BioCardia Announces Henry Ford Health Enrolls Their First Patient in Phase 3 CardiAMP HF II Cell Therapy Pivotal Trial
BioCardia (NASDAQ: BCDA) announced that Henry Ford Health enrolled its first patient on Nov 10, 2025 in the ongoing Phase 3 CardiAMP HF II trial for ischemic heart failure with reduced ejection fraction (HFrEF).
Company commentary notes prior CardiAMP-HF data where the primary endpoint was not met but highlighted subgroup and secondary findings reporting reduced mortality, fewer major adverse cardiac events, and improved quality of life with the investigational autologous cell therapy. BioCardia and Henry Ford position the trial as a confirmatory study intended to enhance microvascular function and patient outcomes in a population with limited treatment options.
BioCardia (NASDAQ: BCDA) ha annunciato che Henry Ford Health ha arruolato il suo primo paziente il 10 novembre 2025 nello studio di fase 3 CardiAMP HF II per l'insufficienza cardiaca ischemica con frazione di eiezione ridotta (HFrEF).
La nota della società rileva dati precedenti di CardiAMP-HF in cui l'obiettivo primario non è stato raggiunto, ma evidenzia risultati di sottogruppi e secondari che riportano mortalità ridotta, meno gravi eventi avversi cardiaci e miglioramento della qualità di vita con la terapia cellulare autologa sperimentale. BioCardia e Henry Ford presentano lo studio come un trial confirmatorio volto a migliorare la funzione microvascolare e gli esiti dei pazienti in una popolazione con opzioni di trattamento limitate.
BioCardia (NASDAQ: BCDA) anunció que Henry Ford Health inscribió a su primer paciente el 10 de noviembre de 2025 en el ensayo de fase 3 CardiAMP HF II para la insuficiencia cardíaca isquémica con fracción de eyección reducida (HFrEF).
La compañía comenta datos previos de CardiAMP-HF donde el objetivo primario no se cumplió, pero se destacan hallazgos de subgrupos y secundarios que reportan menor mortalidad, menos eventos adversos cardíacos mayores y mejora de la calidad de vida con la terapia celular autóloga en investigación. BioCardia y Henry Ford posicionan el estudio como un ensayo confirmatorio destinado a mejorar la función microvascular y los resultados de los pacientes en una población con opciones de tratamiento limitadas.
BioCardia (NASDAQ: BCDA)가 Henry Ford Health가 2025년 11월 10일에 1명의 환자를 등록했다고 발표했습니다. 이는 진행 중인 3상 CardiAMP HF II 시험으로, 허혈성 심부전과 감소된 좌심실 박출계수(HFrEF)에 대한 연구입니다.
기업 논평은 초점은 주요 평가변수가 달성되지 않았던 CardiAMP-HF의 이전 데이터를 지적하면서도, 하위군 및 보조 결과에서 사망률 감소, 주요 심혈관 사건 감소, 탐색적 자가세포 치료의 삶의 질 개선을 보고했다고 밝힙니다. BioCardia와 Henry Ford는 이 시험을 제한된 치료 옵션을 가진 환자 집단의 미세혈관 기능과 결과를 향상시키려는 확증 연구로 자리매김합니다.
BioCardia (NASDAQ: BCDA) a annoncé que Henry Ford Health a recruté son premier patient le 10 novembre 2025 dans l'essai de phase 3 CardiAMP HF II pour l'insuffisance cardiaque ischémique avec fraction d'éjection réduite (HFrEF).
La société commente des données antérieures de CardiAMP-HF où l’objectif primaire n’a pas été atteint, mais met en évidence des résultats de sous-groupes et des conclusions secondaires indiquant une mortalité réduite, moins d’événements cardiovasculaires majeurs et une amélioration de la qualité de vie avec la thérapie cellulaire autologue expérimentale. BioCardia et Henry Ford positionnent l’essai comme une étude de confirmation destinée à améliorer la fonction microvasculaire et les résultats des patients dans une population ayant des options de traitement limitées.
BioCardia (NASDAQ: BCDA) gab bekannt, dass Henry Ford Health am 10. November 2025 den ersten Patienten eingeschlossen hat in die laufende Phase-3-Studie CardiAMP HF II für ischämische Herzinsuffizienz mit reduzierter Auswurfsfraktion (HFrEF).
Unternehmenskommentar verweist auf frühere CardiAMP-HF-Daten, bei denen der primäre Endpunkt nicht erreicht wurde, hebt jedoch Untergruppen- und sekundäre Befunde hervor, die eine verringerte Mortalität, weniger schwere kardiovaskuläre Ereignisse und eine Verbesserung der Lebensqualität mit der experimentellen autologen Zelltherapie berichten. BioCardia und Henry Ford positionieren die Studie als Confirmatory Study, die darauf abzielt, die Mikrozirkulation zu verbessern und die Ergebnisse der Patienten in einer Population mit begrenzten Behandlungsmöglichkeiten zu optimieren.
أعلنت BioCardia (ناسداك: BCDA) أن Henry Ford Health سجلت مريضها الأول في 10 نوفمبر 2025 في الدراسة من المرحلة 3 CardiAMP HF II لعجز القلب الناتج عن انخفاض ضخ الدم (HFrEF) الناتج عن احتشاء عضلة القلب ischemic مع انخفاض نسبة الإخراج.
تشير تعليقات الشركة إلى بيانات CardiAMP-HF السابقة حيث لم يتم بلوغ الهدف الأولي، لكنها سلطت الضوء على نتائج فرعية ومجموعة فرعية تُظهر انخفاض الوفيات، وتقليل الأحداث القلبية الوعائية الكبرى، وتحسن جودة الحياة مع العلاج الخلوي الذاتي قيد البحث. تقف BioCardia وHenry Ford بالدراسة كدراسة تأكيدية تهدف إلى تحسين وظيفة الأوعية الدقيقة ونتائج المرضى في فئة من المرضى الذين لديهم خيارات علاجية محدودة.
- Henry Ford Health enrolled first Phase 3 patient on Nov 10, 2025
- Company reports prior CardiAMP results showing reduced mortality and fewer major adverse cardiac events
- Trial described as a confirmatory Phase 3 test of autologous cell therapy for ischemic HFrEF
- Prior CardiAMP-HF study did not meet its primary endpoint
Insights
Phase 3 enrollment begins; prior trial missed its primary endpoint but showed promising subgroup outcomes.
BioCardia and Henry Ford Health initiated enrollment in the Phase 3 CardiAMP HF II program on
The business mechanism is straightforward: successful Phase 3 enrollment and positive confirmatory data would underpin regulatory submissions and eventual commercialization pathways, while failure to replicate subgroup signals would limit clinical and commercial value. Key dependencies include enrollment speed, the trial achieving its predefined primary endpoint, and reproducibility of the subgroup findings explicitly described; these are the concrete risks that determine trial impact.
Watch enrollment milestones and interim analyses over the next 12–36 months, and any prespecified futility or efficacy reads and their defined endpoints. Monitor reported patient-level results tied to the previously highlighted biomarker-defined subgroup and the trial's primary endpoint timing for signs the earlier signals hold in a larger, confirmatory population.
SUNNYVALE, Calif., Nov. 10, 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 first patient enrolled at Henry Ford Health in its ongoing Phase 3 CardiAMP® HF II clinical trial for patients with ischemic heart failure of reduced ejection fraction (“HFrEF”).
“The CardiAMP-HF trial, in which Henry Ford Health participated, was groundbreaking for the field of heart failure. Although the primary endpoint was not met, the study showed impressive results with an autologous cell therapy in patients with HFrEF, particularly those with elevated biomarkers of heart stress,” said Dr. Gerald Koenig, M.D., Director of the Cardiac Catheterization Laboratory at Henry Ford West Bloomfield Hospital and Director of Clinical Research in the Cardiac Catheterization Laboratory at Henry Ford Health System, and Principal Investigator in the Phase 3 CardiAMP HF II trial. “Our team is actively offering patients the opportunity to participate in this important confirmatory study intended to enhance microvascular function and improve patient outcomes, including quality of life.”
“We greatly value our collaboration with Dr. Koenig and the world class Henry Ford Health team in the CardiAMP HF II Trial,” said Peter Altman, PhD, CEO of BioCardia. “Between the U.S. and the EU, there are roughly 2 million ischemic HFrEF patients with NYHA Class II and III symptoms. Many of these patients have a prognosis worse than many cancers and few remaining options. This places a terrible burden on patients, their families, and the healthcare system. We are excited by the CardiAMP HF results showing that our cell therapy system reduced both mortality and major adverse cardiac events, improved quality of life, and showed positive impacts to other study endpoints in patients with HFrEF. These results suggest that our investigational cell therapy could address important clinical needs.”
About the CardiAMP Heart Failure II Study
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. The study is intended to confirm the safety and efficacy results in these patients observed in the CardiAMP HF study. The CardiAMP HF II study uses a similar three-tier composite primary outcome measure to the CardiAMP HF study consisting of all cause death, nonfatal major adverse cardiac events, and a validated quality of life measure. In CardiAMP HF, this composite efficacy endpoint was achieved with statistical significance in the patients with elevated NTproBNP who are the focus of the CardiAMP HF II study.
Advances in this therapeutic approach for this trial include using the cell population analysis at screening to define treatment doses and improvements to the Helix system including the FDA approved Morph DNA steerable platform.
About CardiAMP Autologous Cell Therapy
Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis, treating microvascular dysfunction.
The CardiAMP Cell Therapy 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 our investigational product candidates, the potential benefits and mechanism of actions of the CardiAMP cell therapy, future regulatory approvals, enrollment in our clinical trials, and the safety and efficacy of our product candidates and therapies. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
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 26, 2025, 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, 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
What did BioCardia (BCDA) announce on Nov 10, 2025 about the CardiAMP HF II trial?
Does the press release say the earlier CardiAMP trial met its primary endpoint for BCDA?
What clinical effects did BioCardia highlight from prior CardiAMP results for BCDA?
What patient population is CardiAMP HF II targeting for BCDA?
What is the purpose of the Phase 3 CardiAMP HF II trial mentioned by BCDA?
Will BioCardia’s CardiAMP HF II results immediately change treatment options for HFrEF?
