Glucotrack (Nasdaq:GCTK) today announced multiple developments in the timeline for its long-term continuous blood glucose monitor (CBGM).
The Rutherford, New Jersey-based company plans to file an FDA investigational device exemption (IDE) submission in the fourth quarter of this year. It also remains on track to implant the first patients in a long-term, multi-center feasibility study in Australia in the third quarter.
“Looking ahead, we are on track to initiate our clinical study in Australia in the third quarter and to continue building our robust body of clinical evidence supporting the use of our well-differentiated, fully implantable, real-time, multi-year CBGM system,” said Paul V. Goode, president and CEO of Glucotrack. “We also anticipate submitting our IDE to the FDA in the fourth quarter, enabling in 2026 the launch of our long-term, multicenter Pilot Study in the US.”
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.
Glucotrack Chief Science Officer Mark Tapsak outlined how the system works at the American Diabetes Association’s 85th Scientific Sessions in Chicago in June. See all the biggest stories out of ADA 2025 here.
The company also reported positive first-in-human outcomes from a study in Brazil at ADA. Glucotrack said the findings validated its system’s safety and performance.
“This quarter, we made meaningful progress across the business… ” Goode said. “At the same time, we strengthened our capital structure, removing the warrant liability and share dilution overhang which, we believe, creates attractive opportunities for new investors to join in our mission to bring our potentially life-improving technology to the millions of diabetes patients who need it most.”
