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 8.1% at Day 30 and 4.5% at Day 60. The study was completed with no significant adverse effects.
“We are extremely pleased with these initial results demonstrating that the sensor is both safe and capable of a high level of accuracy” states
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
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.
The company is preparing for first-in-human studies which are expected to start later this year.
About GlucoTrack, Inc.
Investor Contact: investors@glucotrack.com
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