GCTK
GlucoTrackCDocument history
Earnings documents stored for GCTK.
Investor releaseQuarter not tagged2026-05-15Glucotrack Reports First Quarter 2026 Financial Results and Recent Corporate Highlights
GlobeNewswire
Glucotrack Reports First Quarter 2026 Financial Results and Recent Corporate Highlights
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…Read full documentShow less
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 submission represents a key milestone in advancing the Company's CBGM technology into U.S. clinical evaluation, supported by several years of focused engineering, preclinical evaluation, and iterative design work. In a peer-reviewed article titled, “Year-Long Measurement of Glucose Oxidase Deactivation in Electrochemical Glucose Sensors,” published in the IEEE Sensors Journal, the Company reported data validating the long-term stability of its glucose oxidase sensor, providing foundational scientific evidence to support the device’s intended three-year longevity. In a peer-reviewed article titled, “In Vivo Evaluation of a Novel Long-Term Intravascular Implantable Continuous Blood Glucose Monitor in an Ovine Model: A Glucotrack Inc. Investigation,” published in The Journal of Diabetes Research, the Company reported data demonstrating the long-term accuracy and stability of the Company’s fully implantable CBGM system. The in-vivo ovine study showed a 6.8% Mean Absolute Relative Difference (MARD) and sustained sensor performance over 240 days, supporting the platform’s progression toward clinical studies. Anticipated Milestones Initiate U.S. clinical study of the Company’s CBGM in 2H 2026. Present clinical data demonstrating the safety and accuracy of the CBGM technology at additional industry conferences, with timing and venues to be determined as data become available. Continue to gain insight from patients living with diabetes on current management challenges and receive feedback on Glucotrack’s product development and commercialization strategies through additional PAB meetings. Financial Results for the Quarter ended March 31, 2026 Research and Development Expenses: Research and development expenses were $2.1 million for first quarter of 2026 compared to $1.9 million for first quarter of 2025. The increase of $0.2 million was primarily due to timing in product and manufacturing development activities. General and Administrative Expenses: General and Administrative expenses were $2.1 million for the first quarter of 2026 compared to $1.6 million for first quarter of 2025. The increase of $0.5 million was primarily attributable to increased professional fees and personnel costs. Other (Income) Expense, Net: Other expense was $0.1 million for the first quarter 2026, as compared to $3.3 million for the first quarter of 2025. The decrease in other expense is primarily attributed to the current year’s reduction in the change of derivative liabilities. Net Loss: Net loss for the first quarter of 2026 was $4.3 million compared to a net loss of $6.8 million for the first quarter of 2025. The decrease in net loss is primarily attributed to the non-cash change in derivative liabilities. Cash Position: Cash and cash equivalents as of March 31, 2026, were $3.9 million, compared with $7.4 million in cash and cash equivalents as of December 31, 2025. The net decrease in cash and cash equivalents was attributable to $4.1 million of cash used in operating activities offset by net proceeds received from financing activities of $0.6 million. Based on current plans and assumptions, the Company believes that its existing cash and cash equivalents will provide sufficient runway into early 3Q 2026, allowing for the initiation of its U.S. human clinical trial shortly thereafter. 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, visit glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release. About Glucotrack, Inc. Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes. Glucotrack’s Continuous Blood Glucose Monitor (CBGM) is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. The Glucotrack CBGM is an Investigational Device and is limited by federal (or United States) law to investigational use. For more information, please visit http://www.glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “anticipate”, “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2025 as filed with the SEC on March 30, 2026. Contacts: GLUCOTRACK INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands of US dollars except share data) GLUCOTRACK INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands of US dollars except share data) (unaudited)
Investor releaseQuarter not tagged2026-03-31Glucotrack Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Highlights
GlobeNewswire
Glucotrack Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Highlights
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-c…Read full documentShow less
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 losses of $7.5 million related to the settlement of debt and the issuance of warrants containing derivative features recognized in the prior year. Cash Position: Cash and cash equivalents as of December 31, 2025, were $7.4 million, compared with $5.6 million in cash and cash equivalents as of December 31, 2024. The net increase of $1.8 million in cash and cash equivalents compared to December 31, 2024 was attributable to the $17.0 million from financing activities offset by cash used in operating and investing activities of $15.3 million. Based on current plans and assumptions, the Company believes that its existing cash and cash equivalents will be sufficient to fund its 2026 operating plan by the end of Spring allowing for its IDE submission and initiate U.S. human clinical trials in 2026. # # # About Glucotrack, Inc. Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes. Glucotrack’s Continuous Blood Glucose Monitor (CBGM) is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. The Glucotrack CBGM is an Investigational Device and is limited by federal (or United States) law to investigational use. For more information, please visit http://www.glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “anticipate”, “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including FDA approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2025 as filed with the SEC on March 30, 2026. Contacts: GLUCOTRACK INC. CONSOLIDATED BALANCE SHEETS GLUCOTRACK INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Investor releaseQuarter not tagged2025-11-14Glucotrack Reports Third Quarter 2025 Financial Results and Provides Update on Recent Corporate Highlights
GlobeNewswire
Glucotrack Reports Third Quarter 2025 Financial Results and Provides Update on Recent Corporate Highlights
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 p…Read full documentShow less
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 professional fees, and personnel costs. For the three months ended September 30, 2025, the Company reported a net loss of $4.2 million, or $4.64 per share, compared to a net loss of $5.1 million, or $1,092 per share, for the same period in 2024. The reduction in net loss for the three months ended September 30, 2025, was primarily attributed to prior year revaluation expenses. Nine Months Ended September 30, 2025 and 2024 Research and development expenses were $8.2 million for the nine months ended September 30, 2025, compared to $7.8 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 $4.4 million for the nine months ended September 30, 2025, compared to $2.9 million for the same period in 2024. The increase was primarily attributable to increased legal and professional fees, and personnel costs. 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. The increase in net loss for the nine months ended September 30, 2025, was primarily attributed to increased general and administrative expense and the non-cash fair value change in derivative liabilities. Cash Position Cash and cash equivalents as of September 30, 2025, were $7.9 million, compared with $5.6 million in cash and cash equivalents as of December 31, 2024. The net increase in cash and cash equivalents was attributable to the $13.7 million of net proceeds received from financing activities offset by cash used in operating and investing activities of $11.4 million. Based on current plans and assumptions, the Company believes that its existing cash and cash equivalents will be sufficient to fund its operating plan through first quarter 2026. # # # About Glucotrack, Inc. Glucotrack, Inc. (Nasdaq: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes. Glucotrack’s Continuous Blood Glucose Monitor (CBGM) is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. The Glucotrack CBGM is an Investigational Device and is limited by federal (or United States) law to investigational use. For more information, please visit http://www.glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “anticipate”, “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 31, 2025. Contacts: CONSOLIDATED BALANCE SHEETS (in thousands of US dollars except share data) GLUCOTRACK INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands of US dollars except share data) (unaudited)
Investor releaseQuarter not tagged2025-08-15Glucotrack Reports Second Quarter 2025 Financial Results and Recent Corporate Highlights
GlobeNewswire
Glucotrack Reports Second 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 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…Read full documentShow less
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-term, multicenter Pilot Study in the US.” Second Quarter 2025 & Recent Highlights Corporate Highlights Strengthened capital structure through the repurchase of Series A Warrants. The transaction eliminated the warrant liability accounting and share dilution overhang, preserving shareholder value and providing optionality for potential investors. Appointed David S. Hirsh, M.D., as Medical Director – Cardiology, expanding the clinical advisory team. Dr. Hirsh brings extensive cardiology and electrophysiology experience to Glucotrack, and his procedural expertise will be invaluable in optimizing the Company’s implantation protocols and ensuring patient safety. Elected Victoria E. Carr-Brendel, Ph.D., to the Company’s Board of Directors. Dr. Carr-Brendel brings extensive leadership experience as a medical device executive, with particular expertise in implantable technologies. Established a Patient Advisory Board (PAB) to inform the development of the Company’s CBGM technology. The PAB comprises leading patient voices and advocates within the diabetes community with firsthand experiences and understanding of the impact diabetes management has on daily living. The PAB was established to keep patients’ insights at the forefront of Glucotrack’s development plans for its CBGM. Advanced Product and Clinical Development Presented a poster at the Association of Diabetes Care & Education Specialists (ADCES) Annual Conference held August 8-10, 2025, titled “Endocrinologists’ Perspectives on an Implantable Continuous Blood Glucose Monitor,” demonstrating strong endocrinologist interest in the continuous blood glucose monitoring concept due to its extended sensor life, freedom from wearables, and the potential for greater accuracy from blood-based readings. At a sensor life of 3 years, 73% of the 100 endocrinologists surveyed expressed a willingness to prescribe the CBGM. Presented compelling data at the American Diabetes Association’s (ADA) 85th Scientific Sessions held June 20-23, 2025: In a poster presentation titled, “Early Feasibility Study to Evaluate an Intravascular Continuous Blood Glucose Monitor in Adults with Diabetes Mellitus,” Glucotrack reported positive final results of their first-in-human study for continuous blood glucose monitoring. The Company leveraged OneTwo Analytics’ advanced artificial intelligence and machine learning platform to generate deeper insights into the performance and clinical impact of the Company’s technology. 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 begin to validate the safety and performance of the Company’s long-term, implantable CBGM. In an oral presentation titled “Re-Imagining the Future of Continuous Glucose Monitoring with CBGM,” Glucotrack discussed the future of continuous glucose monitoring and the Company’s CBGM technology. Received ethical approval in Australia to initiate long-term clinical study of the Company’s 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. Anticipated Milestones in 2025 Implanting first patients in long-term, multicenter feasibility study of the fully implantable CBGM system in Australia, anticipated in third quarter of 2025. Submitting the Company’s Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration in the fourth quarter of 2025, to initiate a U.S. long-term, multicenter Pilot Study of the CBGM system, subject to current agency response timelines. Presenting clinical data demonstrating the safety and accuracy of the CBGM at additional industry conferences. Further expanding Advisory Boards with world-renowned experts in endocrinology and cardiology and others essential to the diabetes community. Financial Results for the year-to-date six months ended June 30, 2025 Research and Development Expenses: Research and development expenses were $5.0 million for the six months ended June 30, 2025, compared to $5.7 million for the prior-year period. The decrease of $0.7 million was primarily due to timing in product and manufacturing development activities. Marketing, General and Administrative Expenses: Marketing, General and Administrative expenses were $3.3 million for the six months ended June 30, 2025, compared to $1.7 million for the prior-year period. The increase of $1.6 million was primarily attributable to increased legal and professional fees and personnel costs. Net Loss: 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 prior-year period. The increase in net loss is attributable primarily to the non-cash $3.3 million change in fair value of derivative liabilities and increase of $0.9 million in operating expenses. Cash Position: Cash and cash equivalents as of June 30, 2025, were $9.6 million, compared with $5.6 million in cash and cash equivalents as of December 31, 2024. The net increase in cash and cash equivalents of $4.0 million was attributable to the $10.7 million net proceeds from public equity financings offset by cash used in operating and investing activities of $6.7 million for the first six months of 2025. Based on current plans and assumptions, the Company believes that its existing cash and cash equivalents will be sufficient to fund its 2025 operating plan to initiate human clinical trials and related milestones. # # # About Glucotrack, Inc. Glucotrack, Inc. (Nasdaq: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes. Glucotrack’s Continuous Blood Glucose Monitor (CBGM) is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. The Glucotrack CBGM is an Investigational Device and is limited by federal (or United States) law to investigational use. For more information, please visit http://www.glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “anticipate”, “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 31, 2025. Contacts: GLUCOTRACK INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands of US dollars except share data) GLUCOTRACK INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands of US dollars except share data) (unaudited)
Investor releaseQuarter not tagged2025-06-25Glucotrack and OneTwo Analytics Present Positive Final Results of First-In-Human Study for Continuous Blood Glucose Monitor at American Diabetes Association’s 85th Scientific Sessions
GlobeNewswire
Glucotrack and OneTwo Analytics Present Positive Final Results of First-In-Human Study for Continuous Blood Glucose Monitor at American Diabetes Association’s 85th Scientific Sessions
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…Read full documentShow less
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 time compared to venous blood samples. The system successfully remained in place throughout the study period and was successfully removed at study completion, with patients then followed for 7 days post-removal. “This study represents an important milestone validating our CBGM technology’s potential,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “With a MARD of 7.7%, which is comparable to leading CGM systems but with direct blood measurement instead of interstitial fluid, we're advancing our novel technology into further clinical trials, taking us closer to providing patients with a long-term, less burdensome solution for diabetes management. We are excited to be sharing our data at this important industry congress.” Glucotrack expects to initiate a long-term early feasibility study in Q3 2025, which will evaluate safety and performance over an extended period, bringing the technology closer to its goal of providing patients with a less-intrusive alternative to continuous glucose monitoring. Unlike traditional continuous glucose monitors, the Glucotrack CBGM is a fully implantable continuous glucose monitor, consisting of a sensor lead implanted into the subclavian vein and connected to subcutaneous electronics that communicate with a mobile application. It measures glucose directly from the blood, eliminating the lag time associated with interstitial fluid glucose monitors. Designed for a three-year sensor life with continuous, accurate blood glucose monitoring, the system offers a more convenient and less intrusive solution for people with diabetes, with no on-body wearable component and minimal calibration requirements. “We’re proud to have applied our clinical analytics expertise to validate the performance of Glucotrack’s innovative CBGM technology,” said Lars Cederblad, Chief Executive Officer of OneTwo Analytics. “The results demonstrate excellent safety and accuracy profiles that could meaningfully improve diabetes care.” 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, visit glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release. For more information about OneTwo Analytics AB, visit onetwo-analytics.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release. About Glucotrack, Inc. Glucotrack, Inc. (Nasdaq: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes. Glucotrack’s CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. For more information, please visit http://www.glucotrack.com. About OneTwo Analytics OneTwo Analytics is a leader in AI-driven healthcare solutions, specializing in the analysis of diabetes data, real-world evidence, and clinical trial outcomes. The company develops advanced diabetes technology stacks for device manufacturers while recently launching a suite of solutions that are empowering healthcare providers and patients with data-driven intelligence to simplify diabetes disease management and improve efficiencies and outcomes. OneTwo Analytics’ innovative tools provide healthcare professionals with valuable perspectives for personalized and efficient care, while also offering tailored solutions for stakeholders in the diabetes care sector. The company delivers a comprehensive Diabetes Technology Stack and White-Label solutions for organizations specializing in diabetes technologies. For more information, please visit https://onetwo-analytics.com/en/. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 31, 2025. Contacts: Investor Relations: [email protected] Media: [email protected]
Investor releaseQuarter not tagged2025-05-15Glucotrack Reports First Quarter 2025 Financial Results and Recent Corporate Highlights
GlobeNewswire
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 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…Read full documentShow less
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 subclavian vein, and demonstrated solid Bluetooth performance with accuracy comparable to animal studies. These data were presented at the 2025 International Conference on Advanced Technologies & Treatment for Diabetes (ATTD). Received ISO 13485:2016 certification from the British Standards Institute (BSI) demonstrating our commitment and ability to meet rigorous global standards for design and manufacturing of high-quality medical devices. Anticipated Milestones in 2025 Presenting clinical data demonstrating the safety and accuracy of the CBGM at additional industry conferences. Further expanding Advisory Boards with world-renowned experts in endocrinology and cardiology and others essential to the diabetes community. Implanting first patients in long-term, multicenter feasibility study of the fully implantable CBGM system in Australia, anticipated in Q3 2025. Securing IDE approval from the U.S. Food and Drug Administration for a long-term, multicenter Pilot Study of the CBGM system, anticipated in Q4 2025, subject to current agency response timelines. Financial Results for the Quarter ended March 31, 2025 Research and Development Expenses: Research and development expenses were $1.9 million for first quarter of 2025 compared to $2.1 million for first quarter of 2024. The decrease of $0.2 million was primarily due to timing in product and manufacturing development activities. Marketing, General and Administrative Expenses: Marketing, General and Administrative expenses were $1.6 million for the first quarter of 2025 compared to $0.8 million for first quarter of 2024. The increase of $0.8 million was primarily attributable to increased legal and professional fees and personnel costs. Net Loss: Net loss for the first quarter of 2025 was $6.8 million compared to a net loss of $2.9 million for the first quarter of 2024. The increase in net loss is attributable primarily to the non-cash $3.4 million change in fair value of derivative liabilities and increase of $0.5 million in operating expenses. Cash Position: Cash and cash equivalents as of March 31, 2025, were $9.1 million, compared with $5.6 million in cash and cash equivalents as of December 31, 2024. The net increase in cash and cash equivalents was attributable to the $6.4 million received from financing activities offset by cash used in operating and investing activities of $2.9 million. Based on current plans and assumptions, the Company believes that its existing cash and cash equivalents will be sufficient to fund its 2025 operating plan to initiate human clinical trials and related milestones. 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, visit glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release. About Glucotrack, Inc. Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes. Glucotrack’s CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. For more information, please visit http://www.glucotrack.com. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “anticipate”, “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 31, 2025. Contacts: GLUCOTRACK INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands of US dollars except share data) GLUCOTRACK INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands of US dollars except share data) (unaudited)
Investor releaseQuarter not tagged2025-04-01Glucotrack Reports Full Year 2024 Financial Results and Recent Corporate Highlights
GlobeNewswire
Glucotrack Reports Full Year 2024 Financial Results and Recent Corporate Highlights
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…Read full documentShow less
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 performance of the technology: The study met its primary endpoint with no procedure- or device-related serious adverse events reported from placement, use and through removal. The study confirmed the function and placement of the CBGM sensor lead in the subclavian vein and verified no additional tools or skillset beyond typical cardiac pacemaker lead placement are needed. The study confirmed reliable Bluetooth performance and demonstrated similar accuracy as seen in animal studies. Received ISO 13485:2016 certification from the British Standards Institute (BSI) demonstrating our commitment and ability to meet rigorous global standards for design and manufacturing of high-quality medical devices. Presented preclinical data at the Diabetes Technology Meeting in October 2024, highlighting the robust early performance of our CBGM. Successfully completed the first-ever long-term preclinical study of glucose monitoring in the epidural space, creating a pathway for strategic opportunities in integrated chronic disease management. Strengthened Financial Position Secured $16.3 million in proceeds through multiple rounds of funding from November 2024 through March 2025. The proceeds provide runway for the Company to achieve near-term product and clinical development milestones in 2025. Strengthened Leadership and Board to Drive Clinical Development Appointed Guillermo Umpierrez, MD, CDCES, FACE, MACP to the Medical Advisory Board. As a former president of the American Diabetes Association for Medicine and Science, Dr. Umpierrez has extensive experience leading and participating in clinical research that has significantly advanced the understanding and treatment of diabetes. Appointed Peter Wulff as Chief Financial Officer. Mr. Wulff is an industry veteran with over 35 years of financial management experience in both public and privately held companies in the emerging growth life sciences sector. Appointed Ted Williams as Vice President of Regulatory Affairs. Mr. Williams is a seasoned executive with a proven track record of successfully guiding highly complex Class III medical devices through various regulatory pathways. Appointed Sandra Martha as Vice President Clinical Operations. Ms. Martha brings over 20 years of clinical research experience in both medical technology and drug development, leading all aspects of clinical trials and successful delivery of clinical trials to quickly advance products through the clinical lifecycle. Anticipated Milestones in 2025 Presenting clinical data demonstrating the safety and accuracy of the CBGM at major medical conferences Early Feasibility Study to Evaluate an Intravascular Continuous Blood Glucose Monitor in Adults with Diabetes Mellitus Poster Presentation at the recent 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2025), March 19-22, 2025, Amsterdam, The Netherlands. Further expanding our Advisory Board with world-renowned experts in endocrinology and cardiology. Commencing a long-term, multicenter feasibility study of the fully implantable CBGM system in Australia, anticipated in Q2 2025. Securing IDE approval from the U.S. Food and Drug Administration for a long-term, multicenter Pilot Study of the CBGM system, anticipated in Q4 2025, subject to current agency response timelines. Financial Results for the Year Ended December 31, 2024 Research and Development Expenses: Research and development expenses were $9.5 million for the full year 2024 compared to $4.7 million for the full year 2023. The increase of $4.8 million was primarily attributable to increased activities related to product design, development and manufacturing activities and pre-clinical animal studies. Marketing, General and Administrative Expenses: Marketing, General and Administrative expenses were $5.1 million for the full year 2024 compared to $2.4 million for the full year 2023. The increase of $2.7 million was primarily attributable to increased legal and professional fees, personnel costs and placement agent fees. Net Loss: Net loss for the full year 2024 was $22.6 million compared to a net loss of $7.1 million for the full year 2023. The increase in net loss is attributable primarily to the operating expenses of $7.5 million discussed above in addition to non-cash losses of $7.5 million related to the settlement of debt and the issuance of warrants containing derivative features. Cash Position: Cash and cash equivalents as of December 31, 2024, were $5.6 million, compared with $4.5 million in cash and cash equivalents as of December 31, 2023. The net increase in cash and cash equivalents compared to December 31, 2023 was attributable to the $13.7 million from financing activities offset by cash used in operating and investing activities of $12.6 million. On a pro forma basis, cash and cash equivalents as of December 31, 2024 was $11.9 million when adjusted for proceeds from financing activities during the first quarter 2025 of $6.3 million. Based on current plans and assumptions, the Company believes that its existing cash and cash equivalents will be sufficient to fund its 2025 operating plan to initiate human clinical trials and related milestones. GLUCOTRACK INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS GLUCOTRACK INC.CONSOLIDATED BALANCE SHEETS GLUCOTRACK INC.UNAUDITED PRO FORMA BALANCE SHEET The unaudited pro forma information gives effect to the first quarter 2025 Offerings, the exchange of Series B Warrants to common stock, and the revaluation of Series A Warrants. The unaudited pro forma financial information is presented for informational purposes only and does not purport to represent what the results of operations or financial position of the Company would have been had the transactions described above actually occurred on the dates indicated, nor do they purport to project the financial condition of the Company for any future period or as of any future date. The unaudited pro forma financial information should be read in conjunction with the Company’s financial statements and notes thereto included elsewhere in this Annual Report. UNAUDITED PRO FORMA CONDENSED BALANCE SHEET About Glucotrack, Inc. Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes. Glucotrack’s CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. For more information, please visit http://www.glucotrack.com. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 31, 2025. Contacts: Investor Relations:[email protected] Media:[email protected]
Investor releaseQuarter not tagged2025-03-19Glucotrack to Present First-In-Human Study Results for Continuous Blood Glucose Monitor at the 2025 International Conference on Advanced Technologies & Treatment for Diabetes
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Glucotrack to Present First-In-Human Study Results for Continuous Blood Glucose Monitor at the 2025 International Conference on Advanced Technologies & Treatment for Diabetes
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…Read full documentShow less
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 release. About Glucotrack, Inc. Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes. Glucotrack’s CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. For more information, please visit http://www.glucotrack.com. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the SEC on March 28, 2024. Contacts: Investor Relations:[email protected] Media:[email protected]

