At the stage of pivotal GLP (Good Laboratory Practice) pre-clinical trial, a control and treatment group of approximately 20 sheep models would undergo a study lasting up to 18 months in total. The first phase of the preclinical trial would involve congestive heart failure model creation in both control and treatment groups. The second phase of the pre-clinical trial would involve treatment intervention using the flow modulation stent for sheep models in the treatment group. Following harvesting of data and analysis of outcomes, an exit strategy involving acquisition by a larger strategic medical device company may be decided.