GLUCOTRACK REPORTS SUCCESSFUL COMPLETION OF FIRST REPORTED LONG-TERM PRECLINICAL STUDY OF ITS EPIDURAL GLUCOSE MONITORING SENSOR
Glucotrack (Nasdaq: GCTK) has announced the successful completion of a 60-day preclinical study for its innovative epidural continuous glucose monitoring sensor. The sensor, implanted in the epidural space of animals, closely tracked glucose levels comparable to both commercially available blood glucose monitors and subcutaneous CGMs. No abnormal clinical signs or delayed latent effects were observed during the study, supporting the sensor's safety and efficacy. This advancement holds promise for simplifying disease management in patients with painful diabetic neuropathy (PDN), a condition affecting over 7 million Americans. CEO Paul V. Goode expressed confidence in the sensor's performance and its potential benefits for diabetes patients.
- Successful completion of a 60-day preclinical study.
- Epidural sensor closely tracks glucose levels comparable to existing monitors.
- No abnormal clinical signs or delayed effects observed.
- Potential for simplifying disease management in patients with PDN.
- Advancement may benefit over 7 million Americans with PDN.
- Study results are preclinical and yet to be proven in human trials.
- No immediate financial impacts or revenue projections provided.
Insights
The successful completion of Glucotrack's long-term preclinical study of its epidural glucose monitoring sensor represents a noteworthy development in diabetes management. The 60-day study demonstrated that the sensor could reliably track glucose levels without causing any adverse clinical signs or delayed effects on the spinal cord or surrounding tissues. This supports the potential for an implantable continuous glucose monitoring solution targeting painful diabetic neuropathy, which affects over
For retail investors, this development signifies a promising step towards a novel, less invasive glucose monitoring method. Traditionally, glucose monitoring has relied on subcutaneous sensors and periodic blood tests, which can be cumbersome and uncomfortable. By targeting the epidural space, Glucotrack aims to simplify disease management for diabetic neuropathy patients. However, it is critical to note that this is preclinical data and additional clinical trials will be necessary to confirm efficacy and safety in humans. The transition from animal models to human trials can present significant challenges and delays.
From a technology standpoint, the development of a glucose monitoring sensor that operates in the epidural space is a significant innovation. Current continuous glucose monitors (CGMs), such as those from Dexcom or Abbott, are typically subcutaneous, meaning they are inserted under the skin. Glucotrack’s approach, placing the sensor in the epidural space, could potentially offer more accurate readings due to its proximity to major blood vessels and nerves.
This technology could reduce the frequency of sensor replacements and minimize discomfort associated with subcutaneous CGMs. However, the implantation procedure may require more medical expertise and could present a barrier to widespread adoption. Investors should consider these factors when evaluating the technology's market potential. Furthermore, the integration with existing diabetes management systems will be important for widespread adoption and usability.
From a financial perspective, the completion of this preclinical study is a positive milestone for Glucotrack. It enhances the company's value proposition and positions it as an innovator in the diabetes management market. If Glucotrack can successfully navigate through clinical trials and achieve regulatory approval, the product could tap into a significant market, given that over
However, investors should remain cautious. The transition from preclinical to clinical stages is fraught with risks, including potential delays and additional costs. Furthermore, the competitive landscape for CGMs is intense, with well-established players like Dexcom and Abbott. Glucotrack will need to demonstrate clear advantages over existing technologies to capture market share. Additionally, the company will need substantial financial resources to fund further development and bring the product to market.
Completion of the novel epidural continuous glucose monitoring study confirms its potential for providing simplified disease management for patients with painful diabetic neuropathy
Rutherford, NJ, June 13, 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, 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.
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.
“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 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.
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.
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.
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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
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 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.
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