$ECTE..from latest quarterly update. We submitted our CE mark technical file in January to support our CE mark application for the Symphony CGM system in Europe. We have received comments from the notified body and we are working with them to respond to those comments and update our technical file as needed to address their feedback. As previously mentioned, the CE mark trial was the first time we had used all three components of the currently configured Symphony CGM system, which we refer to as the Gen1 product, together in a clinical study. During the trial and in subsequent analysis, we identified a number of system modifications that could potentially improve overall performance and usability, and we have begun incorporating those modifications into our Gen2 product.
Based on the trial results and subsequent analysis, we have made a number of changes in the strategic approach that we are taking in the development of our Gen2 product. Two important decisions which we believe will be beneficial in terms of productivity, were to outsource software development and to make the switch to a contract manufacturer that better meets our needs. We are in the process of implementing these changes.
In terms of enhancements for the Gen2 system, we are implementing an updated algorithm modifying the skin prep device to obtain more consistent skin microabrasions and exploring an adjusted warm-up period and calibration schedule. As you recall, during this same trial we also identified senor interference with an IV formulation of acetaminophen but not with the more commonly used oral formulation. We believe we have identified a solution to resolve this interference issue and we are currently in the process of implementing the change into our Gen2 product. We believe that once we have made these product enhancements and assuming we gain CE mark approval, we should be prepared for a limited European market launch and initiation of the FDA pivotal trial with the Gen2 device. While it is difficult to predict timing on the implementation of these product enhancements, we currently believe that the limited launch in Europe and the initiation of the FDA pivotal trial will occur early next year.
In parallel to the product development process on the Gen2 product, our next steps with the FDA will be to meet with them again and submit a pre-submission supplement with a statistical plan, along with endpoints and other metrics. We also plan to file an IDE for a clamping study to manipulate glucose levels on volunteers with diabetes that will provide us with additional data on tracking and trending of glucose levels, particularly in the hypo and hyperglycemic ranges. The data collected in this study will help support our eventual PMA submission.
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