Core Insights - Glucotrack, Inc. is advancing its continuous blood glucose monitoring (CBGM) technology and plans to submit an Investigational Device Exemption (IDE) to the FDA in Spring 2026 [1][3] - The company has strengthened its balance sheet and expanded its clinical advisory team, appointing Dr. Usman Latif as a key expert in pain management and medical technology [1][5] Financial Highlights - For Q3 2025, research and development expenses increased to $3.2 million from $2.1 million in Q3 2024, primarily due to higher product and manufacturing development costs [7] - The net loss for Q3 2025 was $4.2 million, or $4.64 per share, compared to a net loss of $5.1 million, or $1,092 per share, in Q3 2024 [9] - For the nine months ended September 30, 2025, the company reported a net loss of $15.8 million, or $30.09 per share, compared to a net loss of $12.5 million, or $2,868 per share, for the same period in 2024 [12] Cash Position - As of September 30, 2025, cash and cash equivalents were $7.9 million, up from $5.6 million at the end of 2024, with a net increase attributed to $13.7 million in financing activities [13] Corporate Developments - The company has initiated a long-term multicenter feasibility study in Australia to evaluate the CBGM product's performance and safety [10] - Glucotrack presented at industry conferences, highlighting strong interest from endocrinologists in the CBGM product, with 73% of surveyed endocrinologists willing to prescribe it [10] - The company is committed to expanding its advisory boards with experts in endocrinology and cardiology to enhance its diabetes management solutions [10]

Core Insights - Glucotrack, Inc. has established a Patient Advisory Board (PAB) to incorporate patient perspectives into the development of its long-term implantable Continuous Blood Glucose Monitor (CBGM) technology [1][2][3] - The PAB consists of individuals with diabetes who will provide insights on the challenges of diabetes management, influencing all stages of the CBGM's development from clinical trials to commercialization [2][3] - The CBGM is designed to offer continuous, accurate blood glucose monitoring for up to three years without a wearable component, measuring glucose directly from blood rather than interstitial fluid [4][7] Company Overview - Glucotrack, Inc. focuses on the design, development, and commercialization of innovative technologies for diabetes management [6] - The company is currently developing a long-term implantable continuous blood glucose monitoring system aimed at improving the convenience and accuracy of glucose monitoring for individuals with diabetes [6][7] Product Details - The CBGM system is characterized by its long-term implantable nature, sensor longevity of three years, and minimal calibration requirements [4][7] - Unlike traditional systems, the CBGM provides real-time glucose readings without the lag associated with interstitial fluid measurements, enhancing the user experience [4]

Core Insights - Glucotrack, Inc. is progressing towards the initiation of a long-term multicenter feasibility study for its fully implantable continuous blood glucose monitor (CBGM) system in Australia, expected to begin in Q3 2025 [1][6] - The company anticipates receiving Investigational Device Exemption (IDE) approval from the FDA for its novel CBGM technology in Q4 2025 [1][6] - The CEO expressed confidence in the clinical study's potential to enhance the body of evidence supporting the CBGM system, while also focusing on strengthening the company's capital structure [2] Product and Clinical Development - The company received ethical approval in Australia to start a long-term clinical study involving participants with type 1 and type 2 diabetes [6] - Glucotrack is participating in the FORGETDIABETES initiative, which aims to develop an artificial pancreas for type 1 diabetes, utilizing its CBGM technology for real-time glucose data [6] - A collaboration with OneTwo Analytics has been established to apply AI and machine learning to clinical study data, aiming to gain deeper insights into the technology's performance [6] - A first-in-human clinical study of the CBGM was successfully completed, meeting its primary endpoint with no serious adverse events reported [6] Financial Results - Research and development expenses for Q1 2025 were $1.9 million, a decrease from $2.1 million in Q1 2024, primarily due to timing in product development activities [7] - Marketing, general, and administrative expenses increased to $1.6 million in Q1 2025 from $0.8 million in Q1 2024, mainly due to higher legal and professional fees [8] - The net loss for Q1 2025 was $6.8 million, compared to a net loss of $2.9 million in Q1 2024, largely due to a non-cash change in fair value of derivative liabilities [9] Cash Position - As of March 31, 2025, cash and cash equivalents were $9.1 million, up from $5.6 million at the end of 2024, attributed to $6.4 million from financing activities [10] - The company believes its existing cash will be sufficient to fund its 2025 operating plan, including the initiation of human clinical trials [11] Milestones and Future Plans - The company plans to implant the first patients in the long-term multicenter feasibility study of the CBGM system in Australia in Q3 2025 [6] - IDE approval from the FDA for a long-term multicenter pilot study of the CBGM system is anticipated in Q4 2025 [6]

Core Insights - Glucotrack, Inc. is participating in the FORGETDIABETES initiative to develop a long-term automated insulin delivery system for optimal glucose control without patient intervention [1][2] - The FORGETDIABETES initiative is funded by the European Union's Horizon 2020 program, which has a budget of €75 billion for various research and innovation projects [2] - The initiative aims to create a bionic pancreas that alleviates the daily management burden of type 1 diabetes, transforming it into a more manageable lifestyle condition [3][4] Company Overview - Glucotrack focuses on designing, developing, and commercializing novel technologies for diabetes management, including a Continuous Blood Glucose Monitor (CBGM) [6][7] - The CBGM is a long-term implantable system with a sensor longevity of 3 years, requiring minimal calibration and no on-body wearable component [7] Initiative Details - The FORGETDIABETES initiative includes various participants, such as the University of Padova, BioRobotics Institute, and several health institutions across Europe [4] - The initiative aims to integrate Glucotrack's CBGM into automated insulin delivery systems, enhancing diabetes management [4]