Glucotrack (Nasdaq:GCTK) announced that it expects FDA investigational device exemption (IDE) for its long-term CBGM later this year.
Rutherford, New Jersey-based Glucotrack develops a long-term implantable continuous blood glucose monitor (CBGM). The 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.
Earlier this year, the company completed the first-in-human study of the system. Now, it expects IDE to conduct a long-term, multi-center pilot study for the CBGM, in the fourth quarter of 2025. The study would likely help the company work toward a submission to bring the device to market in the U.S. down the line.
Paul Goode, Glucotrack’s president and CEO, says it would be the first fully implantable CBGM technology with a multi-year monitoring system and real-time measuring capabilities, offering differentiated benefits of accuracy, convenience and independence.
“As we look to 2025, I am pleased with the progress we are making to advance our technology,” Goode said. “Moving towards these goals, we will continue to look for ways to strengthen our capital structure. … “We are committed to pursuing additional financing strategies that align with our mission, create value for our shareholders, and provide additional runway to enable us to continue executing on our strategic priorities. We are optimistic about 2025 and look forward to updating you on our progress periodically.”
