Novel INXN-4001 Triple Effector Plasmid in Heart Failure

Inclusion Criteria:

- Male and female adult patients with a stable LVAD implanted for end-stage heart
failure

- Must be managed in an outpatient setting and on stable medication regimen

Exclusion Criteria:

- Women who are pregnant or nursing

- Patients who have been on another clinical trial for heart failure in the last 90
days, or have received any stem cell or gene therapy within the previous year.

- Patient is not able to complete a Six Minute Walk Test or unable to tolerate an LVAD
wean in the past 3 months

- Patient has an active infection requiring systemic antibiotics or an autoimmune
disease requiring systemic immunosuppressants

- Patient has a history of arrhythmia, uncontrolled diabetes, diabetic retinopathy,
systemic lupus erythematosus, macular degeneration, hyper-coagulation, or stroke

- Patient has had a myocardial infarction related to ischemia within the past 30 days

- Patient has had certain prior surgeries such as organ transplant, cardiac
transplantation, left ventricle reduction surgery, or cardiomyoplasty

- Patient has infectious disease, such as hepatitis B or C, or human immunodeficiency
virus (HIV)

- Patient has a history of cancer within the past 3 years