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BioCardia Announces Late Breaking Clinical Trial Presentation on CardiAMP Heart Failure Trial at the American College of Cardiology 2025 Scientific Sessions

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BioCardia (NASDAQ: BCDA) has announced that its CardiAMP HF Phase 3 study results will be presented at the American College of Cardiology 2025 Scientific Sessions in Chicago, March 29-31, 2025. The presentation, featuring results from the double-blind randomized placebo-controlled trial investigating an autologous cell therapy in patients with HFrEF, will be delivered by Dr. Amish N. Raval from the University of Wisconsin at Madison.

The presentation is scheduled for March 30, 2025, at 3:30 PM in the Main Tent as part of the Featured Clinical Research II session. The American College of Cardiology Scientific Sessions is a prominent forum for cardiovascular clinical trial developments, attracting experts from medical, pharmaceutical, biotechnology, and medical device sectors.

BioCardia (NASDAQ: BCDA) ha annunciato che i risultati del suo studio CardiAMP HF Fase 3 saranno presentati alle Sessioni Scientifiche 2025 dell'American College of Cardiology a Chicago, dal 29 al 31 marzo 2025. La presentazione, che evidenzierà i risultati di uno studio randomizzato, in doppio cieco, controllato con placebo che indaga una terapia cellulare autologa in pazienti con HFrEF, sarà tenuta dal Dott. Amish N. Raval dell'Università del Wisconsin a Madison.

La presentazione è programmata per il 30 marzo 2025, alle 15:30 nel Main Tent, come parte della sessione Featured Clinical Research II. Le Sessioni Scientifiche dell'American College of Cardiology sono un importante forum per lo sviluppo di trial clinici cardiovascolari, attirando esperti dai settori medico, farmaceutico, biotecnologico e dei dispositivi medici.

BioCardia (NASDAQ: BCDA) ha anunciado que los resultados de su estudio CardiAMP HF Fase 3 se presentarán en las Sesiones Científicas 2025 del American College of Cardiology en Chicago, del 29 al 31 de marzo de 2025. La presentación, que presentará resultados de un ensayo controlado aleatorio, doble ciego y controlado con placebo que investiga una terapia celular autóloga en pacientes con HFrEF, será realizada por el Dr. Amish N. Raval de la Universidad de Wisconsin en Madison.

La presentación está programada para el 30 de marzo de 2025, a las 3:30 PM en la Main Tent, como parte de la sesión Featured Clinical Research II. Las Sesiones Científicas del American College of Cardiology son un destacado foro para el desarrollo de ensayos clínicos cardiovasculares, atrayendo expertos de los sectores médico, farmacéutico, biotecnológico y de dispositivos médicos.

BioCardia (NASDAQ: BCDA)CardiAMP HF 3상 연구 결과가 2025년 3월 29일부터 31일까지 시카고에서 열리는 미국 심장 학회(American College of Cardiology) 과학 세션에 발표될 것이라고 발표했습니다. 이 발표는 HFrEF 환자에서 자가 세포 요법을 조사하는 이중 맹검 무작위 대조 시험의 결과를 특징으로 하며, 매디슨의 위스콘신 대학교에 있는 Amish N. Raval 박사가 진행합니다.

발표는 2025년 3월 30일 오후 3:30에 Main Tent에서 Featured Clinical Research II 세션의 일환으로 예정되어 있습니다. 미국 심장 학회 과학 세션은 심혈관 임상 시험 개발을 위한 유명한 포럼으로, 의료, 제약, 생명공학 및 의료 기기 분야의 전문가들을 끌어모으고 있습니다.

BioCardia (NASDAQ: BCDA) a annoncé que les résultats de son étude CardiAMP HF Phase 3 seront présentés lors des Sessions Scientifiques 2025 de l'American College of Cardiology à Chicago, du 29 au 31 mars 2025. La présentation, qui mettra en avant les résultats d'un essai contrôlé randomisé en double aveugle et contrôlé par placebo portant sur une thérapie cellulaire autologue chez des patients atteints de HFrEF, sera faite par le Dr Amish N. Raval de l'Université du Wisconsin à Madison.

La présentation est prévue pour le 30 mars 2025 à 15h30 dans le Main Tent, dans le cadre de la session Featured Clinical Research II. Les Sessions Scientifiques de l'American College of Cardiology constituent un forum de premier plan pour le développement des essais cliniques cardiovasculaires, attirant des experts des secteurs médical, pharmaceutique, biotechnologique et des dispositifs médicaux.

BioCardia (NASDAQ: BCDA) hat angekündigt, dass die Ergebnisse seiner CardiAMP HF Phase 3 Studie bei den wissenschaftlichen Sitzungen 2025 des American College of Cardiology in Chicago vom 29. bis 31. März 2025 präsentiert werden. Die Präsentation, die Ergebnisse aus der doppelblinden, randomisierten, placebokontrollierten Studie zur Untersuchung einer autologen Zelltherapie bei Patienten mit HFrEF umfasst, wird von Dr. Amish N. Raval von der University of Wisconsin in Madison gehalten.

Die Präsentation ist für den 30. März 2025 um 15:30 Uhr im Main Tent als Teil der Sitzung Featured Clinical Research II angesetzt. Die wissenschaftlichen Sitzungen des American College of Cardiology sind ein bedeutendes Forum für die Entwicklung kardiovaskulärer klinischer Studien und ziehen Experten aus den Bereichen Medizin, Pharmazeutik, Biotechnologie und Medizintechnik an.

Positive
  • Phase 3 trial results secured prestigious late-breaking presentation slot at major cardiovascular conference
  • Study results deemed significant enough for inclusion in Featured Clinical Research session
Negative
  • None.

SUNNYVALE, Calif., Jan. 27, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [NASDAQ: BCDA] today announced that the results of its double-blind randomized placebo-controlled CardiAMP HF Phase 3 study have been accepted for presentation in a late-breaking symposium at the American College of Cardiology 2025 Scientific Sessions, taking place in Chicago, March 29-31, 2025.

Title: A Double Blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF: Principal Results from the CardiAMP-HF Trial
Presenter: Amish N. Raval, M.D., Professor of Medicine and Biomedical Engineering, Chair of Cardiovascular Regenerative Medicine Focus Group, and Medical Director of UW Health ST Elevation Program, University of Wisconsin at Madison
Date: March 30, 2025
Session Title: Featured Clinical Research II
Session Type: Late-Breaking Clinical Trials
Session Time: 3:30:00 PM
Session Location: Main Tent

The American College of Cardiology Scientific Sessions meeting is one of the leading forums for the latest developments in clinical trials for cardiovascular disease. Attendees include experts from across the cardiovascular medical, pharmaceutical, biotechnology, and medical device communities who share a common goal of advancing treatment for cardiovascular disease.

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: 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 presentation at the American College of Cardiology. 

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, 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 its CardiAMP HF Phase 3 trial results?

BioCardia will present the CardiAMP HF Phase 3 trial results on March 30, 2025, at 3:30 PM during the American College of Cardiology 2025 Scientific Sessions in Chicago.

What type of study is BioCardia's CardiAMP HF trial?

The CardiAMP HF trial is a double-blind, randomized, placebo-controlled Phase 3 study evaluating an autologous cell therapy in patients with HFrEF (Heart Failure with reduced Ejection Fraction).

Who will present BCDA's CardiAMP HF trial results at ACC 2025?

Dr. Amish N. Raval, Professor of Medicine and Biomedical Engineering at the University of Wisconsin at Madison, will present the trial results.

What session type will feature BCDA's CardiAMP trial presentation?

The CardiAMP trial results will be presented in a Late-Breaking Clinical Trials session, specifically in the Featured Clinical Research II session.

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