CardiAMP Cell Therapy (BCDA-01) / BioCardia - LARVOL DELTA

CardiAMP™ Cell Therapy for Heart Failure Trial (clinicaltrials.gov) - P3 | N=125 | Completed | Sponsor: BioCardia, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Jun 2025

Trial completion • Trial completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

BioCardia Submits Request for Clinical Data Review Meeting with Japan PMDA To Discuss Approval Pathway for CardiAMP Cell Therapy in Ischemic Heart Failure (GlobeNewswire) - "BioCardia...announced today that it submitted its CardiAMP autologous cell therapy investigational heart failure treatment for clinical consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This milestone marks a significant step toward potential regulatory approval in Japan, a key market for advanced heart failure therapies...In addition to responding to PMDA’s questions stemming from previous consultations, the submission made consisted of a detailed clinical data package including the full CardiAMP HF Trial data, along with the principal clinical portion of the Summary Technical Documentation, or STED, which is an extensive summary of the technical information to demonstrate to regulatory authorities that the CardiAMP System meets safety and performance requirements....'Success in these efforts could result in our being engaged in a meaningful post marketing study in Japan next year.'"

Trial status • Heart Failure

BCDA-01 CardiAMP Autologous Cell Therapy in Heart Failure (HF) (GlobeNewswire) - "CardiAMP HF manuscript – Q4 2025; CardiAMP HF Japan PMDA Clinical Review – Q4 2025; CardiAMP HF FDA meetings on approvability based on subgroup and safety – Q4 2025; CardiAMP HF II Enrollment – Ongoing."

FDA event • Trial status • Heart Failure

BioCardia Announces First Patient in Phase 3 Randomized Controlled Double-Blind CardiAMP HF II Clinical Trial of the Company’s Lead Cell Therapy for Treatment of Heart Failure (GlobeNewswire) - "BioCardia, Inc...announced the first patient enrolled in the Phase III randomized procedure placebo-controlled double-blind CardiAMP HF II clinical trial of the Company’s lead autologous cell therapy program for the treatment of heart failure at BayCare Morton Plant Hospital in Clearwater, Florida...CardiAMP HF II is a 250-patient randomized multicenter procedure placebo-controlled study of the CardiAMP autologous cell therapy as a one-time treatment for patients with ischemic heart failure with reduced ejection fraction (HFrEF) on guideline directed medical therapy having elevated NTproBNP."

Enrollment open • Heart Failure

BioCardia Initiates Patient Enrollment at Emory University School of Medicine for Ongoing CardiAMP HF II Pivotal Study (GlobeNewswire) - "BioCardia, Inc...announced today that Emory University School of Medicine in Atlanta Georgia is now enrolling patients with ischemic heart failure in the Company’s ongoing pivotal Phase III CardiAMP HF II trial. Emory University joins esteemed clinical sites throughout the United States participating in the study...The CardiAMP HF II Study is evaluating the Company’s lead therapeutic product candidate, a system designed for the harvest, processing, and minimally invasive delivery of autologous mononuclear cells to the heart intended to enhance microvascular density and reduce fibrosis. The study is comparing treatment with CardiAMP Therapy to a placebo procedure with all patients on stable guideline directed medical therapy....'We believe this collaboration will assist the Company on many levels, including their anticipated strong support in accelerating patient enrollment in the CardiAMP HF II trial towards its target completion in 2027.'"

Enrollment open • Trial completion date • Heart Failure

CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction (clinicaltrials.gov) - P=N/A | N=250 | Recruiting | Sponsor: BioCardia, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2024 ➔ Aug 2024

Enrollment open • Trial initiation date • Cardiovascular • Congestive Heart Failure • Heart Failure

A Personalized Cell-Based Therapy for Ischemic Heart Failure With Reduced Ejection Fraction: Safety and Feasibility Outcomes of the Roll-In Cohort of the CardiAMP Cell Therapy Trial and Review of Similar Trials. (PubMed, Cardiol Rev) - "Four patients were reduced to New York Heart Association class I at 24 months and Minnesota Living with Heart Failure Questionnaire score was improved in 6 of 10 patients at 24 months. The improved clinical outcomes demonstrated in CardiAMP are consistent with previous clinical trials including the Transendocardial Autologous Cells in Ischemic Heart Failure (TAC-HFT) trial, Prospective Randomized Trial of Direct Endomyocardial Implantation of Bone Marrow Cells for Treatment of Severe Coronary Artery Diseases (PROTECT-CAD), and REGENERATE-Ischemic Heart Disease trial."

Journal • Review • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Myocardial Infarction

The CardiAMP Cell Therapy for Heart Failure trial. (PubMed, Tex Heart Inst J) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Ischemia

CardiAMP™ Cell Therapy for Heart Failure Trial (clinicaltrials.gov) - P3 | N=125 | Active, not recruiting | Sponsor: BioCardia, Inc. | Recruiting ➔ Active, not recruiting | N=250 ➔ 125

Enrollment change • Enrollment closed • Cardiovascular • Congestive Heart Failure • Heart Failure

CardiAMP™ Cell Therapy for Heart Failure Trial (clinicaltrials.gov) - P3 | N=250 | Recruiting | Sponsor: BioCardia, Inc. | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2023 ➔ Dec 2024

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

CARDIAC REMODELING AFTER INTRAMYOCARDIAL AUTOLOGOUS BONE MARROW MONONUCLEAR CELL THERAPY FOR ISCHEMIC CARDIOMYOPATHY: 2-YEAR ECHOCARDIOGRAPHY RESULTS FROM THE CARDIAMP CELL THERAPY HEART FAILURE TRIAL OPEN-LABEL ROLL-IN COHORT (ACC-WCC 2023) - P3 | "At 24 months after ABM-MNC treatment, LVEF was improved or stable with evidence of continuing improvements in WMSI due to recruitment of akinetic myocardial segments. The ongoing randomized, controlled, blinded pivotal trial is designed to confirm these findings and evaluate key patient centric HFrEF outcomes."

Clinical • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

CardiAMP™ Cell Therapy Heart Failure Trial (clinicaltrials.gov) - P3 | N=250 | Recruiting | Sponsor: BioCardia, Inc. | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction

CardiAMP™ Cell Therapy Heart Failure Trial (clinicaltrials.gov) - P3; N=250; Recruiting; Sponsor: BioCardia, Inc.; Trial completion date: Dec 2022 ➔ Dec 2024; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction

Randomized Controlled Pivotal Trial Of Autologous Bone Marrow Mononuclear Cells Using The Cardiamp Cell Therapy System In Patients With NYHA Class II And III Ischemic Systolic Heart Failure (HFSA 2021) - "However, a robust randomized controlled trial is required to further establish clinical efficacy. The purpose of this trial is to determine the safety and efficacy of CardiAMP cell therapy for treating post-infarct heart failure."

Clinical • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure

Women With Heart Failure In The CardiAMP Cell Therapy Trial (HFSA 2021) - P3 | "Concentration of CD34+ cells (Table) did not differ significantly between males and females (p=0.354). Females met the CPA criterion at a higher rate than males (75% vs 65%). All subjects who passed the CPA were successfully randomized into the cell therapy treatment or control arms per protocol."

Clinical • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • CD34

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) - P3, N=250; NCT02438306; Sponsor: BioCardia, Inc.; "Enrollment in the Phase III pivotal CardiAMP™ Heart Failure Trial expanded to three additional active sites....Thirty-two patients have been treated to date with no treatment emergent major adverse cardiac events reported. Twelve-month results for the initial 10-patient roll-in cohort for the CardiAMP™ Heart Failure Trial were presented at the American Heart Association Scientific Sessions in November 2018. At one year, eight of the 10 patients experienced clinically meaningful improvement in exercise capacity, seven patients enjoyed clinically meaningful improvement in quality of life..."

Enrollment status • P3 data

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