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BioCardia, Inc. - BCDA STOCK NEWS

Welcome to our dedicated page for BioCardia news (Ticker: BCDA), a resource for investors and traders seeking the latest updates and insights on BioCardia stock.

BioCardia, Inc. (Nasdaq: BCDA) is a cutting-edge clinical-stage company based in Sunnyvale, California, specializing in the development of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. The company’s biotherapeutic platforms, CardiAMP™ and CardiALLO™, are designed to address serious unmet medical needs and are supported by compelling clinical data.

Core Business:
BioCardia’s primary focus is on advancing novel therapies for cardiovascular diseases. The CardiAMP™ platform utilizes autologous bone marrow cells for treating ischemic heart failure with reduced ejection fraction (HFrEF) and chronic myocardial ischemia (CMI). Meanwhile, CardiALLO™ leverages allogeneic mesenchymal stem cells (MSC) to offer an “off-the-shelf” solution for HFrEF and acute respiratory distress syndrome (ARDS).

Recent Achievements:
BioCardia has made significant strides in its clinical trials. Recently, the Phase III trial for CardiAMP in advanced chronic heart failure patients showed promising interim results, including a 37% relative risk reduction in heart death equivalents and significant improvements in various clinical endpoints. Additionally, the FDA has approved the CardiAMP Heart Failure II Trial with reimbursement coverage from CMS.

Current Projects:
The company is actively enrolling patients in multiple clinical trials. The CardiAMP HF II Trial aims to confirm the efficacy of the CardiAMP Cell Therapy, while the CardiALLO trial is progressing through its dose escalation phase with no observed adverse events to date.

Partnerships and Products:
BioCardia collaborates with several biotherapeutic companies, providing its proprietary Helix™ transendocardial delivery systems and Morph® vascular access products. These platforms are designed for precise and safe delivery of therapeutic agents to the heart, enhancing the efficacy of the treatments.

Financial Condition:
BioCardia continues to secure funding through various channels, including federal reimbursements and partnerships. The company’s robust pipeline and strategic collaborations provide a solid foundation for future growth and development.

Conclusion:
BioCardia, with its focus on innovative biotherapeutic solutions and strong clinical data, is poised to make a significant impact in the treatment of cardiovascular diseases. The company’s ongoing trials and partnerships underscore its commitment to advancing medical science and improving patient outcomes. For more information, visit www.BioCardia.com.

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BioCardia, Inc. (Nasdaq: BCDA) Enrolls First Patient in CardiALLO Allogeneic Mesenchymal Cell Therapy Phase I/II Trial
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BioCardia, Inc. [Nasdaq: BCDA] announced that PMDA minutes support the understanding that CardiAMP autologous cell therapy may be approved for ischemic heart failure with reduced ejection fraction based on follow-up data from the CardiAMP Heart Failure Trial. Despite not meeting the primary endpoint, treated patients showed reduced mortality and major adverse cardiovascular events. The FDA approved the CardiAMP Heart Failure II Study protocol, and BioCardia expects to submit for approval in Japan based on the data available in late Q4 2024.
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BioCardia, Inc. (Nasdaq: BCDA) provided an update after its recent consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure of reduced ejection fraction (HFrEF). PMDA requested further details on elements included in BioCardia’s CardiAMP preclinical and clinical packages. BioCardia management believes these can be readily addressed. PMDA indicated they would like to see detailed interim and the final results from the CardiAMP Heart Failure Trial, which has completed patient enrollment and is finishing up study patient follow-up visits. Formal minutes from the PMDA meeting are expected in four weeks and a follow-up consultation is being planned.
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BioCardia, Inc. [Nasdaq: BCDA] Announces Registered Direct Offering of Common Stock
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BioCardia, Inc. (Nasdaq: BCDA) announces FDA approval of Phase III clinical trial for CardiAMP autologous cell therapy in the treatment of ischemic heart failure. Interim analysis shows significant clinical improvements over controls, including a 59% relative risk reduction in heart death and a 54% relative risk reduction of Major Adverse Cardiovascular or Cerebrovascular events (MACCE). FDA approves proposed CardiAMP Heart Failure II study protocol with modified primary efficacy endpoint and eligibility requirements.
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BioCardia, Inc. [Nasdaq: BCDA] reports Q3 2023 financial results and operational updates, including progress in CardiAMP Cell Therapy program for heart failure and chronic myocardial ischemia. The company also highlights strategic efforts to secure partnerships and grants for clinical development.
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BioCardia, Inc. will provide a corporate update and report its financial results for Q3 and 9 months ended September 30, 2023. The conference call will take place on November 8, 2023, at 4:30 PM ET. Participants can register for the conference call through the provided link. The call will also be available through a live webcast, with a replay available afterwards.
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BioCardia completes enrollment in CardiAMP Heart Failure Trial and initiates discussion with FDA for second pivotal study
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BioCardia announces clarification and next steps on its autologous CardiAMP cell therapy programs. Interim results show potential for a successful trial for product registration in the United States. FDA prefers replacing 6MWD with Cardiopulmonary Exercise Testing. BCDA-02 shows great potential for success. BioCardia expects to focus on accelerating pivotal program. Anticipated upcoming milestones and events provided.
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BioCardia announces interim data review for Phase III trial of CardiAMP Cell Therapy for Heart Failure
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FAQ

What is the current stock price of BioCardia (BCDA)?

The current stock price of BioCardia (BCDA) is $2 as of December 24, 2024.

What is the market cap of BioCardia (BCDA)?

The market cap of BioCardia (BCDA) is approximately 9.2M.

What is BioCardia, Inc.?

BioCardia, Inc. is a clinical-stage regenerative medicine company developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases.

What are the main products of BioCardia?

BioCardia's main products are the CardiAMP™ autologous cell therapy and the CardiALLO™ allogeneic cell therapy platforms.

What recent achievements has BioCardia accomplished?

BioCardia has achieved positive interim results in its Phase III CardiAMP trial and received CMS approval for reimbursement coverage of its CardiAMP HF II Trial.

What is the CardiAMP Cell Therapy?

CardiAMP Cell Therapy is an autologous therapy using a patient's own bone marrow cells delivered to the heart to stimulate natural healing processes.

What diseases are targeted by CardiALLO therapy?

CardiALLO therapy targets ischemic heart failure with reduced ejection fraction (HFrEF) and acute respiratory distress syndrome (ARDS).

What are BioCardia’s delivery systems?

BioCardia uses the Helix™ transendocardial delivery system and Morph® vascular access products for precise and safe delivery of therapeutic agents to the heart.

How is BioCardia funded?

BioCardia secures funding through federal reimbursements, partnerships, and various other channels to support its clinical trials and development programs.

What partnerships does BioCardia have?

BioCardia collaborates with several biotherapeutic companies, providing its proprietary delivery systems and development support for their programs.

Where is BioCardia headquartered?

BioCardia is headquartered in Sunnyvale, California.

Where can I learn more about BioCardia?

For more information, visit BioCardia’s official website at www.BioCardia.com.

BioCardia, Inc.

Nasdaq:BCDA

BCDA Rankings

BCDA Stock Data

9.17M
3.92M
14.07%
2.22%
2.46%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States of America
SUNNYVALE