GLUCOTRACK ANNOUNCES EARLY ACCURACY DATA FOR ITS IMPLANTABLE CONTINUOUS GLUCOSE MONITOR
January 02 2024 - 12:33PM
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 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 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.
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