Form 8-K - Current report
13 October 2023 - 9:20PM
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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): October 12, 2023
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 October 12th, 2023, GlucoTrack, Inc. (the “Company”)
issued a press release with an initial Animal Study.
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:
October 13, 2023
|
GLUCOTRACK, INC. |
|
|
|
|
By: |
/s/ Paul Goode |
|
Name: |
Paul Goode |
|
Title: |
Chief Executive Officer |
Exhibit 99.1
GLUCOTRACK
ANNOUNCES PRECLINICAL TESTING WITH IMPLANTABLE CONTINUOUS GLUCOSE MONITOR
Rutherford,
NJ, October 12, 2023 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical
device company focused on glucose monitoring technologies for people with diabetes and prediabetes, announced today that it has achieved
another milestone in its development of an implantable continuous glucose monitor (CGM) by commencing preclinical animal testing.
The
Company previously announced the completion and positive results of a laboratory-based feasibility study demonstrating that the CGM sensor
design is capable of measuring glucose for at least two years post-implant. Further preclinical testing, in animals, advances the development
of the implantable CGM by demonstrating that the sensor design functions as expected after an implant procedure and 30 days thereafter.
The
objectives of the preclinical animal study were to assess the implant procedure techniques and tools as well as to determine the acute
and chronic biological effect of the implant and the implant procedure. At this stage of development, the study was not intended to assess
sensor measurement accuracy.
The
results from the preclinical study have established that the sensor implant procedure takes approximately 15-20 minutes to perform, does
not require sophisticated implant techniques or tools, and was able to be completed with no adverse short-term (up to 3 days) or long-term
(up to 30 days) effect on the animals.
“This
preclinical study is a key step in furthering the development of our long-term implantable CGM enabling us to initiate preparations for
a long-term preclinical study to assess sensor performance and accuracy,” said Paul Goode, PhD, CEO of Glucotrack. “We are
pleased to be one step closer to bringing this technology to the millions of people living with diabetes.”
Glucotrack
is committed to commercializing an implantable CGM with a long-term sensor life, no requirement for an additional wearable component,
and a once-only calibration. Long-term preclinical studies on sensor performance are expected to start in late Q4 of this year.
About
Glucotrack, Inc.
Glucotrack,
Inc. (NASDAQ: GCTK), (formerly known as Integrity Applications, Inc.) is focused on the design, development, and commercialization of
novel technologies for people with diabetes and prediabetes. The Company’s initial product, Glucotrack®, is a proprietary
non-invasive glucose monitoring device designed to obtain glucose level measurements without the pain, incremental cost, difficulty,
or discomfort of conventional invasive finger stick devices. For more information, please visit and 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 “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 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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