Design iterations based on bench testing, adherence to customer requirements and physician feedback will continue until the design is frozen, expected in late 2020. Functional prototypes are being tested in animal and bench test models. The design and testing is being conducted in-house and at American Preclinical Services located in Coon Rapids, Minnesota. We will have completed all pre clinical testing and have filed our IDE to obtain approval to start human clinical testing by the fourth quarter 2021
Since the Company’s inception, several design iterations of the implantable compression chamber ventricular wrap have been developed and constructed. Using 3-D software, prototypes of the compression jacket have been made and are in different phases of testing.