GLUCOTRACK ANNOUNCES SHAREHOLDER UPDATE - Seite 2

An additional shift has occurred in the access and coverage landscape where there has been expansion of insurance coverage for CGM beyond the type 1 diabetes market and into the insulin using type 2 diabetes market, driven by the considerable body of clinical evidence demonstrating CGM utility in this population. Earlier this year, the Centers for Medicare & Medicaid Services (CMS) granted CGM coverage for all people with diabetes who are on insulin or who meet a defined hypoglycemia profile. Our expectation is that CGM utilization will continue to expand in this population given the favorable reimbursement environment while point-in-time glucose monitoring slowly declines. This shift in the landscape demonstrates the increasing market demand and acceptance for continuous glucose monitoring.

Within the glucose sensing competitive landscape, CGM devices have reached similar accuracy as BGM devices, fueling their market acceptance and utilization. In the last shareholder update, we had recognized that this would raise the regulatory bar for any non-invasive glucose sensor performance. To date, our understanding is that the current generation of BGMs and CGMs have attained levels of accuracy and performance that outpace all known non-invasive point-in-time technologies that have progressed to real-world evaluations. As a result, the ability to achieve regulatory approval remains elusive and a substantial challenge for many non-invasive glucose sensor companies. This is further evidence supporting the transition of our business strategy to the CGM category, where current and future performance standards are more clearly defined, accepted and attainable.

Today represents an important step in Glucotrack’s journey as we reset our priorities, improve our commercial outlook and refine our business strategy to focus on our implantable CGM technology. We have significantly advanced the development program for the implantable CGM since launching its development in late Q4 last year and having recently achieved several key milestones. In July, we announced the completion and positive results of a laboratory-based feasibility study demonstrating that the CGM sensor is capable of measuring glucose for at least two years post-implant. In October, we announced the progression into initial preclinical animal studies which has established that the sensor functions as expected after the implant procedure and 30 days thereafter. Subsequently, we have initiated preparations for long-term preclinical studies on sensor performance that are expected to start in late Q4 of this year.