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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

 

Exhibit   Description
99.1   Press Release dated October 12, 2023
104   Cover Page Interactive Data File (Embedded within the Inline XBRL document)

 

 

 

 

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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