BioCardia Initiates Patient Enrollment at Emory University School of Medicine for Ongoing CardiAMP HF II Pivotal Study
BioCardia (NASDAQ: BCDA) announces the initiation of patient enrollment at Emory University School of Medicine for its pivotal Phase III CardiAMP HF II trial. The study evaluates the CardiAMP™ Cell Therapy product for treating ischemic heart failure patients with reduced ejection fraction and elevated cardiac stress markers.
Dr. Arshed Quyyumi, Professor of Medicine at Emory's Division of Cardiology and Co-Director of the Emory Clinical Cardiovascular Research Institute, will serve as Principal Investigator. The trial compares CardiAMP Therapy, which involves harvesting and delivering autologous mononuclear cells to enhance microvascular density and reduce fibrosis, against a placebo procedure.
The study, which includes multiple clinical sites across the United States, aims for completion in 2027. Recent trial results presented at the American College of Cardiology Scientific Sessions showed compelling benefits for treated patients.
BioCardia (NASDAQ: BCDA) annuncia l'inizio dell'arruolamento dei pazienti presso la Emory University School of Medicine per il suo studio cruciale di Fase III CardiAMP HF II. Lo studio valuta il prodotto di terapia cellulare CardiAMP™ per il trattamento di pazienti con insufficienza cardiaca ischemica, caratterizzati da una frazione di eiezione ridotta e marcatori di stress cardiaco elevati.
Il Dr. Arshed Quyyumi, Professore di Medicina presso la Divisione di Cardiologia di Emory e Co-Direttore dell'Emory Clinical Cardiovascular Research Institute, sarà il Ricercatore Principale. L'esperimento confronta la Terapia CardiAMP, che prevede il prelievo e la somministrazione di cellule mononucleari autologhe per migliorare la densità microvascolare e ridurre la fibrosi, con una procedura placebo.
Lo studio, che include più siti clinici negli Stati Uniti, mira a concludersi nel 2027. I recenti risultati della sperimentazione presentati alle American College of Cardiology Scientific Sessions hanno mostrato benefici significativi per i pazienti trattati.
BioCardia (NASDAQ: BCDA) anuncia el inicio de la inscripción de pacientes en la Escuela de Medicina de la Universidad de Emory para su ensayo pivotal de Fase III CardiAMP HF II. El estudio evalúa el producto de Terapia Celular CardiAMP™ para tratar a pacientes con insuficiencia cardíaca isquémica con fracción de eyección reducida y marcadores de estrés cardíaco elevados.
El Dr. Arshed Quyyumi, Profesor de Medicina en la División de Cardiología de Emory y Co-Director del Instituto de Investigación Cardiovascular Clínica de Emory, será el Investigador Principal. El ensayo compara la Terapia CardiAMP, que implica la recolección y entrega de células mononucleares autólogas para mejorar la densidad microvascular y reducir la fibrosis, con un procedimiento placebo.
El estudio, que incluye múltiples sitios clínicos en los Estados Unidos, tiene como objetivo completarse en 2027. Los resultados recientes del ensayo presentados en las Sesiones Científicas del Colegio Americano de Cardiología mostraron beneficios significativos para los pacientes tratados.
BioCardia (NASDAQ: BCDA)는 에모리 대학교 의과대학에서 주요 3상 CardiAMP HF II 시험을 위한 환자 등록을 시작한다고 발표했습니다. 이 연구는 감소된 박출률과 상승된 심장 스트레스 마커를 가진 허혈성 심부전 환자를 치료하기 위한 CardiAMP™ 세포 치료 제품을 평가합니다.
에모리의 심장학부 교수이자 에모리 임상 심혈관 연구소의 공동 이사인 Dr. Arshed Quyyumi가 주요 연구자로 활동할 예정입니다. 이 시험은 자가 단핵 세포를 수확하고 전달하여 미세혈관 밀도를 향상시키고 섬유증을 줄이는 CardiAMP 치료를 위약 절차와 비교합니다.
이 연구는 미국 전역의 여러 임상 사이트를 포함하며, 2027년 완료를 목표로 하고 있습니다. 미국 심장학회 과학 세션에서 발표된 최근 시험 결과는 치료받은 환자들에게 상당한 이점을 보여주었습니다.
BioCardia (NASDAQ: BCDA) annonce le début de l'inscription des patients à l'École de Médecine de l'Université Emory pour son essai pivotal de Phase III CardiAMP HF II. L'étude évalue le produit de thérapie cellulaire CardiAMP™ pour traiter les patients atteints d'insuffisance cardiaque ischémique avec une fraction d'éjection réduite et des marqueurs de stress cardiaque élevés.
Le Dr Arshed Quyyumi, professeur de médecine au sein de la division de cardiologie d'Emory et co-directeur de l'Emory Clinical Cardiovascular Research Institute, sera l'investigateur principal. L'essai compare la thérapie CardiAMP, qui consiste à récolter et à administrer des cellules mononucléaires autologues pour améliorer la densité microvasculaire et réduire la fibrose, à une procédure placebo.
L'étude, qui inclut plusieurs sites cliniques à travers les États-Unis, vise à être complétée en 2027. Les résultats récents de l'essai présentés lors des sessions scientifiques du Collège américain de cardiologie ont montré des avantages convaincants pour les patients traités.
BioCardia (NASDAQ: BCDA) gibt den Beginn der Patientenrekrutierung an der Emory University School of Medicine für seine wegweisende Phase-III-Studie CardiAMP HF II bekannt. Die Studie bewertet das Produkt der CardiAMP™ Zelltherapie zur Behandlung von Patienten mit ischämischer Herzinsuffizienz, die eine reduzierte Ejektionsfraktion und erhöhte kardiale Stressmarker aufweisen.
Dr. Arshed Quyyumi, Professor für Medizin an der Kardiologie-Abteilung von Emory und Co-Direktor des Emory Clinical Cardiovascular Research Institute, wird als Hauptprüfer fungieren. Die Studie vergleicht die CardiAMP-Therapie, die das Ernten und Liefern von autologen mononukleären Zellen zur Verbesserung der Mikrovaskulären Dichte und zur Verringerung von Fibrose beinhaltet, mit einem Placebo-Verfahren.
Die Studie, die mehrere klinische Standorte in den Vereinigten Staaten umfasst, zielt auf einen Abschluss im Jahr 2027 ab. Jüngste Studienergebnisse, die bei den wissenschaftlichen Sitzungen des American College of Cardiology vorgestellt wurden, zeigten überzeugende Vorteile für die behandelten Patienten.
- Expansion of Phase III trial to prestigious Emory University medical center
- Positive preliminary results reported at ACC Scientific Sessions
- Trial on track for completion by 2027 with clear timeline
- Phase III trial still ongoing with results pending
- Extended timeline to 2027 for study completion
Insights
BioCardia's addition of Emory University to their pivotal Phase III CardiAMP HF II trial represents incremental progress in their clinical development program, though not a transformative milestone. The significance lies in expanding trial site capacity with a prestigious institution, which could help accelerate patient enrollment toward their 2027 completion target.
The mention of "compelling benefits" from recently presented data at the American College of Cardiology Scientific Sessions suggests positive interim results, though without specific efficacy metrics provided. For context, Phase III trials represent the final major hurdle before potential FDA submission, making any advancement in this stage more meaningful than earlier-phase progress.
For a micro-cap company with
This development reflects standard clinical progression rather than unexpected acceleration or setbacks in their lead program. While the news sustains confidence in continued development, it doesn't fundamentally alter the company's near-term prospects or commercialization timeline.
The CardiAMP cell therapy represents an interesting approach to treating ischemic heart failure with reduced ejection fraction. The therapy harvests and processes a patient's own (autologous) mononuclear cells before delivering them to the heart via minimally invasive techniques. The mechanism targets two key pathological features of heart failure: improving microvascular density and reducing fibrotic tissue.
What's technically noteworthy is the selective approach mentioned by Dr. Quyyumi – screening for CD34+ cell composition and delivering high cell doses. CD34+ cells are associated with angiogenic potential, suggesting the therapy aims to improve cardiac blood supply. This selective approach aligns with emerging evidence that specific cell populations may offer greater therapeutic benefit than unselected bone marrow mononuclear cells used in earlier-generation cardiac cell therapies.
The interventional cardiology delivery setting indicates catheter-based deployment rather than surgical approaches, representing a lower-risk procedure profile for this high-risk patient population. This matters substantially for heart failure patients who often have multiple comorbidities making them poor surgical candidates.
For context, ischemic heart failure with reduced ejection fraction has regenerative treatment options despite advances in pharmacological and device therapies. While standard guideline-directed medical therapy has improved outcomes, there remains significant unmet need for patients who continue to deteriorate despite optimal care. This trial's placebo-controlled design with patients maintained on guideline therapy provides a rigorous framework to evaluate whether this cell therapy offers incremental benefit beyond current standard of care.
CardiAMP HF II is Evaluating the CardiAMP™ Cell Therapy Product for Treating Patients with Ischemic Heart Failure of Reduced Ejection Fraction and Elevated Markers of Cardiac Stress
Dr. Arshed Quyyumi, Professor of Medicine, Division of Cardiology, Department of Medicine, Emory University School of Medicine, and Co-Director of the Emory Clinical Cardiovascular Research Institute to Serve as Principal Investigator
SUNNYVALE, Calif., April 11, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, 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.
“The CardiAMP cell therapy has shown compelling benefits for the treated patients in the trial results recently presented at the American College of Cardiology Scientific Sessions,” said Dr. Arshed Quyyumi, MD, Professor of Medicine, Division of Cardiology, Department of Medicine, Emory University School of Medicine, and Co-Director Emory Clinical Cardiovascular Research Institute. “The screening for CD34+ cell composition and high dosage being delivered in a interventional cardiology setting is in alignment with our own past research and enhances both my confidence in the results recently presented and the potential for treated patients to do well in the study ahead. Our team at Emory is looking forward to offering patients with heart failure the opportunity to participate in this minimally invasive autologous cell therapy trial.”
“Dr. Quyyumi’s significant expertise in these trials and inspiring leadership, coupled with the world-class capabilities at Emory University School of Medicine, a leading institution in the development of the field of interventional cardiology in the United States, is a great addition to the CardiAMP-HF II trial,” said Peter Altman, PhD, President and CEO of BioCardia. “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.”
About Chronic Heart Failure of Reduced Ejection Fraction (HFrEF)
Heart failure of reduced ejection fraction (HFrEF) is a clinical condition in which the output of blood from the heart is insufficient to meet the metabolic demands of the body. In 2022, the American Heart Association report on heart disease statistics estimated that 3 million American adults ages 20 and older have heart failure of reduced ejection fraction with a prevalence expected to increase to more than 4 million people by 2030. During heart failure progression, the heart steadily loses its ability to respond to increased metabolic demand, and mild exercise soon exceeds the heart’s ability to maintain adequate output. Towards the end stage of the disease, the heart cannot pump enough blood to meet the body’s needs at rest. At this stage, fluids accumulate in the extremities or in the lungs making the patient bedridden and unable to perform the activities of daily living. Despite guideline-directed therapies employing a wide range of pharmacologic, device, and surgical options, many patients deteriorate over time and develop advanced heart failure symptoms that cannot be effectively managed by existing medical therapies.
About CardiAMP Cell Therapy
Granted Breakthrough Designation by the FDA, the CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. Clinical development to date in randomized controlled double blinded trials has shown trends towards enhanced patient survival, reduced major adverse cardiac events, and improved quality of life. 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) for both treatment and control procedures. CAUTION - Limited by United States law to investigational use.
About CardiAMP Heart Failure Clinical Development
Final study results from the randomized double blinded controlled one hundred and twenty-five subjects CardiAMP Heart Failure Study were presented at the American College of Cardiology in March 2025. Results demonstrated increased survival and reduced major adverse cardiac and cerebrovascular events (MACCE) observed study-wide. Statistically significant improvement in composite outcome measure comprised of survival, MACCE, and quality of life seen in patients suffering from active heart stress (those with elevated NTproBNP and BNP biomarkers) treated with CardiAMP Cell Therapy (p=0.02). CardiAMP HF II will focus on these patient responders.
BioCardia’s clinical and regulatory team is actively working to share final results with both the FDA and Japan’s Pharmaceutical and Medical Device Agency in support of approval of the CardiAMP Cell Therapy for these patients with elevated NTproBNP, for whom existing medications may not be sufficient, and also in support of separate approval for the Helix transendocardial biotherapeutic delivery system, whose approval will have value for many biotherapeutic delivery partners.
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 the Company’s investigational product candidates, the potential benefits of CardiAMP cell therapy for patients with ischemic HFrEF, the rate of enrollment in clinical trials ahead, and the approvability of the Company’s investigational product candidates in Japan and the United States. 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.” 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
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