GlucoTrack Inc. (NASDAQ:GCTK) shares are up on Friday as the company is preparing to file a significant investigational device exemption (IDE) with the FDA for its continuous blood glucose monitoring technology.

FDA Filing Target Set

The company on Friday announced that it aims to submit the IDE to the U.S. Food and Drug Administration (FDA) during the second quarter of 2026, following the completion of its first-in-human study in Brazil and the initiation of a follow-up study in Australia.

This progress is crucial as it positions GlucoTrack to advance its continuous blood glucose monitoring system, which is designed to meet the needs of insulin-dependent individuals.

In addition, GlucoTrack has established a dual-source manufacturing strategy in the U.S. and identified a reimbursement pathway that supports its economic profile.

The company is also enhancing its intellectual property portfolio, which is vital for its go-to-market strategy.

Management Highlights Industry Experience

“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 Inc. (NASDAQ:DXCM), Abbott Laboratories (NYSE:ABT), Senseonics Holdings Inc. (NASDAQ:SENS), and Medtronic Plc (NYSE:MDT),” commented Paul Goode, President and CEO of Glucotrack.

First-In-Human Data Shows Accuracy And Safety

Detailed analysis of the first in-human trial 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.

GCTK Stock Price Activity: GlucoTrack shares were trading up 47.62% at $1.619 at the time of publication on Friday, according to Benzinga Pro data.

Image via Glucotrack