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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): May 16, 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
May 16, 2024, Glucotrack, Inc., a Delaware corporation (the “Company”) issued a press release (the “Press Release”)
highlighting the successful completion of the first 30 days of a 60-day long-term preclinical study of epidural glucose monitoring. 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:
May 16, 2024 |
|
|
|
|
GLUCOTRACK,
INC. |
|
|
|
|
By: |
/s/
Paul Goode |
|
Name: |
Paul
Goode |
|
Title: |
Chief
Executive Officer |
Exhibit
99.1
GLUCOTRACK’S
EPIDURAL GLUCOSE MONITORING SENSOR DEMONSTRATES
SUCCESSFUL 30-DAY SAFETY & PERFORMANCE IN LONG-TERM PRECLINICAL STUDY
Promising
results support the potential of epidural glucose monitoring for simplified disease
management for patients with painful diabetic neuropathy
Rutherford,
NJ, May 16, 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, today
announced that its implantable continuous glucose monitor has successfully completed 30 days of a 60-day long-term preclinical study
on measuring glucose in the epidural space.
The
Glucotrack sensor, implanted in the epidural space of animals, closely tracked both blood glucose and a commercially available subcutaneous
continuous glucose monitor (CGM) throughout the 30-day period. The implantation procedure took approximately 20 minutes, and the animals
recovered without complications. No abnormal clinical signs or findings in the spinal cord or surrounding tissues were observed.
“We
are excited by the performance of our epidural glucose sensor in this long-term study, which builds on the encouraging results from our
acute testing,” said Paul V. Goode, PhD, CEO of Glucotrack. “We are proud to be at the forefront of developing this exciting
technology, which has the potential to benefit millions of people with diabetes.”
The
60-day long-term study is ongoing, with periodic glucose tolerance testing to compare the performance of the Glucotrack epidural sensor
performance against blood glucose and subcutaneous CGM.
Glucotrack
previously announced that it had completed preclinical animal testing in an acute setting and had initiated this long-term animal study
to assess sustained epidural glucose monitoring performance. While the acute study demonstrated feasibility of accurately measuring glucose
in the epidural space over several hours, this long-term study assesses the durability of the epidural glucose sensor measurement over
a significantly longer duration of monitoring.
Painful
diabetic neuropathy is a progressive neurological disorder that affects approximately one-fifth of the more than 38 million Americans
with diabetes, equating to more than 7 million individuals.1,2 The Company believes that, if approved, a continuous glucose monitoring system that takes readings
in the spinal epidural space may be integrated with existing treatments for these patients, simplifying their device and disease management.
For
more information about Glucotrack, visit glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into
this press release.
#
# #
1
Abbott CA, Malik RA, van Ross ER, Kulkarni J, Boulton AJ. Prevalence and characteristics of painful diabetic neuropathy in a large
community-based diabetic population in the U.K. Diabetes Care 2011;34:2220–2224.
2
Centers for Disease Control and Prevention. (2022). National Diabetes Statistics Report website. https://www.cdc.gov/diabetes/data/statistics-report/index.html
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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