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GlucoTrack(GCTK) - 2024 Q2 - Quarterly Report
2024-08-13 20:06
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]
GLUCOTRACK ANNOUNCES THE APPOINTMENT OF ANDY BALO TO BOARD OF DIRECTORS
Newsfilter· 2024-06-20 12:30
Mr. Balo brings decades of regulatory, clinical and quality experience in the medical technology industry. In 2002 he joined Dexcom as part of the original executive team where he remained for the next 22 years playing a critical role in shaping the company's future. During his tenure, he was responsible for numerous glucose monitoring regulatory submissions and clinical trials worldwide and coordinated quality activities across multiple manufacturing facilities. In March 2024, Mr. Balo retired from Dexcom ...
GLUCOTRACK ANNOUNCES THE APPOINTMENT OF ANDY BALO TO BOARD OF DIRECTORS
GlobeNewswire News Room· 2024-06-20 12:30
Core Viewpoint - Glucotrack, Inc. has appointed Andy Balo to its Board of Directors to enhance its efforts in developing and commercializing continuous blood glucose monitoring technology for diabetes patients [1][5]. Company Overview - Glucotrack, Inc. is focused on designing, developing, and commercializing novel technologies specifically for people with diabetes [6]. - The company is currently working on a long-term implantable continuous blood glucose monitoring system that aims to improve the management of diabetes [6][7]. Appointment of Andy Balo - Andy Balo brings over 20 years of experience in the medical technology industry, having previously served as Executive Vice President at Dexcom, where he played a key role in regulatory submissions and clinical trials [2][3]. - Balo has a strong background in regulatory and clinical strategies, having been involved in the approval of over 100 medical devices, including continuous glucose monitors [3][4]. - His expertise is expected to be invaluable as Glucotrack moves into human clinical studies for its innovative technology [5]. Product Details - Glucotrack's continuous blood glucose monitor (CBGM) is designed to be a long-term, implantable system that measures blood glucose levels continuously, with a sensor longevity of over 2 years and minimal calibration required [7].
GLUCOTRACK REPORTS SUCCESSFUL COMPLETION OF FIRST REPORTED LONG-TERM PRECLINICAL STUDY OF ITS EPIDURAL GLUCOSE MONITORING SENSOR
Newsfilter· 2024-06-13 13:19
Completion of the novel epidural continuous glucose monitoring study confirms its potential for providing simplified disease management for patients with painful diabetic neuropathy The Glucotrack sensor, implanted in the epidural space of animals, closely tracked glucose values from both a commercially available blood glucose monitor and a subcutaneous continuous glucose monitor (CGM) throughout the 60-day period. No abnormal clinical signs were observed throughout the study period, and no abnormal finding ...
GLUCOTRACK TO PRESENT IN THE JUNE 2024 SIDOTI SMALL CAP CONFERENCE
GlobeNewswire News Room· 2024-06-10 14:50
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. Contacts: Media: GlucotrackPR@icrinc.com Rutherford, NJ, June 10, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) ("Glucotrack" or the "Company"), a medical technology company focused on the design, development, and commercial ...
GLUCOTRACK TO PRESENT IN THE JUNE 2024 SIDOTI SMALL CAP CONFERENCE
Newsfilter· 2024-06-10 14:50
Paul V. Goode, CEO of Glucotrack, will present on Wednesday, June 12, 2024 at 3:15 PM ET and will hold one-on-one meetings. Interested parties may register using the following webcast link: https://sidoti.zoom.us/webinar/register/WN_3OUskG4NTs2IvCBJSB4b4w#/registration Glucotrack's CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 2+ years, no on-body wearable component and with minimal calibration. For more information, please visit http://www ...
GLUCOTRACK ANNOUNCES 90-DAY PRECLINICAL STUDY RESULTS THAT DEMONSTRATE SUSTAINED ACCURACY OF ITS IMPLANTABLE CONTINUOUS BLOOD GLUCOSE MONITOR
Newsfilter· 2024-06-05 12:30
Highly accurate continuous blood glucose monitor demonstrates Mean Absolute Relative Difference (MARD) of 4.7% at Day 90 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 ...
GLUCOTRACK'S EPIDURAL GLUCOSE MONITORING SENSOR DEMONSTRATES SUCCESSFUL 30-DAY SAFETY & PERFORMANCE IN LONG-TERM PRECLINICAL STUDY
Newsfilter· 2024-05-16 12:30
Promising results support the potential of epidural glucose monitoring for simplified disease management for patients with painful diabetic neuropathy Rutherford, NJ, May 16, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (NASDAQ:GCTK) ("Glucotrack" or the "Company"), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced that its implantable continuous glucose monitor has successfully completed 30 days of a 60-day long-t ...
GlucoTrack(GCTK) - 2024 Q1 - Quarterly Report
2024-05-15 21:12
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 001-41141 GLUCOTRACK, INC. (Exact name of registrant as specified in its charter) Delaware 98-066 ...
GLUCOTRACK ANNOUNCES ABSTRACTS ACCEPTED FOR POSTER PRESENTATION AT 84TH SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION
Newsfilter· 2024-05-02 13:00
Continuous blood glucose monitor's preclinical data and sensor longevity modeling to be presented at major diabetes conference Rutherford, NJ, May 02, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (NASDAQ:GCTK) ("Glucotrack" or the "Company"), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced two abstracts have been accepted for poster presentation at the American Diabetes Association (ADA) 84th Scientific Sessions ...