Beginning in 2013 and throughout 2014, we’ve actively supported leading investigators in advancing this development of artificial pancreas solutions by providing Bluetooth enabled pump, hardware and software. We are committed to continue advancing the clinical applications of Tandem’s technology.
To this effort, in 2014, we initiated the R&D concept phase of our artificial pancreas offering. Our first AP product will utilize Tandem’s proprietary technology platform and will partially automate insulin delivery based on CGM information and predictive algorithms to aid a user and maintaining their targeted blood glucose level and may reduce the frequency and severity of hyper or hypoglycemic events.
In the second half of 2015, we plan to file an Investigational Device Exemption or IDE with the FDA for a clinical study in rolling our first AP product. Our discussions with FDA surrounding this IDE will help decline regulatory pathway, which we anticipate will require preliminary approval and will include data from one or more clinical studies.