The underwriters for the offering are Cantor Fitzgerald, Roth Capital Partners, and Maxim Group.
This is a clinical-stage regenerative medicine company that develops novel therapeutics for cardiovascular diseases with large unmet medical needs. Its lead therapeutic candidate is the CardiAMP Cell Therapy System (CardiAMP).
The company anticipates enrolling the first patient in its phase 3 pivotal trial for CardiAMP in ischemic systolic heart failure in 2015, then obtaining top-line data in the second half of 2017. If the phase 3 pivotal trial is successful, BioCardia believes it will be the first company to reach the market with a cell-based therapy to treat heart failure.
The second therapeutic candidate is the CardiALLO Cell Therapy System (CardiALLO). The company anticipates acceptance of an Investigational New Drug (IND) application by the FDA in 2016 for a phase 2 trial for CardiALLO in ischemic systolic heart failure.
The proceeds from this offering are expected to be put towards the phase 3 trial of CardiAMP cell therapy system, and the remainder of funds will be used for working capital, research and development of additional future products or therapies, and general corporate purposes.
In the filing the company described its market opportunity as:
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.
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