FDA Update

Immuno-Genic Corporation (IGC) has conducted a "Proof of Concept" pilot study to prove efficacy and safety. This study and the data collected through the veterinary usage of the product has been analyzed. The results have been submitted to the Food and Drug Administration (FDA) in the form of a 510(k) submission for FDA clearance to market the product to the human market. The application is in process. To date the FDA has classified the Ig2000 as an Athermic, NON-Significant Risk Device.