BioCardia, Inc. (BCDA)

NCM – Цена в реальном времени. Валюта: USD

1.12

+0.01 (0.90%)

При закрытии: May 12, 2026, 4:00 PM EDT

1.10

-0.02 (-1.54%)

До открытия: May 13, 2026, 5:00 AM EDT

20.04.2026

BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure

SUNNYVALE, Calif., April 20, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported a positive outcome in its formal clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA). PMDA has determined that the clinical safety and efficacy evidence for the CardiAMP® Cell Therapy in ischemic heart failure is likely sufficient to support market clearance.

25.03.2026

BioCardia, Inc. (BCDA) Q4 2025 Earnings Call Transcript

24.03.2026

BioCardia Reports 2025 Business Highlights and Financial Results

SUNNYVALE, Calif., March 24, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the year ended December 31, 2025 and filed its annual report on Form 10-K with the Securities and Exchange Commission.

19.03.2026

BioCardia to Host 2025 Financial Results and Corporate Update Conference Call on March 24, 2026

SUNNYVALE, Calif., March 19, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ:BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced it will provide a corporate update and report its financial results for the year ended December 31, 2025 by conference call on Tuesday, March 24, 2026 at 4:30 PM EDT. Following management's formal remarks, there will be a question-and-answer session.

10.02.2026

BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart

SUNNYVALE, Calif., Feb. 10, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported it has completed its Pre-Submission to FDA under its Q-Submission program for the approval of its Helix Transendocardial Delivery Catheter (“Helix”) for intramyocardial therapeutic and diagnostic agent delivery.

16.12.2025

BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

SUNNYVALE, Calif., Dec. 16, 2025 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announces it has completed a third preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) on our CardiAMP Cell Therapy intended for treatment of Heart Failure with Reduced Ejection Fraction (HFrEF). The meeting was held in further preparation for formal clinical consultation on acceptability of the existing clinical data for submission of an application for approval. Based on the discussions in the most recent meeting, PMDA said it will allow BioCardia to advance to formal clinical consultation. Should PMDA agree in formal consultation that the available data provides sufficient evidence of safety and efficacy, BioCardia would be able to file for regulatory approval in Japan.

01.12.2025

BioCardia to Present at December 2025 CSI Focus Devices in Heart Failure Congress

SUNNYVALE, Calif., Dec. 01, 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 announces it will participate at the CSI Focus Devices in Heart Failure this week in Frankfurt, Germany. BioCardia's President and Chief Executive Officer, Peter Altman, PhD, will make an invited presentation entitled, “Intramyocardial Cell Therapy for Ischemic Heart Failure of Reduced Ejection.”

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Пресс-релизы

20.04.2026

BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure

24.03.2026

BioCardia Reports 2025 Business Highlights and Financial Results

10.02.2026

BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart

16.12.2025

BioCardia, Inc. (BCDA)

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BioCardia, Inc. (BCDA)

BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure

BioCardia, Inc. (BCDA) Q4 2025 Earnings Call Transcript

BioCardia Reports 2025 Business Highlights and Financial Results

BioCardia to Host 2025 Financial Results and Corporate Update Conference Call on March 24, 2026

BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart

BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

BioCardia to Present at December 2025 CSI Focus Devices in Heart Failure Congress

Видео

No Data

Пресс-релизы

BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure

BioCardia Reports 2025 Business Highlights and Financial Results

BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart

BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure

BioCardia, Inc. (BCDA) Q4 2025 Earnings Call Transcript

BioCardia Reports 2025 Business Highlights and Financial Results

BioCardia to Host 2025 Financial Results and Corporate Update Conference Call on March 24, 2026

BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart

BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

BioCardia to Present at December 2025 CSI Focus Devices in Heart Failure Congress

Видео

No Data

Пресс-релизы

BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure

BioCardia Reports 2025 Business Highlights and Financial Results

BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart

BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

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BioCardia, Inc. (BCDA)

Получите доступ ко всем премиум-функциям лучшего инструмента для анализа акций

Finranks

Компания

Контакты

Мы в соцсетях

BioCardia, Inc. (BCDA)

BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure

BioCardia, Inc. (BCDA) Q4 2025 Earnings Call Transcript

BioCardia Reports 2025 Business Highlights and Financial Results

BioCardia to Host 2025 Financial Results and Corporate Update Conference Call on March 24, 2026

BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart

BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

BioCardia to Present at December 2025 CSI Focus Devices in Heart Failure Congress

Видео

No Data

Пресс-релизы

BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure

BioCardia Reports 2025 Business Highlights and Financial Results

BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart

BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure

BioCardia, Inc. (BCDA) Q4 2025 Earnings Call Transcript

BioCardia Reports 2025 Business Highlights and Financial Results

BioCardia to Host 2025 Financial Results and Corporate Update Conference Call on March 24, 2026

BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart

BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

BioCardia to Present at December 2025 CSI Focus Devices in Heart Failure Congress

Видео

No Data

Пресс-релизы

BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure

BioCardia Reports 2025 Business Highlights and Financial Results

BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart

BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA