Tag: BioCardia

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. […]

BioCardia Awarded New U.S. Patent Covering Helix System for Local Biotherapeutic Delivery of Autologous and Allogenic Cells to the Heart

SAN CARLOS, Calif., April 28, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc., (OTC: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the issuance of United States Patent No. 10,632,281, entitled “Drug Delivery Catheters that Attach to Tissue and Methods for Their Use.” This new […]

BioCardia Announces Litigation Financing in the Case Captioned Boston Scientific Corp., et al., v. BioCardia Inc.

SAN CARLOS, Calif., April 14, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported it has entered into an agreement for litigation financing which has been filed today with the Securities and Exchange Commission on Form 8-K. BioCardia, Inc. […]

BIOCARDIA ANNOUNCES POSITIVE DSMB RECOMMENDATION TO CONTINUE PHASE III PIVOTAL CARDIAMP HEART FAILURE STUDY, AS PLANNED

Company to Host Conference Call with National Co-Principal Investigators Today at 4:15 p.m. ET to Provide Study Updates SAN CARLOS, Calif., March 31, 2020 (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) […]

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 […]