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].

Company Overview - Glucotrack, Inc. is a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes [5] - The company is developing a long-term implantable continuous blood glucose monitoring system [5][6] Product Details - Glucotrack's Continuous Blood Glucose Monitor (CBGM) is designed to measure blood glucose levels directly from the blood, without the need for on-body wearables, and has a sensor longevity of up to three years [3][6] - The CBGM aims to minimize daily disruptions for diabetes patients by addressing limitations of traditional continuous glucose monitors (CGM), such as frequent sensor changes and challenges associated with on-body wearables [3] Upcoming Events - Glucotrack will participate in the 2025 Association of Diabetes Care and Education Specialists (ADCES) Annual Meeting from August 8-11, 2025, in Phoenix, AZ [1] - The company will showcase its CBGM at Booth 1724 and present a poster on physician perspectives regarding continuous blood glucose monitoring technology [2][3]

Core Insights - Glucotrack's Continuous Blood Glucose Monitor (CBGM) technology has demonstrated safety and accuracy with a Mean Absolute Relative Difference (MARD) of 7.7% in a first-in-human clinical study [1][2][5] Study Results - The clinical study met all primary and secondary endpoints, achieving a 99% data capture rate and no serious adverse events related to the procedure or device [2][4] - Analysis showed that 92% of CBGM measurement values were in the green zone according to the Diabetes Technology Society Error Grid, indicating high clinical accuracy [3] Technology Overview - The CBGM is a fully implantable system that measures glucose directly from blood, eliminating lag time associated with traditional interstitial fluid monitors [6] - Designed for a three-year sensor life, the system requires minimal calibration and has no on-body wearable component, offering a less intrusive solution for diabetes management [6][11] Future Plans - Glucotrack plans to initiate a long-term early feasibility study in Q3 2025 to further evaluate the safety and performance of the CBGM technology [5]

Company Overview - Glucotrack, Inc. is focused on the design, development, and commercialization of novel technologies for people with diabetes [5] - The company is currently developing a long-term implantable continuous blood glucose monitoring (CBGM) system [5][6] Leadership Addition - Victoria E. Carr-Brendel, PhD, has been elected to Glucotrack's Board of Directors effective May 22, 2025 [1] - Dr. Carr-Brendel brings extensive experience in medical devices and implantable technologies, having held leadership roles at various companies including Vicarious Surgical Inc. and Sonova Group [2][3] Technology Development - Glucotrack's CBGM is designed as a long-term implantable system that provides continuous blood glucose monitoring for up to three years [3][6] - The system measures glucose directly from blood, offering real-time readings without the lag time associated with traditional continuous glucose monitoring systems [3] Strategic Importance - Dr. Carr-Brendel expressed her commitment to contributing to Glucotrack's strategic and clinical milestones, emphasizing the potential of the CBGM to address unmet needs for diabetes management [3]