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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): August 15, 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)
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)) |
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 |
|
The
Nasdaq Stock Market LLC |
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
7.01 Regulation FD Disclosure
On
August 15, 2024, Glucotrack, Inc., a Delaware corporation (the “Company”) issued a press release (the “Press Release”)
regarding certain market research. The Press Release is furnished as Exhibit 99.1 and incorporated into this Item 7.01 by reference.
The
information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, and shall not be deemed incorporated by reference into any filing with the Securities and Exchange
Commission, except as expressly set forth by specific reference in such a filing.
Item
9.01 Financial Statements and Exhibits
(d)
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:
August 15, 2024 |
|
|
|
|
GLUCOTRACK,
INC. |
|
|
|
|
By: |
/s/
Paul Goode |
|
Name: |
Paul
Goode |
|
Title: |
Chief
Executive Officer |
Exhibit
99.1
Glucotrack’s
Innovative Blood Glucose Monitoring Concept Resonates with Patients with Diabetes, According to New Survey Presented at Association of
Diabetes Care and Education Specialists (ADCES) 2024 Annual Conference
Glucotrack
ADCES poster highlights over 50% of surveyed diabetes patients are open to new Continuous Blood Glucose Monitor concept
Rutherford,
NJ, August 15, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical
technology innovator focused on the design, development, and commercialization of novel technologies for people with diabetes, today
announced new findings from a recent market research study evaluating the acceptance of its new Continuous Blood Glucose Monitor (CBGM)
concept among people with insulin-requiring diabetes. The poster was presented at the Association of Diabetes Care and Education Specialists
(ADCES) 2024 Annual Conference held Aug. 9-12, 2024, in New Orleans.
The
study, conducted with a diverse group of participants, revealed that over 50% of respondents are open to adopting Glucotrack’s
new CBGM concept – a small
device placed under the skin. This technology is designed to offer continuous, accurate blood glucose monitoring for up to 3 years without
the calibration, comfort and wearability challenges associated with traditional Continuous Glucose Monitor (CGM) approaches.
Key
features that garnered the most interest include the long-term sensor life (2-year sensor-life was tested during the study), the absence
of a wearable component, and the provision of real-time blood glucose readings. These top three appealing aspects were consistent across
all segments of respondents.
The
study included 757 respondents with intensive insulin therapy (49% type 1 diabetes and 51% type 2 diabetes), comprised of current CGM
users (67%), non-users (25%) and ex-users (8%). Respondents used various insulin delivery methods: multiple daily injections (60%) and
insulin pump (40%, including 21% automated insulin delivery or AID and 19% non-AID).
“This
market research shows us that there is clear need for innovation in continuous glucose monitoring and that Glucotrack’s innovative
approach has tremendous market potential as it addresses unmet needs,” said Paul Goode, President & CEO at Glucotrack. “Our
goal has always been to develop innovative solutions that improve the quality of life for people with diabetes. The insights gained from
this study will be invaluable as we continue to refine our CBGM technology to better meet the needs of our users.”
The
new CBGM concept represents a significant advancement in diabetes management, offering a more convenient and less intrusive way for individuals
to monitor their blood glucose levels. Glucotrack remains committed to leveraging cutting-edge technology to empower people with diabetes
to live healthier, more independent lives.
Glucotrack,
Inc. has recently made significant strides in its clinical progress. The company successfully completed a 60-day long-term preclinical
study of its implantable CGM, demonstrating the feasibility of glucose monitoring in the epidural space. Additionally, a 90-day preclinical
study confirmed the sustained accuracy of its CBGM, with a mean absolute relative difference of 4.7%, which is considered highly accurate
for a continuous glucose monitor. These advancements pave the way for upcoming human clinical trials that the company plans to initiate
later this year, marking a crucial step towards providing a more convenient and discreet glucose monitoring solution for people with
diabetes.
For
more information about Glucotrack’s CBGM, visit glucotrack.com.
#
# #
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.
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
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