Note 1 - Summary of Business and Basis of Presentation

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Business Description and Basis of Presentation [Text Block]

( 1 ) Summary of Business and Basis of Presentation

Description of Business

BioCardia, Inc., (“we” or “the Company”), is a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs. Our lead therapeutic candidate is the CardiAMP Cell Therapy System, an investigational autologous bone marrow derived cell therapy being advanced for

two

large cardiac indications under FDA approved pivotal trials. Our

second

therapeutic candidate is the CardiALLO Cell Therapy System, an investigational allogenic culture expanded “off the shelf” mesenchymal cell therapy being advanced initially to treat patients who are

not

eligible for CardiAMP cell therapy due to the quality of their cells. To date, we have devoted substantially all our resources to research and development efforts relating to our therapeutic candidates and biotherapeutic delivery systems including conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support for these operations and protecting our intellectual property.

We have

three

enabling device product lines which have

one

or more approvals in the USA and/or EU: (

1

) the CardiAMP cell processing system; (

2

) the Helix biotherapeutic delivery system, or Helix; and (

3

) the Morph vascular access product line, or Morph. We manage our operations as a single segment for the purposes of assessing performance and making operating decisions.