0001493152-24-020136.txt : 20240516 0001493152-24-020136.hdr.sgml : 20240516 20240516084245 ACCESSION NUMBER: 0001493152-24-020136 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20240516 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240516 DATE AS OF CHANGE: 20240516 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GlucoTrack, Inc. CENTRAL INDEX KEY: 0001506983 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 980668934 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-41141 FILM NUMBER: 24953685 BUSINESS ADDRESS: STREET 1: 301 RT 17 NORTH STREET 2: SUITE 800 CITY: RUTHERFORD STATE: NJ ZIP: 07070 BUSINESS PHONE: 972 (8) 675-7878 MAIL ADDRESS: STREET 1: 301 RT 17 NORTH STREET 2: SUITE 800 CITY: RUTHERFORD STATE: NJ ZIP: 07070 FORMER COMPANY: FORMER CONFORMED NAME: Integrity Applications, Inc. DATE OF NAME CHANGE: 20101203 8-K 1 form8-k.htm
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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

 

Exhibit No.   Description
99.1   Press Release, dated May 16, 2024
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: May 16, 2024  
   
  GLUCOTRACK, INC.
     
  By: /s/ Paul Goode
  Name: Paul Goode
  Title: Chief Executive Officer

 

 

 

 EX-99.1 2 ex99-1.htm

 

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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Cover
May 16, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date May 16, 2024
Entity File Number 001-41141
Entity Registrant Name GLUCOTRACK, INC.
Entity Central Index Key 0001506983
Entity Tax Identification Number 98-0668934
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 301 Rte 17 North
Entity Address, Address Line Two Ste. 800
Entity Address, City or Town Rutherford
Entity Address, State or Province NJ
Entity Address, Postal Zip Code 07070
City Area Code (201)
Local Phone Number 842-7715
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock
Trading Symbol GCTK
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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