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]

Core Insights - Glucotrack, Inc. is set to present 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) in Amsterdam from March 19 to 22, 2025 [1][2] - The CBGM technology allows for real-time glucose monitoring directly from blood, potentially offering greater accuracy without the need for on-body wearables, marking a significant advancement in diabetes management [2][3] 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 CBGM is designed to be a long-term implantable device with a sensor longevity of three years, providing continuous and accurate blood glucose monitoring without external components [3][6]

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 currently developing a long-term implantable continuous blood glucose monitoring (CBGM) system [5][6] Key Appointment - Dr. Guillermo Umpierrez has been appointed as a new member of Glucotrack's Medical Advisory Board, effective immediately [1] - Dr. Umpierrez is a Professor of Medicine at Emory University and has extensive experience in diabetes care and clinical research [2] Technology Development - Glucotrack's CBGM system is designed to directly measure blood glucose levels without the lag time associated with traditional continuous glucose monitoring systems [3] - The CBGM system features a sensor life of 3 years, no wearable component, and aims to improve real-time accuracy, longevity, comfort, and supply management [3][6] Clinical Development - Dr. Umpierrez's expertise will be instrumental as Glucotrack advances its CBGM technology through clinical development and into human clinical trials [2] - The company aims to make glucose monitoring less burdensome for individuals living with diabetes [2]

Core Viewpoint - Glucotrack, Inc. has announced a public offering of approximately 2.6 million shares of common stock at a price of $1.15 per share, aiming to raise approximately $3.0 million before expenses [1][2]. Company Overview - Glucotrack, Inc. is a medical technology company focused on developing novel technologies for diabetes management, including a long-term implantable continuous blood glucose monitoring system [5][6]. Offering Details - The public offering is being conducted under a registration statement declared effective by the SEC on October 3, 2024, and is expected to close on or about February 5, 2025, pending customary closing conditions [3][1]. - Dawson James Securities, Inc. is acting as the sole placement agent for this public offering [2].

RUTHERFORD, N.J., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (NASDAQ:GCTK) ("Glucotrack" or the "Company"), a medical technology company focused on the design, development, and commercialization of novel technologies for people with diabetes, announced the successful completion of its first in human clinical study, marking a significant milestone in continuous glucose monitoring. This study represents the first real-time, continuous blood glucose monitor (CBGM) placed in the subclavian vein, offerin ...

RUTHERFORD, N.J., Jan. 30, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (NASDAQ:GCTK) ("Glucotrack" or the "Company"), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced that it will effect a 1-for-20 reverse stock split (the "Reverse Stock Split") of its issued and outstanding common stock par value $0.001 per share (the "Common Stock"), effective with the opening of trading on Tuesday, February 4, 2025. Glucotrack ...

Company Announcement - Glucotrack Inc announced the appointment of Peter C Wulff as Chief Financial Officer effective immediately [1] - Peter C Wulff brings over 35 years of financial management experience in the life sciences sector with a strong track record in capital raising and strategic transactions [2] - The new CFO expressed enthusiasm about commercializing Glucotrack's technology and supporting the company's long-term strategic vision [3] Leadership Commentary - Glucotrack's President and CEO highlighted Wulff's exceptional track record in delivering results and creating value [4] - The CEO emphasized Wulff's extensive experience in capital markets and strategic planning as valuable assets for advancing the company's continuous blood glucose monitor through clinical development and future commercialization [4] Company Overview - Glucotrack Inc is a medical technology company focused on developing novel technologies for people with diabetes [5] - The company is developing a long-term implantable continuous blood glucose monitoring system [5] - Glucotrack's CBGM features a 3-year sensor longevity, no on-body wearable component, and minimal calibration requirements [6] Product Information - Glucotrack's Continuous Blood Glucose Monitor (CBGM) is a long-term implantable system designed for continuous glucose measurement [6] - The CBGM system offers significant advantages including extended sensor life and reduced user burden compared to traditional monitoring methods [6]

Company Overview - Glucotrack Inc is a medical technology company focused on designing, developing, and commercializing novel technologies for people with diabetes [5] - The company is currently developing a long-term implantable continuous blood glucose monitoring (CBGM) system for diabetes patients [5] - The CBGM system features a 3-year sensor longevity, no on-body wearable component, and requires minimal calibration [6] ISO Certification Achievement - Glucotrack has received ISO 13485:2016 certification from the British Standards Institute (BSI) [1] - The certification demonstrates the company's compliance with rigorous global standards for medical device design and manufacturing [2] - ISO 13485 is an internationally recognized quality management standard specifically for medical devices, building upon ISO 9001 with additional regulatory requirements [3] - The certification aligns with the U.S. FDA's Quality Management System Regulation (QMSR) Final Rule issued in 2024, which harmonizes U.S. requirements with global standards [3] Product Development - The company has successfully completed Stage I and Stage II Assessments by BSI, verifying its quality management system meets ISO 13485:2016 standards [2] - Glucotrack's CBGM represents a revolutionary approach to continuous blood glucose monitoring for diabetes patients [2] - The company continues to achieve clinical and developmental milestones for its CBGM system [2]

Company Announcement - Glucotrack, Inc announced the appointment of Ted Williams as Vice President of Regulatory Affairs, effective immediately [1] - Ted Williams brings nearly 25 years of experience in Regulatory Affairs and Quality Assurance for Class III medical devices, including implantable continuous glucose monitors (CGM) and drug/device combination products [2] - Williams previously served as Vice President of Regulatory Affairs/Quality Assurance at Glysens Inc, a company focused on developing implantable CGM technology [2] Product Development - Glucotrack is developing a long-term implantable continuous blood glucose monitoring system (CBGM) with a sensor longevity of 3 years and minimal calibration requirements [3] - The CBGM system does not require an on-body wearable component, distinguishing it from other CGM technologies [3] - The company is advancing human clinical trials and creating a strategic regulatory program for the CBGM [8] Leadership Perspective - Paul V Goode, PhD, President and CEO of Glucotrack, emphasized that Williams' expertise in regulatory pathways will be instrumental in progressing the CBGM through FDA approval and beyond [4] - Williams expressed honor in joining Glucotrack at a pivotal time as the company advances its clinical trials and regulatory strategy for the CBGM [8] Company Overview - Glucotrack, Inc is a medical technology company focused on designing, developing, and commercializing novel technologies for people with diabetes [7] - The company's primary focus is on developing a long-term implantable continuous blood glucose monitoring system for diabetes patients [7]