Form 8-K

8-K — Glucotrack, Inc.

Accession: 0001493152-26-013095

Filed: 2026-03-27

Period: 2026-03-27

CIK: 0001506983

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

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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): March 27, 2026

GLUCOTRACK,

INC.

(Exact

name of registrant as specified in its charter)

Delaware

001-41141

98-0668934

(State

or Other Jurisdiction

(Commission

(IRS

Employer

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, par value $0.001 per share

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 ☐

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

March 27, 2026, Glucotrack, Inc., a Delaware corporation (the “Company”), issued a press release (the “Press Release”).

The Press Release is furnished herewith as Exhibit 99.1.

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 (the “Exchange Act”), or otherwise subject to the liabilities of that section, unless the

Company specifically states that the information is to be considered “filed” under the Exchange Act or specifically incorporates

it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.

Item

9.01 Financial Statements and Exhibits

(d)

Exhibits

Exhibit

No.

Description

99.1

Press Release dated March 27, 2026

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:

March 27, 2026

GLUCOTRACK,

INC.

By:

/s/

Paul Goode

Name:

Paul

Goode

Title:

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Glucotrack

to File Significant IDE with FDA for US Clinical Trial in Early Q2 Based on Critical 2025 Milestones

Experience

From Brazilian and Australian Clinical Trials Positions the Company to Submit Investigational Device Exemption (IDE) to FDA for Novel

CBGM Technology in Q2 2026

Rutherford,

NJ, March 27, 2026 (GLOBE NEWSWIRE) — Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”),

a medical technology company focused on the design, development, and commercialization of novel technologies for people with diabetes,

today provided a comprehensive recap of the critical operational milestones which have positioned the Company to submit an IDE to the

U.S. Food and Drug Administration (FDA) for its novel continuous blood glucose monitoring (CBGM) technology, with a goal to file requisite

documents with the FDA during Q2 of 2026.

“In

2025 we made meaningful progress in advancing the development of our fully implantable continuous blood glucose monitoring technology

and strengthening Glucotrack’s foundation,” commented Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack.

“The completion of our first-in-human study in Brazil and initiation of our follow up study in Australia enables us to advance

toward our U.S. clinical program. With trial infrastructure in place and product enhancements completed, we are prepared to initiate

the study, pending FDA approval.”

“In

parallel, we have continued to strengthen the commercial and operational foundation of the business,” Dr. Goode added. “We

have completed extensive U.S. market research across patients and multiple healthcare provider segments, which indicates an unmet need

for a fully implantable CBGM solution. Diabetes represents one of the largest addressable healthcare markets

globally, with Continuous Glucose Monitor (CGM) among its fastest-growing and most dynamic segments. Our research indicates that our

differentiated technology has the potential to deliver meaningful, scalable impact for millions of patients.”

“We

have also identified a clear U.S. reimbursement pathway that supports a compelling economic profile, built a dual-source U.S. manufacturing

strategy with two qualified contract manufacturing partners, and assembled a seasoned management team with deep experience in diabetes

and implantable medical technologies from industry leaders such as Dexcom, Abbott, Senseonics, and Medtronic.”

“We

are extremely proud of the accomplishments we achieved as a team in 2025, and we are prepared to execute further on the development of

our first-to-market CBGM system to meet the needs of the millions of people living with diabetes in the

US alone,” concluded Dr. Goode.

First

In-Human Study

Q1, the Company completed its first in-human clinical trial. The objective of this 5-day in-hospital study was to assess the insertion,

use, and removal of the intravascular lead which was connected to externalized electronics.The study, which was conducted at the Interventional

Cardiology at Instituto do Coração in São Paulo, Brazil between December 13, 2024 and January 31, 2025, included

ten participants with either Type 1 or Type 2 diabetes who were on intensive insulin therapy. The insertion and removal procedures were

performed by interventional cardiologists using established percutaneous techniques.

Detailed

analysis showed consistent performance during glucose tolerance testing with minimal lag time compared to venous blood samples. The study

met all primary and secondary endpoints, demonstrating excellent accuracy with a Mean Absolute Relative Difference (MARD) of 7.7% across

122 matched pairs, a 99% data capture rate, and no procedure or device-related serious adverse events. These findings support the safety

and performance of the Company’s long-term, implantable CBGM, which measures glucose from blood

rather than interstitial fluid, eliminating the typical lag time associated with traditional continuous glucose monitoring systems.

Australia

Clinical Trial

July 2025, the Company initiated a feasibility clinical trial at the Diabetes Technology Research Group of St Vincent’s Hospital

in Melbourne, Australia. While the system performance was similar to that observed in the Brazilian trial, this study provided meaningful

protocol and product learnings which have been incorporated for the next planned clinical study (discussed below).

Clinical Trial Readiness

Following

the completion of these trials, the Company has completed several key clinical trial readiness activities for its planned U.S. clinical

study. A U.S. clinical trial site has been secured, and a Clinical Research Organization (CRO) experienced with diabetes Medtech has

been engaged to manage and conduct the study. In parallel, the Company has completed targeted product design iterations to further enhance

functionality and performance. With these foundational elements in place, the Company is currently engaged in discussions with the FDA

regarding its planned U.S. clinical trial program. Glucotrack expects to be positioned to initiate the study in the second half of 2026,

subject to FDA approval of its IDE submission.

Patents

October and November 2025, the Company was successfully awarded three critical patents relating to the Company’s CBGM platform, a long-term implantable device designed for three-year sensor longevity, including proprietary sensor

chemistry, intravascular lead design, and low-power electronics. The US Patent and Trademark Office (USPTO) issued Patent Nos. US 12,453,494,

US 12,458,257, and US 12,458,258 for the Company’s CBGM platform.

Together,

these innovations bridge the gap between short-lived subcutaneous sensors and larger pacemaker-class devices, securing critical components

of the Company’s intellectual property portfolio for the long-term. These three new patents were critical to securing and expanding

the Company’s core intellectual property portfolio as it reinforces its go-to-market strategy.

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

Continuous Blood Glucose Monitor (CBGM) is a long-term, implantable system that continually measures blood glucose levels with a sensor

longevity of 3 years, no on-body wearable component and with minimal calibration. The Glucotrack CBGM is an Investigational Device and

is limited by federal (or United States) law to investigational use.

For

more information, please visit http://www.glucotrack.com. Information on the Company’s website does not constitute a part of and

is not incorporated by reference into this press release.

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 “anticipate”, “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, 2024 as filed with the SEC on March 31, 2025.

Contacts:

Investor

Relations:

Media:

investors@glucotrack.com

GlucotrackPR@icrinc.com

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