Tag: CardiAMP

BioCardia Anticipates DSMB Feedback on Interim Data From Pivotal Phase 3 CardiAMP Heart Failure Trial

SAN CARLOS, Calif., Dec. 14, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. (Nasdaq: BCDA)(BioCardia or the “Company”) today announces that it anticipates data safety monitoring board (DSMB) verbal feedback by the end of December 15, 2020 on interim data from the Company’s pivotal Phase 3 CardiAMP Heart Failure Trial that is currently enrolling […]

BioCardia Reports Published Study Showing Helix Biotherapeutic Delivery System Used in CardiAMP Phase III Heart Failure Trial Has Fewest Adverse Events Among Competitive Delivery Systems

SAN CARLOS, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA] today announced that the Company’s proprietary Helix Biotherapeutic Delivery System (the Helix System) demonstrated the best safety profile among clinical transendocardial catheter injection systems used for cardiac cell therapy delivery in an in-press corrected proof published in the journal, Cardiovascular […]

Published Peer-reviewed Initial Data from BioCardia Pivotal Phase 3 Clinical Trial of CardiAMP Demonstrates Improvement in Heart Failure Patients Measured by Exercise Outcomes and Cardiac Function

Paper Published in International Journal of Cardiology Demonstrates Safety and Tolerability While Showing Functional Improvement at Six Months SAN CARLOS, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA](“BioCardia” or the “Company”), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the publication of data from the Company’s initial open-label roll-in cohort that served as the […]

BioCardia Announces Activation of Pivotal Trial Studying CardiAMP Cell Therapy Trial to Treat Chronic Myocardial Ischemia

First Site Initiation Visit in Trial Completed and Executive Steering Committee Named SAN CARLOS, Calif., July 01, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [NASDAQ:BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced activation of a pivotal trial studying the Company’s investigational CardiAMP® cell therapy in the treatment of […]

BioCardia Announces CardiAMP Heart Failure Pivotal Trial Continues with First Patient Randomized in COVID-19 Era

SAN CARLOS, Calif., June 29, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc., (OTC: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the Company has resumed cases in the CardiAMP Heart Failure Trial. The first patient procedure completed since elective procedures were paused due to […]

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 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 Announces Issuance of Chinese Patent for Image-Guided Biotherapeutic Delivery

SAN CARLOS, Calif., June 12, 2019 (GLOBE NEWSWIRE) — BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the China National Intellectual Property Administration has recently issued the Company Patent No: ZL 2014 8 00125575 for “Target Site Selection, Entry and Update […]

BioCardia Reports 2018 Financial Results and Recent Business Highlights

SAN CARLOS, Calif.–(BUSINESS WIRE)–BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results for the fourth quarter and full year ended December 31, 2018, filed its annual 10-K with the Securities and Exchange Commission, and shared recent business highlights. Recent Business […]

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 cardiovascular catheters into the heart, including via the left side […]