Latest news with #Glucotrack
Associated Press
29-05-2025
- Business
- Associated Press
Upcoming Benzinga Webinar With Glucotrack To Discuss The Potential Of Its Innovative CBGM Technology To Transform Diabetes Care And Patient Lives
By Meg Flippin Benzinga DETROIT, MICHIGAN - May 29, 2025 ( NEWMEDIAWIRE ) - Glucotrack Inc. (NASDAQ: GCTK) will host a virtual webinar on Thursday, May 29, from 11 a.m. to 12 p.m. ET to discuss its Continuous Blood Glucose Monitor (CBGM) technology, a potentially game-changing medical device that could reshape how diabetes is managed. Experts from the Rutherford, New Jersey medical technology company will lead the session, providing a deep dive into how CBGM technology works and how it can transform the lives of people suffering from diabetes. Glucotrack experts will also discuss the critical role real-time continuous blood glucose tracking can play and why diabetes patients need a new, innovative solution. The Existing Tools Are Too Cumbersome When it comes to managing diabetes, historically the main way of tracking a person's sugar in their blood has been via a glucose meter, which requires the person to prick his or her finger several times a day to get a sample of the blood. The results are generally accurate, granted it is stored properly and the patient remembers to test often. Continuous glucose monitoring (CGM) offers a less intrusive alternative. With it, a person's blood glucose level is monitored automatically through a device 24 hours a day. It enables the diabetes patient to review their blood glucose level in real time to make well-informed decisions and adjust behavior on the spot. Glucotrack's Different Approach When it comes to CGMs, not all devices are created equally. The duration for which the monitoring lasts, the placement of the device and how often data is received differ from one manufacturer to the next. Plus, the sensors and implantables on the market need to be reapplied or recalibrated every ten to 90 days. Glucotrack is different. Glucotrack's implantable CBGM measures glucose in the blood, without the lag time associated with subcutaneous sensors that measure glucose in interstitial fluid. With it, Glucotrack says users get real-time readings instead of interstitial lag. What's more, Glucotrack's implant can last two to three years, compared to less than one year for many of the CGMs on the market. Glucotrack's CBGM also offers many other benefits, which will be discussed at the webinar. The webinar will offer insights into how the technology works, the critical role of continuous blood glucose monitoring and the necessity for innovation in the field. Glucotrack is also kicking off a long-term clinical study of its continuous blood glucose monitor in participants with type 1 and type 2 diabetes. A recently completed long-term preclinical study showed a Mean Absolute Relative Difference (MARD) of 4.7% at day 90, which is considered highly accurate for a continuous glucose monitor, reports Glucotrack. During the webinar, experts from the company will share highlights from its clinical research, and share details of the latest study. Rounding Things Off – Live Q&A Session Capping off the webinar will be a live Q&A session in which attendees can submit questions directly to Glucotrack about its CBGM device, its trial and where the company sees its device and the diabetes market headed. The event is geared toward anybody who wants to learn more about cutting-edge technology being applied to a disease that is projected to impact 643 million people around the globe by 2030, with the number soaring to 783 million by 2045. Click here to register now! Featured photo courtesy of Glucotrack. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. This content was originallypublished on further disclosureshere. View the original release on
Associated Press
28-05-2025
- Business
- Associated Press
Glucotrack Strengthens Board of Directors with Election of Victoria E. Carr-Brendel, PhD
RUTHERFORD, N.J., May 28, 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, announced today that Victoria E. Carr-Brendel, PhD, was elected to the Company's Board of Directors, effective May 22, 2025. 'We are delighted to welcome Dr. Carr-Brendel to Glucotrack's Board of Directors,' said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. 'With her exceptional leadership in medical devices and deep expertise in implantable technologies, she will be an invaluable addition to the Board as we advance our continuous blood glucose monitoring (CBGM) technology through clinical development and move closer to commercialization.' Dr. Carr-Brendel currently serves as a member of the board of directors of Vicarious Surgical Inc. (NYSE: RBOT) since January 2023 and previously served from 2018 to 2024 as President and Group Vice President of Cochlear Implants at Sonova Group. Prior to that, she served as Chief Executive Officer of JenaValve Technology, Inc., a medical device company focused on developing minimally invasive transcatheter aortic valve repair systems for patients suffering from severe aortic valve disease. Previously, Dr. Carr-Brendel held various leadership roles at Boston Scientific, including overseeing the acquisition of Bayer's interventional radiology division in 2014. She started her career as a scientist in R&D with roles at Dexcom and Baxter Healthcare, amassing over forty patents and taking on increasingly senior business and management roles. She holds a BA in Biology from Monmouth College, an MS in Microbiology from Iowa State University, and a PhD in Microbiology and Immunology from the University of Illinois at Chicago. 'I am honored to be joining Glucotrack's Board of Directors at this pivotal time in the company's development,' said Victoria E. Carr-Brendel, PhD. 'The innovative CBGM has tremendous potential to address significant unmet needs for people with diabetes and enhance automated insulin delivery. I look forward to contributing to the Company as it works to achieve its strategic and clinical milestones.' Glucotrack's CBGM is a long-term implantable system with no wearable component, designed for up to three years of continuous, accurate blood glucose monitoring, offering a more convenient and less intrusive glucose monitoring solution. The CBGM measures glucose directly from blood, unlike traditional continuous glucose monitoring systems which measure glucose from interstitial fluid. Thus, it aims to provide real-time readings without the lag time typically associated with interstitial glucose measurements. 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 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 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: Investor Relations: [email protected] Media: [email protected]
Yahoo
14-05-2025
- Business
- Yahoo
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 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 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 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: Investor Relations: Media: investors@ GlucotrackPR@ GLUCOTRACK CONSOLIDATED BALANCE SHEETS(in thousands of US dollars except share data) In thousands of US dollars(except stock data) March 31,2025 December 31,2024 Unaudited Current Assets Cash and cash equivalents 9,100 5,617 Other current assets 355 151 Total current assets 9,455 5,768 Operating lease right-of-use asset, net 53 59 Property and equipment, net 94 95 Restricted cash 10 10 TOTAL ASSETS 9,612 5,932 LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) Current Liabilities Accounts payable 1,612 992 Operating lease liability, current 26 26 Convertible promissory notes 9 5 Other current liabilities 303 252 Total current liabilities 1,950 1,275 Non-Current Liabilities Derivative financial liabilities (Note 2F and Note 3B) 177 17,421 Operating lease liability, non-current 26 33 Loans from stockholders 201 203 Total liabilities 2,354 18,932 Commitments and contingent liabilities (Note 4) Stockholders' Equity (Deficit) Common Stock of $0.001 par value ('Common Stock'): 250,000,000 and 100,000,000 shares authorized as of March 31, 2025 and December 31, 2024, respectively; 25,585,853 and 791,609 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively 26 1 Additional paid-in capital 146,259 119,229 Receipts on account of shares 228 228 Accumulated other comprehensive income 28 (8 ) Accumulated deficit (139,283 ) (132,450 ) Total stockholders' equity (deficit) 7,258 (13,000 ) TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) 9,612 5,932 GLUCOTRACK CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands of US dollars except share data) (unaudited) Three-month period endedMarch 31, 2025 2024 Operating expenses Research and development $ 1,871 $ 2,148 General and administrative 1,499 733 Selling and marketing expenses 128 70 Total operating expenses 3,498 2,951 Operating loss 3,498 2,951 Other (income) expense Change in fair value of derivative liabilities 3,376 - Other (income) expense, net (4 ) - Finance expenses (income), net (37 ) (24 ) Net Loss 6,833 2,927 Other comprehensive income: Foreign currency translation adjustment (36 ) (6 ) Comprehensive loss for the period $ 6,797 $ 2,921 Basic and diluted net loss per common stock $ (0.67 ) $ (11.73 ) Weighted average number of common stock used in computing basic and diluted loss per common stock 10,160,725 249,598 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-05-2025
- Health
- Yahoo
Glucotrack gains HREC approval for clinical study of CBGM device
Glucotrack has announced the receipt of St Vincent's Hospital Melbourne Human Research Ethics Committee's (HREC) approval for a multi-centre clinical study of its continuous blood glucose monitor (CBGM) in type 1 and type 2 diabetic patients. The single-arm, prospective study aims to assess the safety and performance of the device over a year, with potential extensions up to three years. It is set to enrol up to 30 subjects needing intensive insulin therapy and glucose monitoring. With the approval in place, Glucotrack will notify Australia's Therapeutic Goods Administration (TGA) before continuing with the enrolment process. The implantation procedure for the first subjects is expected to take place by July 2025. The CBGM is a long-term implantable system without a wearable component, tailored for continuous blood glucose monitoring for up to three years. It claims to directly measure glucose from blood, offering real-time readings and aiming to eliminate the lag time associated with interstitial glucose measurements. Australia's University of Melbourne professor David O'Neal will act as the study's principal investigator and oversee the research, alongside associate professor Neale Cohen from the Baker Heart and Diabetes Institute. The Glucotrack CBGM is limited by US federal law for investigational use only. The device's features include three-year sensor longevity, the absence of an on-body wearable component, and minimal calibration requirements. Glucotrack CEO and president Paul Goode said: 'Securing this approval represents a major milestone for our clinical programme and builds on the successful completion of our first-in-human study earlier this year. 'This year-long study will provide critical insights into the long-term performance, safety, and reliability of our innovative technology, which is designed to address key challenges identified by people with diabetes – including the need for extended sensor life, elimination of on-body wearables, and the benefits of direct blood glucose measurement.' The company designs, develops and commercialises technologies for diabetic people. In February 2025, the company completed a first-in-human study with its CGM that directly measures glucose levels from a blood vessel. "Glucotrack gains HREC approval for clinical study of CBGM device" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Associated Press
25-02-2025
- Business
- Associated Press
Glucotrack Commences Transition From Concept To Reality With Breakthrough Clinical Trial
NEWMEDIAWIRE) - Glucotrack, Inc. (NASDAQ: GCTK) reports it has achieved a significant milestone in its mission to transform diabetes management through three distinct advances: direct blood glucose measurement, hassle-free monitoring and the first multi-year continuous glucose monitoring (CGM) system. The company announced the successful completion of its first human clinical trial for its Continuous Blood Glucose Monitor (CBGM), a device that could eliminate both the accuracy limitations of current glucose monitors and the burden of frequent sensor changes. Unlike existing continuous glucose monitors that measure interstitial fluid and require sensor replacement every 10 to 15 days, Glucotrack says its CBGM represents a radical shift in diabetes care through: Direct blood measurement: By measuring glucose levels directly in the blood rather than interstitial fluid, the CBGM can provide more accurate, real-time data when it matters most for treatment decisions Significant reduction of maintenance: With no external components to manage, the fully implantable system frees patients from the constant cycle of sensor changes, supply orders and device management that defines current diabetes care Unsurpassed longevity: With a sensor life of three years, the CBGM moves the longevity conversation from days or weeks to number of years, much longer than any of the traditional CGMs, according to Glucotrack. This step forward comes as the continuous glucose monitoring market is projected to reach $11.5 billion in annual revenue for 2024 (based on $2.9 billion in 1Q24, $2.9 billion in 2Q24 and $2.8 billion in 3Q24) and will continue growing at 7.19% annually, according to Close Concerns, in its publication, Closer Look. Current market leaders Dexcom Inc and Abbott Laboratories serve a growing but increasingly demanding patient population, highlighting the opportunity for innovations that address core limitations in conventional glucose monitoring. Given the severe health risks, glucose monitoring is non-negotiable for many people with diabetes. Some rely on traditional fingerstick blood glucose monitors, which only provide one reading at a specific point in time – which makes determination of trends difficult. Many others have switched to CGMs which include a wearable component connected to a subcutaneous sensor to provide one reading every few minutes, therefore enabling the user to see trends in their glucose levels and be alerted when their glucose levels need attention. However, today's CGM systems only measure glucose in interstitial fluid, not blood, causing some lag in glucose readings that is most noticeable at times when glucose levels are rapidly changing. Beyond this limitation on accuracy, people with diabetes must also manage frequent sensor changes, deal with adhesive issues and coordinate regular supply deliveries. While current CGMs have made important advances in diabetes care, these fundamental challenges – delayed readings, ongoing maintenance requirements and short sensor life – remain largely unaddressed until now, the company says. Glucotrack's entry into the diabetes management ecosystem potentially marks a fundamental leap forward for patients. The CBGM doesn't merely revolve around surface-level improvements such as software integrations or reduced-size form factors. Rather, it could offer increased lifestyle freedom and represent an advancement that is potentially emblematic of an evolution in diabetes care. The Clinical Trial: A Critical Step Toward Real-World Adoption Building on these innovations, the company's first in-human clinical trial marks a decisive transition from theory to real-world application. The recently completed first in-human clinical study validates the safety, feasibility and procedural simplicity of the CBGM system, clearing a major hurdle in its journey toward widespread adoption, Glucotrack says. Conducted as a short-term, in-hospital study over four days, the trial focused on the safety and procedural aspects of placing, using and removing the CBGM sensor lead. Six diabetes patients requiring glucose monitoring and intensive insulin therapy participated in the study. The sensor lead was placed in the subclavian vein via a percutaneous procedure and connected to a prototype external sensor electronics component placed on the skin for this initial trial, though the commercial system will be fully implanted. The trial assessed whether the sensor lead could be implanted and removed without complications, while also confirming proper sensor lead placement and procedural efficiency. Glucotrack reports that the results were a success. The study met its primary endpoint with no procedure- or device-related serious adverse events, from placement, during the four-day in-hospital stay and through the seven-day post-removal period. Importantly, the procedures were performed by three different interventional cardiologists who were already familiar with implanting similar devices and working with patients who live with diabetes. This stamp of approval from healthcare providers is an important factor for future adoption, as it could simplify integration into existing clinical workflows. Although this initial study was not intended to measure sensor accuracy, Glucotrack noted that the system performed as expected, delivering results in line with preclinical animal studies. This reinforces confidence in the CBGM system's ability to deliver real-time, accurate glucose readings without the drawbacks of conventional CGMs. Beyond the immediate validation of safety and procedural feasibility, this successful trial serves as a gateway to larger-scale human studies. Glucotrack says it is poised to expand clinical testing, meet regulatory requirements and advance commercialization efforts. The company plans to present these findings at an upcoming diabetes conference, providing critical exposure and engagement with key stakeholders in the medical community. A New Path Forward With the successful completion of its first in-human clinical study, Glucotrack has moved beyond concept and into real-world feasibility. The trial's confirmation of safety, procedural simplicity and expected performance lays the groundwork for larger clinical studies and eventual regulatory approval, bringing the CBGM system closer to patients who need a better solution. As the diabetes management industry continues to evolve, Glucotrack stands to potentially redefine continuous glucose monitoring. The CBGM is not just another iteration of existing technology – it represents a fundamental leap forward, the company says, shifting the burden of glucose monitoring away from patients and into a less intrusive background process. With clinical validation now underway, the company says it is positioned to expand its trials, working to strengthen its market presence and redefine how diabetes care is delivered.
