef F. Israel、Paul W. W.W.Wu、Charles E. Argoff、Charles E. Nasr、David S. Taylor、David L. Caraway、Nagy A. Mekhail;耐久性对传统治疗难以治愈的疼痛性糖尿病神经病患者的高频 10kHz 脊髓刺激:一项随机对照试验的 12 个月结果。2022年1月5日糖尿病护理;45(1):e3-e6。 https://doi.org/10.2337/dc21-1813
5 Dydyk AM,Tadi P. 脊髓刺激器植入物。[2023 年 7 月 3 日更新]。在:StatPearls [互联网]。金银岛(佛罗里达州):StatPearls 出版社;2024 年 1 月可从以下地址获得: https://www.ncbi.nlm.nih.gov/books/NBK555994/

译文内容由第三方软件翻译。


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