** Shares of medical device maker BioCardia BCDA.O rise 18% to $1.08 premarket

** BCDA says U.S. Food and Drug Administration confirmed that the company's ongoing late-stage study of a heart failure procedure could help support a future marketing application

** The experimental treatment CardiAMP Cell Therapy System is being tested in patients with ischemic heart failure with reduced pumping function

** CardiAMP uses a patient's own bone marrow cells, which are delivered to the heart through a minimally invasive catheter procedure

** The therapy has received FDA breakthrough designation, a status meant to speed development of products that may offer meaningful improvements over existing options

** As of last close, BCDA stock was down ~27% YTD