GCTK News & Events

Glucotrack submitted its Investigational Device Exemption application to the U.S. Food and Drug Administration to initiate a US clinical study for its fully implantable continuous blood glucose monitoring technology. "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 Goode, CEO. "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."

Glucotrack announced the publication of a peer-reviewed scientific article in the Institute of Electrical and Electronics Engineers, IEEE, Sensors Journal characterizing the long-term in-vitro stability of electrochemical glucose sensors of the type used in the Company's fully implantable continuous blood glucose monitoring system. The findings represent the first year-long measurement of glucose oxidase enzyme decay reported in the literature and support the feasibility of long-life implantable continuous glucose monitors. "This work provides externally reviewed scientific evidence relevant to the design of long-life implantable glucose sensors. Peer-reviewed characterization of foundational sensor data is an important step as we continue to advance our development program and work toward clinical and regulatory milestones," commented Dr. Paul Goode, President and Chief Executive Officer of Glucotrack.

Glucotrack provided a recap of the critical operational milestones which have positioned the company to submit an IDE to the FDA for its continuous blood glucose monitoring technology, with a goal to file requisite documents with the FDA during Q2. "In 2025 we made meaningful progress in advancing the development of our fully implantable continuous blood glucose monitoring technology and strengthening Glucotrack's foundation," commented Paul Goode, president and CEO of Glucotrack. "The completion of our first-in-human study in Brazil and initiation of our follow up study in Australia enables us to advance toward our U.S. clinical program. With trial infrastructure in place and product enhancements completed, we are prepared to initiate the study, pending FDA approval."

Glucotrack announced that the US Patent and Trademark Office, USPTO, has issued Patent Nos. US 12,453,494, US 12,458,257, and US 12,458,258 for the Company's continuous blood glucose monitoring, CBGM, platform. The patents strengthen Glucotrack's competitive position and intellectual property protection as the Company advances its multi-year, fully implantable CBGM system toward commercialization. "These patents represent a significant milestone in protecting our innovative technology that is at the core of our CBGM system," said Paul Goode, PhD, President and Chief Executive Officer of Glucotrack. "Securing our intellectual property is fundamental to our strategy as we advance our fully implantable, long-term sensor through further clinical testing and toward commercialization. These patents establish important competitive barriers and strengthen our position to deliver a differentiated approach to diabetes management."