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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): January 2, 2024
GLUCOTRACK,
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-41141 |
|
98-0668934 |
(State
or Other Jurisdiction |
|
(Commission |
|
(IRS
Employer |
of
Incorporation) |
|
File
Number) |
|
Identification
No.) |
301
Rte 17 North, Ste. 800
Rutherford, NJ |
|
07070 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (201) 842-7715
N/A
(Former
name or former address, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock |
|
GCTK |
|
Nasdaq
Capital Market |
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §
230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR § 240.12b-2).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
8.01 Other Events
On
January 2nd, 2024, GlucoTrack, Inc. (the “Company”) issued a press release announcing data from a recent animal
study. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item
9.01 Exhibits
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Date:
January 2, 2024
GLUCOTRACK,
INC. |
|
|
|
|
By: |
/s/
Paul Goode |
|
Name: |
Paul
Goode |
|
Title: |
Chief
Executive Officer |
|
Exhibit 99.1
GLUCOTRACK
ANNOUNCES EARLY ACCURACY DATA FOR ITS IMPLANTABLE CONTINUOUS GLUCOSE MONITOR
Rutherford,
NJ, January 2, 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 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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