Heart failure is a major public health issue—over 23 million people worldwide and 5.8 million people in the United States (US). Nearly 900,000 new heart failure cases are diagnosed annually in the US. Projections show that the US prevalence of heart failure will increase 46% from 2012 to 2030, resulting in more than 8 million people (18 years of age or older) diagnosed with heart failure.

Only 2,000 donor hearts become available in the United States each year. Donor heart need is almost entirely unmet for the vast majority of end-stage heart failure patients.