{"success":true,"data":{"pressRelease":{"id":"26308","rtpr_id":"nGNX2wD6yd","ticker":"GCTK","exchange":"NASDAQ","all_tickers":["GCTK"],"title":"Glucotrack Announces IDE Submission for U.S. Clinical Study of its Novel Implantable Continuous Blood Glucose Monitoring Technology","author":"Globe Newswire","published_at":"2026-05-07T17:00:00.253Z","article_body":"RUTHERFORD, N.J., May 07, 2026 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq:\nGCTK) (“Glucotrack” or the “Company”), a medical technology company\nfocused on the design, development, and commercialization of novel\ntechnologies for people with diabetes, today announced that it has submitted\nits Investigational Device Exemption (IDE) application to the U.S. Food and\nDrug Administration (FDA) to initiate a US clinical study for its fully\nimplantable continuous blood glucose monitoring (CBGM) technology.\n\nThe IDE submission represents an important step for Glucotrack and reflects\nthe Company’s progress to date in its preclinical development and technical\nfoundation of the technology. With this submission, Glucotrack moves closer to\nadvancing its implantable monitoring system toward clinical evaluation in the\nUnited States, with the goal of offering people with diabetes a new option for\ncontinuous glucose monitoring designed to provide long-term, real-time,\nblood-based accuracy without an on-body wearable. The Company plans to proceed\nwith its U.S. clinical study following FDA review and approval.\n\n“Submission of our IDE represents meaningful progress in the development of\nour CBGM technology and underscores our commitment to helping people with\ndiabetes live more fully,” said Paul V. Goode, PhD, President and Chief\nExecutive Officer of Glucotrack. “Our fully implantable solution is designed\nto be comfortable and discreet so that people can focus on their daily lives\n– allowing them to work, exercise, sleep, and socialize without the\ndisruption of frequent sensor changes, visible wearables, or reordering\nsupplies. We look forward to generating the clinical data needed to advance\ntoward regulatory approval and demonstrate that continuous glucose monitoring\ncan be both highly accurate and virtually invisible.”\n\nThe IDE submission follows several years of focused engineering, preclinical\nevaluation, and iterative design work supporting the development of a\nlong‑term, fully implantable CBGM system. Data generated to date support\nadvancing the technology into U.S. clinical evaluation as the Company enters\nthe next phase of development.\n\nFor more information about Glucotrack's CBGM, visit www.glucotrack.com.\n\nAbout Glucotrack, Inc.\n\nGlucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and\ncommercialization of novel technologies for people with diabetes. The Company\nis currently developing a long-term implantable continuous blood glucose\nmonitoring system for people living with diabetes.\n\nGlucotrack’s Continuous Blood Glucose Monitor (CBGM) is a long-term,\nimplantable system that continually measures blood glucose levels with a\nsensor longevity of 3 years, no on-body wearable component and with minimal\ncalibration. The Glucotrack CBGM is an Investigational Device and is limited\nby federal (or United States) law to investigational use.\n\nFor more information, please visit http://www.glucotrack.com. Information on\nthe Company’s website does not constitute a part of and is not incorporated\nby reference into this press release.\n\nForward-Looking Statements\n\nThis news release contains forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995. Statements contained in\nthis news release that are not statements of historical fact may be deemed to\nbe forward-looking statements. Without limiting the generality of the\nforegoing, words such as “anticipate”, “believe”, “expect”,\n“plan” and “will” are intended to identify forward-looking statements.\nSuch forward-looking statements are based on the beliefs of management, as\nwell as assumptions made by, and information currently available to,\nmanagement. These statements relate only to events as of the date on which the\nstatements are made, and Glucotrack undertakes no obligation to publicly\nupdate any forward-looking statements, whether as a result of new information,\nfuture events or otherwise, except as required by law. All of the\nforward-looking statements made in this press release are qualified by these\ncautionary statements, and there can be no assurance that the actual results\nanticipated by Glucotrack will be realized or, even if substantially realized,\nthat they will have the expected consequences to or effects on us or our\nbusiness or operations. Readers are cautioned that certain important factors\nmay affect Glucotrack’s actual results and could cause such results to\ndiffer materially from any forward-looking statements that may be made in this\nnews release. Factors that may affect Glucotrack’s results include, but are\nnot limited to, the ability of Glucotrack to raise additional capital to\nfinance its operations (whether through public or private equity offerings,\ndebt financings, strategic collaborations or otherwise); risks relating to the\nreceipt (and timing) of regulatory approvals (including U.S. Food and Drug\nAdministration approval); risks relating to enrollment of patients in, and the\nconduct of, clinical trials; risks relating to Glucotrack’s future\ndistribution agreements; risks relating to its ability to hire and retain\nqualified personnel, including sales and distribution personnel; and the\nadditional risk factors described in Glucotrack’s filings with the U.S.\nSecurities and Exchange Commission (the “SEC”), including its Annual\nReport on Form 10-K for the year ended December 31, 2025 as filed with the SEC\non March 30, 2026.\n\n Contacts:                                          \n Investor Relations:       Media:                   \n investors@glucotrack.com  GlucotrackPR@icrinc.com  \n\n\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/3e47bd1b-0cc6-4104-b91d-0ddb9f30f4cc)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX2wD6yd","title":"Glucotrack Announces IDE Submission for U.S. Clinical Study of its Novel Implantable Continuous Blood Glucose Monitoring Technology","author":"Globe Newswire","ticker":"GCTK","created":"2026-05-07T17:00:00.253Z","tickers":["GCTK"],"exchange":"NASDAQ","article_body":"RUTHERFORD, N.J., May 07, 2026 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq:\nGCTK) (“Glucotrack” or the “Company”), a medical technology company\nfocused on the design, development, and commercialization of novel\ntechnologies for people with diabetes, today announced that it has submitted\nits Investigational Device Exemption (IDE) application to the U.S. Food and\nDrug Administration (FDA) to initiate a US clinical study for its fully\nimplantable continuous blood glucose monitoring (CBGM) technology.\n\nThe IDE submission represents an important step for Glucotrack and reflects\nthe Company’s progress to date in its preclinical development and technical\nfoundation of the technology. With this submission, Glucotrack moves closer to\nadvancing its implantable monitoring system toward clinical evaluation in the\nUnited States, with the goal of offering people with diabetes a new option for\ncontinuous glucose monitoring designed to provide long-term, real-time,\nblood-based accuracy without an on-body wearable. The Company plans to proceed\nwith its U.S. clinical study following FDA review and approval.\n\n“Submission of our IDE represents meaningful progress in the development of\nour CBGM technology and underscores our commitment to helping people with\ndiabetes live more fully,” said Paul V. Goode, PhD, President and Chief\nExecutive Officer of Glucotrack. “Our fully implantable solution is designed\nto be comfortable and discreet so that people can focus on their daily lives\n– allowing them to work, exercise, sleep, and socialize without the\ndisruption of frequent sensor changes, visible wearables, or reordering\nsupplies. We look forward to generating the clinical data needed to advance\ntoward regulatory approval and demonstrate that continuous glucose monitoring\ncan be both highly accurate and virtually invisible.”\n\nThe IDE submission follows several years of focused engineering, preclinical\nevaluation, and iterative design work supporting the development of a\nlong‑term, fully implantable CBGM system. Data generated to date support\nadvancing the technology into U.S. clinical evaluation as the Company enters\nthe next phase of development.\n\nFor more information about Glucotrack's CBGM, visit www.glucotrack.com.\n\nAbout Glucotrack, Inc.\n\nGlucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and\ncommercialization of novel technologies for people with diabetes. The Company\nis currently developing a long-term implantable continuous blood glucose\nmonitoring system for people living with diabetes.\n\nGlucotrack’s Continuous Blood Glucose Monitor (CBGM) is a long-term,\nimplantable system that continually measures blood glucose levels with a\nsensor longevity of 3 years, no on-body wearable component and with minimal\ncalibration. The Glucotrack CBGM is an Investigational Device and is limited\nby federal (or United States) law to investigational use.\n\nFor more information, please visit http://www.glucotrack.com. Information on\nthe Company’s website does not constitute a part of and is not incorporated\nby reference into this press release.\n\nForward-Looking Statements\n\nThis news release contains forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995. Statements contained in\nthis news release that are not statements of historical fact may be deemed to\nbe forward-looking statements. Without limiting the generality of the\nforegoing, words such as “anticipate”, “believe”, “expect”,\n“plan” and “will” are intended to identify forward-looking statements.\nSuch forward-looking statements are based on the beliefs of management, as\nwell as assumptions made by, and information currently available to,\nmanagement. These statements relate only to events as of the date on which the\nstatements are made, and Glucotrack undertakes no obligation to publicly\nupdate any forward-looking statements, whether as a result of new information,\nfuture events or otherwise, except as required by law. All of the\nforward-looking statements made in this press release are qualified by these\ncautionary statements, and there can be no assurance that the actual results\nanticipated by Glucotrack will be realized or, even if substantially realized,\nthat they will have the expected consequences to or effects on us or our\nbusiness or operations. Readers are cautioned that certain important factors\nmay affect Glucotrack’s actual results and could cause such results to\ndiffer materially from any forward-looking statements that may be made in this\nnews release. Factors that may affect Glucotrack’s results include, but are\nnot limited to, the ability of Glucotrack to raise additional capital to\nfinance its operations (whether through public or private equity offerings,\ndebt financings, strategic collaborations or otherwise); risks relating to the\nreceipt (and timing) of regulatory approvals (including U.S. Food and Drug\nAdministration approval); risks relating to enrollment of patients in, and the\nconduct of, clinical trials; risks relating to Glucotrack’s future\ndistribution agreements; risks relating to its ability to hire and retain\nqualified personnel, including sales and distribution personnel; and the\nadditional risk factors described in Glucotrack’s filings with the U.S.\nSecurities and Exchange Commission (the “SEC”), including its Annual\nReport on Form 10-K for the year ended December 31, 2025 as filed with the SEC\non March 30, 2026.\n\n Contacts:                                          \n Investor Relations:       Media:                   \n investors@glucotrack.com  GlucotrackPR@icrinc.com  \n\n\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/3e47bd1b-0cc6-4104-b91d-0ddb9f30f4cc)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-05-07T17:00:00.292424415Z","server_sent_at_ms":1778173200292},"received_at":"2026-05-07T17:00:00.393Z","source_url":"https://www.globenewswire.com/news-release/2026/05/07/3290388/0/en/glucotrack-announces-ide-submission-for-u-s-clinical-study-of-its-novel-implantable-continuous-blood-glucose-monitoring-technology.html"},"analysis":{"id":"20601","press_release_id":"26308","analysis_json":{"industry":{"label":"Health Care Equipment & Supplies","sector":"Health Care"},"redFlags":[],"eventType":"regulatory","narrative":"Glucotrack submitted an Investigational Device Exemption (IDE) application to the FDA to initiate a U.S. clinical study for its fully implantable continuous blood glucose monitoring (CBGM) technology.\n\nThe submission marks progress from preclinical development toward clinical evaluation, aiming to provide a long-term, real-time, blood-based monitoring option without an on-body wearable.\n\nManagement highlighted the device's 3-year sensor longevity and designed comfort, with plans to proceed with the study following FDA review.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"IDE submission clears path for pivotal US clinical trials of implantable glucose monitor."},"keyFigures":{"customDimensions":{"sensor_longevity_years":3}},"quotedText":"Submission of our IDE represents meaningful progress in the development of our CBGM technology and underscores our commitment to helping people with diabetes live more fully","namedEntities":{"people":[{"name":"Paul V. 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