Financial Performance - Glucotrack reported a net loss of 7.1 million in 2023, reflecting an increase in operating expenses and non-cash losses [8]. - Research and development expenses rose to 4.7 million in 2023, primarily due to increased product design and pre-clinical study activities [6]. - Cash and cash equivalents increased to 4.5 million at the end of 2023, with a pro forma cash position of 16.3 million in funding from multiple rounds between November 2024 and March 2025, providing necessary runway for product and clinical development milestones in 2025 [4]. Clinical Studies and Approvals - The first human clinical study of the continuous blood glucose monitor (CBGM) was successfully completed, meeting its primary endpoint with no serious adverse events reported [3]. - Anticipated FDA approval for Investigational Device Exemption (IDE) for the CBGM technology is expected in Q4 2025 [1]. - The company plans to commence a long-term multicenter feasibility study of the fully implantable CBGM system in Australia in Q2 2025 [5]. Compliance and Certification - The company received ISO 13485:2016 certification, demonstrating compliance with global standards for medical device design and manufacturing [5]. Leadership and Team Development - Glucotrack appointed several key executives to strengthen its leadership team, including a new Chief Financial Officer and Vice President of Regulatory Affairs [5]. Product Innovation - Glucotrack's CBGM technology aims to provide a fully implantable system with a sensor longevity of 3 years, enhancing convenience and accuracy for diabetes management [21].
GlucoTrack(GCTK) - 2024 Q4 - Annual Results