Tag: CardiAMP

BioCardia Submits 510(k) Application to FDA for AVANCE Steerable Introducer for Transseptal Access to Heart

SAN CARLOS, Calif.–(BUSINESS WIRE)–BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced its 510(k) submission for U.S. Food and Drug Administration (FDA) clearance of the AVANCE™ steerable introducer, designed for introducing various […]

Positive Data On BioCardia’s Investigational CardiAMP Cell Therapy For Heart Failure Presented At Transcatheter Cardiovascular Therapeutics (TCT) Conference

SAN DIEGO and SAN CARLOS, Calif., Sept. 24, 2018 /PRNewswire/ — BioCardia®, Inc. (OTC :BCDA ), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that positive data from two studies of its investigational CardiAMP stem cell therapy were presented today […]

Preliminary Results From BioCardia’s Phase III Pivotal CardiAMP Heart Failure Trial Reported In Circulation Research Journal

SAN CARLOS, Calif., Aug. 22, 2018 /PRNewswire/ — In a Viewpoint paper published online today in Circulation Research, the Phase III CardiAMP Heart Failure Trial (CardiAMP-HF Trial) studying the investigational CardiAMP stem cell therapyfrom BioCardia®, Inc. (OTC: BCDA) was highlighted as an example of personalized medicine, […]

Centers for Medicare and Medicaid Services Approves Reimbursement for BioCardia’s CardiAMP Cell Therapy in Pivotal Clinical Trial Studying Second Indication in Chronic Myocardial Ischemia

SAN CARLOS, Calif.–(BUSINESS WIRE)–BioCardia®, Inc., (OTC: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the Centers for Medicare and Medicaid Services (CMS) has approved national reimbursement coverage for the CardiAMP Chronic Myocardial […]

CardiAMP Cell Therapy Receives FDA Approval for Pivotal Trial in Chronic Myocardial Ischemia

SAN CARLOS, Calif.–(BUSINESS WIRE)–BioCardia, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the FDA has approved an Investigational Device Exemption for the CardiAMP Chronic Myocardial Ischemia (CMI) Trial to treat patients with refractory […]