0001493152-24-000071.txt : 20240102 0001493152-24-000071.hdr.sgml : 20240102 20240102144231 ACCESSION NUMBER: 0001493152-24-000071 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20240102 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240102 DATE AS OF CHANGE: 20240102 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: 24501962 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): January 2, 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)

 

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 January 2nd, 2024, GlucoTrack, Inc. (the “Company”) issued a press release announcing data from a recent animal study. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01 Exhibits

 

Exhibit   Description
99.1   Press Release dated January 2, 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: January 2, 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 ANNOUNCES EARLY ACCURACY DATA FOR ITS IMPLANTABLE CONTINUOUS GLUCOSE MONITOR

 

Rutherford, NJ, January 2, 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, provides, updates on initial and long-term preclinical testing for the implantable Continuous Blood Glucose Monitor™ (CBGM).

 

The Company announces the successful completion of their first preclinical study of the implantable CBGM. The study’s objective was to assess implant technique and device safety. In addition, a small sample size of sensors was used to determine device functionality. Although not intended to be an accuracy study, the sensor demonstrates a Mean Absolute Relative Difference (MARD) of 8.1% at Day 30 and 4.5% at Day 60. The study was completed with no significant adverse effects.

 

“We are extremely pleased with these initial results demonstrating that the sensor is both safe and capable of a high level of accuracy” states Paul Goode, PhD, CEO of GlucoTrack. “Because this study was performed using initial prototype devices, we expect to see similar results with improved prototypes that are manufactured using refined production techniques. So, we are very confident as we continue to advance our development program and as we share more information about our novel approach.”

 

The implantable CBGM utilizes an intravascular approach, in which the device is implanted subcutaneously and connected to a lead that is placed directly into a blood vessel. This facilitates continuous blood glucose measurements with zero lag time. In comparison, many continuous glucose monitoring (CGM) systems measure glucose in the interstitial fluid, which lags behind blood glucose.

 

The approach is based on design elements, implant techniques, and implant tools commonly used for active implantable devices in the cardiovascular space. As a result, it is a recognized, established, and widely utilized implant procedure and device form factor. This initial preclinical study demonstrates that this approach facilitates a simple implant procedure of approximately 20 minutes.

 

“The intravascular approach creates a system that is truly differentiated in the diabetes market. By measuring glucose in the blood, our system operates in a way that is comparable to what people expect with conventional fingerstick blood glucose monitoring. And, we accomplish this on a continuous basis with long-term use, improved simplicity, and increased discretion. We believe that our implantable CBGM technology will be a significant advancement for the millions of people living with diabetes” adds Mr. Goode.

 

 
 

 

The Company also announces a second milestone: the commencement of long-term preclinical testing on the implantable CBGM. The objective of this study is to assess sensor accuracy and longevity with a refined prototype and larger sample size.

 

GlucoTrack is committed to commercializing an implantable CBGM with a long-term sensor life, no requirement for an additional wearable component, and a once-only calibration event.

 

The company is preparing for first-in-human studies which are expected to start later this year.

 

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 glucose monitoring system for people living with diabetes. For more information, please visit 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 “believe”, “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 GlucoTrack’s ability to maintain compliance with the Nasdaq Stock Market LLC’s continued listing requirements; risks relating to the failure to select or capitalize on the most scientifically, clinically or commercially promising or profitable product candidates, 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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Cover
Jan. 02, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Jan. 02, 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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