SUNNYVALE, Calif. , July 05, 2023 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces it completed its submission of the CardiAMP Cell Therapy System to Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval for the […]
Tag: CardiAMP
BioCardia Announces FDA Completes Review of Proposed Adaptive Statistical Analysis Design for Ongoing CardiAMP Cell Therapy in Heart Failure Pivotal Study
SUNNYVALE, Calif., June 20, 2023 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that FDA Center for Biologics Evaluation and Research (CBER) has completed review of the CardiAMP Cell Therapy System adaptive statistical analysis design supplement […]
BioCardia Announces Timing of the Next Data Safety Monitoring Board Meeting for the CardiAMP Cell Therapy in Heart Failure Pivotal Study
SUNNYVALE, Calif., May 23, 2023 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases today announced that the next Data Safety Monitoring Board (DSMB) meeting for the CardiAMP Cell Therapy Trial for Heart Failure is scheduled to take place […]
Positive Echocardiography Data from BioCardia Phase III CardiAMP Cell Therapy Heart Failure Trial Presented at American College of Cardiology Annual Meeting
New Data from Roll-in Cohort of Trial Shows Progression of Patients from Baseline through One and Two Years Results Suggest CardiAMP Cell Therapy May Have Ability to Restore and Maintain Heart Function to Previously Non-Functioning Areas of the Heart Up to Two Years After Treatment SUNNYVALE, Calif., March 06, 2023 […]
BioCardia Announces FDA Approval of IND Application for Allogeneic NK1R+ Human Mesenchymal Stem Cells for Ischemic Heart Failure
Approval marks second clinical trial approved by FDA this year for Company’s NK1R+ MSC platform Allogeneic CardiALLO therapy for heart failure to complement autologous cell therapy currently enrolling in Phase III CardiAMP Heart Failure clinical trial SUNNYVALE, Calif.–(BUSINESS WIRE)–BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment […]
BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial
Adaptive Statistical Analysis Plan Recommended SUNNYVALE, Calif., Aug. 31, 2022 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a developer of 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 ongoing Phase […]
BioCardia Announces First Canadian Clinical Site for CardiAMP Cell Therapy Heart Failure Trial
SUNNYVALE, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces the activation of Ottawa Heart Institute, the first Canadian clinical investigational site for the CardiAMP® Cell Therapy Heart Failure Trial. “The Ottawa Heart […]
BioCardia Announces New Center for Medicare and Medicaid Services Reimbursement Code Applicable to the CardiAMP Cell Therapy Procedure
New Procedure Reimbursement Code Expected to Enhance Study Performance for Clinical Centers Participating in the CardiAMP Cell Therapy Heart Failure Trial and the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial SUNNYVALE, Calif., March 22, 2022 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment […]
BioCardia Receives No Objection Letter from Health Canada, Enabling Company to Expand CardiAMP Cell Therapy Heart Failure Trial into Canada
SUNNYVALE, Calif., March 01, 2022 (GLOBE NEWSWIRE) — BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has received a No Objection Letter from Health Canada, the country’s health services agency, allowing the CardiAMP® Heart Failure Trial to […]
BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed
SUNNYVALE, Calif., Feb. 14, 2022 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a developer of 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 ongoing Phase III pivotal CardiAMP™ Cell Therapy Heart […]