CardiAMP™ Heart Failure Trial

Heart failure is a clinical condition in which the output of blood from the heart is
insufficient to meet the metabolic demands of the body. In 2015, the American Heart
Association, or AHA, report on heart disease statistics estimated that there are 5.7 million
Americans over the age of 20 that have heart failure. Heart failure is increasingly prevalent
due to the aging population and the increase in major cardiovascular risk factors, including
obesity and diabetes.

The AHA also estimates that one in five adults will develop heart failure after the age of
40. During heart failure progression, the heart steadily loses its ability to respond to
increased metabolic demand, and mild exercise soon exceeds the heart's ability to maintain
adequate output. Towards the end stage of the disease, the heart cannot pump enough blood to
meet the body's needs at rest. At this stage, fluids accumulate in the extremities or in the
lungs making the patient bedridden and unable to perform the activities of daily living. The
long-term prognosis associated with heart failure is approximately 50% mortality at five
years following the initial diagnosis.

CardiAMP is a comprehensive therapeutic treatment that comprises (i) a point of care cell
processing platform, and (ii) a biotherapeutic delivery system. CardiAMP is the first
comprehensive therapeutic treatment utilizing a patient's own cells for the treatment of
ischemic systolic heart failure, which is heart failure that develops after a heart attack.
In the screening process, the physician extracts a small sample of the patient's bone marrow
in an outpatient procedure performed under local anesthesia. The clinic sends the sample to a
centralized diagnostic lab, which tests the sample. During the treatment, a clinician
harvests and then prepares the patient's own bone marrow mononuclear cells, or autologous
cells, using the CardiAMP point of care cell processing platform, which a cardiologist then
delivers into the heart using the Helix biotherapeutic delivery system.

BioCardia intends to submit data obtained from this clinical trial in a Pre-Market Approval
Application to the United States Food and Drug Administration

Inclusion Criteria:

- New York Heart Association (NYHA) Class II or III

- A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial
infarction (MI).

- On stable evidence-based medical and device therapy for heart failure or
post-infarction left ventricular dysfunction, per the 2013 ACC/AHA Heart Failure
guidelines, for at least three (3) months prior to randomization.

- Left ventricular ejection fraction between 20% and 40%.

Exclusion Criteria:

• Other cardiac or vascular system or other health-related criteria which may be seen in a
patient's history and physical examination.