Tag: BioCardia

Biocardia Announces FDA Clearance for Morph DNA Deflectable Guide Catheter

SAN CARLOS, Calif., Jan. 14, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Morph® DNA deflectable guide catheter used to guide the Helix™ Biotherapeutic Delivery System […]

BioCardia Announces New U.S. Patent Covering CardiAMP Cell Therapy and Issuance of Two Asian Patents Covering Radial Artery Approach for Cardiac Cell and Gene Therapy Delivery

SAN CARLOS, Calif., Jan. 08, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [NASDAQ: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the issuance of three new patents for the company’s technologies in the U.S., China and Japan. The new U.S. patent relates to the cell potency […]

BioCardia Reports 2019 Third Quarter Financial Results and Business Highlights

SAN CARLOS, Calif., Nov. 19, 2019 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and business highlights for the third quarter 2019 and filed its quarterly report on Form 10-Q for the three and nine months ended […]

BioCardia Receives CE Mark Renewal For Helix Biotherapeutic Delivery Catheter And Morph Guide Catheter Through May 2024

SAN CARLOS, Calif., Oct. 08, 2019 (GLOBE NEWSWIRE) — BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced renewal of the CE Mark for the Helix™ Biotherapeutic Delivery Catheter and Morph® Universal Deflectable Guide Catheter, both used in the delivery of biotherapeutics to the heart. CE Mark renewal enables […]

BioCardia Initiates Commercial Release of AVANCE Steerable Introducer Designed to Enhance Physician Control for Complex Cardiac Procedures

SAN CARLOS, Calif., Oct. 01, 2019 (GLOBE NEWSWIRE) — BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. commercial availability of its AVANCE™ Bi-Directional Steerable Introducer Sheath for introducing various cardiovascular catheters into the heart, including via the left side of the heart through […]

BioCardia Announces Positive DSMB Recommendation to Continue Phase 3 Pivotal CardiAMP Heart Failure Study as Planned

SAN CARLOS, Calif., Sept. 16, 2019 (GLOBE NEWSWIRE) — BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP Heart Failure Trial, which included safety […]

BioCardia Reports 2019 Second Quarter Financial Results and Business Highlights

SAN CARLOS, Calif., Aug. 21, 2019 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and business highlights for the second quarter 2019 and filed its quarterly report on Form 10-Q for the three and six months ended […]

BioCardia Announces Issuance of European Patent for Breakthrough Diagnostic Assay for Patient Selection Prior to Cardiac Cell Therapy Delivery

SAN CARLOS, Calif., Aug. 08, 2019 (GLOBE NEWSWIRE) — BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the European Patent Office has issued the Company Patent No: 3063172 for “Methods of Measuring Potential for Therapeutic Potency and Defining Dosages for Autologous […]