Glucotrack Announces IDE Submission for U.S. Clinical Study of its Novel Implantable Continuous Blood Glucose Monitoring Technology

Glucotrack (Nasdaq: GCTK) submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration on May 7, 2026 to initiate a U.S. clinical study of its fully implantable continuous blood glucose monitoring (CBGM) system.

Rhea-AI Summary

Glucotrack (Nasdaq: GCTK) submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration on May 7, 2026 to initiate a U.S. clinical study of its fully implantable continuous blood glucose monitoring (CBGM) system. The filing follows preclinical testing and iterative design work and, if approved, would allow clinical evaluation of a long‑term, blood‑based CGM without an on‑body wearable.

Glucotrack says it will proceed with the U.S. study after FDA review and approval and intends to generate clinical data to support future regulatory advancement.

Positive

• IDE application submitted to FDA on May 7, 2026
• Submission advances device toward U.S. clinical evaluation
• Company reports preclinical data supporting clinical progression

Negative

• U.S. clinical study contingent on FDA IDE review and approval
• Clinical and regulatory timelines are unspecified and may delay progress

Argus May 7 session

+0.76% close to close Open Argus

Details

News Market Reaction – GCTK

On May 7, the day this news came out, GCTK closed 0.76% above the previous close.

Data tracked by StockTitan Argus for the May 7 session.

Market Context

This announcement advances Glucotrack’s CBGM program from planning toward U.S. clinical evaluation v...

Analysis

This announcement advances Glucotrack’s CBGM program from planning toward U.S. clinical evaluation via an FDA Investigational Device Exemption submission. It follows prior milestones such as first-in-human studies and ethics approvals, indicating steady development of a long-term implantable system. Investors may watch for FDA feedback, trial design details, funding progress given a $19.4 million 2025 net loss, and how the 3,224,803-share resale registration interacts with future data readouts.

Key Figures

Share price: $0.8535 Daily price change: 16.92% Trading volume: 99,871,111 shares +5 more

Share price

$0.8535

Pre-news level on 2026-05-07

Daily price change

16.92%

Change over prior 24 hours

Trading volume

99,871,111 shares

Volume on 2026-05-07 vs 20-day average 12,072,291

Market cap

$2,671,274

Market capitalization pre-news

Registered resale shares

3,224,803 shares

S-3 shelf for warrant holder resales filed 2026-01-13

Cash balance

$7.4 million

Cash at 2025 year-end per 10-K

2025 net loss

$19.4 million

Full-year 2025 net loss per 10-K

Shares outstanding

910,688 shares

Outstanding as of January 12, 2026 (S-3 disclosure)

Previous Clinical trial Reports

5 past events · Latest: Mar 27

Same Type 5 events

1. Mar 27

   IDE plan outlined

   24h Move

   -9.2%

   Planned Q2 2026 IDE filing and H2 2026 U.S. trial timeline.

2. May 13

   Ethics approval

   24h Move

   -1.8%

   Ethical approval for long-term CBGM study in Melbourne hospital.

3. Apr 03

   AI analytics tie-up

   24h Move

   -6.6%

   Collaboration with OneTwo Analytics to analyze CBGM clinical data.

4. Feb 04

   First human study

   24h Move

   -28.9%

   Successful completion of first human CBGM study meeting primary endpoint.

5. Dec 03

   Enrollment started

   24h Move

   +0.7%

   Initiation of patient enrollment for short-term human CBGM study.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

investigational device exemption, ide, u.s. food and drug administration, fda, +2 more

6 terms

investigational device exemption regulatory

"it has submitted its Investigational Device Exemption (IDE) application to the U.S."

An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.

ide regulatory

"Submission of our IDE represents meaningful progress in the development of our CBGM"

An IDE (Investigational Device Exemption) is a regulatory permission that allows a company to test an unapproved medical device in human clinical trials to gather safety and effectiveness data. Think of it as a temporary road permit for a new product: getting the IDE moves a technology from concept toward approval and market access, which can reduce uncertainty and increase value for investors, while delays or denials raise development risk and potential costs.

u.s. food and drug administration regulatory

"application to the U.S. Food and Drug Administration (FDA) to initiate a US clinical"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

fda regulatory

"application to the U.S. Food and Drug Administration (FDA) to initiate a US clinical"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

continuous glucose monitoring medical

"blood‑based continuous glucose monitoring platformRUTHERFORD, N.J., May 07, 2026 --"

Continuous glucose monitoring is a system that tracks blood sugar levels in real-time throughout the day and night. It provides constant updates, similar to a car's dashboard showing speed and fuel level at all times. For investors, advancements in this technology can signal progress in health monitoring devices, which may influence the growth and valuation of companies in the healthcare sector.

clinical study medical

"FDA) to initiate a US clinical study for its fully implantable continuous blood"

A clinical study is a research process that tests how well a new medicine, treatment, or medical device works and whether it is safe for people. It often involves volunteers and follows a structured plan to gather evidence about the product’s effectiveness. For investors, clinical studies are important because successful results can lead to new products, increased sales, and potential growth for the companies involved.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Submission supports advancement of a long‑term, fully implantable, blood‑based continuous glucose monitoring platform

RUTHERFORD, N.J., May 07, 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 announced that it has submitted its Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to initiate a US clinical study for its fully implantable continuous blood glucose monitoring (CBGM) technology.

The IDE submission represents an important step for Glucotrack and reflects the Company’s progress to date in its preclinical development and technical foundation of the technology. With this submission, Glucotrack moves closer to advancing its implantable monitoring system toward clinical evaluation in the United States, with the goal of offering people with diabetes a new option for continuous glucose monitoring designed to provide long-term, real-time, blood-based accuracy without an on-body wearable. The Company plans to proceed with its U.S. clinical study following FDA review and approval.

“Submission of our IDE represents meaningful progress in the development of our CBGM technology and underscores our commitment to helping people with diabetes live more fully,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “Our fully implantable solution is designed to be comfortable and discreet so that people can focus on their daily lives – allowing them to work, exercise, sleep, and socialize without the disruption of frequent sensor changes, visible wearables, or reordering supplies. We look forward to generating the clinical data needed to advance toward regulatory approval and demonstrate that continuous glucose monitoring can be both highly accurate and virtually invisible.”

The IDE submission follows several years of focused engineering, preclinical evaluation, and iterative design work supporting the development of a long‑term, fully implantable CBGM system. Data generated to date support advancing the technology into U.S. clinical evaluation as the Company enters the next phase of development.

For more information about Glucotrack's CBGM, visit www.glucotrack.com.

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, 2025 as filed with the SEC on March 30, 2026.

Contacts:
Investor Relations:	Media:
investors@glucotrack.com	GlucotrackPR@icrinc.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Glucotrack (GCTK) announce on May 7, 2026 about its implantable CGM?

Glucotrack submitted an IDE to the FDA to start a U.S. clinical study of its implantable CBGM. According to Glucotrack, the submission follows preclinical evaluation and moves the technology toward clinical testing in the United States.

What does an IDE submission mean for Glucotrack's (GCTK) product development timeline?

An IDE submission requests permission to begin clinical trials in the U.S.; approval is required before starting the study. According to Glucotrack, the company will proceed with its U.S. clinical study only after FDA review and approval.

How is Glucotrack's implantable CBGM different from current CGM options?

Glucotrack's device is a fully implantable, blood‑based continuous glucose monitor designed to operate without an on‑body wearable. According to Glucotrack, the system aims for long‑term, real‑time blood accuracy while being discreet and requiring fewer visible components.

Will Glucotrack (GCTK) begin human trials immediately after the IDE submission?

No; human trials in the U.S. require FDA IDE approval before starting. According to Glucotrack, the company plans to initiate its U.S. clinical study only following FDA review and approval of the IDE application.

What development work supported Glucotrack's (GCTK) IDE submission?

The company cites several years of engineering, preclinical evaluation, and iterative design work supporting the submission. According to Glucotrack, data generated to date support advancing the technology into U.S. clinical evaluation.