BioCardia Announces Primary Outcome Measures Data Freeze in CardiAMP Heart Failure Trial for Presentation at the American College of Cardiology 2025 Scientific Sessions
BioCardia (BCDA) has completed data verification for its Phase 3 CardiAMP HF study, a double-blind randomized placebo-controlled trial evaluating an autologous cell therapy for ischemic heart failure. The study, involving 115 randomized patients, represents the largest cohort of ischemic HFrEF patients in a randomized autologous cell therapy trial.
The trial data has been transferred to the Statistical Data Analysis Center for analysis, with results scheduled for presentation at the Late-Breaking Clinical Trials symposium at the American College of Cardiology 2025 Scientific Sessions on March 30, 2025. The study is notable for using a precision medicine approach to identify potential responders based on cell characteristics.
The trial aims to demonstrate therapeutic benefit for HFrEF patients with elevated NT-proBNP who haven't responded sufficiently to medication. Results will support regulatory approvals in the US and Japan for both the CardiAMP cell therapy system and the Helix biotherapeutic delivery system.
BioCardia (BCDA) ha completato la verifica dei dati per il suo studio di Fase 3 CardiAMP HF, uno studio controllato randomizzato in doppio cieco che valuta una terapia cellulare autologa per l'insufficienza cardiaca ischemica. Lo studio, che coinvolge 115 pazienti randomizzati, rappresenta la più grande coorte di pazienti con HFrEF ischemica in uno studio randomizzato di terapia cellulare autologa.
I dati dello studio sono stati trasferiti al Centro di Analisi Statistica dei Dati per l'analisi, con risultati programmati per la presentazione al simposio delle sperimentazioni cliniche in ritardo durante le Sessioni Scientifiche 2025 del Collegio Americano di Cardiologia il 30 marzo 2025. Lo studio è notevole per l'uso di un approccio di medicina di precisione per identificare i potenziali rispondenti sulla base delle caratteristiche cellulari.
Lo studio mira a dimostrare un beneficio terapeutico per i pazienti con HFrEF con NT-proBNP elevato che non hanno risposto sufficientemente ai farmaci. I risultati supporteranno le approvazioni regolatorie negli Stati Uniti e in Giappone sia per il sistema di terapia cellulare CardiAMP che per il sistema di somministrazione bioterapeutica Helix.
BioCardia (BCDA) ha completado la verificación de datos para su estudio de Fase 3 CardiAMP HF, un ensayo controlado aleatorizado en doble ciego que evalúa una terapia celular autóloga para la insuficiencia cardíaca isquémica. El estudio, que involucra a 115 pacientes aleatorizados, representa la cohorte más grande de pacientes con HFrEF isquémica en un ensayo de terapia celular autóloga aleatorizado.
Los datos del ensayo se han transferido al Centro de Análisis de Datos Estadísticos para su análisis, con resultados programados para ser presentados en el simposio de Ensayos Clínicos de Última Hora en las Sesiones Científicas 2025 del Colegio Americano de Cardiología el 30 de marzo de 2025. El estudio es notable por utilizar un enfoque de medicina de precisión para identificar a los posibles respondedores en función de las características celulares.
El ensayo tiene como objetivo demostrar un beneficio terapéutico para los pacientes con HFrEF con NT-proBNP elevado que no han respondido suficientemente a la medicación. Los resultados apoyarán las aprobaciones regulatorias en EE. UU. y Japón tanto para el sistema de terapia celular CardiAMP como para el sistema de entrega bioterapéutica Helix.
BioCardia (BCDA)는 허혈성 심부전 치료를 위한 자가세포 요법을 평가하는 이중 맹검 무작위 위약 대조 시험인 3상 CardiAMP HF 연구의 데이터 검증을 완료했습니다. 115명의 무작위 환자가 참여한 이 연구는 자가세포 요법 임상 시험에서 허혈성 HFrEF 환자의 가장 큰 집단을 나타냅니다.
시험 데이터는 분석을 위해 통계 데이터 분석 센터로 전송되었으며, 결과는 2025년 3월 30일 미국 심장학회 2025 과학 세션에서 열리는 최신 임상 시험 심포지엄에서 발표될 예정입니다. 이 연구는 세포 특성을 기반으로 잠재적인 반응자를 식별하기 위해 정밀 의학 접근 방식을 사용한 점에서 주목할 만합니다.
시험은 약물에 충분히 반응하지 않은 NT-proBNP 수치가 높은 HFrEF 환자에게 치료적 이점을 입증하는 것을 목표로 합니다. 결과는 CardiAMP 세포 치료 시스템과 Helix 생물 치료 전달 시스템에 대한 미국과 일본의 규제 승인을 지원할 것입니다.
BioCardia (BCDA) a terminé la vérification des données pour son étude de phase 3 CardiAMP HF, un essai contrôlé randomisé en double aveugle évaluant une thérapie cellulaire autologue pour l'insuffisance cardiaque ischémique. L'étude, impliquant 115 patients randomisés, représente la plus grande cohorte de patients HFrEF ischémiques dans un essai de thérapie cellulaire autologue randomisé.
Les données de l'essai ont été transférées au Centre d'Analyse Statistique des Données pour analyse, avec des résultats prévus pour présentation lors du symposium sur les essais cliniques à résultats tardifs lors des Sessions Scientifiques 2025 du Collège Américain de Cardiologie le 30 mars 2025. L'étude est remarquable pour son utilisation d'une approche de médecine de précision afin d'identifier les potentiels répondeurs en fonction des caractéristiques cellulaires.
L'essai vise à démontrer un bénéfice thérapeutique pour les patients HFrEF avec NT-proBNP élevé qui n'ont pas suffisamment répondu aux médicaments. Les résultats soutiendront les approbations réglementaires aux États-Unis et au Japon pour le système de thérapie cellulaire CardiAMP et le système de délivrance biothérapeutique Helix.
BioCardia (BCDA) hat die Datenverifizierung für seine Phase-3-Studie CardiAMP HF abgeschlossen, eine doppelblinde, randomisierte, placebo-kontrollierte Studie zur Bewertung einer autologen Zelltherapie bei ischämischer Herzinsuffizienz. Die Studie, an der 115 randomisierte Patienten teilnehmen, stellt die größte Kohorte von Patienten mit ischämischer HFrEF in einer randomisierten autologen Zelltherapiestudie dar.
Die Studiendaten wurden zur Analyse an das Statistische Datenanalysezentrum übermittelt, und die Ergebnisse sollen am 30. März 2025 auf dem Symposium für spät einreichbare klinische Studien während der wissenschaftlichen Sitzungen 2025 des American College of Cardiology präsentiert werden. Die Studie ist bemerkenswert, da sie einen Ansatz der Präzisionsmedizin verwendet, um potenzielle Ansprechende basierend auf Zellmerkmalen zu identifizieren.
Die Studie zielt darauf ab, einen therapeutischen Nutzen für HFrEF-Patienten mit erhöhtem NT-proBNP zu demonstrieren, die nicht ausreichend auf Medikamente angesprochen haben. Die Ergebnisse werden regulatorische Genehmigungen in den USA und Japan sowohl für das CardiAMP-Zelltherapiesystem als auch für das Helix-Biotherapeutikabgabesystem unterstützen.
- Completed data verification for Phase 3 trial with 115 patients
- First precision medicine approach in autologous cell therapy for heart failure
- Potential dual regulatory approval pathway in US and Japan
- Largest ischemic HFrEF patient cohort in randomized autologous cell therapy trial
- Final trial results still pending analysis
- Regulatory approvals not yet secured
Insights
BioCardia's announcement of data freeze in its Phase 3 CardiAMP HF trial represents a critical inflection point for this micro-cap biotech. With primary outcome measures now locked and transferred for analysis, the company is positioning for a high-profile data reveal at ACC's Late-Breaking Clinical Trials session on March 30 – a venue typically reserved for potentially practice-changing clinical results.
This trial's significance extends beyond its size (115 patients). The study employs a precision medicine approach that screens patients based on their cellular characteristics, potentially addressing a key limitation of previous cardiac cell therapies that failed due to treating heterogeneous populations. The reference to confirming interim analysis results suggests earlier data may have shown positive signals, though specifics remain undisclosed.
For investors, this represents a binary catalyst with asymmetric risk/reward potential given BioCardia's
The heart failure market represents an enormous opportunity, with approximately 6.2 million Americans suffering from heart failure and effective interventions for advanced HFrEF beyond medication optimization and devices. A successful cell therapy could command premium pricing and rapid adoption.
Watch for three key elements in the March presentation: primary endpoint achievement (likely exercise capacity), safety profile, and magnitude of benefit relative to existing therapies. Positive results would likely trigger partnership discussions or acquisition interest, while negative outcomes would raise serious questions about BioCardia's future viability given its cash position.
SUNNYVALE, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the completion of source data verification and freezing of primary outcomes data in the double-blind randomized placebo-controlled Phase 3 CardiAMP HF study of its autologous minimally invasive cell therapy for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF). Data from the 115 randomized patients in the study has been transferred to the Statistical Data Analysis Center core laboratory for analysis. Results are scheduled to be presented at the Late-Breaking Clinical Trials symposium at the American College of Cardiology (ACC) 2025 Scientific Sessions in Chicago on March 30, 2025.
We believe this data represents the largest ischemic HFrEF patient cohort studied in a randomized trial of an autologous cell therapy, and the first to use a precision medicine approach to identify patients likely to respond to therapy based on the nature of their cells. Should the results presented at ACC confirm the interim analysis, the trial will provide evidence of meaningful therapeutic benefit of this cell therapy for HFrEF patients insufficiently responsive to medication as characterized by elevated NT-proBNP.
“This clinical study is intended to provide evidence supporting the safety and effectiveness of our CardiAMP cell therapy system for future approvals in the United States and Japan,” said Peter Altman, PhD, BioCardia President and CEO. “The results are also expected to support the safety and effectiveness of the Helix biotherapeutic delivery system for standalone approval for the intramyocardial delivery of agents to the heart.”
About CardiAMP Autologous Cell Therapy
Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response to increase capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The mechanisms that lead to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial autonomic dysfunction, are all targets of CardiAMP cell therapy, largely through production of growth factors, cytokines, chemokines, and other factors that directly counteract each of these mechanisms.
The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS).
CAUTION - Limited by United States law to investigational use.
About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms. For more information visit: https://www.biocardia.com/
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, the timing of availability of data from this trial, the likelihood of safety and patient benefit, statements related to the mechanisms of action of the CardiAMP Cell Therapy, references to the presentation at the American College of Cardiology and potential future regulatory approvals. These forward-looking statements are made as of the date of this press release.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Media Contact:
Miranda Peto, Marketing / Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
FAQ
When will BioCardia (BCDA) present the CardiAMP Heart Failure Trial results?
How many patients were enrolled in BCDA's Phase 3 CardiAMP HF trial?
What regulatory approvals is BCDA seeking with the CardiAMP trial results?
What makes BCDA's CardiAMP Heart Failure trial unique?
