Biocardia announces fda-recommended modifications to primary endpoint for cardiamp cell therapy heart failure trial to support marketing approval

San carlos, calif., april 30, 2020 (globe newswire) -- biocardia®, inc. [nasdaq: bcda], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported that it has accepted and implemented fda-recommended modifications to the primary endpoint for the cardiamp® cell therapy heart failure trial and associated statistical analysis plan. the agency proposed these modifications to support the potential for marketing approval for the therapy based on the currently enrolling pivotal trial.
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