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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 announces the issuance of a new U.S. patent for its radial and transendocardial delivery catheter, Patent No. 11,986,611, which will expire in 2036.

This patent pertains to methods and systems for delivering substances to the heart via the radial artery, enabling minimally invasive procedures.

The radial artery approach allows patients to leave the hospital soon after the procedure and significantly reduces overall healthcare costs.

BioCardia's Helix system, used in ongoing clinical trials, is the only known system capable of radial transendocardial biotherapeutic delivery and the new patent enhances its protection and value.

Therapeutic cell aggregates have potential advantages over single cell suspensions but also carry risks like strokes if they leak into the ventricular chamber.

BioCardia's delivery systems are designed to mitigate these risks by preventing leakage during the delivery process.

According to CEO Dr. Peter Altman, the patent issuance strengthens the company's technology and product offerings, benefiting both shareholders and patients.

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BioCardia announced a 1-for-15 reverse stock split of its common stock, effective May 30, 2024, to meet Nasdaq's minimum bid price requirement. Shares will trade on a split-adjusted basis under the ticker BCDA. The reverse stock split will uniformly affect all shareholders, converting every 15 shares into 1 share without altering percentage ownership. Fractional shares will not be issued; instead, cash payments will be made. The authorized shares of common stock will be reduced from 100 million to 50 million. Further details are available in the company's proxy statement on the SEC's website.

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BioCardia (Nasdaq: BCDA) reported its Q1 2024 financial results and business highlights. Key developments include a 37% relative risk reduction in mortality for patients with ischemic heart failure using CardiAMP therapy, and a confirmatory pivotal trial with CMS reimbursement. CardiAMP therapy for refractory angina improved exercise tolerance and reduced chest pain. CardiALLO therapy showed no adverse events in the low-dose cohort. The company reported Q1 revenues of $55,000, a net loss of $2.3 million, and a $1.5 million operational cash burn. Significant milestones for 2024 include advancing pivotal trials, FDA submissions, and biotherapeutic delivery partnerships.

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BioCardia, Inc. will host a conference call on May 14, 2024, to discuss its financial results for the first quarter of 2024 and provide a corporate update. The company specializes in developing therapeutics for cardiovascular and pulmonary diseases.

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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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FAQ

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

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6.22M
17.59M
33.84%
7.71%
2%
Surgical and Medical Instrument Manufacturing
Manufacturing
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United States of America
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