Core Viewpoint - Glucotrack, Inc. is making significant advancements in the development of its fully implantable continuous blood glucose monitor (CBGM) system, with plans to initiate clinical studies in Australia and submit an Investigational Device Exemption (IDE) to the FDA by the end of 2025, while also strengthening its corporate structure and expanding its advisory boards [1][2][11]. Corporate Highlights - The company is on track to implant the first patients in a long-term, multicenter feasibility study of the CBGM system in Australia in Q3 2025 [1]. - An IDE submission to the FDA for the novel CBGM technology is anticipated in Q4 2025 [1]. - The Board of Directors has been strengthened with the appointment of Dr. David S. Hirsh as Medical Director - Cardiology and Dr. Victoria E. Carr-Brendel to the Board [2][5]. - A Patient Advisory Board has been established to incorporate patient perspectives into the development of the CBGM technology [2][5]. Financial Overview - Cash and cash equivalents as of June 30, 2025, were $9.6 million, an increase from $5.6 million as of December 31, 2024, primarily due to $10.7 million in net proceeds from public equity financings [12]. - Research and development expenses for the six months ended June 30, 2025, were $5.0 million, down from $5.7 million in the prior-year period [8]. - Marketing, general, and administrative expenses increased to $3.3 million for the six months ended June 30, 2025, compared to $1.7 million in the prior-year period [9]. - The net loss for the six months ended June 30, 2025, was $11.6 million, compared to a net loss of $7.4 million for the same period in the previous year [10]. Clinical Development - Positive results were reported from a first-in-human study for the CBGM, achieving a Mean Absolute Relative Difference (MARD) of 7.7% across 122 matched pairs, with a 99% data capture rate [11]. - The company received ethical approval in Australia to initiate a long-term clinical study of the CBGM in participants with type 1 and type 2 diabetes [11]. - Glucotrack is participating in the FORGETDIABETES initiative, which aims to develop an artificial pancreas for type 1 diabetes, utilizing the CBGM technology for real-time glucose data [11].

Core Insights - Glucotrack, Inc. is set to present safety and performance data from its first-in-human trial of an implantable continuous blood glucose monitoring (CBGM) system at the American Diabetes Association's 85th Scientific Sessions in June 2025 [1][4] - The CBGM system is designed to measure glucose directly from the blood, offering real-time, accurate readings without the need for wearable devices, and has a sensor longevity of up to three years [5][8] Company Overview - Glucotrack, Inc. focuses on the design, development, and commercialization of innovative technologies for diabetes management [7] - The company aims to redefine diabetes management through its long-term CBGM system, which minimizes daily disruptions for users [4][5] Event Details - The American Diabetes Association's 85th Scientific Sessions will take place in Chicago from June 20 to June 23, 2025, where Glucotrack will participate in the Innovation Hub program [2] - Mark Tapsak, the Chief Scientific Officer of Glucotrack, will deliver a live presentation on the future of continuous glucose monitoring [2][7] Technology Highlights - Glucotrack's CBGM system is an investigational device that operates from within the body, measuring blood glucose levels directly, unlike traditional monitors that measure interstitial fluid [5][8] - The system is designed for minimal calibration and aims to provide a more convenient solution for diabetes management [8]

Core Insights - Glucotrack, Inc. has received ethical approval for a long-term clinical study of its continuous blood glucose monitor (CBGM) for type 1 and type 2 diabetes patients [1][2] - The study will enroll up to 30 participants and evaluate the device's performance and safety over an initial period of 1 year, with potential extension to 3 years [2][4] - The CBGM is designed to provide real-time blood glucose measurements directly from blood, offering advantages over traditional systems that measure interstitial fluid [3][4] Company Overview - Glucotrack, Inc. focuses on the design, development, and commercialization of innovative technologies for diabetes management [6] - The CBGM is a long-term implantable system with a sensor longevity of up to 3 years and minimal calibration required [7] Clinical Study Details - The study will be led by Professor David O'Neal and will take place at St. Vincent's Hospital Melbourne [2][3] - The first patient implants are expected to occur by July 2025 [2] - The study aims to address key challenges faced by diabetes patients, including the need for extended sensor life and the elimination of on-body wearables [4]