Expansion offers the potential for continuous, discreet and simplified epidural glucose monitoring solutions for patients with Painful Diabetic Neuropathy
Rutherford, NJ, April 16, 2024 (GLOBE NEWSWIRE) — 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).
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.
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.
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.
“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.”
For more information about Glucotrack, visit glucotrack.com.
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About 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’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.
Forward-Looking Statements
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.
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References:
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/
