About Glucotrack, Inc. Patients get a seat at the table in development of long-term implantable continuous blood glucose monitoring technology RUTHERFORD, N.J., May 20, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced the formation of a Patient Advisory Board (PAB) comprised of leading patient voices and advocates within the diabetes community. Following ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 001-41141 GLUCOTRACK, INC. (Exact name of registrant as specified in its charter) Delaware 98-0668934 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 301 Route 17 North, Suite 800 Rutherford, ...

Exhibit 99.1 Glucotrack Reports First Quarter 2025 Financial Results and Recent Corporate Highlights On track to implant first patients in long-term, multicenter feasibility study of the fully implantable continuous blood glucose monitor (CBGM) system in Australia in Q3 2025 Investigational Device Exemption (IDE) approval for novel CBGM technology from FDA expected in Q4 2025 Rutherford, NJ, May 14, 2025 (GLOBE NEWSWIRE) — Glucotrack, Inc. (Nasdaq: GCTK) ("Glucotrack" or the "Company"), a medical technology ...

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. 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]

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]

Core Insights - Glucotrack, Inc. has entered into a collaboration with OneTwo Analytics AB to enhance the clinical study data analysis of its Continuous Blood Glucose Monitor (CBGM) using AI and machine learning technologies [1][3] - The CBGM is designed to provide real-time blood glucose readings directly from blood, offering a more accurate and less intrusive monitoring solution compared to traditional continuous glucose monitors [2][6] - The partnership aims to create a comprehensive ecosystem for diabetes management, integrating blood glucose insights, risk stratification data, and patient engagement tools [3][7] Company Overview - Glucotrack, Inc. focuses on developing innovative technologies for diabetes management, specifically a long-term implantable continuous blood glucose monitoring system [5][6] - OneTwo Analytics specializes in AI-driven healthcare solutions, particularly in diabetes data analysis and technology stack development [7][8] Product Features - The CBGM is a long-term implantable device with a sensor longevity of three years, requiring minimal calibration and having no external components [2][6] - This device aims to provide continuous and accurate blood glucose monitoring, enhancing the convenience for users [2][6] Strategic Goals - The collaboration with OneTwo Analytics is expected to leverage their analytics expertise to quantify the long-term benefits of the CBGM technology [3] - Both companies aim to revolutionize diabetes management by delivering an end-to-end solution for healthcare providers and patients [3][7]

Financial Performance - Glucotrack reported a net loss of $22.6 million for the full year 2024, compared to a net loss of $7.1 million in 2023, reflecting an increase in operating expenses and non-cash losses [8]. - Research and development expenses rose to $9.5 million in 2024, up from $4.7 million in 2023, primarily due to increased product design and pre-clinical study activities [6]. - Cash and cash equivalents increased to $5.6 million as of December 31, 2024, compared to $4.5 million at the end of 2023, with a pro forma cash position of $11.9 million after accounting for first quarter 2025 financing [9][10]. Funding and Development - The company secured $16.3 million in funding from multiple rounds between November 2024 and March 2025, providing necessary runway for product and clinical development milestones in 2025 [4]. Clinical Studies and Approvals - The first human clinical study of the continuous blood glucose monitor (CBGM) was successfully completed, meeting its primary endpoint with no serious adverse events reported [3]. - Anticipated FDA approval for Investigational Device Exemption (IDE) for the CBGM technology is expected in Q4 2025 [1]. - The company plans to commence a long-term multicenter feasibility study of the fully implantable CBGM system in Australia in Q2 2025 [5]. Compliance and Certification - The company received ISO 13485:2016 certification, demonstrating compliance with global standards for medical device design and manufacturing [5]. Leadership and Team Development - Glucotrack appointed several key executives to strengthen its leadership team, including a new Chief Financial Officer and Vice President of Regulatory Affairs [5]. Product Innovation - Glucotrack's CBGM technology aims to provide a fully implantable system with a sensor longevity of 3 years, enhancing convenience and accuracy for diabetes management [21].

Core Insights - Glucotrack, Inc. has successfully transitioned from a preclinical to a clinical stage company, focusing on the development of its continuous blood glucose monitoring (CBGM) technology [2][3] - The company anticipates FDA approval for its CBGM technology's Investigational Device Exemption (IDE) in Q4 2025, which is expected to enhance patient outcomes for those living with diabetes [1][2] Financial Performance - For the year ended December 31, 2024, research and development expenses increased to $9.5 million from $4.7 million in 2023, primarily due to heightened product design and development activities [7] - Marketing, general, and administrative expenses rose to $5.1 million in 2024 from $2.4 million in 2023, driven by increased legal and professional fees [8] - The net loss for 2024 was $22.6 million, compared to a net loss of $7.1 million in 2023, attributed to higher operating expenses and non-cash losses related to debt settlements [9] Cash Position - As of December 31, 2024, cash and cash equivalents were $5.6 million, up from $4.5 million in 2023, with a net increase due to financing activities [10] - Pro forma cash and cash equivalents, adjusted for early 2025 financing activities, were $11.9 million, indicating sufficient funds to support the 2025 operating plan [11][22] Clinical Development - The first human clinical study of the CBGM was successfully completed, meeting its primary endpoint without serious adverse events, confirming the technology's reliability and accuracy [4] - The company received ISO 13485:2016 certification, demonstrating its commitment to high-quality medical device standards [4] Leadership and Advisory Board - Glucotrack has strengthened its leadership team with key appointments, including a new Chief Financial Officer and Vice Presidents for Regulatory Affairs and Clinical Operations, enhancing its capacity for clinical development [12][12] Future Milestones - The company plans to commence a long-term multicenter feasibility study of the fully implantable CBGM system in Australia in Q2 2025 and aims to secure IDE approval for a pilot study [12][12]

Core Insights - Glucotrack, Inc. announced the presentation of safety and performance data from its first-in-human trial of a long-term continuous blood glucose monitoring (CBGM) system at the 2025 International Conference on Advanced Technologies & Treatment for Diabetes (ATTD) [1][2] - The CBGM system is designed to measure glucose directly from the blood, offering real-time monitoring with potentially greater accuracy and without the need for on-body wearables, marking a significant advancement in diabetes management [2][3] - The device is an implantable system with a sensor longevity of three years, providing a more convenient and less intrusive glucose monitoring solution compared to traditional continuous glucose monitors [3][6] Company Overview - Glucotrack, Inc. focuses on the design, development, and commercialization of innovative technologies for diabetes care, currently developing a long-term implantable continuous blood glucose monitoring system [5][6] - The company aims to advance its clinical program with an upcoming chronic implant study following the presentation of findings at the ATTD conference [2][3]