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GENERAL
 12 Months Ended
Dec. 31, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
GENERAL

NOTE 1 – GENERAL

 

  A.

The Company was incorporated on May 18, 2010 under the laws of the State of Delaware. The Company is currently developing an implantable CBGM, the Glucotrack CBGM, for persons with Type 1 diabetes and insulin-dependent Type 2 diabetes.

     
   

The Glucotrack CBGM is being developed for use by Type 1 diabetes patients as well as insulin-dependent Type 2 patients. Implant longevity is key to the success of such a device. The Company has continued to evolve its sensor chemistry following the successful in-vitro feasibility study demonstrating that a minimum two-year implant life is highly probable with the current sensor design. Recently the Company announced that a 3-year longevity is feasible leveraging both in-vitro and in-silico test results. The Company has also completed multiple animal studies with initial prototype systems which demonstrated a simple implant procedure with good safety and functionality. The results of both were presented in poster form at the 2024 American Diabetes Association annual conference.

 

Further to the above progress on the Glucotrack CBGM, the Company has also successfully demonstrated continuous glucose sensing in the epidural space. This latter approach is of importance for patients with diabetes already contemplating spinal cord stimulation therapy for their condition.

 

A regulatory submission has been made for a first in human study outside of the United States. This will be an acute study intended to demonstrate device performance and safety. All preparatory clinical activities and applicable regulatory approvals are complete. In parallel, the Company is also preparing for a long-term clinical trial outside the United States that is expected to begin in the second quarter of 2025.

 

The Company believes its technology, if successful, has the potential to be more accurate, more convenient and have a longer duration than other implantable glucose monitors that are either in the market or currently under development.

 

  B. Liquidity and capital resources

 

   

To date, the Company has not yet commercialized the Glucotrack CBGM Product. Further development and commercialization efforts are expected to require substantial additional expenditure. Therefore, the Company is dependent upon external sources for financing its operations. As of December 31, 2024, the Company has incurred an accumulated deficit of $132,450. In addition, the Company has generated operating losses and negative cash flow from operations since inception. As of December 31, 2024, the balance of cash and cash equivalents amounted to $5,617.

 

During the year ended December 31, 2024, the Company raised approximately $15 million through public offerings and debt issuances which were subsequently converted to equity. In addition, subsequent to the balance sheet date, the Company raised $6.3 million through the sale of shares of Common Stock. See Note 4 and 14. The Company plans to finance its operations through the sale of equity securities (and/or debt securities). There can be no assurance that the Company will succeed in obtaining the necessary financing or generating sufficient revenue from sale of its Glucotrack CBGM Product in order to continue its operations as a going concern.

 

Management has considered the significance of such conditions in relation to the Company’s ability to meet its current obligations and to achieve its business targets and determined that these conditions raise substantial doubt about the Company’s ability to continue as a going concern.

   

 

The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.