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

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

Company Update - Glucotrack Inc will present an update on its Continuous Blood Glucose Monitor (CBGM) at the TechBio Showcase during Biotech Showcase 2025 [1] - The presentation will be given by Paul V Goode, President and CEO of Glucotrack [1] - The CBGM is a long-term implantable system with a sensor longevity of 3 years, no on-body wearable component, and minimal calibration [6] Event Details - The TechBio Showcase presentation will take place on Tuesday, January 14 at 9:30am PT in Yosemite C (Ballroom Level) [2] - TechBio Showcase is part of Biotech Showcase, an investor conference focused on therapeutic development and networking opportunities [2][4] - Biotech Showcase is in its 17th year and features multiple tracks of presenting companies, plenary sessions, workshops, and one-to-one meetings [4] Company Overview - Glucotrack Inc is a medical technology company focused on developing novel technologies for people with diabetes [5] - The company is currently developing a long-term implantable continuous blood glucose monitoring system [5] Additional Information - More details about Glucotrack's CBGM can be found on the company's website [3] - The TechBio Showcase is produced by Demy-Colton and EBD Group, organizations with a long history of supporting the biotechnology and life sciences industry [4]

Feasibility study underway for the Company’s novel continuous blood glucose monitor in patients with diabetes, with data expected within 6-8 weeks Rutherford, NJ, Dec. 03, 2024 (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, has announced the commencement of patient enrollment for its short-term human clinical study. The study will focus ...

Core Viewpoint - Glucotrack, Inc. successfully closed a public offering, raising approximately $10 million to support its operations and development of diabetes-related technologies [1][2]. Group 1: Public Offering Details - The public offering included 2,437,340 shares of common stock and 4,756,900 pre-funded warrants, with each share and warrant accompanied by series A and series B common warrants priced at $1.81 per share [1]. - The combined offering price for each share of common stock with accompanying warrants was $1.39, while the price for each pre-funded warrant was $1.389 [1]. - Dawson James Securities, Inc. acted as the sole placement agent for the public offering, which was registered under Form S-1 and declared effective by the SEC on November 12, 2024 [2]. Group 2: Private Placement - Concurrently with the public offering, Glucotrack closed a private placement that converted approximately $4.0 million in outstanding secured convertible notes into equity on similar terms as the public offering [4]. Group 3: Company Overview - Glucotrack, Inc. focuses on designing, developing, and commercializing innovative technologies for diabetes management, including a long-term implantable continuous blood glucose monitoring system [6][7].

Continuous blood glucose monitor to be among 100+ future-focused presentations at industry investor conference Rutherford, NJ, Oct. 22, 2024 (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 announced that it will participate in the 2024 BioFuture Conference, to be held at Cure in New York City from October 28-30, 2024. Paul V. Goode, ...

Updated preclinical data for the continuous blood glucose monitor to be presented at major diabetes technology conference Rutherford, NJ, Oct. 01, 2024 (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 announced that updated preclinical data for its continuous blood glucose monitor ("CBGM") will be presented at the 24th Annual Diabete ...

Biotech veteran joins Glucotrack's Board to support bringing novel continuous blood glucose monitoring technology to people with diabetes Rutherford, NJ, Sept. 03, 2024 (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 announced the appointment of John Ballantyne, PhD to its Board of Directors, effective immediately. "We are pleased t ...

Glucotrack ADCES poster highlights over 50% of surveyed diabetes patients are open to new Continuous Blood Glucose Monitor concept Rutherford, NJ, Aug. 15, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) ("Glucotrack" or the "Company"), a medical technology innovator focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced new findings from a recent market research study evaluating the acceptance of its new Continuous Blood Glucose Mo ...

Financial Performance - The company incurred a net loss of approximately $7.5 million for the six months ended June 30, 2024, compared to a net loss of approximately $1.3 million for the same period in 2023[77] - Net loss for the six-month period ended June 30, 2024, was approximately $7.4 million, an increase from approximately $2.5 million for the same period in the prior year[90] - Net cash used in operating activities was approximately $4.8 million for the six months ended June 30, 2024, compared to approximately $2.3 million for the same period in 2023[90] - The company has incurred substantial accumulated losses and negative operating cash flow, with a significant accumulated deficit[94] Accumulated Deficit and Cash Position - The company has an accumulated deficit of approximately $117.3 million as of June 30, 2024[77] - Cash and cash equivalents were approximately $159,000 as of June 30, 2024, which is insufficient to realize business plans for the next twelve months[78] - As of June 30, 2024, the company believes its cash on hand will not provide sufficient working capital for its current operations for the next twelve months[94] Research and Development - Research and development expenses increased to approximately $5.7 million for the six months ended June 30, 2024, from approximately $1.3 million in the prior-year period, reflecting ramped-up product development activities[86] - The company has initiated a regulatory submission for a first-in-human study of its Implantable Continuous Blood Glucose Monitor (CBGM), expected to start in Q3 2024[68] - The company has successfully demonstrated a three-year implant longevity for its sensor design, which is crucial for the success of the Implantable CBGM[68] Marketing and Business Development - Marketing expenses were approximately $170,000 for the six-month period ended June 30, 2024, compared to $0 for the prior-year period, indicating increased business development efforts[87] General and Administrative Expenses - General and administrative expenses were approximately $1.5 million for the six months ended June 30, 2024, compared to approximately $1.2 million for the prior-year period, due to accrued professional fees[88] Financing Activities - Financing income, net was approximately $26,000 for the six months ended June 30, 2024, compared to approximately $1,000 for the prior-year period, reflecting increased interest income[89] - Net cash provided by financing activities was approximately $580,000 for the six months ended June 30, 2024, a significant decrease from $8.7 million for the same period in 2023[91] - The company expects to finance future cash needs through a combination of public or private equity offerings, debt financings, and other arrangements[94] Internal Control and Management Actions - Management has identified material weaknesses in internal control over financial reporting, including insufficient internal accounting personnel and lack of segregation of duties[95] - Management intends to implement corrective actions during fiscal year 2024 to address identified material weaknesses[96] Other Information - The company has withdrawn its CE Mark for Glucotrack and is no longer pursuing its commercialization, focusing instead on the development of the Implantable CBGM[67] - As of June 30, 2024, the company has no off-balance sheet arrangements[92] - Net cash used in investing activities was $71,000 for the six-month period ended June 30, 2024, compared to $0 for the same period in 2023[91]