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Henry Ford Health Initiates Patient Enrollment for BioCardia’s CardiAMP HF II Pivotal Study for Ischemic Heart Failure of Reduced Ejection Fraction

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BioCardia (NASDAQ:BCDA) announced that Henry Ford Health in Detroit has begun enrolling patients with ischemic heart failure in the pivotal CardiAMP HF II trial. The study investigates an autologous cell therapy using patients' own bone marrow cells to treat ischemic heart failure with reduced ejection fraction (HFrEF).

The investigational therapy aims to promote microvascular repair, reduce fibrosis, and increase capillary density. The procedure involves harvesting and processing patients' cells at bedside, followed by minimally invasive catheter delivery to damaged heart areas. This confirmatory trial builds on promising results from previous TABMMI, TACHFT, and CardiAMP HF trials.

BioCardia (NASDAQ:BCDA) ha annunciato che Henry Ford Health a Detroit ha iniziato a reclutare pazienti con insufficienza cardiaca ischemica per lo studio cardine CardiAMP HF II. Lo studio valuta una terapia cellulare autologa che utilizza le cellule del midollo osseo dei pazienti per trattare l'insufficienza cardiaca ischemica con frazione di eiezione ridotta (HFrEF).

La terapia sperimentale mira a favorire la riparazione microvascolare, ridurre la fibrosi e aumentare la densità capillare. La procedura prevede il prelievo e la lavorazione delle cellule dei pazienti direttamente al letto del paziente, seguita dalla somministrazione tramite catetere minimamente invasivo nelle aree cardiache danneggiate. Questo studio confermativo si basa sui risultati promettenti dei precedenti trial TABMMI, TACHFT e CardiAMP HF.

BioCardia (NASDAQ:BCDA) anunció que Henry Ford Health en Detroit ha comenzado a inscribir pacientes con insuficiencia cardíaca isquémica en el ensayo pivotal CardiAMP HF II. El estudio investiga una terapia celular autóloga que utiliza las propias células de la médula ósea de los pacientes para tratar la insuficiencia cardíaca isquémica con fracción de eyección reducida (HFrEF).

La terapia experimental busca promover la reparación microvascular, reducir la fibrosis y aumentar la densidad capilar. El procedimiento implica la recolección y procesamiento de las células de los pacientes junto a la cama, seguido de la administración mediante catéter mínimamente invasivo en las áreas dañadas del corazón. Este ensayo confirmatorio se basa en resultados prometedores de los previos estudios TABMMI, TACHFT y CardiAMP HF.

BioCardia (NASDAQ:BCDA)� 디트로이트의 Henry Ford Health가 허혈� 심부� 환자� 대상으� 중추적인 CardiAMP HF II 시험� 환자 등록� 시작했다� 발표했습니다. � 연구� 환자 자신� 골수 세포� 이용� 자가 세포 치료법으�, 좌심� 수축 기능� 저하된 허혈� 심부�(HFrEF)� 치료하는 것을 목표� 합니�.

시험 중인 치료법은 미세혈관 재생� 촉진하고 섬유화를 줄이� 모세혈관 밀도를 증가시키� 것을 목표� 합니�. 시술은 환자 침상에서 세포� 채취하고 처리� �, 최소 침습 카테터를 통해 손상� 심장 부위에 전달하는 방식입니�. � 확인 시험은 이전 TABMMI, TACHFT, CardiAMP HF 시험에서� 유망� 결과� 바탕으로 진행됩니�.

BioCardia (NASDAQ:BCDA) a annoncé que Henry Ford Health à Detroit a commencé à recruter des patients atteints d'insuffisance cardiaque ischémique dans l'essai pivot CardiAMP HF II. L'étude porte sur une thérapie cellulaire autologue utilisant les propres cellules de la moelle osseuse des patients pour traiter l'insuffisance cardiaque ischémique avec fraction d'éjection réduite (HFrEF).

Cette thérapie expérimentale vise à favoriser la réparation microvasculaire, réduire la fibrose et augmenter la densité capillaire. La procédure consiste à prélever et traiter les cellules des patients au chevet, suivie d'une administration par cathéter minimalement invasive dans les zones cardiaques endommagées. Cet essai confirmatoire s'appuie sur les résultats prometteurs des précédents essais TABMMI, TACHFT et CardiAMP HF.

BioCardia (NASDAQ:BCDA) gab bekannt, dass Henry Ford Health in Detroit mit der Rekrutierung von Patienten mit ischämischer Herzinsuffizienz für die wegweisende CardiAMP HF II-Studie begonnen hat. Die Studie untersucht eine autologe Zelltherapie, bei der körpereigene Knochenmarkzellen der Patienten zur Behandlung der ischämischen Herzinsuffizienz mit reduzierter Ejektionsfraktion (HFrEF) eingesetzt werden.

Die experimentelle Therapie zielt darauf ab, die mikrovaskuläre Reparatur zu fördern, Fibrose zu reduzieren und die Kapillardichte zu erhöhen. Das Verfahren umfasst die Entnahme und Aufbereitung der Zellen am Krankenbett, gefolgt von einer minimal-invasiven Katheterabgabe in die geschädigten Herzbereiche. Diese Bestätigungsstudie baut auf vielversprechenden Ergebnissen der vorherigen TABMMI-, TACHFT- und CardiAMP HF-Studien auf.

Positive
  • Trial enrollment initiated at major healthcare institution (Henry Ford Health)
  • Treatment uses patient's own cells, minimizing rejection risks
  • Same-day procedure with minimally invasive approach
  • Building on promising results from three previous trials
Negative
  • Still in clinical trial phase, requiring FDA approval
  • Limited to specific patient population with ischemic heart failure

Insights

Henry Ford Health enrolling patients in BioCardia's pivotal heart failure trial represents meaningful progress toward potential therapy commercialization.

Henry Ford Health in Detroit has begun enrolling patients with ischemic heart failure with reduced ejection fraction (HFrEF) in BioCardia's pivotal CardiAMP HF II trial. This marks significant progress in the company's clinical development program for its autologous cell therapy.

The CardiAMP HF II is a confirmatory trial following their completed CardiAMP HF trial which showed promising results. This therapy takes the patient's own bone marrow cells (autologous), processes them bedside, and delivers them to damaged heart areas using minimally invasive catheters. The treatment aims to promote microvascular repair, reduce fibrosis, and increase capillary density - all critical for heart function improvement.

What makes this approach noteworthy is its same-day, point-of-care procedure that leaves nothing behind except the patient's own cells. This potentially reduces risks associated with foreign materials or extended procedures.

The involvement of Henry Ford Health, a major medical institution, adds credibility to BioCardia's clinical program. Dr. Gerald Koenig's participation as Principal Investigator further strengthens the trial's standing.

For context, the company's pipeline is built on previous trials (TABMMI, TACHFT, and CardiAMP HF) that collectively support this therapeutic approach. Successful completion of this confirmatory trial could position BioCardia to seek regulatory approval for this heart failure treatment, addressing a significant unmet need for the millions of patients with ischemic HFrEF who have limited treatment options beyond standard care.

SUNNYVALE, Calif., July 16, 2025 (GLOBE NEWSWIRE) --  [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that Henry Ford Health in Detroit, Michigan is now enrolling patients with ischemic HFrEF in the Company’s ongoing pivotal CardiAMP HF II trial.

“The CardiAMP HF cell therapy trials are important for patients with ischemic heart failure in need of new therapies,� said Gerald Koenig, MD, Director of the Cardiac Catheterization Laboratory, Henry Ford West Bloomfield Hospital, and Principal Investigator of CardiAMP HF II for Henry Ford Health System. “Together with the other investigators in this trial, we hope to confirm the promising results in the CardiAMP HF trial and enable our patients early access to this novel investigational autologous cell therapy.�

The CardiAMP HF II trial is a confirmatory trial of autologous bone marrow derived mononuclear cell therapy for patients suffering from ischemic heart failure. The investigational therapy is intended to promote microvascular repair, reduce fibrosis, and increase capillary density. Patients who qualify for the study have cells harvested the day of the procedure, processed at their bedside, and delivered in the same procedure using minimally invasive catheter delivery systems. At the end of the procedure, nothing is left behind other than high doses of the patients� own cells adjacent to damaged zones in their hearts.

“We are delighted to continue our partnership with Dr. Koenig and the world class cardiovascular clinical research team at Henry Ford Health in CardiAMP HF II,� said Peter Altman, PhD, BioCardia’s CEO. “We share the common mission of enhancing therapies to treat cardiovascular disease. The results from our completed TABMMI, TACHFT, and CardiAMP HF trials underlie the potential to improve the lives of patients with heart failure and the families who care for them.�

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 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 CardiAMP HF, with tier 1 all cause death, tier 2 nonfatal major adverse cardiac events, and with tier 3 using a validated quality of life patient self-assessment instrument. In CardiAMP HF, this composite efficacy endpoint was achieved with statistical significance in the patients with elevated NTproBNP that are the focus of the CardiAMP HF II study.

About Heart Failure

According to the Centers for Disease Control and Prevention, about 6.2 million adults in the U.S. over 20 years old have heart failure. It is the cause of an estimated one in eight deaths in U.S., and each year, there are approximately 960,000 new cases of heart failure diagnosed, according to the American Heart Association. Current treatments for heart failure include lifestyle changes, medications, and certain devices or surgical procedures. While improving quality of life and longevity for many, these treatments often fail to halt the progression of the disease, and some patients do not respond well, experience adverse effects from medications, or have complications from invasive procedures, often requiring ongoing and more aggressive interventions.

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 to 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 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: 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, 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
:
Phone: 650-226-0120

Investor Contact:
David McClung, Chief Financial Officer
:
Phone: 650-226-0120


FAQ

What is the CardiAMP HF II trial by BioCardia (NASDAQ:BCDA)?

The CardiAMP HF II is a confirmatory trial investigating an autologous bone marrow cell therapy for treating ischemic heart failure. The therapy uses patients' own cells to promote microvascular repair and reduce fibrosis.

How does BioCardia's (BCDA) CardiAMP HF II treatment work?

The treatment involves harvesting the patient's own bone marrow cells, processing them at bedside, and delivering them through minimally invasive catheters to damaged areas of the heart, all in a single procedure.

Who is conducting BioCardia's (BCDA) CardiAMP HF II trial?

The trial is being conducted at Henry Ford Health in Detroit, with Dr. Gerald Koenig, Director of the Cardiac Catheterization Laboratory at Henry Ford West Bloomfield Hospital, serving as Principal Investigator.

What previous trial results support BioCardia's (BCDA) CardiAMP HF II study?

The study builds on promising results from three previous trials: TABMMI, TACHFT, and CardiAMP HF trials.

What patients are eligible for BioCardia's (BCDA) CardiAMP HF II trial?

The trial is enrolling patients with ischemic heart failure with reduced ejection fraction (HFrEF) at Henry Ford Health in Detroit.
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Biotechnology
Biological Products, (no Disgnostic Substances)
United States
SUNNYVALE