Glucotrack (Nasdaq:GCTK) today announced a slight delay in its plans to submit its long-term glucose monitor to the FDA for IDE.
The company said in August that it expected a fourth-quarter investigational device exemption (IDE) submission for the long-term implantable continuous blood glucose monitor (CBGM). However, it says today that it anticipates a submission in Spring 2026.
Glucotrack’s device features no on-body external component. The company designed it for three years of continuous, accurate blood glucose monitoring for a more convenient, less intrusive solution. Unlike traditional CGMs that measure glucose in interstitial fluid, the CBGM measures glucose levels directly from the blood. It aims to provide real-time readings without the lag time typically associated with interstitial glucose measurements.
Despite pushing back that timeline, the company was on-time in initiating a long-term, multi-center feasibility study in Australia for the CBGM. It evaluates the system’s safety and performance over an initial period of one year. Initial observations included complexities related to how certain health conditions may impact study eligibility.
As a result, the company plans to undertake certain protocol amendments to refine participant selection before future enrollments. It also plans to implement certain product improvements.
Glucotrack Chief Science Officer Mark Tapsak outlined how the system works at the American Diabetes Association’s 85th Scientific Sessions in Chicago in June.
The company reported its third-quarter financial results, which included $3.2 million in R&D expenses. That compares to $2.1 million in the same period in 2024. Glucotrack attributed this rise to increased costs related to the development of its CBGM.
Additionally, the company reported $1.1 million in marketing and general administrative expenses. It recorded a net loss of $4.2 million, or $4.64 per share.
Glucotrack said it strengthened its balance sheet. It expects cash and equivalents to fund operations through March 2026, including long-term feasibility trials and related milestones.
“During the quarter we continued to make steady progress towards our corporate and clinical objectives. We strengthened our balance sheet by securing flexible funding to support us through key milestones, and expanded our clinical advisory team with the addition of Dr. [Usman] Latif, who will provide strategic counsel as we advance our epidural glucose monitoring application alongside our continuous blood glucose monitor (CBGM) product,” said Paul V. Goode, president and CEO of Glucotrack. “Looking ahead, we are committed to advancing our clinical program both in the US and abroad. We continue to work closely with the FDA toward securing IDE approval to initiate a long-term clinical study of our product in the U.S., with our IDE submission expected in the Spring of 2026.”
