Glucotrack, Inc.

First In-Human Study

In Q1, the Company completed its first in-human clinical trial. The objective of this 5-day in-hospital study was to assess the insertion, use, and removal of the intravascular lead which was connected to externalized electronics.The study, which was conducted at the Interventional Cardiology at Instituto do Coração in São Paulo, Brazil between December 13, 2024 and January 31, 2025, included ten participants with either Type 1 or Type 2 diabetes who were on intensive insulin therapy. The insertion and removal procedures were performed by interventional cardiologists using established percutaneous techniques.

Detailed analysis showed consistent performance during glucose tolerance testing with minimal lag time compared to venous blood samples. The study met all primary and secondary endpoints, demonstrating excellent accuracy with a Mean Absolute Relative Difference (MARD) of 7.7% across 122 matched pairs, a 99% data capture rate, and no procedure or device-related serious adverse events. These findings support the safety and performance of the Company’s long-term, implantable CBGM, which measures glucose from blood rather than interstitial fluid, eliminating the typical lag time associated with traditional continuous glucose monitoring systems.