GCTK

Submitted Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to initiate a U.S. clinical study for fully implantable continuous blood glucose monitoring (CBGM) technology Company targeting U.S. clinical trial launch in second half of 2026 Peer-Reviewed Studies published in The Journal of Diabetes Research and in the Institute of Electrical and Electronics Engineers (IEEE) Sensors Journal support advancement of Company’s implantable CBGM technology Rutherford, NJ, May 14, 2026 (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, today reported financial results and recent corporate highlights for the first quarter ended March 31, 2026. “During the quarter, we made meaningful progress advancing our CBGM program while further strengthening our foundation as a company,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “We successfully completed our presub process with FDA, culminating in the submission of our IDE to the FDA, an important milestone that brings us closer to initiating U.S. clinical studies. We also published two key sets of preclinical and in-vitro data in peer-reviewed journals, further supporting the development of our technology, and strengthened our balance sheet by reducing debt and extending our financial runway.” First Quarter 2026 & Recent Highlights Corporate Highlights The Company held its third Patient Advisory Board (PAB) meeting during which patients shared perspectives on diabetes device prescribing and initiation, as well as their experiences with healthcare provider education and preparedness. Strengthened balance sheet with debt reduction. The Company reduced the outstanding balance of its $3.6 million promissory note to approximately $1.6 million, primarily through the exchange of a portion of the note into shares of common stock at market price. Subsequent to quarter end, the Company drew approximately $1.0 million under its existing equity line of credit facility, further strengthening its cash position. Advanced Product and Clinical Development The Company successfully submitted its IDE application to the FDA to initiate a U.S. clinical study for its fully implantable CBGM technology. The...

Company prepares to file Investigational Device Exemption (IDE) for Novel CBGM Technology, targeting US Clinical Trial Launch in Second Half of 2026 US Patent and Trademark Office (USPTO) issued patents for Glucotrack’s implantable continuous blood glucose monitoring (CBGM) technology, strengthening the Company’s intellectual property portfolio Rutherford, NJ, March 30, 2026 (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, today reported financial results and recent corporate highlights for the fourth quarter and full year ended December 31, 2025. “In 2025 we made meaningful progress in advancing the development of our fully implantable continuous blood glucose monitoring technology and strengthening Glucotrack’s foundation. We strengthened our competitive position with three new patents issued by the USPTO and continued to work closely with the FDA on alignment as we progress toward securing IDE approval and initiating our U.S. clinical study program of our CBGM product,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “We entered 2026 with strong momentum and a reinforced balance sheet, positioning the Company to execute on important development and regulatory milestones.” Fourth Quarter 2025 & Recent Highlights Corporate Highlights Advanced Product and Clinical Development Anticipated Milestones Financial Results for the Year Ended December 31, 2025 Research and Development Expenses: Research and development expenses were $9.8 million for the full year 2025 compared to $9.5 million for the full year 2024. The increase of $0.3 million was primarily attributable to increased activities related to product design, development and manufacturing activities and pre-clinical animal studies. General and Administrative Expenses: General and administrative expenses were $6.3 million for the full year 2025 compared to $5.1 million for the full year 2024. The increase of $1.2 million was primarily attributable to increased professional fees, personnel costs and placement agent fees. Net Loss: Net loss for the full year 2025 was $19.4 million compared to a net loss of $22.6 million for the full year 2024. The decrease of $3.2 million was primarily attributable to non-cash...

Company to submit Investigational Device Exemption (IDE) to FDA for novel CBGM technology in Spring 2026 Expanded clinical advisory team with appointment of pain management and medical technology expert, Usman Latif, MD, MBA Strengthened balance sheet, cash and cash equivalents expected to fund operations through March 2026, including long-term feasibility clinical trials and achievement of related milestones Rutherford, NJ, Nov. 13, 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, today reported financial results and recent corporate highlights for the third quarter ended September 30, 2025. “During the quarter we continued to make steady progress towards our corporate and clinical objectives. We strengthened our balance sheet by securing flexible funding to support us through key milestones, and expanded our clinical advisory team with the addition of Dr. Latif, who will provide strategic counsel as we advance our epidural glucose monitoring application alongside our continuous blood glucose monitor (CBGM) product,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. Dr. Goode continued, “Looking ahead, we are committed to advancing our clinical program both in the US and abroad. We continue to work closely with the FDA toward securing IDE approval to initiate a long-term clinical study of our product in the U.S., with our IDE submission expected in the Spring of 2026.” Third Quarter 2025 & Recent Highlights Corporate Highlights Advanced Product and Clinical Development Anticipated Milestones Third Quarter and Nine Month 2025 Financial Highlights Third Quarter Ended September 30, 2025 and 2024 Research and development expenses were $3.2 million for the three months ended September 30, 2025, compared to $2.1 million for the same period in 2024. The increase was primarily due to increased product and manufacturing development costs related to the development of the Glucotrack CBGM Product. Marketing and general and administrative expense were $1.1 million for the three months ended September 30, 2025, compared to $1.2 million for the same period in 2024. The decrease is primarily attributable to reduced board of director and legal fees, offset by increased pro...

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 submission to FDA of novel CBGM technology in Q4 2025 Strengthened Board of Directors, expands clinical advisory board, and established a Patient Advisory Board Improved capital structure, cash and cash equivalents expected to fund operations through 2025, including initiation of OUS clinical trials and achievement of related milestones Rutherford, NJ, Aug. 14, 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, today reported financial results and recent corporate highlights for the six months ended June 30, 2025. “This quarter, we made meaningful progress across the business, including the expansion of our clinical advisory team with the appointment of Dr. Hirsh, an expert in implantation protocols, as Medical Director - Cardiology, and the election of Dr. Carr-Brendel, a seasoned medical device executive, to our Board of Directors. We also established a Patient Advisory Board to ensure patient perspectives remain central as we continue to refine and advance our CBGM technology. We are also encouraged by the growing momentum and strong interest in our technology, particularly among key opinion leaders, as demonstrated by the standing-room-only audience at our presentation during the ADA conference in June,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “At the same time, we strengthened our capital structure, removing the warrant liability and share dilution overhang which, we believe, creates attractive opportunities for new investors to join in our mission to bring our potentially life-improving technology to the millions of diabetes patients who need it most.” Dr. Goode continued, “Looking ahead, we are on track to initiate our clinical study in Australia in the third quarter and to continue building our robust body of clinical evidence supporting the use of our well-differentiated, fully implantable, real-time, multi-year CBGM system. We also anticipate submitting our IDE to the FDA in the fourth quarter, enabling in 2026 the launch of our long-te...

Comprehensive analysis confirms safety and strong accuracy of Glucotrack's innovative blood-based continuous glucose monitoring technology, with MARD of 7.7% RUTHERFORD, N.J. and STOCKHOLM, June 25, 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 results from its completed first-in-human clinical study presented at the American Diabetes Association’s (ADA) 85th Scientific Sessions, which took place June 20-23, 2025, in Chicago. The study met all primary and secondary endpoints, demonstrating excellent accuracy with a Mean Absolute Relative Difference (MARD) of 7.7% across 122 matched pairs, a 99% data capture rate, and no procedure or device-related serious adverse events. These findings validate the safety and performance of the Company's long-term, implantable Continuous Blood Glucose Monitor (CBGM), which measures glucose from blood rather than interstitial fluid, eliminating the typical lag time associated with traditional continuous glucose monitoring systems. These results were presented on June 21 to a standing room only crowd in the Innovation Hub of the Exhibit Hall at the ADA meeting. Glucotrack leveraged OneTwo Analytics’ next-generation artificial intelligence and machine learning-based analytics to evaluate the data and assess its clinical value. Analysis using the Diabetes Technology Society Error Grid showed that 92% of the CBGM measurement values were in the green zone and none were recorded in the unsafe zones, demonstrating very high clinical accuracy when compared to the reference blood glucose values. The study, which was conducted at the Interventional Cardiology at Instituto do Coração in São Paulo, Brazil between December 13, 2024 and January 31, 2025, included ten participants with either Type 1 or Type 2 diabetes who were on intensive insulin therapy. The insertion and removal procedures were performed by interventional cardiologists using established percutaneous techniques. Following the device placement, each participant underwent inpatient observation for 4 days. During this period, frequent blood sampling and glucose tolerance tests were conducted to assess device performance. Detailed analysis showed consistent performance during glucose tolerance testing with minimal lag t...

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 company focused on the design, development, and commercialization of novel technologies for people with diabetes, today reported financial results and recent corporate highlights for the first quarter ended March 31, 2025. “I am pleased with the progress we made during the quarter and look forward to commencing our clinical study in Australia, where we expect to continue growing our body of clinical evidence to support the use of our well-differentiated, fully implantable, real-time, multi-year continuous blood glucose monitoring system,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “At the same time, we remain focused on strengthening our capital structure and ensuring that we have the runway to bring our potentially life-improving technology to the millions of diabetes patients who need it most.” First Quarter 2025 & Recent Highlights Advanced Product and Clinical Development Received ethical approval in Australia to initiate long-term clinical study of the Company’s continuous blood glucose monitor (CBGM) in participants with type 1 and type 2 diabetes. Announced participation in FORGETDIABETES, a prominent European research initiative dedicated to developing an immuno-optimized, fully-implantable, fully-automated, artificial pancreas for people with type 1 diabetes. Glucotrack’s CBGM technology will provide real-time glucose data to guide insulin dosing decisions within the artificial pancreas. Announced collaboration with OneTwo Analytics to apply advanced artificial intelligence and machine learning analytics to clinical study data from the Company’s CBGM. The partnership aims to generate deeper insights into the performance and clinical impact of the Company’s technology. Successfully completed a first-in-human clinical study of the CBGM that met its primary endpoint with no procedure- or device-related serious adverse events reported. The study confirmed successful function and placement of the sensor lead in the...

Transformational 2024: successfully advanced from preclinical to clinical stage company Strengthened leadership team to drive growth and advance clinical development Investigational Device Exemption (IDE) approval for continuous blood glucose monitoring (CBGM) technology from FDA expected in Q4 2025 Rutherford, NJ, March 31, 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, today reported financial results and recent corporate highlights for the fourth quarter and full year ended December 31, 2024. “2024 was transformative for Glucotrack as we advanced the development of our CBGM technology and successfully transitioned from a preclinical to a clinical stage company. As we move into the next phase of growth, we have also strengthened our leadership team with key additions to our senior leadership, clinical and regulatory management team as well as our Medical Advisory Board,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “We are confident that our differentiated technology for blood glucose monitoring will change the lives of those living with diabetes and improve patient outcomes. This will be the first fully implantable CBGM technology with a multi-year monitoring system and real-time measuring capabilities, offering differentiated benefits of accuracy, convenience and independence for patients.” Dr. Goode continued, “As we look to 2025, I am pleased with the progress we are making to advance our technology. Moving towards these goals, we will continue to look for ways to strengthen our capital structure. We recently secured multiple funding rounds, demonstrating investors’ continued support of our mission, vision, and strategy. We are committed to pursuing additional financing strategies that align with our mission, create value for our shareholders, and provide additional runway to enable us to continue executing on our strategic priorities. We are optimistic about 2025 and look forward to updating you on our progress periodically.” Fourth Quarter 2024 & Recent Highlights Advanced Product and Clinical Development Successfully completed the first human clinical study of the continuous blood glucose monitor (CBGM) clearly demonstrating the promise and p...

Safety and performance data from direct blood glucose measurement technology to be featured at international diabetes technology conference RUTHERFORD, N.J., March 19, 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 that safety and performance data from its first-in-human trial of its long-term continuous blood glucose monitoring (CBGM) system will be presented at the 2025 International Conference on Advanced Technologies & Treatment for Diabetes (ATTD). ATTD is an important global conference focused on technological innovations in diabetes care. The conference will be held in Amsterdam, the Netherlands, taking place March 19 – 22, 2025. “We are pleased to be showcasing these significant results from our first-in-human trial, demonstrating the safety, feasibility and promising performance of our CBGM,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “This ground-breaking study supports our approach to measuring glucose directly from the blood, rather than interstitial fluid, which enables real-time glucose monitoring with potentially greater accuracy and without on-body wearables, representing a potentially transformative advancement in diabetes management. We look forward to sharing detailed findings from this important study at ATTD and advancing our clinical program with our upcoming chronic implant study.” The poster will be presented at the meeting and will be made available on the Glucotrack website following the conference. Poster Title: Early Feasibility Study to Evaluate an Intravascular Continuous Blood Glucose Monitor in Adults with Diabetes Mellitus Unlike traditional continuous glucose monitors, the CBGM is a long-term implantable device with no on-body external component, designed for three years of continuous, accurate blood glucose monitoring, offering a more convenient and less intrusive glucose monitoring solution. The Glucotrack Continuous Blood Glucose Monitor is an Investigational Device and is limited by federal (or United States) law to investigational use. For more information about Glucotrack’s CBGM technology, visit glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press...