CardiALLO (BCDA-03) / BioCardia - LARVOL DELTA

Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells (clinicaltrials.gov) - P1/2 | N=39 | Active, not recruiting | Sponsor: BioCardia, Inc. | Enrolling by invitation ➔ Active, not recruiting | Trial completion date: Jul 2025 ➔ Dec 2027 | Trial primary completion date: Jul 2025 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

ANTICIPATED UPCOMING MILESTONES AND EVENTS (GlobeNewswire) - "BCDA-02 CardiAMP Autologous Cell Therapy in Chronic Myocardial Ischemia: CardiAMP CMI Top line Data Rollin Cohort – Q4 2025....BCDA-03 CardiALLO Allogeneic MSC Cell Therapy in Heart Failure: CardiALLO HF Nondilutive Funding – Q1 2026."

Clinical data • Financing • Cardiovascular • Heart Failure

BioCardia Announces Positive DSMB Review of CardiALLO Allogeneic Cell Therapy for Heart Failure Phase 1/2 Clinical Trial (GlobeNewswire) - "BioCardia, Inc....today announced that the study’s independent DSMB, which conducted a planned review of the 30-day safety data from the roll-in 20 million cell dosing cohort in the CardiALLO-HF trial, recommended that the study continue as designed. There have been no treatment emergent major adverse cardiac events observed nor has there been any clinical evidence of immune reactions to the allogeneic cells implanted."

DSMB • Cardiovascular • Heart Failure

BioCardia reports 2018 financial results and recent business highlights (Businesswire) - "BioCardia’s biologics group filed an Investigational New Drug (IND) application with the FDA for the CardiALLO™ Cell Therapy System, an investigational allogenic culture-expanded “off the shelf” mesenchymal cell therapy for the treatment of ischemic heart failure....This therapy is intended for the treatment of patients that do not qualify for CardiAMP™ cell therapy due to low bone marrow cell potency, as determined by the proprietary CardiAMP™ assay."

IND

BioCardia reports 2018 financial results and recent business highlights (Businesswire) - "The Company closed on $4 million in new financing, with the intent that it will bridge the company through filing for submission of the CardiALLO™ IND and FDA clearance of AVANCE™, and contribute to enhanced enrollment in the CardiAMP™ Heart Failure Trial."

Financing

BioCardia reports 2018 financial results and recent business highlights (Businesswire) - "Anticipated Upcoming Milestones: FDA acceptance of the CardiALLO™ IND application; Q3 2019: Second pre-specified Data and Safety Monitoring Board (DSMB) readout of Phase III Pivotal CardiAMP™ Heart Failure Trial; Q3 2020: Third pre-specified DSMB readout of Phase III Pivotal CardiAMP™ Heart Failure Trial; Q3 2020: Completion of enrollment in the CardiAMP™ Heart Failure Trial...Once the CardiAMP Heart Failure Trial reaches the later stages of enrollment, the company is prepared to activate a second pivotal trial of CardiAMP cell therapy in chronic myocardial ischemia..."

DSMB • Enrollment status • IND • New trial • P3 data