GLUCOTRACK ANNOUNCES EARLY ACCURACY DATA FOR ITS IMPLANTABLE CONTINUOUS GLUCOSE MONITOR
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Insights
The completion of the preclinical study by GlucoTrack represents a significant milestone in the development of their implantable Continuous Blood Glucose Monitor (CBGM). The reported Mean Absolute Relative Difference (MARD) figures, 8.1% at Day 30 and 4.5% at Day 60, are noteworthy as they suggest a high level of accuracy for the prototype device. In the context of diabetes management, accuracy is paramount for patient safety and effective glycemic control. The MARD is a standard measure of accuracy for glucose monitoring devices and the industry benchmark is typically around 10%. Thus, the reported figures are impressive and indicate that the device could potentially exceed current industry standards if these results can be replicated in larger human trials.
The lack of significant adverse effects is also an encouraging sign for the device's safety profile. However, it is important to note that these results are from a preclinical study with a small sample size, which may not fully represent the device's performance in a larger population. Future clinical trials will be critical to validate these findings and assess the long-term reliability and safety of the device.
For investors and stakeholders in GlucoTrack, the successful preclinical study outcomes could have a positive impact on the company's valuation and stock market performance. The diabetes care market is a high-growth sector and innovative technologies like GlucoTrack's CBGM have the potential to capture significant market share if they demonstrate superior performance and safety. The company's confidence in improved prototypes suggests a robust product development strategy, which could lead to a competitive advantage.
However, investors should consider the stages of regulatory approval and market adoption that lie ahead. The journey from preclinical studies to commercialization is often lengthy and fraught with challenges. Investment in GlucoTrack should be weighed against the risks associated with the development of medical devices, including potential regulatory hurdles, the need for further capital to fund larger trials and the time required to bring the product to market.
The diabetes management market is rapidly evolving, with a growing demand for non-invasive and continuous monitoring solutions. GlucoTrack's implantable CBGM technology could meet a significant unmet need within this space, particularly for patients seeking alternatives to traditional fingerstick methods. The global diabetic population is on the rise and technologies that offer improved accuracy and patient convenience are well-positioned to disrupt the market.
It is essential to monitor the competitive landscape, as other companies may also be developing similar technologies. Market success will depend not only on the efficacy and safety of the CBGM but also on factors such as cost, reimbursement policies and integration with digital health platforms. GlucoTrack's progress in these areas will be crucial for its long-term market positioning and financial success.
Rutherford, NJ, Jan. 02, 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, provides, updates on initial and long-term preclinical testing for the implantable Continuous Blood Glucose Monitor™ (CBGM).
The Company announces the successful completion of their first preclinical study of the implantable CBGM. The study’s objective was to assess implant technique and device safety. In addition, a small sample size of sensors was used to determine device functionality. Although not intended to be an accuracy study, the sensor demonstrates a Mean Absolute Relative Difference (MARD) of
“We are extremely pleased with these initial results demonstrating that the sensor is both safe and capable of a high level of accuracy” states Paul Goode, PhD, CEO of GlucoTrack. “Because this study was performed using initial prototype devices, we expect to see similar results with improved prototypes that are manufactured using refined production techniques. So, we are very confident as we continue to advance our development program and as we share more information about our novel approach.”
The implantable CBGM utilizes an intravascular approach, in which the device is implanted subcutaneously and connected to a lead that is placed directly into a blood vessel. This facilitates continuous blood glucose measurements with zero lag time. In comparison, many continuous glucose monitoring (CGM) systems measure glucose in the interstitial fluid, which lags behind blood glucose.
The approach is based on design elements, implant techniques, and implant tools commonly used for active implantable devices in the cardiovascular space. As a result, it is a recognized, established, and widely utilized implant procedure and device form factor. This initial preclinical study demonstrates that this approach facilitates a simple implant procedure of approximately 20 minutes.
“The intravascular approach creates a system that is truly differentiated in the diabetes market. By measuring glucose in the blood, our system operates in a way that is comparable to what people expect with conventional fingerstick blood glucose monitoring. And, we accomplish this on a continuous basis with long-term use, improved simplicity, and increased discretion. We believe that our implantable CBGM technology will be a significant advancement for the millions of people living with diabetes” adds Mr. Goode.
The Company also announces a second milestone: the commencement of long-term preclinical testing on the implantable CBGM. The objective of this study is to assess sensor accuracy and longevity with a refined prototype and larger sample size.
GlucoTrack is committed to commercializing an implantable CBGM with a long-term sensor life, no requirement for an additional wearable component, and a once-only calibration event.
The company is preparing for first-in-human studies which are expected to start 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 glucose monitoring system for people living with diabetes. For more information, please visit http://www.glucotrack.com.
Investor Contact: investors@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. 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 GlucoTrack’s ability to maintain compliance with the Nasdaq Stock Market LLC’s continued listing requirements; risks relating to the failure to select or capitalize on the most scientifically, clinically or commercially promising or profitable product candidates, risks relating to the receipt (and timing) of regulatory approvals (including FDA approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to its 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, 2022 as filed with the SEC on March 31, 2023.
FAQ
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