Tag: CardiAMP

BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure

SUNNYVALE, Calif.–(BUSINESS WIRE)–BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP® Cell Therapy System for the treatment of heart failure. It is believed […]

BioCardia Establishes New Manufacturing Facility to Enable Its Cell Therapy Product Candidates

Facility Being Built Out to Support CardiAMP Cell Therapy Systems, Allogeneic NK1R+ MSC and Biotherapeutic Delivery Device Manufacturing for Clinical Trials of Multiple Programs and Early Commercial Activities SAN CARLOS, Calif., Dec. 15, 2021 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of […]

BioCardia Announces First Patient Treated in CardiAMP Cell Therapy Trial for Chronic Myocardial Ischemia

SAN CARLOS, Calif., Oct. 21, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA] a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the treatment of the first patient in its Phase III pivotal CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial for patients […]

BioCardia Announces First Cross-Over Patient Treated in CardiAMP Cell Therapy Heart Failure Trial

SAN CARLOS, Calif., Oct. 07, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA] a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the treatment of the first cross-over patient in the ongoing Phase III Pivotal CardiAMP® Cell Therapy in Heart Failure Trial […]

CardiAMP Cell Therapy Heart Failure Trial to be Featured in Two Presentations at Heart Failure Society of America Annual Meeting 2021

SAN CARLOS, Calif., Sept. 10, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces data from its CardiAMP® Cell Therapy Heart Failure pivotal trial (ClinicalTrials.gov Identifier: NCT02438306), which are being presented at the Heart […]

BioCardia Announces Fourth Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed

SAN CARLOS, Calif., June 23, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP™ […]

BioCardia to Present CardiAMP Cell Therapy Clinical Trial Data at European Society of Cardiology Heart Failure 2021

Cell Therapy Platform Demonstrates High Dose CD34+ Cell Performance Characteristics in Patients with Ischemic Heart Failure SAN CARLOS, Calif., June 22, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces data from its CardiAMP […]

BioCardia Announces European Patent Office Decision to Grant Patent on Autologous Cell Therapy Patient Selection Diagnostic Assay

SAN CARLOS, Calif., June 21, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the European patent office has issued a Decision to Grant European Patent No. 3593810 to BioCardia with publication on June 23, 2021. […]

BioCardia Signs Agreement with Leading Japanese Biotechnology Company for Catheter Biotherapeutic Delivery Product Candidates

Second Biotherapeutic Partnership of 2021 SAN CARLOS, Calif., April 26, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], today announced that it has entered into an agreement with a leading Japanese biotechnology company related to BioCardia Helix catheter biotherapeutic delivery product candidates.  Under the terms of the agreement, BioCardia will receive $500,000, […]

BioCardia Update on Cell Therapy Product Development and 2021 Milestones

SAN CARLOS, Calif., Feb. 02, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA] a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today provides an update on its cell therapy product development and 2021 milestones. BCDA-01, our CardiAMP autologous cell therapy under Phase III clinical development for the treatment of […]