GLUCOTRACK ANNOUNCES 90-DAY PRECLINICAL STUDY RESULTS THAT DEMONSTRATE SUSTAINED ACCURACY OF ITS IMPLANTABLE CONTINUOUS BLOOD GLUCOSE MONITOR
Glucotrack announced the successful completion of a 90-day preclinical study for its Continuous Blood Glucose Monitor (CBGM), demonstrating sustained accuracy with a Mean Absolute Relative Difference (MARD) of 4.7%. The study, which involved a larger number of animal subjects than previous studies, showcased the CBGM's ability to offer real-time blood glucose measurement without the lag associated with subcutaneous sensors. The device showed no significant adverse effects and outperformed both a commercial blood glucose monitor and a subcutaneous glucose monitor. Glucotrack plans to initiate human clinical trials later this year.
- MARD of 4.7% at Day 90 indicates high accuracy for the CBGM.
- Study involved a larger number of subjects and extended duration, validating sustained performance.
- Direct measurement of blood glucose offers a less intrusive monitoring approach.
- No significant adverse effects reported in the study.
- Prototype manufactured with refined techniques closer to commercial readiness.
- Plans to initiate human clinical trials later this year.
- Results are still preclinical; human trials have yet to begin.
- Long-term effectiveness and safety in humans remain unproven.
- Potential regulatory hurdles and time needed for market approval.
- Commercial viability still uncertain without human trial data.
Insights
The recent preclinical study results for Glucotrack's Continuous Blood Glucose Monitor (CBGM) are promising. Achieving a Mean Absolute Relative Difference (MARD) of
Moreover, the device's ability to measure glucose directly in blood, as opposed to interstitial fluid, can offer more precise real-time readings. This eliminates the lag time seen with subcutaneous sensors, which can be important for timely interventions. The absence of significant adverse effects in the study adds to the device's credibility and safety profile.
If the upcoming human clinical trials confirm these preclinical findings, Glucotrack's CBGM could revolutionize diabetes management by offering a less intrusive, more accurate monitoring solution. This could significantly enhance patient compliance and quality of life. However, it's essential to remain cautious, as successful preclinical results do not always guarantee similar outcomes in human trials.
Glucotrack's CBGM represents a technological leap in diabetes care. The device's ability to provide continuous blood glucose monitoring without requiring frequent calibration or a wearable device is notable. Current CGM devices often require users to carry additional hardware and undergo routine calibration, which can be inconvenient and intrusive. By simplifying this process, Glucotrack's CBGM can improve user experience and adherence.
Furthermore, the use of refined production techniques in manufacturing the prototypes is a positive development. This indicates that the company is progressing towards a commercially viable product. The fact that the device performed well over a 90-day period with sustained accuracy demonstrates its potential robustness and reliability for long-term use.
However, transitioning from preclinical to human trials brings its own set of challenges. It will be important to monitor how well the technology performs in human subjects, particularly in terms of accuracy, safety and ease of use. The market will be closely watching the outcomes of these trials.
For investors, these promising preclinical results may signal a significant opportunity. If human clinical trials corroborate the sustained accuracy and performance of Glucotrack's CBGM, the company could see substantial market interest. Continuous glucose monitoring is a rapidly growing sector, driven by the increasing prevalence of diabetes worldwide.
Glucotrack's ability to offer a more discreet and user-friendly device could give it a competitive edge over existing products. This could translate into strong adoption rates and, consequently, robust revenue growth. However, investors should consider the risks involved, including the potential for setbacks during human trials and regulatory hurdles before market approval.
From a financial perspective, it's also essential to look at Glucotrack's current cash flow and investment capacity to sustain the development and commercialization phases. If the company has a solid financial foundation, it will be better positioned to navigate any challenges that arise during the transition to human trials and eventual market entry.
Highly accurate continuous blood glucose monitor demonstrates Mean Absolute Relative Difference (MARD) of
Continuous blood glucose monitor offers the potential for simplified, discreet and less intrusive glucose monitoring for people with diabetes
Rutherford, NJ, June 05, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical technology company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced that it has successfully completed a second long-term preclinical study for its Continuous Blood Glucose Monitor (CBGM). This study further validates the CBGM’s sustained accuracy and performance with a Mean Absolute Relative Difference (MARD) of
MARD is a key metric used to assess the accuracy of glucose monitoring devices, measuring the average difference between the CBGM device’s measurement and a reference measurement, most often obtained via capillary blood glucose. Lower values indicate better performance.
Glucotrack’s CBGM measures glucose in the blood, without the lag time associated with subcutaneous sensors that measure glucose in interstitial fluid. The ability to directly measure blood glucose in real time and on a continuous basis enables a less burdensome approach to glucose monitoring for extended periods of time.
The 90-day preclinical study, which included a larger number of animal subjects and a longer duration than the initial 60-day study announced earlier this year, further validates the CBGM’s sustained accuracy and performance. The study incorporated periodic glucose tolerance testing to compare the performance of the Glucotrack CBGM against both a commercially available blood glucose monitor and a subcutaneous continuous glucose monitor. The study was completed with no significant adverse effects.
“We are again very pleased with the performance of our sensor during a long-term preclinical study and look forward to moving into human clinical trials” stated Paul Goode, PhD, CEO of Glucotrack. “Our CBGM’s ability to continuously measure blood glucose for 2+ years with accuracy, minimal calibration and without a wearable device represents a significant advancement in glucose monitoring. We believe this technology has the potential to greatly improve the quality of life for people with diabetes by providing a more convenient and discreet monitoring solution.”
Glucotrack previously announced that it had completed preclinical animal testing in an acute setting and had initiated a long-term animal study to assess sustained glucose monitoring performance. The CBGM prototypes used in this study were manufactured using refined production techniques that bring the device closer to the commercially desired product. The Company plans to initiate human clinical trials later this year.
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. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this news release.
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.
Contacts:
Investor Relations:
investors@glucotrack.com
Media:
GlucotrackPR@icrinc.com
FAQ
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