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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.

Rhea-AI Summary

BioCardia, Inc., a developer of therapeutics for cardiovascular and pulmonary diseases, announced positive results from the CardiAMP Cell Therapy Trial in Chronic Myocardial Ischemia. Patients showed increased exercise tolerance and reduced angina episodes, outperforming FDA-approved therapies. The webcast can be accessed for further details. The results support BioCardia's efforts in transforming angina treatment through cost-effective cell-based therapy.

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BioCardia, Inc. (NASDAQ: BCDA) has completed the enrollment and primary endpoint results collection for the open label roll-in cohort of the CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial. The company will discuss the results and details of the pivotal randomized trial with clinical leadership on April 30, 2024, at 3:00 PM ET.
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BioCardia, Inc. (BCDA) reported financial results for 2023, focusing on its CardiAMP Heart Failure trial, which showed positive interim data despite missing the primary endpoint. The company aims to seek approval in Japan and advance the CardiAMP Heart Failure II Trial in 2024. BioCardia also highlighted its CardiALLO and Helix Biotherapeutic Delivery businesses. Financially, revenues decreased to $0.5 million in 2023, with a net loss of $11.6 million. The company ended the year with $1.1 million in cash and intends to remain listed on Nasdaq.
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BioCardia, Inc. [NASDAQ:BCDA] will report its 2023 financial results and provide a corporate update on March 27, 2024. The conference call will include a Q&A session, and participants can register online. The call will be accessible via phone and webcast, with replays available.
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BioCardia, Inc. (BCDA) and StemCardia, Inc. partner to advance investigational stem cell therapy for heart failure, leveraging BioCardia's biotherapeutic delivery system. The partnership aims to accelerate clinical development and broaden future commercial access to an off-the-shelf heart regeneration treatment.
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BioCardia, Inc. (BCDA) receives CMS approval for reimbursement coverage of the CardiAMP Phase III clinical trial for ischemic heart failure treatment. The trial aims to enroll up to 250 patients at 40 clinical centers, focusing on reducing mortality and improving quality of life.
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BioCardia, Inc. (Nasdaq: BCDA) announced positive interim results from the Phase III trial of CardiAMP cell therapy in patients with chronic heart failure, showing significant risk reductions in heart death equivalents and non-fatal events. The therapy demonstrated promising outcomes, especially in patients with elevated NTproBNP levels, leading to the launch of a follow-on Phase III trial. The company also reported progress in the safety phase of a Phase I/II study of CardiALLO MSC therapy.
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BioCardia, Inc. announces the activation of CardiAMP HF II, a pivotal trial of its CardiAMP autologous cell therapy for patients with ischemic heart failure. The study was approved by the FDA in Q4 2023 and aims to target heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates. The trial size is 250 patients with a statistical probability of success greater than 90 percent. The interim results of the ongoing CardiAMP Heart Failure autologous cell therapy study will be shared at the upcoming Technology and Heart Failure Therapeutics meeting on March 4, 2024, with final results expected in Q4 2024.
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BioCardia, Inc. (Nasdaq: BCDA) is targeting heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates. The company announced that two scientific abstracts on its CardiAMP and CardiALLO clinical stage therapeutic programs have been accepted for presentation at the Technology and Heart Failure Therapeutics Conference. The abstracts will be presented in the Late-Breaking Clinical Science/First-In-Human & Early Feasibility Studies session. The company's CardiAMP Phase 3 autologous cell therapy study showed benefits of reduced all-cause heart death equivalents and reduced major adverse cardiac events without safety concerns, but the study was halted as it was not likely to meet its primary endpoint. The CardiALLO Phase I/II allogeneic mesenchymal stem cell therapy study began enrollment in a 3+3 dose escalation design in December. Both cell therapy candidates are delivered with the company's proprietary minimally invasive Helix transendocardial biotherapeutic delivery system, approved for use in Europe and for investigational use in the United States.
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BioCardia, Inc. (Nasdaq: BCDA) completed 2023 with three active clinical programs for cellular and cell-derived therapeutics to treat heart disease, expecting to report clinical data in 2024. The company also provided an update on its Biotherapeutic Delivery Partnering (BDP) and Morph Access Innovations (Morph) businesses, with new partnerships anticipated and recent patent issuances in Japan and the EU.
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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)
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United States of America
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